B pharm & D pharm syllabus






B.pharm


Subject :
Human anatomy and physiology 1
Pharmaceutical analysis
Pharmaceutics
Pharmaceutical Inorganic Chemistry


Human Anatomy And Physiology 1

Unit 1

Introduction to human body

Definition and scope of anatomy and physiology, levels of structural organization and body systems, basic life processes, homeostasis, basic anatomical terminology.

Cellular level of organization

Structure and functions of cell, transport across cell membrane, cell division, cell junctions. General principles of cell communication, intracellular signaling pathway activation by extracellular signal molecule, Forms of intracellular signaling: a) Contact-dependent     b) Paracrine c) Synaptic d) Endocrine

Tissue level of organization

Classification of tissues, structure, location and functions of epithelial, muscular and nervous and connective tissues.

UNIT 2


Integumentary system

Structure and functions of skinl


Skeletal system

Divisions of skeletal system, types of bone, salient features and functions of bones of axial and appendicular skeletal system Organization of skeletal muscle, physiology of muscle contraction, neuromuscular junction


Joints

Structural and functional classification, types of joints movements and its articulation


Unit 3


Body fluids and blood

Body fluids, composition and functions of blood, hemopoeisis, formation of hemoglobin, anemia, mechanisms of coagulation, blood grouping, Rh factors, transfusion, its significance and disorders of blood, Reticulo endothelial system.


Lymphatic system

Lymphatic organs and tissues, lymphatic vessels, lymph circulation and functions of lymphatic system.


Unit 4


Peripheral nervous system

Classification of peripheral nervous system: Structure and functions of sympathetic and parasympathetic nervous system. Origin and functions of spinal and cranial nerves.


Special senses

Structure and functions of eye, ear, nose and tongue and their disorders.


Unit 5

Cardiovascular system

Heart - anatomy of heart, blood circulation, blood vessels, structure and functions of artery, vein and capillaries, elements of conduction system of heart and heart beat, its regulation by autonomic nervous system, cardiac output, cardiac cycle. Regulation of blood pressure, pulse, electrocardiogram and disorders of heart.




     Pharmaceutical Analysis


Unit 1


Pharmaceutical analysis

Definition and scope
i) Different techniques of analysis
ii) Methods of expressing concentration
iii) Primary and secondary standards.
iv) Preparation and standardization of various molar and normal solutions- Oxalic acid, sodium hydroxide, hydrochloric acid, sodium thiosulphate, sulphuric acid, potassium permanganate and ceric ammonium sulphate

Errors

Sources of errors, types of errors, methods of minimizing errors, accuracy, precision and significant figures

Pharmacopoeia, Sources of impurities in medicinal agents,limit tests.

Unit 2


Acid base titration

Theories of acid base indicators, classification of acid base titrations and theory involved in titrations of strong, weak, and very weak acids and bases, neutralization curves

Non aqueous titration

Solvents, acidimetry and alkalimetry titration and estimation of Sodium benzoate and Ephedrine HCl


Unit 3


Precipitation titrations

Mohr’s method, Volhard’s, Modified Volhard’s, Fajans method, estimation of sodium chloride.


Complexometric titration

Classification, metal ion indicators, masking and demasking reagents, estimation of Magnesium sulphate, and calcium gluconate.


Gravimetry 

Principle and steps involved in gravimetric analysis. Purity of the precipitate: co-precipitation and post precipitation, Estimation of barium sulphate.


Basic Principles,methods and application of diazotisation titration. Estimation of sodium nitrite and sodium nitrate.


Unit 4


Redox titrations


Concepts of oxidation and reduction
Types of redox titrations (Principles and applications)
Cerimetry, Iodimetry, Iodometry, Bromatometry, Dichrometry, Titration with potassium iodate


Unit 5


Electrochemical methods of analysis

Conductometry 

 Introduction, Conductivity cell, Conductometric titrations, applications.

Potentiometry 

Electrochemical cell, construction and working of reference (Standard hydrogen, silver chloride electrode and calomel electrode) and indicator electrodes (metal electrodes and glass electrode), methods to determine end point of potentiometric titration and applications.

Polarography 

 Principle, Ilkovic equation, construction and working of dropping mercury electrode and rotating platinum electrode, applications.




         Pharmaceutics 1


Unit 1


Historical background and development of profession of pharmacy 

History of profession of Pharmacy in India in relation to pharmacy education, industry and organization, Pharmacy as a career, Pharmacopoeias: Introduction to IP, BP, USP and Extra Pharmacopoeia.


Dosage forms

Introduction to dosage forms, classification and definitions


Prescription

Definition, Parts of prescription, handling of Prescription and Errors in prescription.


Posology

Definition, Factors affecting posology. Pediatric dose calculations based on age, body weight and body surface area.


Unit 2


Pharmaceutical calculations

Weights and measures - Imperial & Metric system, Calculations involving percentage solutions, alligation, proof spirit and isotonic solutions based on freezing point and molecular weight.

Powders

Definition, classification, advantages and disadvantages,Simple & compound powders - official preparations, dusting powders, effervescent, efflorescent and hygroscopic powders, eutectic mixtures. Geometric dilutions.

Liquid dosage forms

Advantages and disadvantages of liquid dosage forms. Excipients used in formulation of liquid dosage forms. Solubility enhancement techniques


Unit 3


Monophasic liquids 

Definitions and preparations of Gargles, Mouthwashes, Throat Paint, Eardrops, Nasal drops, Enemas, Syrups, Elixirs, Liniments and Lotions.


Biphasic liquids :


Suspensions: Definition, advantages and disadvantages, classifications, Preparation of suspensions; Flocculated and Deflocculated suspension & stability problems and methods to overcome.

Emulsions: Definition, classification, emulsifying agent, test for the identification of type ofEmulsion, Methods of preparation & stability problems and methods to overcome.


Unit 4


Suppositories

Definition, types, advantages and disadvantages, types of bases, methods of preparations. Displacement value & its calculations, evaluation of suppositories.

Pharmaceutical incompatibilities

Definition, classification, physical, chemical and therapeutic incompatibilities with examples.


Unit 5


Semisolid dosage forms

Definitions, classification, mechanisms and factors influencing dermal penetration of drugs. Preparation of ointments, pastes, creams and gels. Excipients used in semi solid dosage forms. Evaluation of semi solid dosages forms




Pharmaceutical Inorganic Chemistry


Unit 1


Impurities in pharmaceutical substances

History of Pharmacopoeia, Sources and types of impurities, principle involved in the limit test for Chloride, Sulphate, Iron, Arsenic, Lead and Heavy metals, modified limit test for Chloride and Sulphate


General methods of preparation, assay for the compounds superscripted with asterisk (*), properties and medicinal uses of inorganic compounds belonging to the following classes


Unit 2


Acids, Bases and Buffers

Buffer equations and buffer capacity in general, buffers in pharmaceutical systems, preparation, stability, buffered isotonic solutions, measurements of tonicity, calculations and methods of adjusting isotonicity.


Major extra and intracellular electrolytes

Functions of major physiological ions, Electrolytes used in the replacement therapy: Sodium chloride\*, Potassium chloride, Calcium gluconate* and Oral Rehydration Salt (ORS), Physiological acid base balance.


Dental products

Dentifrices, role of fluoride in the treatment of dental caries, Desensitizing agents, Calcium carbonate, Sodium fluoride, and Zinc eugenol cement.


Unit 3

Gastrointestinal agents

Acidifiers Ammonium chloride* and Dil. HCl

Antacid: Ideal properties of antacids, combinations of antacids, Sodium Bicarbonate*, Aluminum hydroxide gel, Magnesium hydroxide mixture

Cathartics: Magnesium sulphate, Sodium orthophosphate, Kaolin and Bentonite

Antimicrobials: Mechanism, classification, Potassiu permanganate, Boric acid, Hydrogen peroxide*, Chlorinated lime*, Iodine and its preparations


Unit 4


Miscellaneous compounds

Expectorants: Potassium iodide, Ammonium chloride*.

Emetics: Copper sulphate*, Sodium potassium tartarate

Haematinics: Ferrous sulphate*, Ferrous gluconate

Poison and Antidote: Sodium thiosulphate*, Activated charcoal, Sodium nitrite333

Astringents: Zinc Sulphate, Potash Alum


Unit 5

Radiopharmaceuticals :

Radio activity, Measurement of radioactivity, Properties of α, β, γ radiations, Half life, radio isotopes and study of radio isotopes - Sodium iodide I131, Storage conditions, precautions & pharmaceutical application of radioactive substances.

Subject :
Human anatomy and physiology 2
Pharmaceutical organic chemistry 1
Biochemistry 
Pathophysiology


Human Anatomy And Physiology 2

Unit 1

Nervous system

Organization of nervous system, neuron, neuroglia, classification and properties of nerve fibre, electrophysiology, action potential, nerve impulse, receptors, synapse, neurotransmitters. Central nervous system: Meninges, ventricles of brain and cerebrospinal fluid.structure and functions of brain (cerebrum, brain stem, cerebellum), spinal cord (gross structure, functions of afferent and efferent nerve tracts,reflex activity)

Unit 2

Digestive system

Anatomy of GI Tract with special reference to anatomy and functions of stomach, ( Acid production in the stomach, regulation of acid production through parasympathetic nervous system, pepsin role in protein digestion) small intestine and large intestine, anatomy and functions of salivary glands, pancreas and liver, movements of GIT, digestion and absorption of nutrients and disorders of GIT.

Energetics

Formation and role of ATP, Creatinine Phosphate and BMR.


Unit 3

Respiratory system

Anatomy of respiratory system with special reference to anatomy of lungs, mechanism of respiration, regulation of respiration

Lung Volumes and capacities transport of respiratory gases, artificial respiration, and resuscitation methods.

Urinary system

 Anatomy of urinary tract with special reference to anatomy of kidney and nephrons, functions of kidney and urinary tract, physiology of urine formation, micturition reflex and role of kidneys in acid base balance, role of RAS in kidney and disorders of kidney.


Unit 4

Endocrine system 

Classification of hormones, mechanism of hormone action, structure and functions of pituitary gland, thyroid gland, parathyroid gland, adrenal gland, pancreas, pineal gland, thymus and their disorders.

Unit 5

Reproductive system 

Anatomy of male and female reproductive system, Functions of male and female reproductive system, sex hormones, physiology of menstruation, fertilization, spermatogenesis, oogenesis, pregnancy and parturition

Introduction to genetics 

Chromosomes, genes and DNA, protein synthesis, genetic pattern of inheritance



Pharmaceutical Organic Chemistry 1

Unit 1

Classification, nomenclature and isomerism

Classification of Organic Compounds Common and IUPAC systems of nomenclature of organic compounds (up to 10 Carbons open chain and carbocyclic compounds) Structural isomerisms in organic compounds

Unit 2

Alkanes*, Alkenes* and Conjugated dienes*
SP3 hybridization in alkanes, Halogenation of alkanes, uses of paraffins.
 Stabilities of alkenes, SP2 hybridization in alkenes 
E1 and E2 reactions - kinetics, order of reactivity of alkyl halides, rearrangement of carbocations, Saytzeffs orientation and evidences. E1 verses E2 reactions, Factors affecting E1 and E2 reactions. Ozonolysis, electrophilic addition reactions of alkenes, Markownikoff’s orientation, free radical addition reactions of alkenes, Anti Markownikoff’s orientation. 
Stability of conjugated dienes, Diel-Alder, electrophilic addition, free radical addition reactions of conjugated dienes, allylic rearrangement


Unit 3

Alkyl halides*

SN1 and SN2 reactions - kinetics, order of reactivity of alkyl halides, stereochemistry and rearrangement of carbocations. 
SN1 versus SN2 reactions, Factors affecting SN1 and SN2 reactions 
Structure and uses of ethylchloride, Chloroform, trichloroethylene, tetrachloroethylene, dichloromethane, tetrachloromethane and iodoform.

Alcohols*

Qualitative tests, Structure and uses of Ethyl alcohol, Methyl alcohol, chlorobutanol, Cetosteryl alcohol, Benzyl alcohol, Glycerol, Propylene glycol


Unit 4

Carbonyl compounds* (Aldehydes and ketones)

Nucleophilic addition, Electromeric effect, aldol condensation, Crossed Aldol condensation, Cannizzaro reaction, Crossed Cannizzaro reaction, Benzoin condensation, Perkin condensation, qualitative tests, Structure and uses of Formaldehyde, Paraldehyde, Acetone, Chloral hydrate, Hexamine, Benzaldehyde, Vanilin, Cinnamaldehyde.


Unit 5

Carboxylic acids*

Acidity of carboxylic acids, effect of substituents on acidity, inductive effect and qualitative tests for carboxylic acids ,amide and ester 
Structure and Uses of Acetic acid, Lactic acid, Tartaric acid, Citric acid, Succinic acid. Oxalic acid, Salicylic acid, Benzoic acid, Benzyl benzoate, Dimethyl phthalate, Methyl salicylate and Acetyl salicylic acid


Aliphatic amines*

Basicity, effect of substituent on Basicity. Qualitative test, Structure and uses of Ethanolamine, Ethylenediamine, Amphetamine


               Biochemistry

Unit 1

Biomolecules

 Introduction, classification, chemical nature and biological role of carbohydrate, lipids, nucleic acids, amino acids and proteins.Biochemistry textbooks

Bioenergetics 

Concept of free energy, endergonic and exergonic reaction, Relationship between free energy, enthalpy and entropy; Redox potential.

Energy rich compounds; classification; biological significances of ATP and cyclic AMP


Unit 2


Carbohydrate metabolism

Glycolysis - Pathway, energetics and significance
Citric acid cycle- Pathway, energetics and significance 
HMP shunt and its significance; Glucose-6-Phosphate dehydrogenase (G6PD) deficiency 
Glycogen metabolism Pathways and glycogen storage diseases (GSD) 
Gluconeogenesis- Pathway and its significance 
Hormonal regulation of blood glucose level and Diabetes mellitus

Biological oxidation

Electron transport chain (ETC) and its mechanism
Oxidative phosphorylation & its mechanism and substrate phosphorylation 
Inhibitors ETC and oxidative phosphorylation/Uncouplers


Unit 3


Lipid metabolism

Oxidation of saturated fatty acid (Palmitic acid)

Formation and utilization of ketone bodies; ketoacidosis 
De novo synthesis of fatty acids (Palmitic acid) 
Biological significance of cholesterol and conversion of cholesterol into bile acids, steroid hormone and vitamin D 
Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis, fatty liver and obesity.

Amino acid metabolism

General reactions of amino acid metabolism: Transamination, deamination & decarboxylation, urea cycle and its disorders 
Catabolism of phenylalanine and tyrosine and their metabolic disorders (Phenyketonuria, Albinism, alkeptonuria, tyrosinemia) 
Synthesis and significance of biological substances; 5-HT, melatonin, dopamine, noradrenaline, adrenaline 
Catabolism of heme; hyperbilirubinemia and jaundice


Unit 4

Nucleic acid metabolism and genetic information transfer

Biosynthesis of purine and pyrimidine nucleotides 
Catabolism of purine nucleotides and Hyperuricemia and Gout disease 
Organization of mammalian genome 
Structure of DNA and RNA and their functions 
DNA replication (semi conservative model) 
Transcription or RNA synthesis 
Genetic code, Translation or Protein synthesis and inhibitors


Unit 5

Enzymes

Introduction, properties, nomenclature and IUB classification of enzymes 
Enzyme kinetics (Michaelis plot, Line Weaver Burke plot) 
Enzyme inhibitors with examples 
Regulation of enzymes: enzyme induction and repression, allosteric enzymes regulation 
Therapeutic and diagnostic applications of enzymes and isoenzymes 
Coenzymes -Structure and biochemical functions


             Pathophysiology


Unit 1

Basic principles of Cell injury and Adaptation: 

Introduction, definitions, Homeostasis, Components and Types of Feedback systems, Causes of cellular injury,Pathogenesis (Cell membrane damage, Mitochondrial damage, Ribosome damage, Nuclear damage),Morphology of cell injury - Adaptive changes (Atrophy, Hypertrophy, hyperplasia, Metaplasia, Dysplasia),Cell swelling, Intra cellular accumulation, Calcification, Enzyme leakage and Cell Death Acidosis &Alkalosis,Electrolyte imbalance

Basic mechanism involved in the process of inflammation and repair: 

Introduction, Clinical signs of inflammation, Different types of Inflammation,Mechanism of Inflammation - Alteration in vascular permeability and blood flow, migration of WBC’s,Mediators of inflammation,Basic principles of wound healing in the skin,Pathophysiology of Atherosclerosis


Unit 2


Cardiovascular System:

Hypertension, congestive heart failure, ischemic heart disease (angina,myocardial infarction, atherosclerosis and arteriosclerosis)

Respiratory system: 

Asthma, Chronic obstructive airways diseases.

Renal system: 

Acute and chronic renal failure


Unit 3

Haematological Diseases:

 Iron deficiency, megaloblastic anemia (Vit B12 and folic acid), sickle cell anemia, thalasemia, hereditary acquired anemia, hemophilia

Endocrine system: 

Diabetes, thyroid diseases, disorders of sex hormones

Nervous system: 

Epilepsy, Parkinson’s disease, stroke, psychiatric disorders: depression, schizophrenia and Alzheimer’s disease.

Gastrointestinal system: 

Peptic Ulcer


Unit 4

Inflammatory bowel diseases, jaundice, hepatitis (A,B,C,D,E,F) alcoholic liver disease.

Disease of bones and joints: 

Rheumatoid arthritis, osteoporosis and gout

Principles of cancer:

 Classification, etiology and pathogenesis of cancer

Diseases of bones and joints: 

Rheumatoid Arthritis, Osteoporosis,Gout


Unit 5

Infectious diseases: 

Meningitis,Typhoid, Leprosy, Tuberculosis Urinary tract infections

Sexually transmitted diseases: 

AIDS, Syphilis, Gonorrhea



Subjects :
Pharmaceutical organic chemistry 2
Physical pharmaceutics 1
Pharmaceutical microbiology
Pharmaceutical engineering


Pharmaceutical Organic Chemistry 2

Unit 1

Benzene and its derivatives

Analytical, synthetic and other evidences in the derivation of structure of benzene, Orbital picture, resonance in benzene, aromatic characters, Huckel’s rule
Reactions of benzene - nitration, sulphonation, halogenationreactivity, Friedelcrafts alkylation- reactivity, limitations, Friedelcrafts acylation.
Substituents, effect of substituents on reactivity and orientation of mono substituted benzene compounds towards electrophilic substitution reaction
Structure and uses of DDT, Saccharin, BHC and Chloramine

Unit 2

Phenol* - Acidity of phenols, effect of substituents on acidity, qualitative tests, Structure and uses of phenol, cresols, resorcinol, naphthols

Aromatic Amines* - Basicity of amines, effect of substituents on basicity, and synthetic uses of aryl diazonium salts

Aromatic Acids* - Acidity, effect of substituents on acidity and important reactions of benzoic acid.


Unit 3

Fats and Oils

Fatty acids - reactions.
Hydrolysis, Hydrogenation, Saponification and Rancidity of oils, Drying oils.
Analytical constants - Acid value, Saponification value, Ester value, Iodine value, Acetyl value, Reichert Meissl (RM) value - significance and principle involved in their determination.

Unit 4

Polynuclear hydrocarbons:

Synthesis, reactions
Structure and medicinal uses of Naphthalene, Phenanthrene, Anthracene, Diphenylmethane, Triphenylmethane and their derivatives

Unit 5

Cyclo alkanes*

Stabilities - Baeyer’s strain theory, limitation of Baeyer’s strain theory, Coulson and Moffitt’s modification, Sachse Mohr’s theory (Theory of strainless rings), reactions of cyclopropane and cyclobutane only

 Physical Pharmaceutics 1


Unit 1

Solubility of drugs:

Solubility expressions, mechanisms of solute solvent interactions, ideal solubility parameters, solvation & association, quantitative approach to the factors influencing solubility of drugs, diffusion principles in biological systems. Solubility of gas in liquids, solubility of liquids in liquids, (Binary solutions, ideal solutions) Raoult’s law, real solutions. Partiallymiscible liquids, Critical solution temperature and applications. Distribution law, its limitations and applications


Unit 2

States of Matter and properties of matter:

State of matter, changes in the state of matter, latent heats, vapour pressure, sublimation critical point, eutectic mixtures, gases, aerosols - inhalers, relative humidity, liquid complexes, liquid crystals, glassy states, solidcrystalline, amorphous & polymorphism.

Physicochemical properties of drug molecules:

Refractive index, optical rotation, dielectric constant, dipole moment, dissociation constant, determinations and applications


Unit 3

Surface and interfacial phenomenon:

Liquid interface, surface & interfacial tensions, surface free energy, measurement of surface & interfacial tensions, spreading coefficient, adsorption at liquid interfaces, surface active agents, HLB Scale, solubilisation, detergency, adsorption at solid interface.


Unit 4

Complexation and protein binding:

Introduction, Classification of Complexation, Applications, methods of analysis, protein binding, Complexation and drug action, crystalline structures of complexes and thermodynamic treatment of stability constants.


Unit 5

pH, buffers and Isotonic solutions:

Sorensen’s pH scale, pH determination (electrometric and calorimetric), applications of buffers, buffer equation, buffer capacity, buffers in pharmaceutical and biological systems, buffered isotonic solutions.



Pharmaceutical Microbiology


Unit 1

Introduction, history of microbiology, its branches, scope and its importance. 
Introduction to Prokaryotes and Eukaryotes 
Study of ultra-structure and morphological classification of bacteria, nutritional requirements, raw materials used for culture media and physical parameters for growth, growth curve, isolation and preservation methods for pure cultures, cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable count). Study of different types of phase constrast microscopy, dark field microscopy and electron microscopy.


Unit 2

Identification of bacteria using staining techniques (simple, Gram’s &Acid fast staining) and biochemical tests (IMViC). 
Study of principle, procedure, merits, demerits and applications of physical, chemical gaseous,radiation and mechanical method of sterilization. 
Evaluation of the efficiency of sterilization methods. 
Equipments employed in large scale sterilization. Sterility indicators.


Unit 3

Study of morphology, classification, reproduction/replication and cultivation of Fungi and Viruses. 
Classification and mode of action of disinfectants 
Factors influencing disinfection, antiseptics and their evaluation. For bacteriostatic and bactericidal actions 
Evaluation of bactericidal & Bacteriostatic. 
Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP.

Unit 4

Designing of aseptic area, laminar flow equipments; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification. 
Principles and methods of different microbiological assay. Methods for standardization of antibiotics, vitamins and amino acids. 
Assessment of a new antibiotic.


Unit 5


Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources and types of microbial contaminants, assessment of microbial contamination and spoilage. 
Preservation of pharmaceutical products using antimicrobial agents, evaluation of microbial stability of formulations.

Growth of animal cells in culture, general procedure for cell culture, Primary, established and transformed cell cultures. 
Application of cell cultures in pharmaceutical industry and research


Pharmaceutical Engineering

Unit 1

Flow of fluids : 

Types of manometers, Reynolds number and its significance, Bernoulli’s theorem and its applications, Energy losses, Orifice meter, Venturimeter, Pitot tube and Rotometer.

Size Reduction: 

Objectives, Mechanisms & Laws governing size reduction, factors affecting size reduction, principles, construction, working, uses, merits and demerits of Hammer mill, ball mill, fluid energy mill, Edge runner mill & end runner mill.

Size Separation: 

Objectives, applications & mechanism of size separation, official standards of powders, sieves, size separation Principles, construction, working, uses, merits and demerits of Sieve shaker, cyclone separator, Air separator, Bag filter & elutriation tank.


Unit 2


Heat Transfer: 

Objectives, applications & Heat transfer mechanisms. Fourier’s law, Heat transfer by conduction, convection & radiation. Heat interchangers & heat exchangers.

Evaporation: 

Objectives, applications and factors influencing evaporation, differences between evaporation and other heat process. principles, construction, working, uses, merits and demerits of Steam jacketed kettle, horizontal tube evaporator, climbing film evaporator, forced circulation evaporator, multiple effect evaporator& Economy of multiple effect evaporator.

Distillation: 

Basic Principles and methodology of simple distillation,flash distillation, fractional distillation, distillation under reduced pressure, steam distillation & molecular distillation


Unit 3


Drying: 

Objectives, applications & mechanism of drying process, measurements & applications of Equilibrium Moisture content, rate of drying curve. principles, construction, working, uses, merits and demerits of Tray dryer, drum dryer spray dryer, fluidized bed dryer, vacuum dryer, freeze dryer.

Mixing: 

Objectives, applications & factors affecting mixing, Difference between solid and liquid mixing, mechanism of solid mixing, liquids mixing and semisolids mixing. Principles, Construction, Working, uses, Merits and Demerits of Double cone blender, twin shell blender, ribbon blender, Sigma blade mixer, planetarymixers, Propellers, Turbines, Paddles & Silverson Emulsifier


Unit 4

Filtration: 

Objectives, applications, Theories & Factors influencing filtration, filter aids, filter medias. Principle, Construction, Working, Uses, Merits and demerits of plate & frame filter, filter leaf, rotary drum filter, Meta filter & Cartridge filter, membrane filters and Seidtz filter.

Centrifugation: 

Objectives, principle & applications of Centrifugation, principles, construction, working, uses, merits and demerits of Perforated basket centrifuge, Non-perforated basket centrifuge, semi continuous centrifuge & super centrifuge.


Unit 5

Materials of pharmaceutical plant construction, Corrosion and its prevention:

 Factors affecting during materials selected for Pharmaceutical plant construction, Theories of corrosion, types of corrosion and there prevention. Ferrous and nonferrous metals, inorganic and organic non metals, basic of material handling systems.


Subjects :
Pharmaceutical organic chemistry 3
Medicinal chemistry 1
Physical pharmaceutics 2
Pharmacology 1
Pharmacognosy & photochemistry 1



Pharmaceutical Organic Chemistry 3


Unit 1

Stereo isomerism

Optical isomerism -
Optical activity, enantiomerism, diastereoisomerism, meso compounds

Elements of symmetry, chiral and achiral molecules

DL system of nomenclature of optical isomers, sequence rules, RS system of nomenclature of optical isomers

Reactions of chiral molecules

Racemic modification and resolution of racemic mixture. 
Asymmetric synthesis: partial and absolute


Unit 2

Geometrical isomerism :

Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)

Methods of determination of configuration of geometrical isomers.

Conformational isomerism in Ethane, n-Butane and Cyclohexane. Stereo isomerism in biphenyl compounds (Atropisomerism) and conditions for optical activity.

Stereospecific and stereoselective reactions


Unit 3

Heterocyclic compounds:

Nomenclature and classification

Synthesis, reactions and medicinal uses of following compounds/derivatives

Pyrrole, Furan, and Thiophene

Relative aromaticity and reactivity of Pyrrole, Furan and Thiophene


Unit 4

Synthesis, reactions and medicinal uses of following compounds/derivatives

Pyrazole, Imidazole, Oxazole and Thiazole.

Pyridine, Quinoline, Isoquinoline, Acridine and Indole. Basicity of pyridine

Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their derivatives


Unit 5

Reactions of synthetic importance

Metal hydride reduction (NaBH4 and LiAlH4), Clemmensen reduction, Birch reduction, Wolff Kishner reduction.

Oppenauer-oxidation and Dakin reaction.

Beckmanns rearrangement and Schmidt rearrangement.

Claisen-Schmidt condensation


   Medicinal Chemistry 1

Unit 1

Introduction to Medicinal Chemistry
History and development of medicinal chemistry
Physicochemical properties in relation to biological action
Ionization, Solubility, Partition Coefficient, Hydrogen bonding, Protein binding, Chelation, Bioisosterism, Optical and Geometrical isomerism


Drug metabolism

Drug metabolism principles- Phase I and Phase II

Factors affecting drug metabolism including stereo chemical aspects.


Unit 2

Drugs acting on Autonomic Nervous System

Adrenergic Neurotransmitters:

Biosynthesis and catabolism of catecholamine.

Adrenergic receptors (Alpha & Beta) and their distribution.


Sympathomimetic agents: SAR of Sympathomimetic agents

Direct acting: Nor-epinephrine, Epinephrine, Phenylephrine*, Dopamine, Methyldopa, Clonidine, Dobutamine, Isoproterenol, Terbutaline, Salbutamol*, Bitolterol, Naphazoline, Oxymetazoline and Xylometazoline.
Indirect acting agents: Hydroxyamphetamine, Pseudoephedrine, Propylhexedrine.
Agents with mixed mechanism: Ephedrine, Metaraminol.

Adrenergic Antagonists:

Alpha adrenergic blockers: 

Tolazoline*, Phentolamine, Phenoxybenzamine, Prazosin, Dihydroergotamine, Methysergide.

Beta adrenergic blockers: 

SAR of beta blockers, Propranolol*,Metibranolol, Atenolol, Betazolol, Bisoprolol, Esmolol, Metoprolol,Labetolol, Carvedilol.

Unit 3

Cholinergic neurotransmitters:

Biosynthesis and catabolism of acetylcholine.

Cholinergic receptors (Muscarinic & Nicotinic) and their distribution.


Parasympathomimetic agents: SAR of Parasympathomimetic agents

Direct acting agents:

Acetylcholine, Carbachol*, Bethanechol, Methacholine, Pilocarpine.


Indirect acting/ Cholinesterase inhibitors (Reversible & Irreversible):

Physostigmine, Neostigmine\*, Pyridostigmine, Edrophonium chloride, Tacrine hydrochloride, Ambenonium chloride, Isofluorphate, Echothiophate iodide, Parathione, Malathion.


Cholinesterase reactivator:

Pralidoxime chloride.

Cholinergic Blocking agents: SAR of cholinolytic agents


Solanaceous alkaloids & analogues:

Atropine sulphate, Hyoscyamine sulphate, Scopolamine hydrobromide, Homatropine hydrobromide, Ipratropium bromide*.

Synthetic cholinergic blocking agents:

Tropicamide, Cyclopentolate hydrochloride, Clidinium bromide, Dicyclomine hydrochloride*, Glycopyrrolate, Methantheline bromide, Propantheline bromide, Benztropine mesylate, Orphenadrine citrate, Biperidine hydrochloride, Procyclidine hydrochloride\*, Tridihexethyl chloride, Isopropamide iodide, Ethopropazine hydrochloride.


Unit 4

Drugs acting on Central Nervous System


1. Sedatives and Hypnotics

Benzodiazepines:

SAR of Benzodiazepines, Chlordiazepoxide, Diazepam*, Oxazepam, Chlorazepate, Lorazepam, Alprazolam, Zolpidem

Barbiturtes:

SAR of barbiturates, Barbital\*, Phenobarbital, Mephobarbital, Amobarbital, Butabarbital, Pentobarbital, Secobarbital

Miscelleneous:

Amides & imides: Glutethmide.

Alcohol & their carbamate derivatives: Meprobomate, Ethchlorvynol.

Aldehyde & their derivatives: Triclofos sodium, Paraldehyde.


2. Antipsychotics

Phenothiazeines:


SAR of Phenothiazeines - Promazine hydrochloride, Chlorpromazine hydrochloride*,Triflupromazine, Thioridazine hydrochloride, Piperacetazine hydrochloride,Prochlorperazine maleate, Trifluoperazine hydrochloride.

Ring Analogues of Phenothiazeines:


Chlorprothixene, Thiothixene, Loxapine succinate, Clozapine.

Fluro buterophenones: 

Haloperidol, Droperidol, Risperidone.

Beta amino ketones: 

Molindone hydrochloride.

Benzamides: 

Sulpieride.


3. Anticonvulsants:

SAR of Anticonvulsants, mechanism of anticonvulsant action


Barbiturates: 

Phenobarbitone, Methabarbital.

Hydantoins: 

Phenytoin*, Mephenytoin, Ethotoin

Oxazolidine diones: 

Trimethadione, Paramethadione

Succinimides: 

Phensuximide, Methsuximide, Ethosuximide*

Urea and monoacylureas: 

Phenacemide, Carbamazepine*

Benzodiazepines: 

Clonazepam

Miscellaneous: 

Primidone, Valproic acid , Gabapentin, Felbamate


Unit 5


Drugs acting on Central Nervous System


General anesthetics:

Inhalation anesthetics: 
Halothane*, Methoxyflurane, Enflurane, Sevoflurane, Isoflurane, Desflurane.

Ultra short acting barbitutrates: 
Methohexital sodium*, Thiamylal sodium, Thiopental sodium.

Dissociative anesthetics: Ketamine hydrochloride*


Narcotic and non-narcotic analgesics

Morphine and related drugs: 

SAR of Morphine analogues, Morphine sulphate, Codeine, Meperidine hydrochloride, Anilerdine hydrochloride, Diphenoxylate hydrochloride, Loperamide hydrochloride, Fentanyl citrate*, Methadone hydrochloride*, Propoxyphene hydrochloride, Pentazocine, Levorphanol tartarate.

Narcotic antagonists: 

Nalorphine hydrochloride, Levallorphan tartarate, Naloxone hydrochloride.

Anti-inflammatory agents: 

Sodium salicylate, Aspirin, Mefenamic acid*, Meclofenamate, Indomethacin, Sulindac, Tolmetin, Zomepriac, Diclofenac, Ketorolac, Ibuprofen*, Naproxen, Piroxicam, Phenacetin, Acetaminophen, Antipyrine, Phenylbutazone.


Physical Pharmaceutics 2


Unit 1

Colloidal dispersions: Classification of dispersed systems & their general characteristics, size & shapes of colloidal particles, classification of colloids & comparative account of their general properties. Optical, kinetic & electrical properties. Effect of electrolytes, coacervation, peptization& protective action.


Unit 2

Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of temperature, non-Newtonian systems, pseudoplastic, dilatant, plastic, thixotropy, thixotropy in formulation, determination of viscosity, capillary, falling Sphere, rotational viscometers

Deformation of solids: Plastic and elastic deformation, Heckel equation, Stress, Strain, Elastic Modulus


Unit 3

Coarse dispersion: 

Suspension, interfacial properties of suspended particles, settling in suspensions, formulation of flocculated and deflocculated suspensions. Emulsions and theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions, preservation of emulsions, rheological properties of emulsions and emulsion formulation by HLB method.


Unit 4

Micromeretics: 

Particle size and distribution, mean particle size, number and weight distribution, particle number, methods for determining particle size by different methods, counting and separation method, particle shape, specific surface, methods for determining surface area, permeability, adsorption, derived properties of powders, porosity, packing arrangement, densities, bulkiness & flow properties.


Unit 5

Drug stability: 

Reaction kinetics: zero, pseudo-zero, first & second order, units of basic rate constants, determination of reaction order. Physical and chemical factors influencing the chemical degradation of pharmaceutical product: temperature, solvent, ionic strength, dielectric constant, specific & general acid base catalysis, Simple numerical problems. Stabilization of medicinal agents against common reactions like hydrolysis & oxidation. Accelerated stability testing in expiration dating of pharmaceutical dosage forms. Photolytic degradation and its prevention


Pharmacology 1


Unit 1

1. General Pharmacology

Introduction to Pharmacology- Definition, historical landmarks and scope of pharmacology, nature and source of drugs, essential drugs concept and routes of drug administration, Agonists, antagonists( competitive and non competitive), spare receptors, addiction, tolerance, dependence, tachyphylaxis, idiosyncrasy, allergy.

Pharmacokinetics- Membrane transport, absorption, distribution, metabolism and excretion of drugs .Enzyme induction, enzyme inhibition, kinetics of elimination


Unit 2

General Pharmacology

Pharmacodynamics- Principles and mechanisms of drug action. Receptor theories and classification of receptors, regulation of receptors. drug receptors interactions signal transduction mechanisms, G-protein-coupled receptors, ion channel receptor, transmembrane enzyme linked receptors, transmembrane JAK-STAT binding receptor and receptors that regulate transcription factors, dose response relationship, therapeutic index, combined effects of drugs and factors modifying drug action.

Adverse drug reactions.

Drug interactions (pharmacokinetic and pharmacodynamic)

Drug discovery and clinical evaluation of new drugs -Drug discovery phase, preclinical evaluation phase, clinical trial phase, phases of clinical trials and pharmacovigilance.


Unit 3


Pharmacology of drugs acting on peripheral nervous system

Organization and function of ANS.
Neurohumoral transmission,co-transmission and classification of neurotransmitters.
Parasympathomimetics, Parasympatholytics, Sympathomimetics, sympatholytics.
Neuromuscular blocking agents and skeletal muscle relaxants (peripheral).
Local anesthetic agents.
Drugs used in myasthenia gravis and glaucoma


Unit 4


Pharmacology of drugs acting on central nervous system

Neurohumoral transmission in the C.N.S.special emphasis on importance of various neurotransmitters like with GABA, Glutamate, Glycine, serotonin, dopamine.
General anesthetics and pre-anesthetics.
Sedatives, hypnotics and centrally acting muscle relaxants.
Anti-epileptics
Alcohols and disulfiram


Unit 5

Pharmacology of drugs acting on central nervous system

Drugs used in Parkinsons disease and Alzheimer’s disease.
CNS stimulants and nootropics.
Opioid analgesics and antagonists
Drug addiction, drug abuse, tolerance and dependence.


Pharmacognosy 1


Unit 1

Introduction to Pharmacognosy:

Definition, history, scope and development of Pharmacognosy
Sources of Drugs - Plants, Animals, Marine & Tissue culture
Organized drugs, unorganized drugs (dried latex, dried juices, dried extracts, gums and mucilages, oleoresins and oleo- gum -resins).

Classification of drugs:

Alphabetical, morphological, taxonomical, chemical, pharmacological, chemo and sero taxonomical classification of drugs


Quality control of Drugs of Natural Origin:

Adulteration of drugs of natural origin. Evaluation by organoleptic, microscopic, physical, chemical and biological methods and properties.


Quantitative microscopy of crude drugs including lycopodium spore method, leafconstants, camera lucida and diagrams of microscopic objects to scale with camera lucida.


Unit 2


Cultivation, Collection, Processing and storage of drugs of natural origin:

Cultivation and Collection of drugs of natural origin

Factors influencing cultivation of medicinal plants.

Plant hormones and their applications.

Polyploidy, mutation and hybridization with reference to medicinal plants.


Conservation of medicinal plants


Unit 3

Plant tissue culture:

Historical development of plant tissue culture, types of cultures, Nutritional requirements, growth and their maintenance.

Applications of plant tissue culture in pharmacognosy.

Edible vaccines.


Unit 4

Pharmacognosy in various systems of medicine:

Role of Pharmacognosy in allopathy and traditional systems of medicine namely, Ayurveda, Unani, Siddha, Homeopathy and Chinese systems of medicine.


Introduction to secondary metabolites:

Definition, classification, properties and test for identification of Alkaloids, Glycosides, Flavonoids, Tannins, Volatile oil and Resins


Unit 5

Study of biological source, chemical nature and uses of drugs of natural origin containing following drugs


Plant Products:

Fibers - Cotton, Jute, Hemp
Hallucinogens, Teratogens, Natural allergens


Primary metabolites:

General introduction, detailed study with respect to chemistry, sources, preparation, evaluation, preservation, storage, therapeutic used and commercial utility as Pharmaceutical Aids and/or Medicines for the following Primary metabolites:


Carbohydrates: 

Acacia, Agar, Tragacanth, Honey

Proteins and Enzymes: 

Gelatin, casein, proteolytic enzymes (Papain, bromelain, serratiopeptidase, urokinase, streptokinase, pepsin).


Lipids(Waxes, fats, fixed oils): 

Castor oil, Chaulmoogra oil, Wool Fat, Bees Wax

Marine Drugs: 

Novel medicinal agents from marine sources


Subjects :
Medicinal chemistry 2
Industrial pharmacy 1
Pharmacology 2
Pharmacognosy 2
Pharmaceutical jurisprudence 


Medicinal Chemistry 2


Unit 1


Antihistaminic agents :

Histamine, receptors and their distribution in the humanbody

H1-antagonists:

Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamines cuccinate, Clemastine fumarate, Diphenylphyraline hydrochloride, Tripelenamine hydrochloride, Chlorcyclizine hydrochloride, Meclizine hydrochloride, Buclizine hydrochloride, Chlorpheniramine maleate, Triprolidine hydrochloride*, Phenidamine tartarate, Promethazine hydrochloride*, Trimeprazine tartrate, Cyproheptadine hydrochloride, Azatidine maleate, Astemizole, Loratadine, Cetirizine, Levocetrazine Cromolyn sodium

H2-antagonists: 

Cimetidine*, Famotidine, Ranitidin.

Gastric Proton pump inhibitors: 

Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole


Anti-neoplastic agents :


Alkylating agents: 

Meclorethamine*, Cyclophosphamide, Melphalan, Chlorambucil, Busulfan, Thiotepa

Antimetabolites: 

Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine, Cytarabine, Methotrexate*, Azathioprine

Antibiotics: 

Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin

Plant products: 

Etoposide, Vinblastin sulphate, Vincristin sulphate

Miscellaneous: 

Cisplatin, Mitotane.


Unit 2

Anti-anginal

Vasodilators: 

Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbide dinitrite*, Dipyridamole.

Calcium channel blockers: 

Verapamil, Bepridil hydrochloride, Diltiazem hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.

Diuretics :

Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide, Dichlorphenamide.

Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide, Cyclothiazide,

Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid.

Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride.

Osmotic Diuretics: Mannitol


Anti-hypertensive Agents :

Timolol, Captopril, Lisinopril, Enalapril, Benazepril hydrochloride, Quinapril hydrochloride, Methyldopate hydrochloride*, Clonidine hydrochloride, Guanethidine monosulphate, Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine, Hydralazine hydrochloride.


Unit 3


Anti-arrhythmic Drugs: 

Quinidine sulphate, Procainamide hydrochloride, Disopyramide phosphate*, Phenytoin sodium, Lidocaine hydrochloride, Tocainide hydrochloride, Mexiletine hydrochloride, Lorcainide hydrochloride, Amiodarone, Sotalol.

Anti-hyperlipidemic agents: 

Clofibrate, Lovastatin, Cholesteramine and Cholestipol

Coagulant & Anticoagulants: 

Menadione, Acetomenadione, Warfarin*, Anisindione, clopidogrel

Drugs used in Congestive Heart Failure:  

Digoxin, Digitoxin, Nesiritide, Bosentan, Tezosentan.


Unit 4


Drugs acting on Endocrine system

Nomenclature, Stereochemistry and metabolism of steroids

Sex hormones: 

Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol, Oestrione, Diethyl stilbestrol.


Drugs for erectile dysfunction: 

Sildenafil, Tadalafil.

Oral contraceptives: 

Mifepristone, Norgestril, Levonorgestrol

Corticosteroids: 

Cortisone, Hydrocortisone, Prednisolone, Betamethasone, Dexamethasone

Thyroid and antithyroid drugs: 

L-Thyroxine, L-Thyronine, Propylthiouracil, Methimazol


Unit 5


Antidiabetic agents:

Insulin and its preparations

Sulfonyl ureas: Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride.

Biguanides: Metformin.

Thiazolidinediones: Pioglitazone, Rosiglitazone

Meglitinides: Repaglinide, Nateglinide.

Glucosidase inhibitors:Acrabose, Voglibose.


Local Anesthetics: 

SAR of Local anesthetics

Benzoic Acid derivatives: 

Cocaine, Hexylcaine, Meprylcaine, Cyclomethycaine, Piperocaine.

Amino Benzoic acid derivatives: 

Benzocaine*, Butamben, Procaine*, Butacaine, Propoxycaine, Tetracaine, 

Lidocaine/Anilide derivatives: 

Lignocaine, Mepivacaine, Prilocaine, Etidocaine.

Miscellaneous: 

Phenacaine, Diperodon, Dibucaine.*

Industrial Pharmacy 1

Unit 1

Preformulation Studies: 

Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.Pharmacy degrees

Physical properties: 

Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism

Chemical Properties: 

Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant

Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.


Unit 2

Tablets:

Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipments and tablet tooling.
Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating.
Quality control tests: In process and finished product tests Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia

Liquid orals:

Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia

Unit 3

 Capsules:

Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.

Soft gelatin capsules: 

Nature of shell and capsule content, size of capsules,importance of base adsorption and minim/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.

Pellets:

Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets


Unit 4


Parenteral Products:

Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity
Production procedure, production facilities and controls, aseptic processing
Formulation of injections, sterile powders, large volume parenterals and lyophilized products.
Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests of parenteral products.


Ophthalmic Preparations:

Introduction, formulation considerations; formulation of eye drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations


Unit 5

Cosmetics:

Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.

Pharmaceutical Aerosols:

Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.

Packaging Materials Science:

Materials used for packaging of pharmaceutical products,factors influencing choice of containers, legal and official requirements for containers,stability aspects of packaging materials,quality control tests.


Pharmacology 2


Unit 1

1. Pharmacology of drugs acting on cardio vascular system

Introduction to hemodynamic and electrophysiology
Drugs used in congestive heart failure
Anti-hypertensive drugs.
Anti-anginal drugs.
Anti-arrhythmic drugs.
Anti-hyperlipidemic

Unit 2

2. Pharmacology of drugs acting on cardio vascular system

Drug used in the therapy of shock.
Hematinics, coagulants and anticoagulants.
Fibrinolytics and anti-platelet drugs
Plasma volume expanders

3. Pharmacology of drugs acting on urinary system

Diuretics
Anti-diuretics.


Unit 3

4.Autocoids and related drugs

Introduction to autacoids and classification
Histamine, 5-HT and their antagonists.
Prostaglandins, Thromboxanes and Leukotrienes.
Angiotensin, Bradykinin and Substance P. e. Non-steroidal anti-inflammatory agents
Anti-gout drugs
Antirheumatic drugs

Unit 4

5. Pharmacology of drugs acting on endocrine system

Basic concepts in endocrine pharmacology. b. Anterior Pituitary hormones- analogues and their inhibitors.
Thyroid hormones- analogues and their inhibitors.
Hormones regulating plasma calcium level- Parathormone, Calcitonin and Vitamin-D.
Insulin, Oral Hypoglycemic agents and glucagon.
ACTH and corticosteroids.

Unit 5

6.Pharmacology of drugs acting on endocrine system

Androgens and Anabolic steroids.
Estrogens, progesterone and oral contraceptives.
Drugs acting on the uterus.

7.Bioassay

Principles and applications of bioassay.
Types of bioassay
Bioassay of insulin, oxytocin, vasopressin, ACTH,d-tubocurarine,digitalis, histamine and 5-HT


Pharmacognosy 2


Unit 1

Metabolic pathways in higher plants and their determination

Brief study of basic metabolic pathways and formation of different secondary metabolites through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.
Study of utilization of radioactive isotopes in the investigation of Biogenetic studies.

Unit 2

General introduction, composition, chemistry & chemical classes, biosources, therapeutic uses and commercial applications of following secondary metabolites:
Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,
Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta
Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis
Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander,
Tannins: Catechu, Pterocarpus
Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony
Glycosides: Senna, Aloes, Bitter Almond
Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids

Unit 3

Isolation, Identification and Analysis of Phytoconstituents
Terpenoids: Menthol, Citral, Artemisin
Glycosides: Glycyrhetinic acid & Rutin
Alkaloids: Atropine,Quinine,Reserpine,Caffeine
Resins: Podophyllotoxin, Curcumin

Unit 4

Industrial production, estimation and utilization of the following phytoconstituents: Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine, Taxol, Vincristine and Vinblastine

Unit 5

Basics of Phytochemistry
Modern methods of extraction, application of latest techniques like Spectroscopy, chromatography and electrophoresis in the isolation, purification and identification of crude drugs.



Pharmaceutical Jurisprudence


Unit 1

Drugs and Cosmetics Act, 1940 and its rules 1945:

Objectives, Definitions, Legal definitions of schedules to the Act and Rules

Import of drugs - Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties.

Manufacture of drugs - Prohibition of manufacture and sale of certain drugs,

Conditions for grant of license and conditions of license for manufacture of drugs,

Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.


Unit 2

Drugs and Cosmetics Act, 1940 and its rules 1945:

Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)

Sale of Drugs - Wholesale, Retail sale and Restricted license. Offences and penalties

Labeling & Packing of drugs- General labeling requirements and specimen labels for

drugs and cosmetics, List of permitted colors. Offences and penalties.

Administration of the Act and Rules - Drugs Technical Advisory Board, Central drugs

Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling authorities, Drugs Inspectors


Unit 3

Pharmacy Act -1948: 

Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties

Medicinal and Toilet Preparation Act -1955: 

Objectives, Definitions, Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations, Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties.

Narcotic Drugs and Psychotropic substances Act-1985 and Rules: 

Objectives, Definitions, Authorities and Officers, Constitution and Functions of narcotic &Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production of poppy straw, manufacture, sale and export of opium, Offences and Penalties


Unit 4

Study of Salient Features of Drugs and Magic Remedies Act and its rules: 

Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties

Prevention of Cruelty to animals Act-1960: 

Objectives, Definitions, Institutional Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of Animals, Performance of Experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties

National Pharmaceutical Pricing Authority: 

Drugs Price Control Order (DPCO)- 2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled formulations, National List of Essential Medicines (NLEM)


Unit 5

Pharmaceutical Legislations :

A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee

Code of Pharmaceutical ethics:

Definition, Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath

Medical Termination of Pregnancy Act


Right to Information Act


Introduction to Intellectual Property Rights (IPR)



Subjects :
Medicinal Chemistry 3
Pharmacology 3
Herbal drug technology
Biopharmaceutics & pharmacokinetics
Pharmaceutical biotechnology
Quality assurance


Medicinal Chemistry 3
Unit 1
 Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products of the following classes.

β-Lactam antibiotics: Penicillin, Cepholosporins, β- Lactamase inhibitors, Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin
Tetracyclines: Tetracycline,Oxytetracycline, Chlortetracycline, Minocycline, Doxycycline
Unit 2
Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products of the following classes.

Macrolide: Erythromycin Clarithromycin, Azithromycin.
Miscellaneous: Chloramphenicol\*, Clindamycin.
Prodrugs: Basic concepts and application of prodrugs design.
Antimalarials: Etiology of malaria. Quinolines: SAR, Quinine sulphate, Chloroquine\*, Amodiaquine, Primaquine phosphate, Pamaquine\*, Quinacrine hydrochloride, Mefloquine. Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone.
Unit 3
Anti-tubercular Agents
Synthetic anti tubercular agents: Isoniozid\*, Ethionamide, Ethambutol, Pyrazinamide, Para amino salicylic acid.*

Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine Streptomycine, Capreomycin sulphate.


Urinary tract anti-infective agents
Quinolones: SAR of quinolones, Nalidixic Acid,Norfloxacin, Enoxacin, Ciprofloxacin\*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin

Miscellaneous: Furazolidine, Nitrofurantoin\*, Methanamine


Antiviral agents:
Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine trifluoride, Acyclovir\*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir, Ritonavir.

Pharmacology 3
Unit 1
1. Pharmacology of drugs acting on Respiratory systemPharmacy curriculum
Anti -asthmatic drugs
Drugs used in the management of COPD
Expectorants and antitussives
Nasal decongestants
Respiratory stimulants

2. Pharmacology of drugs acting on the Gastrointestinal Tract
Antiulcer agents.
Drugs for constipation and diarrhoea.
Appetite stimulants and suppressants.
Digestants and carminatives.
Emetics and anti-emetics.
Unit 2
3. Chemotherapy
General principles of chemotherapy.
Sulfonamides and cotrimoxazole.
Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and fluoroquinolins, tetracycline and aminoglycosides

Unit 3
3. Chemotherapy
Antitubercular agents
Antileprotic agents
Antifungal agents
Antiviral drugs
Anthelmintics
Antimalarial drugs
Antiamoebic agents

Unit 4
3. Chemotherapy
Urinary tract infections and sexually transmitted diseases.
Chemotherapy of malignancy

4. Immunopharmacology
Immunostimulants
Immunosuppressant Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars
Unit 5
5. Principles of toxicology
Definition and basic knowledge of acute, subacute and chronic toxicity.
Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity and mutagenicity
General principles of treatment of poisoning
Clinical symptoms and management of barbiturates, morphine, organophosphosphorus compound and lead, mercury and arsenic poisoning.

6. Chronopharmacology
Definition of rhythm and cycles.
Biological clock and their significance leading to chronotherapy

Herbal Drug Technology
Unit 1
Herbs as raw material
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation Source of Herbs

Selection, identification and authentication of herbal materials Processing of herbal raw material


Biodynamic Agriculture
Good agricultural practices in cultivation of medicinal plants including Organic farming.

Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.


Indian Systems of Medicine
Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas, Ghutika,Churna, Lehya and Bhasma.
Unit 2
Nutraceuticals
General aspects, Market, growth, scope and types of products available in the market. Health

benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable

bowel syndrome and various Gastro intestinal diseases. Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic, Honey, Amla, Ginseng, Ashwagandha, Spirulina


Herbal-Drug and Herb-Food Interactions:
General introduction to interaction and classification. Study of following drugs and their possible side effects and interactions:

Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra


Unit 3
Herbal Cosmetics
Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin care, hair care and oral hygiene products.


Herbal excipients:
Herbal Excipients - Significance of substances of natural origin as excipients - colorants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.


Herbal formulations:
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms like phytosomes

Unit - 4
Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs
Stability testing of herbal drugs. Patenting and Regulatory requirements of natural products:
a) Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and
Biopiracy
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma
& Neem.
Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs. 
Unit - 5
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects. A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India. Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.


Biopharmaceutics & pharmacokinetics 
UNIT-I 10
Hours
Introduction
Biopharmaceutics
to
Absorption; Mechanisms of drug absorption through GIT, factors influencing drug
absorption though GIT, absorption of drug from Non per oral extra-vascular
routes, Distribution Tissue permeability of drugs, binding of drugs, apparent, volume
of drug distribution, plasma and tissue protein binding of drugs, factors affecting
protein-drug binding. Kinetics of protein binding, Clinical significance of protein
binding of drugs
UNIT- II 10
Hours
Elimination: Drug metabolism and basic understanding metabolic pathways renal
excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non renal
routes of drug excretion of drugs
Bioavailability and Bioequivalence: Definition and Objectives of bioavailability, absolute and relative bioavailability, measurement of bioavailability, in-vitro drug
dissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods to
enhance the dissolution rates and bioavailability of poorly soluble drugs.
UNIT- III 10 Hours
Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment
models, Non compartment models, physiological models, One compartment open
model. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra
vascular administrations. Pharmacokinetics parameters - KE ,t1/2,Vd,AUC,Ka, Clt and
CLR- definitions methods of eliminations, understanding of their significance and application. 
UNIT- IV 08 Hours
Multicompartment models: Two compartment open model. IV bolus
Kinetics of multiple dosing, steady state drug levels, calculation of loading and
mainetnance doses and their significance in clinical settins.
UNIT- V 07 Hours
Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity. c. Michaelis-menton method of estimating parameters, Explanation with example of drugs.

Pharmaceutical Biotechnology
Unit 1
1. Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.
2. Enzyme Biotechnology- Methods of enzyme immobilization and applications.
3. Biosensors- Working and applications of biosensors in Pharmaceutical Industries.
4. Brief introduction to Protein Engineering.
5. Use of microbes in industry
6. Basic principles of genetic engineering

Unit 2
1. Study of cloning vectors, restriction endonucleases and DNA ligase.
2. Recombinant DNA technology
3. Application of r DNA technology and genetic engineering in the production of:
Interferon
Vaccines- hepatitis- B
Hormones-Insulin.
Unit 3
Types of immunity- humoral immunity, cellular immunity
1. Structure of Immunoglobulins
2. Structure and Function of MHC
3. Hypersensitivity reactions, Immune stimulation and Immune suppressions.
4. General method of the preparation of bacterial vaccines, toxoids, viral vaccine, antitoxins, serum-immune blood derivatives and other products relative to immunity.
5. Storage conditions and stability of official vaccines
6. Hybridoma technology- Production, Purification and Applications
7. Blood products and Plasma Substituties.

Unit 4
1. Immuno blotting techniques- ELISA, Western blotting, Southern blotting.
2. Genetic organization of Eukaryotes and Prokaryotes
3. Microbial genetics including transformation, transduction, conjugation, plasmids and transposons.
4. Introduction to Microbial biotransformation and applications.
5. Mutation: Types of mutation/mutants.

Unit 5
1. Fermentation methods and general requirements, study of media, equipments, sterilization methods, aeration process, stirring.
2. Large scale production fermenter design and its various controls.
3. Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid, Griseofulvin,
4. Blood Products: Collection, Processing and Storage of whole human blood, dried human plasma, plasma Substituties.

Pharmaceutical Quality Assurance
Unit 1
Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, Quality assurance and GMP

Total Quality Management (TQM): Definition, elements, philosophies

ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines

Quality by design (QbD): Definition, overview, elements of QbD program, tools

ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration

NABL accreditation: Principles and procedures


Unit 2
Organization and personnel: Personnel responsibilities, training, hygiene and personal records

Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination.

Equipments and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials


Unit 3
Quality Control: Quality control test for containers, rubber closures and secondary packing material

Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, and Control Articles, Protocol for Conduct of aNonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
Unit 4
Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and
waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula
Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and
documents, distribution records.
Unit 5
Calibration and Validation: Introduction, definition and general principles of calibration,
qualification and validation, importance and scope of validation, types of validation, validation
master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General
principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management
Subjects :
Instrumental methods of analysis
Industrial pharmacy 2
Pharmacy Practice
Novel drug delivery system


Instrumental Methods Of Analysis
Unit 1
UV Visible spectroscopy
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on absorption spectra, Beer and Lambert's law, Derivation and deviations.

Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectorsPhoto tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.

Applications - Spectrophotometric titrations, Single component and multi component analysis


Unit 2
IR Spectroscopy
Introduction, fundamental modes of vibrations in poly atomic molecules, sample handling, factors affecting vibrations

Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell, Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications


Flame Photometry
Principle, interferences, instrumentation and applications


Atomic absorption spectroscopy
Principle, interferences, instrumentation and applications


Nepheloturbidometry
Principle, instrumentation and applications


Unit 3
Introduction to chromatography

Adsorption and partition column chromatography
Methodology, advantages, disadvantages and applications.


Thin layer chromatography
Introduction, Principle, Methodology, Rf values, advantages, disadvantages and applications.


Paper chromatography
Introduction, methodology, development techniques, advantages, disadvantages and applications


Electrophoresis
Introduction, factors affecting electrophoretic mobility, Techniques of paper, gel, capillary electrophoresis, applications


Unit 4
Gas chromatography
Introduction, theory, instrumentation, derivatization, temperature programming, advantages, disadvantages and applications


High performance liquid chromatography (HPLC)
Introduction, theory, instrumentation, advantages and applications.


Unit 5
Ion exchange chromatography
Introduction, classification, ion exchange resins, properties, mechanism of ion exchange process, factors affecting ion exchange, methodology and applications


Gel chromatography
Introduction, theory, instrumentation and applications


Affinity chromatography
Introduction, theory, instrumentation and applications

Industrial Pharmacy 2
Unit 1
Pilot plant scale up techniques:
General considerations - including significance of personnel requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to platform technology


Unit 2
Technology development and transfer:
WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization - practical aspects and problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues


Unit 3
Regulatory affairs:
Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals


Regulatory requirements for drug approval:
Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.


Unit 4
Quality management systems:
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP


Unit 5
Indian Regulatory Requirements:
Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.


Pharmacy Practice
Unit 1
1. Hospital and it’s organization
Hospital and it’s organization Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals, Classification based on clinical and non- clinical basis, Organization Structure of a Hospital, and Medical staffs involved in the hospital and their functions


2. Hospital pharmacy and its organization
Definition, functions of hospital pharmacy, Organization structure, Location, Layout and staff requirements, and Responsibilities and functions of hospital pharmacists.


3. Adverse drug reaction
Classifications - Excessive pharmacological effects, secondary pharmacological effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions, and pharmacokinetic drug interactions, Methods for detecting drug interactions, spontaneous case reports and record linkage studies, and Adverse drug reaction reporting and management


4. Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal requirements for establishment and maintenance of a drug store, Dispensing of proprietary products, maintenance of records of retail and wholesale drug store.


Unit 2
1. Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of controlled drugs.


2. Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and Drug list, preparation and revision, and addition and deletion of drug from hospital formulary


3. Therapeutic drug monitoring
Need for Therapeutic Drug Monitoring, Factors to be considered during the Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.


4. Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence, and monitoring of patient medication adherence.


5. Patient medication history interview
Need for the patient medication history interview, medication interview forms.


6. Community pharmacy management
Financial, materials, staff, and infrastructure requirements.


Unit 3
1. Pharmacy and therapeutic committee
Organization, functions, Policies of the pharmacy and therapeutic committee in including drugs into formulary, inpatient and outpatient prescription, automatic stop order, and emergency drug list preparation.


2. Drug information services
Drug and Poison information centre, Sources of drug information, Computerised services, and storage and retrieval of information.


3. Patient counseling
Definition of patient counseling; steps involved in patient counseling, and Special cases that require the pharmacist


4. Education and training program in the hospital
Role of pharmacist in the education and training program, Internal and external training program, Services to the nursing homes/clinics, Code of ethics for community pharmacy, and Role of pharmacist in the interdepartmental communication and community health education.


5. Prescribed medication order and communication skills
Prescribed medication order- interpretation and legal requirements, and Communication skills- communication with prescribers and patients.


Unit 4
1. Budget preparation and implementation
Budget preparation and implementation


2. Clinical Pharmacy
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart review, clinical review, pharmacist intervention, Ward round participation, Medication history and Pharmaceutical care. Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern.


3. Over the counter (OTC) sales
Introduction and sale of over the counter, and Rational use of common over the counter medications.


Unit 5
1. Drug store management and inventory control
Organisation of drug store, types of materials stocked and storage conditions, Purchase and inventory control: principles, purchase procedure, purchase order, procurement and stocking, Economic order quantity, Reorder quantity level, and Methods used for the analysis of the drug expenditure


2. Investigational use of drugs
Description, principles involved, classification, control, identification, role of hospital pharmacist, advisory committee.


3. Interpretation of Clinical Laboratory Tests
Blood chemistry, hematology, and urinalysis

Novel Drug Delivery Systems
Unit 1
Controlled drug delivery systems:
Introduction, terminology/definitions and rationale, advantages, disadvantages, selection of drug candidates.Approaches to design controlled release formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and biological properties of drugs relevant to controlled release formulations


Polymers:
Introduction, classification, properties, advantages and application of polymers in formulation of controlled release drug delivery


Unit 2
Microencapsulation:
Definition, advantages and disadvantages, microspheres/microcapsules, microparticles, methods of microencapsulation, applications


Mucosal Drug Delivery system:
Introduction, Principles of bioadhesion /mucoadhesion, concepts, advantages and disadvantages, transmucosal permeability and formulation considerations of buccal delivery systems


Implantable Drug Delivery Systems:
Introduction, advantages and disadvantages, concept of implantsand osmotic pump


Unit 3
Transdermal Drug Delivery Systems:
Introduction, Permeation through skin, factors affecting permeation, permeation enhancers, basic components of TDDS, formulation approaches


Gastroretentive drug delivery systems:
Introduction, advantages, disadvantages, approaches for GRDDS - Floating, high density systems, inflatable and gastroadhesive systems and their applications


Nasopulmonary drug delivery system:
Introduction to Nasal and Pulmonary routes of drug delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays, nebulizers


Unit 4
Targeted drug Delivery:
Concepts and approaches advantages and disadvantages, introduction to liposomes, niosomes, nanoparticles, monoclonal antibodies and their applications


Unit 5
Ocular Drug Delivery Systems:
Introduction, intra ocular barriers and methods to overcome - Preliminary study, ocular formulations and ocuserts


Intrauterine Drug Delivery Systems:
Introduction, advantages and disadvantages, development of intra uterine devices (IUDs) and applications
Subjects :
Biostatistics and Research Methodology 
Social and Preventive Pharmacy
Pharmaceutical marketing
Pharmaceutical regulatory science
Pharmacovigilance
Quality control & standardization of herbals
Computer aided drug design
Cell & molecular biology
Cosmetic science 
Experimental pharmacology
Advanced instrumentation techniques


Biostatistics And Research Methodology

Unit 1
Introduction: Statistics, Biostatistics, Frequency distribution

Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples

Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical problems

Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation - Pharmaceuticals examples

Unit 2
Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x = a + by, Multiple regression, standard error of regression - Pharmaceutical Examples

Probability: Definition of probability, Binomial distribution, Normal distribution,

Poisson’s distribution, properties - problems

Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis, sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard error of mean (SEM) - Pharmaceutical examples

Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One way and Two way), Least Significance difference

Unit 3
Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-Wallis test, Friedman Test

Introduction to Research: Need for research, Need for design of Experiments, Experiential Design Technique, plagiarism

Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph

Designing the methodology: Sample size determination and Power of a study, Report writing and presentation of data, Protocol, Cohorts studies, Observational studies, Experimental studies, Designing clinical trial, various phases.

Unit 4
Blocking and confounding system for Two-level factorials

Regression modeling: Hypothesis testing in Simple and Multiple regressionmodels

Introduction to Practical components of Industrial and Clinical Trials Problems: Statistical Analysis Using Excel, SPSS, MINITAB®, DESIGN OF EXPERIMENTS, R - Online Statistical Software’s to Industrial and Clinical trial approach

Unit 5
Design and Analysis of experiments:

Factorial Design: Definition, 2², 2³ design. Advantage of factorial design

Response Surface methodology: Central composite design, Historical design, Optimization Techniques

Social And Preventive Pharmacy

Unit 1
Concept of health and disease: Definition, concepts and evaluation of public health. Understanding the concept of prevention and control of disease, social causes of diseases and social problems of the sick.Pharmacy booksBuy vitamins and supplements

Social and health education: Food in relation to nutrition and health, Balanced diet, Nutritional deficiencies, Vitamin deficiencies, Malnutrition and its prevention.

Sociology and health: Socio cultural factors related to health and disease, Impact of urbanization on health and disease, Poverty and health

Hygiene and health: personal hygiene and health care; avoidable habits

Unit 2
Preventive medicine: General principles of prevention and control of diseases such as cholera, SARS, Ebola virus, influenza, acute respiratory infections, malaria, chicken guinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer, drug addiction-drug substance abuse

Unit 3
National health programs, its objectives, functioning and outcome of the following: HIV AND AIDS control programme, TB, Integrated disease surveillance program (IDSP), National leprosy control programme, National mental health program, National programme for prevention and control of deafness, Universal immunization programme, National programme for control of blindness, Pulse polio programme

Unit 4
National health intervention programme for mother and child, National family welfare programme, National tobacco control programme, National Malaria Prevention Program, National programme for the health care for the elderly, Social health programme; role of WHO in Indian national program

Unit 5
Community services in rural, urban and school health: Functions of PHC, Improvement in rural sanitation, national urban health mission, Health promotion and education in school.


Pharma marketing management

Unit I 10 Hours
Marketing:
Definition, general concepts and scope of marketing; Distinction between marketing &
selling; Marketing environment; Industry and competitive analysis; Analyzing consumer
buying behavior; industrial buying behavior.
Pharmaceutical market:
Quantitative and qualitative aspects; size and composition of the market; demographic
descriptions and socio-psychological characteristics of the consumer; market
segmentation& targeting.Consumer profile; Motivation and prescribing habits of the
physician; patients' choice of physician and retail pharmacist.Analyzing the Market;Role
of market research.
Unit II 10 Hours
Product decision:
Classification, product line and product mix decisions, product life
cycle,product portfolio analysis; product positioning; New product decisions; Product
branding, packaging and labeling decisions, Product management in pharmaceutical
industry. Unit III 10 Hours
Promotion:
Methods, determinants of promotional mix, promotional budget; An overview of
personal selling, advertising, direct mail, journals, sampling, retailing, medical
exhibition, public relations, online promotional techniques for OTC Products.
Unit IV 10 Hours
Pharmaceutical marketing channels:
Designing channel, channel members, selecting the appropriate channel, conflict in
channels, physical distribution management: Strategic importance, tasks in physical
distribution management.
Professional sales representative (PSR):
Duties of PSR, purpose of detailing, selection and training, supervising, norms for
customer calls, motivating, evaluating, compensation and future prospects of the PSR.
Unit V 10 Hours
Pricing:
Meaning, importance, objectives, determinants of price; pricing methods and strategies,
issues in price management in pharmaceutical industry. An overview of DPCO
(Drug Price Control Order)and NPPA (National Pharmaceutical Pricing Authority). Emerging concepts in marketing:
Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing;
Global Marketing.


Pharmaceutical regulatory science

Unit I 10Hours
New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical
activities, clinical studies, Innovator and generics, Concept of generics, Generic drug
product development.
Unit II 10Hours
Regulatory Approval Process
Approval processes and timelines involved in Investigational New Drug (IND), New
Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an
approved NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia, Japan, Canada (Organization structure and types of applications)
Unit III 10Hours
Registration of Indian drug product in overseas market
Procedure for export of pharmaceutical products, Technical documentation, Drug Master
Files (DMF), Common Technical Document (CTD), electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD)research.
Unit IV 08Hours
Clinical trials
Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee - formation and working procedures, Informed consent process and
procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and
Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials
Unit V 07Hours
Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book

       Pharmacovigilance


Unit I 10 Hours
Introduction to Pharmacovigilance  History and development of Pharmacovigilance  Importance of safety monitoring of Medicine  WHO international drug monitoring programme  Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions  Definitions and classification of ADRs  Detection and reporting
 Methods in Causality assessment  Severity and seriousness assessment  Predictability and preventability assessment  Management of adverse drug reactions
Basic terminologies used in pharmacovigilance

 Terminologies of adverse medication related events  Regulatory terminologies
Unit II 10 hours
Drug and disease classification
 Anatomical, therapeutic and chemical classification of drugs  International classification of diseases  Daily defined doses  International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance  WHO adverse reaction terminologies  MedDRA and Standardised MedDRA queries  WHO drug dictionary
 Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance  Basic drug information resources  Specialised resources for ADRs
Establishing pharmacovigilance programme  Establishing in a hospital  Establishment & operation of drug safety department in industry
 Contract Research Organisations (CROs)  Establishing a national programme
Unit III 10 Hours
Vaccine safety surveillance  Vaccine Pharmacovigilance  Vaccination failure  Adverse events following immunization
Pharmacovigilance methods  Passive surveillance – Spontaneous reports and case series  Stimulated reporting
 Active surveillance – Sentinel sites, drug event monitoring and registries  Comparative observational studies – Cross sectional study, case control study and
cohort study
 Targeted clinical investigations
Communication in pharmacovigilance  Effective communication in Pharmacovigilance  Communication in Drug Safety Crisis management  Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media

Unit IV 8 Hours
Safety data generation
 Pre clinical phase  Clinical phase  Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance  Organization and objectives of ICH
 Expedited reporting
 Individual case safety reports  Periodic safety update reports  Post approval expedited reporting
 Pharmacovigilance planning
 Good clinical practice in pharmacovigilance studies
Unit V 7 hours
Pharmacogenomics of adverse drug reactions  Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
 Paediatrics  Pregnancy and lactation
 Geriatrics
CIOMS
 CIOMS Working Groups  CIOMS Form
CDSCO (India) and Pharmacovigilance  D&C Act and Schedule Y
 Differences in Indian and global pharmacovigilance requirements

Quality control & standardization of herbals


Unit I 10 hours
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage
forms
WHO guidelines for quality control of herbal drugs.
Evaluation of commercial crude drugs intended for use
Unit II 10 hours
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in
traditional system of medicine. WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines
WHO Guidelines on GACP for Medicinal Plants.
Unit III 10 hours
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
Unit IV 08 hours
Stability testing of herbal medicines.Application of various chromatographic techniques
in standardization of herbal products.
Preparation of documents for new drug application and export registration
GMP requirements and Drugs & Cosmetics Act provisions.
Unit V 07 hours
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems
Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products

Computer aided drug design


UNIT-I 10 Hours
Introduction to Drug Discovery and Development
Stages of drug discovery and development
Lead discovery and Analog Based Drug Design
Rational approaches to lead discovery based on traditional medicine, Random screening, Non-random screening, serendipitous drug discovery, lead discovery based on drug metabolism, lead discovery based on
clinical observation.
Analog Based Drug Design:Bioisosterism, Classification, Bioisosteric
replacement. Any three case studies
UNIT-II 10 Hours
Quantitative Structure Activity Relationship (QSAR)
SAR versus QSAR, History and development of QSAR, Types of
physicochemical parameters, experimental and theoretical approaches for
the determination of physicochemical parameters such as Partition
coefficient, Hammet’s substituent constant and Tafts steric constant.
Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like
COMFA and COMSIA.
UNIT-III 10 Hours
Molecular Modeling and virtual screening techniques
Virtual Screening techniques: Drug likeness screening, Concept of
pharmacophore mapping and pharmacophore based Screening, Molecular docking: Rigid docking, flexible docking, manual docking, Docking based screening. De novo drug design.
UNIT-IV 08 Hours
Informatics & Methods in drug design
Introduction to Bioinformatics, chemoinformatics. ADME databases, chemical, biochemical and pharmaceutical databases.
UNIT-V 07 Hours
Molecular Modeling: Introduction to molecular mechanics and quantum
mechanics.Energy Minimization methods and Conformational Analysis,
global conformational minima determination. 


    D.pharm

Subject :
Pharmaceutics
Pharmaceutical chemistry
Pharmacognosy
Human anatomy and physiology(HAP)
Social pharmacy


Subject :
Pharmacology
Community pharmacy & management(CPM)
Biochemistry & clinical pathology
Pharmacotherapeutics
Hospital & clinical pharmacy (HCP)
Pharmacy law & ethics

Pharmacology


Chapter 1

Introduction and scope of Pharmacology

 Various routes of drug administration - advantages and disadvantages
 Drug absorption - definition, types, factors affecting drug absorption
 Bioavailability and the factors affecting bioavailability
 Drug distribution - definition, factors affecting drug distribution
 Biotransformation of drugs - Definition, types of biotransformation reactions, factors influencing drug metabolisms
 Excretion of drugs - Definition, routes of drug excretion
 General mechanisms of drug action and factors modifying drug action

Chapter 2

Drugs Acting on the Peripheral Nervous System

 Steps involved in neurohumoral transmission
 Definition, classification, pharmacological actions, dose,indications, and contraindications of
a) Cholinergic drugs
b) Anti-Cholinergic drugs
c) Adrenergic drugs
d) Anti-adrenergic drugs
e) Neuromuscular blocking agents
f) Drugs used in Myasthenia gravis
g) Local anaesthetic agents
h) Non-Steroidal Anti-Inflammatory drugs
(NSAIDs)

Chapter 3 

Drugs Acting on the Eye

Definition, classification, pharmacological actions, dose,indications and contraindications of
 Miotics
 Mydriatics
 Drugs used in Glaucoma

Chapter 4 

Drugs Acting on the Central Nervous System

Definition, classification, pharmacological actions, dose,indications, and contraindications of
 General anaesthetics
 Hypnotics and sedatives
 Anti-Convulsant drugs
 Anti-anxiety drugs
 Anti-depressant drugs
 Anti-psychotics
 Nootropic agents
 Centrally acting muscle relaxants
 Opioid analgesics

Chapter 5

Drugs Acting on the Cardiovascular System

Definition, classification, pharmacological actions, dose,indications, and contraindications of
 Anti-hypertensive drugs
 Anti-anginal drugs
 Anti-arrhythmic drugs
 Drugs used in atherosclerosis and
 Congestive heart failure
 Drug therapy for shock

Chapter 6

Drugs Acting on Blood and Blood Forming Organs

Definition, classification, pharmacological actions, dose,indications, and contraindications of
 Hematinic agents
 Anti-coagulants
 Anti-platelet agents
 Thrombolytic drugs

Chapter 7 

Definition, classification, pharmacological actions, dose,indications, and contraindications of

 Bronchodilators
 Expectorants
 Anti-tussive agents
 Mucolytic agents

Chapter 8 

Drugs Acting on the Gastro Intestinal Tract

Definition, classification, pharmacological actions, dose,indications, and contraindications of
 Anti-ulcer drugs
 Anti-emetics
 Laxatives and purgatives
 Anti-diarrheal drugs

Chapter 9 

Drugs Acting on the Kidney

Definition, classification, pharmacological actions, dose,indications, and contraindications of
 Diuretics
 Anti-Diuretics

Chapter 10

Hormones and Hormone Antagonists

Physiological and pathological role and clinical uses of
 Thyroid hormones
 Anti-thyroid drugs
 Parathormone
 Calcitonin
 Vitamin D
 Insulin
 Oral hypoglycemic agents
 Estrogen
 Progesterone
 Oxytocin
 Corticosteroids

Chapter 11

Autocoids

 Physiological role of Histamine, 5 HT and Prostaglandins
 Classification, clinical uses, and adverse effects of antihistamines and 5 HT antagonists

Chapter 12

Chemotherapeutic Agents: 

Introduction, basic principles of chemotherapy of infections, infestations and neoplasticdiseases, Classification, dose, indication and contraindications of drugs belonging to following classes:
 Penicillins
 Cephalosporins
 Aminoglycosides
 Fluoroquinolones
 Macrolides
 Tetracyclines
 Sulphonamides
 Anti-tubercular drugs
 Anti-fungal drugs
 Anti-viral drugs
 Anti-amoebic agents
 Anthelmintics
 Anti-malarial agents
 Anti-neoplastic agents

Chapter 13 

Biologicals

Definition, types, and indications of biological agents with examples.


Community Pharmacy and Management 


1.Community Pharmacy Practice : 

Definition, history and development of community pharmacy - International and Indian
scenarios

2.Professional responsibilities of community pharmacists
Introduction to the concept of Good Pharmacy Practice and SOPs.


3.Prescription and prescription handling

 Definition, parts of prescriptions, legality of prescriptions,prescription handling, labelling of dispensed medications(Main label, ancillary label, pictograms), brief instructions on medication usage.
 Dispensing process, Good Dispensing Practices,
dispensing errors and strategies to minimize them.


4.Communication skills

 Definition, types of communication skills
 Interactions with professionals and patients
 Verbal communication skills (one-to-one, over the telephone)
 Written communication skills
 Body language
 Patient interview techniques


5.Patient counselling

 Definition and benefits of patient counselling
 Stages of patient counselling - Introduction, counselling content, counselling process, and closing the counselling session
 Barriers to effective counseling - Types and strategies to overcome the barriers
 Patient counselling points for chronic
diseases/disorders - Hypertension,Diabetes,Asthma,Tuberculosis, Chronic obstructive pulmonary disease, and
AIDS
 Patient Package Inserts - Definition, importance and benefits, Scenarios of PPI use in India and other countries
 Patient Information leaflets - Definition and uses

6.Medication Adherence

Definition, factors influencing non- adherence, strategies to overcome non-adherence


7.Health Screening Services in Community Pharmacy

Introduction, scope, and importance of various health screening services - for routine monitoring of patients, early detection, and
referral of undiagnosed cases

8.Over The Counter (OTC) Medications

 Definition, need and role of Pharmacists in OTC medication dispensing
 OTC medications in India, counseling for OTC products
 Self-medication and role of pharmacists in promoting the safe practices during self-medication
 Responding to symptoms, minor ailments, and advice for self-care in conditions such as - Pain management,Cough, Cold, Diarrhea,Constipation, Vomiting, Fever,Sore throat, Skin disorders, Oral health (mouth ulcers,dental pain, gum swelling)


10.Community Pharmacy Management

 Legal requirements to set up a community pharmacy
 Site selection requirements
 Pharmacy designs and interiors
 Vendor selection and ordering
 Procurement, inventory control methods, and inventory management
 Financial planning and management
 Accountancy in community pharmacy – Day book, Cash book
 Introduction to pharmacy operation softwares – usefulness and availability
 Customer Relation Management (CRM)
 Audits in Pharmacies
 SOP of Pharmacy Management
 Introduction to Digital Health, mHealth and Online pharmacies



Also you can get important questions , information about college,course fee,admission process and many more

After compleying B,D pharm you can prepare for enterance exam and also search for job.You can get information by clicking here