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.

Integumentary system

Structure and functions of skin

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

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.

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.

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.

1. Pharmaceutical analysis

• Definition and scope
• Different techniques of analysis
• Methods of expressing concentration
• Primary and secondary standards.
• 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

2. Errors: Sources of errors, types of errors, methods of minimizing errors, accuracy, precision and significant figures

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

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

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.

Redox titrations

• Concepts of oxidation and reduction
• Types of redox titrations (Principles and applications)

Cerimetry, Iodimetry, Iodometry, Bromatometry, Dichrometry, Titration with potassium iodate

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.

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.

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

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.

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.

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

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

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.

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

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

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.

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)

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.

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.

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.

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

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

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

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

Lipid metabolism

β-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

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

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

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

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

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

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

Infectious diseases: Meningitis,Typhoid, Leprosy, Tuberculosis Urinary tract infections

Sexually transmitted diseases: AIDS, Syphilis, Gonorrhea Recommended Books (Latest Editions)

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

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

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

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.

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

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.

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.

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.

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.

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

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

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.

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.

Polynuclear hydrocarbons:

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

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

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

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

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.

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.

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.

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.

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

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,

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.

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. 83

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

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.

2. 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

3. 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

3. 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.

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.

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

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.

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

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

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.

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.

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

Synthetic cholinergic blocking agents:

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.

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. B

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

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.

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

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

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

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

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

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.

* eology:** 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

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.

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.

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

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.

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.

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.

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

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.

Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine.

Miscellaneous: Phenacaine, Diperodon, Dibucaine.*

Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.

• 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.

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

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

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

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.

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

1. 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

2. Pharmacology of drugs acting on urinary system

• Diuretics
• Anti-diuretics.

3. 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

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.

5. Pharmacology of drugs acting on endocrine system

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

6. Bioassay

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

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.

General introduction, composition, chemistry & chemical classes, biosources, therapeutic uses and commercial applications of following secondary metabolites:

Isolation, Identification and Analysis of Phytoconstituents

• Terpenoids: Menthol, Citral, Artemisin
• Glycosides: Glycyrhetinic acid & Rutin
• Alkaloids: Atropine,Quinine,Reserpine,Caffeine
• Resins: Podophyllotoxin, Curcumin

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

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.

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.

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

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

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)

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 D efinition, 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)

1. Pharmacology of drugs acting on Respiratory system

• 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.

3. Chemotherapy

• General principles of chemotherapy.
• Sulfonamides and cotrimoxazole.
• Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and fluoroquinolins, tetracycline and aminoglycosides

3. Chemotherapy

• Antitubercular agents
• Antileprotic agents
• Antifungal agents
• Antiviral drugs
• Anthelmintics
• Antimalarial drugs
• Antiamoebic agents

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

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

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

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.

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.

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

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.

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.

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.

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.

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.

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

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

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

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

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

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

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

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.

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

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.

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

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

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

Gas chromatography

Introduction, theory, instrumentation, derivatization, temperature programming, advantages, disadvantages and applications

High performance liquid chromatography (HPLC)

Introduction, theory, instrumentation, advantages and applications.

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

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

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

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

Targeted drug Delivery:

Concepts and approaches advantages and disadvantages, introduction to liposomes, niosomes, nanoparticles, monoclonal antibodies and their applications

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

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.

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.

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.

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.

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

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.

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

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

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

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

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.

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

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

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.

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

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