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.
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
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