B Pharma Course Certification- Henry Harvin®

Semester 1

Subject: Pharmaceutics-I (General and Dispensing Pharmacy)

Theory

1. Standardization of analytical weights and calibration of volumetric apparatus.

2. Acid Base Titrations : Acid base concepts, Role of solvent, Relative strengths of acids and bases, Ionization, Law of mass action, Common Ion effect, Ionic product of water, pH, Hydrolysis of salts, Henderson-Hasselbalch equation, Buffer solutions, Neutralization curves, Acid-base indicators,·' Theory of indicators, Choice of indicators, mixed indicators, Polyprotic system, Polyamine and amino acid systems, Amino acid titration, applications in assay of Hl04,NaOH, CaC03 etc

3. Oxidation Reduction Titrations : Concepts of oxidation and reduction, Redox reactions, Strengths and equivalent weights of oxidizing and reducing agents, Theory of redox titrations, Redox indicators, Cell representations, Measurement of electrode potential, Oxidation-reduction curves, Iodimetry and Iodometry, Titrations involving ceric sulfate, potassium iodate, potassium bromate, potassium permanganate; titanous chloride and Sodium 2, 6-dichlorophenol indophenol.

4. Precipitation Titrations: Precipitation reactions, Solubility products, Effect of acids, temperature and solvent upon the solubility of a precipitate. Argentometric titrations and titrations involving ammonium or potassium thiocyanate, mercuric nitrate, and barium sulfate, Indicators, Gaylussac method; Mohr's method, Volhard's method and Fajan's method.

5. Gravimetric Analysis: Precipitation techniques, Solubility products; The colloidal state, Supersaturation co-precipitation, Postprecipitation, Digestional washing of the precipitate, Filtration, Filter papers and crucibles, Ignition, Thermogravimetric curves, Specific examples like barium sulfate, aluminum as aluminum oxide, calcium as calcium oxalate and magnesium as magnesium pyrophosphate, Organic precipitants.

Practical

1. Standardization of analytical weights and calibration of volumetric apparatus.

2. Acid Base Titrations : Preparation and standardization of acids and bases; some exercises related with determination of acids and bases separately or in mixture form, some official assay procedures e.g. boric acid should also be covered.

3. Oxidation Reduction Titrations : Preparation and standardization of some redox titrants e.g. potassium permanganate, potassium dichromate, iodine, sodium thiosulphate, etc. Some exercises related to determination of oxidizing and reducing agents in the sample shall be covered. Exercises involving potassium iodate, potassium bromate, iodine solution, titanous chloride, sodium 2, 6- dichlorophenol indophenol, and ceric ammonium sulfate.

4. Precipitation titrations : Preparation and standardization of titrants like silver nitrate and ammonium thiocyanate, Titrations according to Mohr's, Volhard's and Fajan's methods.

5. Gravimetric Analysis: Preparation of gooch crucible for filtration and use of sintered glass crucible, Determination of water of hydration, Some exercises related to gravimetric analysis should be covered.

Subject: Remedial Mathematics Or Remedial Biology

Theory

1. Algebra : Equations reducible to quadratics, simultaneous equations (linear and quadratic), Determinants, properties of solution of simultaneous equations by Cramer's rule, matrices, definition of special kinds of matrices, arithmetic operations on matrices, inverse of a matrix, solution of simultaneous equations by matrices, pharmaceutical applications of determinants and matrices. Evaluation of Enl, En2, and En3, mensuration and its pharmaceutical applications.

2. Measures of Central Value: Objectives and prerequisites of an ideal, measure, mean, mode and median.

3. Trigonometry: Measurement of angle, T-ratios, addition, subtraction and transformation formulae, T -ratios of multiple, submultiple, allied and certain angles. Application of logarithms in pharmaceutical computations.

4. Analytical Plans Geometry: Certain coordinates, distance between two points, area of triangle, a locus of point, straight line., slope and intercept form, double intercept form, normal (perpendicular form), slope-point and two point form, general equation of first degree.

5. Calculus : Differential : Limits and functions, definition of differential coefficient, differentiation of standard functions, including function of a function (Chain rule). Differentiation of implicit functions, logarithmic differentiation, parametric differentiation, successive differentiation. Integral : Integration as inverse of differentiation, indefinite integrals of standard forms, integration by parts, substitution and partial fractions, formal evaluation of definite integrals. Or

or

1. Methods of classification of plants.

2. Plant Cell: It's structure and non-living inclusions; mitosis and meiosis; different types of plant tissues and their functions

3. Morphology and histology of root, stem, bark, wood, leaf, flower, fruit and seed. Modification of root and stem.

4. General Survey of Animal Kingdom; Structure and life history of parasites as illustrated by amoeba, entamoeba, trypanosoma, plasmodium, taenia, ascaris, schistosoma, oxyuris, and ancylostoma

5. General Structure and life history of insects like mosquito, housefly, mites and silkworm

Practical

1. Morphology of plant parts indicated in theory.

2 Care, use and type of microscopes.

3. Gross identification of slides of structure and life cycle of lower plants animals mentioned in theory

4. Morphology of plant parts indicated in theory

5. preparation, microscopic examination of stem, root and leaf of monocot and dicot plants

6. structure of human parasites and insects mentioned in theory with the help of specimens

Subject: Pharmacognosy – I

Theory

1. definition, history, scope and development of Pharmacognosy

2. Sources of drugs : Biological, marine, mineral and plant tissue cultures as sources of drugs

3. Classification of drugs : Alphabetical, morphological, taxonomical, chemical and pharmacological classification of drugs

4. plant taxonomy : study of the following families with special reference to medicinally important plants – Apocynaceae, Solanaceae, Rutaceae, Umbelliferae, Leguminosae, Rubiaceae, Liliaceae, Gramineae, Labiatae, Cruciferae, Papaveraceae.

5. Cultivation, Collection, Processing and storage of crude drugs: Factors influencing cultivation of medicinal plants. Types of soils and fertilizers of common use. Pest management and natural pest control agents. Plant hormones and their applications. Polyploidy, mutation and hybridization with reference to medicinal plants.

6. quality control of cr4ude drugs: Adulteration of crude drugs and their detection by organoleptic, microscopic, physical, chemical and biological methods and properties

7. An introduction to active constituents of drugs: their isolation, classification and properties

8. Systematic pharmacognostic study of following a) Carbohydrates and derived products: agar, guar gum acacia, Honey, Isabgol, pectin, Starch, sterculia and Tragacanth. b) Lipids: Beeswax, Castor oil, Cocoa butter, Cod~liver oil, Hydnocarpus oil, Kokum butter, Lard, Linseed oil, Rice, Bran oil, Shark liver oil and Wool fat.

Practical

1. Morphological characteristics of plant families mentioned in theory.

2. Microscopic measurements of cells and Cell contents: Starch grains, calcium oxalate crystals and phloem fibers

3. Determination of leaf constants such as stomatal index, stomatal number, vein islet number, vein-termination number and palisade ratio.

4. Identification of crude drugs belonging to carbohydrates and lipids.

5. Preparation of herbarium sheets.

Subject: Pharmaceutical Chemistry - I (Inorganic Pharmaceutical Chemistry)

Theory

1. Acids and Bases: Buffers, Water.

2. Gastrointestinal Agents : Acidifying agents, Antacids, Protectives and Adsorbents, Cathartics

3. Major Intra-and Extra-cellular Electrolytes: Physiological ions. Electrolytes used for replacement therapy, acid-base balance and combination therapy.

4. Essential and Trace Elements: Transition elements and their compounds of pharmaceutical importance : Iron and haematinics, mineral supplements

5. Cationic and anionic components of inorganic drugs useful for systemic effects.

6. Topical Agents: Protectives, Astringents and Anti-infectives

7. Gasses and Vapours : Oxygen, Anesthetics and Respiratory . stimulants

8. Dental Products: Dentifrice, Anti-caries agents.

9. Complexing and chelating agents used in therapy

10. Miscellaneous Agents: Sclerosing agents, expectorants, emetics, poisons and antidotes, sedatives etc. Pharmaceutical Aids Used in the Pharmaceutical Industry. Anti-oxidants, preservatives, filter aids, adsorbents, diluents, excipients, suspending agents, colorants etc.

11. Inorganic RadioPharmaceuticals: Nuclear radiopharmaceuticals, Reactions, Nomenclature, Methods of obtaining their standards and units of activity, measurement of activity, clinical applications and dosage, hazards and precautions.

Practical

The background and systematic qualitative analysis of inorganic mixtures of up to four radicals. Six Mixtures to be analyzed, preferably by semimicro methods. Identification tests for pharmacopoeial inorganic pharmaceuticals and qualitative tests for cations & anions should be covered.

Subject: Basic Electronics and Computer Applications

Theory

1. Basic Electronics: Semiconductors, p-n junction diode, LED, photodiode and its uses. Rectifiers (half wave, full wave/ with filters) Transistors configurations, Transistor amplifiers.

Introduction to Integrated circuits, photocells and photomultiplier tubes.

2. Computers

2.1 Introduction to Computers.

2. 1. History of Computer development and respective generation: Abacus, Napier's Bones, Slide rule, Pascal's Calculator. Need to use computers, applications in pharmacy and in general. Computer Classification: Mainframe, Mini and Micro Computers, comparison of Analog & Digital Computers, Hardware and Software. Calculator and Computer

2.2. Operating Systems: Introduction to types of operating systems, UNIX, MS-DOS, etc. RAM, ROM, Virtual Memory etc.

2.3. Type of Languages: Conventional languages; their advantages, limitations; C, Pascal, FORTRAN, Programming of these languages

2.4. Introduction to Computer Networks: Architecture of seven layers of communications.

2.5. Introduction to Data Structure: Like Queues, list, trees, Binary trees algorithms, Flow chart, Structured Systems, Analysis and development, Ingress-SQL, Gateways etc. Statistics, methodologies. Basic Language: Constants and Variables: Character set, constants, variables, Naming the variables getting data into memory, LET, INPUT, READ. DATA, Print Statement. Expressions: Arithmetic expression, Hierarchy of operations, Rules of Arithmetic, Evaluation of expressions, Relational expressions, Logical operations, Library functions. Printer Control: Comma and semicolon control, the TAB function, PRINT, LPRINT. Functions and Subroutines: User defined functions, subroutines, subscripted variables.

2.6. Computer Graphics

2.7. Computer applications in pharmaceutical and clinical studies.

Practical

1. Computer operating systems like Unix, MS DOS, etc. (practical)

2. Simple program in BASIC

3. Study of soft-ware packages like WORD-STAR, LOTUS-123 etc.

Subject: Pharmaceutics - I (Physical Pharmacy)

Theory

1. Matter, Properties of Matter : State of matter, change in the state of matter, latent heats and vapor pressure, sublimation-critical point, Eutectic mixtures, gasses, aerosols-inhalers, relative humidity, liquid. complexes, liquid crystals, glassy state, solids-crystalline, amorphous and polymorphism.

2. Micromeritics and Powder Rheology: Particle size and distribution, average particle size, number and weight distribution, particle number, methods for determining particle volume, optical microscopy, Asieving, sedimentation, measurement, particle shape, specific surface, methods for determining surface area; permeability, adsorption, derived properties of powders, porosity, packing arrangement, densities, bulkiness & flow properties.

3. Surface and Interfacial Phenomenon: Liquid interface, surface and interfacial tensions, surface free energy, measurement of surface and interfacial tensions, spreading coefficient, adsorption at liquid interfaces, surface active agents, HLB classification, solubilization, detergency, adsorption at solid interfaces, solid-gas and solid-liquid interfaces, complex films, electrical properties 0 meter ace.

4. Viscosity and 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 ball, rotational viscometers.

5. Dispersion Systems: Colloidal Dispersions: Definition, types, properties of colloids, protective colloids, applications of colloids in pharmacy; Suspensions and Emulsions: Interfacial properties of suspended particles, settling in suspensions, theory of sedimentation, effect of Brownian movement" sedimentation of flocculated articles, sedimentation parameters, wetting of particles, controlled flocculation, flocculation in structured vehicles, rheological considerations; Emulsions-types, theories, physical stability.

6. Complexation: Classification of complexes, methods of preparation and analysis, applications.

7. Kinetics and Drug Stability: General considerations & concepts, half-life determination, Influence of temperature, light, solvent, catalytic species and other factors, Accelerated stability study, expiration dating.

8. 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.

Practical

1. Determination of latent heat, vapor pressure, critical point.

2. Studies on polymorphs, their identification and properties.

3. Determination of particle size, particle size distribution and surface area using various methods of particle size analysis.

4. Determination of derived properties of powders like density, porosity, compressibility, angle of repose etc.

5. Determination of surface/interfacial tension, HLB value and critical micellar concentration of surfactants.

6. Study of rheological properties of various types of systems using different Viscometers.

7. Studies of different types of colloids and their properties.

8. Preparation of various types of suspensions and determination of their sedimentation parameters.

9. Preparation and stability studies of emulsions.

10. Studies on different types of complexes and determination of their stability constants.

11. Determination of half-life, rate constant and order of reaction.

12. To study the influence of various factors on the rate of reaction.

13. Accelerated stability testing, shelf-life determination and expiration dating of pharmaceuticals. 14. Preparation of pharmaceutical buffers and determination of buffer capacity. 15. Experiments involving tonicity adjustments
Semester 2

Subject: Advanced Mathematics

1. Differential equations: Revision of integral calculus, definition and formation of differential equations, equations of first order and first degree, variable separable, homogeneous and linear differential equations and equations reducible to such types, linear differential equations of order greater than one with constant coefficients, complementary function and particular integral, simultaneous linear differential equations, pharmaceutical applications.

2. Laplace transforms : Definition, transforms of elementary functions, properties of linearity and shifting, inverse Laplace transforms, transforms of derivatives, solution of ordinary and simultaneous differential equations.

3. Biometrics: Significant digits bend rounding of numbers, data collection, random and non-random sampling methods, sample size, data organization, diagrammatic representation of data, bar, pie, 2-D and 3-D diagrams, measures of central tendency, measures of dispersion, Standard Deviation and standard error of means, coefficient of variation, confidence (fiducial) limits, probability and events, Bayes' theorem, probability theorems, probability distributions, elements of binomial and Poisson distribution, normal Distribution curve & properties, kurtosis and skewness, correlation and regression analysis, method of least squares, statistical inference, Student's and paired t-test, F-test and elements of ANOVA, applications of statistical concepts in Pharmaceutical Sciences.

Subject: Pharmaceutical Chemistry - II (Physical Chemistry)

1. Behavior of Gases: Kinetic theory of gasses, deviation from behaviors and explanation.

2. The Liquid State: Physical properties (surface tension, parachor, viscosity, refractive index, optical rotation, dipole moments and chemical constituents).

3. Solutions: Ideal and real solutions, solutions of gasses in liquids, colligative properties, partition coefficient, conductance and its measurement, Debye Huckel theory.

4. There dynamics: First, second and third laws, Zeroth law, absolute temperature scale, thermochemical equations, phase equilibria and phase rule.

5. Adsorption: Freudlich and Gibbs adsorption, isotherms, Langmuir theory of adsorption

6. Photochemistry: Consequences of light absorption, Jablenski diagram, Lambert Beer Law, Quantum efficiency.

7. Chemical Kinetics: Zero, first and second order reactions, complex reactions, theories of reaction kinetics, characteristics of homogeneous and heterogeneous catalysis, acid base and enzyme catalysis

8. Quantum Mechanics : Postulates of quantum mechanics, operators in quantum mechanics, the schrodinger wave equation.

Practical

1. To determine molar mass by Rast method and cryoscopic method.

2 To determine the refractive index of given liquids and find out the contribution of carbon, hydrogen and oxygen in molar refraction of a compound.

3. To determine molar mass of volatile liquids by Victor-Meyer method.

4. To determine the specific rotation of sucrose at various concentrations and determine the intrinsic rotation.

5. To determine the heat of solution, heat of hydration and heat of neutralization.

6. To determine the cell constant, verify Ostwald dilution law and perform conductometric titration.

7. To determine the rate constant of a simple reaction.

Subject: Pharmaceutical Chemistry - III (Organic Chemistry)

Theory

1. Structure and Properties : Atomic structure, Atomic orbitals, Molecular orbital theory, wave equation, Molecular orbitals, Bonding and Antibonding orbitals, Covalent bond, Hybrid orbitals, Intramolecular forces, Bond dissociation energy, Polarity of bonds, Polarity of molecules, structure and physical properties, Intermolecular forces, Acids and bases.

2. Stereochemistry : Isomerism and nomenclature and associated physicochemical properties, optical activity, stereoisomerism, specification of configuration, Reactions involving stereoisomers, chirality, chiral reagents conformations.

3. Structure; Nomenclature; Preparation and Reactions of: Alkanes, Alkenes, Alkynes; Cycloalkanes, Dienes, Benzene, Polynuclear aromatic compounds, Arenes, Alkyl halides, Alcohols, Ethers, Epoxides, Amines, Phenols, Aldehydes and ketones, Carboxylic acids, Functional derivatives of' carboxylic acids, Reactive intermediates - carbocations, carbanions, carbenes, nitrene and nitrenium ions

Practical

1. The student should be introduced to the various laboratory techniques through demonstrations involving synthesis of selected organic compounds (e.g. aspirin, p-bromoacetanilide, anthraquinone from anthracene, reduction of nitrobenzene etc)

2. Identification of organic compounds and their derivatization.

3. Introduction to the use of stereo models.

Subject: Anatomy, Physiology & Health Education (APHE) -I

Theory

1. Scope of anatomy and physiology and basic terminology used these subjects.

2. Structure of cell, its components and their functions.

3. Elementary Tissues of the Human Body: Epithelial, connective, muscular and nervous tissues, their sub-types and their characteristics.

4. Osseous System : Structure, composition and functions of skeleton Classification of joints, types of movements of joints, Disorders of joints.

5. Skeletal Muscles : Gross anatomy; physiology of muscle contraction, physiological properties of skeletal muscles and their disorders.

6. Haemopoietic System : Composition and functions of blood and its elements, their disorders, blood groups and their significance, mechanism of coagulation, disorders of platelets and coagulation.

7. Lymph and Lymphatic System : Composition, formulation and circulation of lymph; disorders of lymph and lymphatic system. Basic physiology and functions of spleen.

8. Cardiovascular System: Basic anatomy of the heart, Physiology of heart, blood vessels and circulation. Basic understanding of Cardiac cycle, heart sounds and understanding of Cardiac cycle, heart sounds and electrocardiogram. Blood pressure and its regulation. Brief outline of cardiovascular disorders like hypertension, hypotension, arteriosclerosis, angina, myocardial infarction, congestive heart failure and cardiac arrhythmias.

Practical

1. Study of human skeleton.

2. Study of different systems with the help of charts and models.

3. Microscopic study of different tissues

4. Estimation of hemoglobin in blood. Determination of bleeding time, clotting time, R.B.C. Count, Total leucocyte count, D.L.C. and E.S.R.

5 Recording of body temperature, pulse rate and blood pressure, basic understanding of Electrocardiogram-PQRST waves and their significance.
Semester 3

Subject: Pharmaceutics - II (Unit Operations I)

Theory

1. Unit Operations: Introduction, basic laws.

2. Fluid Flow: Types of flow, Reynold's number, Viscosity, Concept of boundary layer, basic equations of fluid flow, valves, flow meters, manometers and measurement of flow and pressure.

3. Material Handling Systems: a. Liquid handling - Different types of pumps. b. Gas handling-Various types of fans, blowers and compressors. c. Solid handling-Bins, Bunkers, Conveyors, Air transport

4. Filtration and Centrifugation: Theory of filtration, filter aids, filter media, industrial filters including filter press, rotary filter, edge filter, etc. Factors affecting filtration, mathematical problems on filtration, optimum cleaning cycle in batch filters. Principles of centrifugation, industrial centrifugal filters, and centrifugal sedimentares.

5. Crystallization: Characteristics of crystals like-purity, size, shape, geometry, habit, forms size and factors affecting them, Solubility curves and calculation of yields. Material and heat balances around Swenson Walker Crystallizer. Supersaturation theory and its limitations, Nucleation mechanisms, crystal growth. Study of various types of Crystallizer, tanks, agitated batch, Swenson Walker, Single vacuum, circulating magma and krystal Crystallizer, Caking of crystals and its prevention. Numerical problems on yields

6. Dehumidification and Humidity Control: Basic concepts and definition, wet bulb and adiabatic saturation temperatures, Psychrometric chart and measurement of humidity, application of humidity measurement in pharmacy, equipment for dehumidification operations.

7. Refrigeration and Air Conditioning: Principal and applications of refrigeration and air conditioning.

8. Material of Construction : General study of composition

Practical

1. Measurement of flow of fluids and their pressure, determination of Reynold's number and calculation of Frictional losses.

2. Evaluation of filter media, determination of rate of filtration and study of factors affecting filtration.

3. Experiments to demonstrate applications of centrifugation.

4. Thermometers and Psychrometric charts

5. Determination of humidity - use of Dry Bulb and Wet Bulb.

6. Elementary Knowledge of Engineering Drawing - Concept of orthographic and isometric views of elevation and third angle projection. Notation and abbreviation used in Engineering drawing.

7. Basic Engineering Drawing Practice - Bolts, nuts, riveted fronts, screws, worn screws as per specification.

8. Drawing of simple pharmaceutical machinery parts.

Subject: Pharmaceutical Chemistry - IV (Organic Chemistry - II)

Theory

Nucleophilic aromatic substitutions; α β unsaturated carbonyl compounds; Conservation of orbital symmetry and rulesElectrocyclic, Cycloaddition and sigmatropic reactions; Neighboring group effects; Catalysis by transition metal complexes, Stereoselective and stereospecific reactions; New organic reagents used in drug synthesis. Heterocyclic Compounds: Chemistry, preparations and properties of some important heterocycles containing 3, 4,5,6 & 7 atoms with one or two heteroatoms like 0, N, S. Chemistry of lipids, Carbohydrates, Proteins and Nucleic acids.

Practical

At least five exercises in synthesis involving various heterocyclic ring systems. An exercise involving stereoselective synthesis of a compound. Resolution of racemic DLalanine or any other example. Workshop on molecular modeling of primary, secondary and tertiary structures of proteins, molecular modeling on double helical structure of nucleic acid showing hydrogen bonding

Subject: Pharmacognosy - II

Theory

1. Resins: Study of Drugs Containing Resins and Resin Combination like Colophony, podophyllum, jalap, cannabis, capsicum, myrrh, asafoetida, balsam of tolu, balsam of peru, benzoin, turmeric, ginger.

2. Tannis : Study of tannins and tannin containing drugs like Gambir, black catechu, gall and myrobalan.

3. Volatile Oils : General methods of obtaining volatile oils from plants, Study of volatile oils of Mentha, Coriander, Cinnamon, Cassia, Lemon peel, Orange peel, Lemon grass, Citronella, Caraway, Dill, Spearmint, Clove, Fennel, Nutmeg, Eucalyptus, Chenopodium, Cardamom, Valerian, Musk, Palmarosa, Gaultheria, Sandalwood.

4. Phytochemical Screening: a. Preparation of extracts. b. Screening of alkaloids, saponins, cardenolides and bufadienolides, flavonoids and leucoanthocyanidins, tannins and polyphenols, anthraquinones, cyanogenic glycosides, amino acids in plant extracts.

5. Fibers: Study of fibers used in pharmacy such as c0tton, silk, wool, nylon, glasswool, polyester and asbestos

6. Pharmaceutical aids: Study of pharmaceutical aids like talc, diatomite, kaolin, bentonite, gelatin and natural colors.

Practical

1. Identification of crude drugs mentioned in theory.

2. Study of fibers and pharmaceutical aids.

3. Microscopic studies of seven-selected crude drugs and their powders mentioned under the category of volatile oils in theory and their chemical tests,

4. General chemical tests for alkaloids, glycosides, steroids, flavonoids and tannins.

Subject: Pharmaceutical Analysis - II

Theory

1.Theoretical considerations, and application in drug analysis and quality control of the following analytical techniques 1. Non-aqueous titrations

2. Complexometric titrations

3. Miscellaneous Methods of Analysis: Diazotization titrations, Kjeldahl method of nitrogen estimation, Karl-Fischer titration, Oxygen flask combustion, gasometry.

4. Extraction procedures including separation of drugs from excipients

5. Chromatography: The following techniques will be discussed with relevant examples of Pharmacopoeial products. TLC, HPLC, GLC, HPTLC, Paper Chromatography and Column Chromatography

6. Potentiometry

7. Conductometry

8. Coulometry

9. Polarography

10. Amperometry

Practical

1. Non Aqueous Titrations: Preparation and standardization of perchloric acid and sodium/potassium/lithium methoxide solutions; Estimations of some pharmacopoeial products.

2. Complexometric Titrations : Preparations and standardization of EDTA solution, some exercises related to pharmacopoeial assays by complexometric titrations.

3. Miscellaneous Determinations: Exercises involving diazotization, Kjeldahl, KarlFischer, Oxygen flask combustion and gasometry methods. Determination of alcohol content in liquid galenicals, procedure (BPC) shall be covered.

4. Experiments involving separation of drugs from excipients.

5. Chromatographic analysis of some pharmaceutical products.

6. Exercises based on acid base titration in aqueous and nonaqueous media, oxidation-reduction titrations using potentiometric technique, Determination of acid-base dissociation constants and plotting of titration curves using pH meter.

7. Exercises involving polarimetry.

8. Exercises involving conductometric and polarographic techniques.

Subject: Anatomy, Physiology and Health Education (APHE -II)

Theory

1. Digestive System: Gross anatomy of the gastro-intestinal tract, functions of its different parts including those of liver, pancreas and gallbladder, various gastrointestinal secretions and their role in the absorption and digestion of food. Disorders of the digestive system.

2. Respiratory System: Anatomy of respiratory organs & its functions, respiration, mechanism and regulation of respiration, respiratory volumes and vital capacity.

3. Central Nervous System: Functions of different parts of the brain and spinal cord. Neurohumoral transmission in the central nervous system, reflex action electroencephalogram, specialized functions of the brain, Cranial nerves and their functions.

4. Autonomic Nervous System : Physiology and functions of the autonomic nervous system. Mechanism of neurohumoral transmission in the A.N.S.

5. Urinary System: Various parts, structures and functions of the kidney and urinary tract. Physiology of urine formation and acid-base balance. Diseases of the urinary system.

6. Reproductive System: Male and female reproductive systems and their hormones, physiology of menstruation, coitus and fertilization. Sex differentiation, spermatogenesis & oogenesis. Pregnancy, maintenance and parturition.

7. Endocrine System: Basic anatomy and physiology of Pituitary, Thyroid, Parathyroid. Adrenals, Pancreas, Testes and ovaries, their hormones and functions.

8. Sense Organs: Basic anatomy and physiology of the eye (vision), ear (hearing), taste buds, nose (smell) and skin (superficial receptors).

9. a. Concepts of health and disease: Disease causing agents and prevention of disease.

b. Classification of food requirements: Balanced diet, nutritional deficiency disorders, their treatment and prevention, specifications for drinking water.

c. Demography and family planning : Medical termination of pregnancy.

d. Communicable diseases: Brief outline, their causative agents, modes of transmission and prevention (Chicken pox, measles, influenza, diphtheria, whooping cough, tuberculosis, poliomyelitis, helminthiasis, malaria, filariasis, rabies, trachoma, tetanus, leprosy, syphilis, gonorrhea, and AIDS).

e. First Aid: Emergency treatment of shock, snake bites, burns, poisoning, fractures and resuscitation methods.

Practical

1. Study of different systems with the help of charts and models.

2. Microscopic studies of different tissues.

3. Simple experiments involved in the analysis of normal and abnormal urine: Collection of specimen, appearance, determination of pH, Sugars, proteins, urea and creatinine.

4. Physiological experiments on nerve-muscle preparations.

5. Determination of vital capacity, experiments on spirometry
Semester 4

Subject: Pharmaceutics - III (Unit Operations II)

Theory

1. Stoichiometry: Unit processes material and energy balances, molecular units, mole fraction, tie substance, gas laws, mole volume, primary and secondary quantities, equilibrium state, rate process, steady and unsteady states, dimensionless equations, dimensionless formulae, dimensionless groups, different types of graphic representation, mathematical problems.

2. Heat Transfer: Source of heat, heat transfer, steam and electricity as heating media, determination of requirement of amount of steam/electrical energy, steam pressure, Boiler capacity, Mathematical problems on heat transfer.

3. Evaporation: Basic concept of phase equilibria, factor affecting evaporation, evaporators, film evaporators, single effect and multiple effect evaporators, Mathematical problems on evaporation.

4. Distillation: Rault's law, phase diagrams, volatility; simple steam and flash distillations, principles of rectification, Mc. Cabe Thiele method for calculations of number of theoretical plates, Azeotropic and extractive distillation. Mathematical problems on distillation.

5. Drying: Moisture content and mechanism of drying, rate of drying and time of drying calculations; classification and types of dryers, dryers used in pharmaceutical industries a..'1d special drying methods. Mathematical problems on drying. .

6. Size Reduction and Size Separation: Definition, objectives of size reduction, factors affecting size reduction, laws governing energy and power requirements of a mill including ball mill, hammer mill, fluid energy mill etc.

7. Mixing: Theory of mixing, solid-solid, solid-liquid and liquid liquid mixing equipment.

8. Automated Process Control Systems : Process variables, temperature, pressure, flow, level and vacuum and their measurements. Elements of automatic process control and introduction to automatic process control systems. Elements of computer aided manufacturing (CAM).

9. Reactors and fundamentals of reactors design for chemical reactions.

Practical

1. Determination of overall heat transfer coefficient.

2. Determination of rate of evaporation.

3. Experiments based on steam, extractive and azeotropic distillations.

4. Determination of rate of drying, free moisture content and bound moisture content.

5. Experiments to illustrate the influence of various parameters on the rate of drying.

6. Experiments to illustrate principles of size reduction, Laws governing energy and power requirements of size Reduction.

7. Experiments to illustrate solid-solid mixing, determination of mixing efficiency using different types of mixers.

Subject: Pharmaceutical Microbiology

Theory

1. Introduction to the scope of microbiology.

2. Structure of bacterial cells.

3. Classification of microbes and their taxonomy. Actinomycetes, bacteria, rickettsiae, spirochetes and viruses.

4. Identification of Microbes : Stains and types of staining techniques, electron microscopy.

5. Nutrition, cultivation, isolation of bacteria, actinomycetes, fungi, viruses, etc.

6. Microbial genetics and variation.

7. Control of microbes by physical and chemical methods. a. Disinfection, factors influencing disinfectants, dynamics of disinfection, disinfectants and antiseptics and their evaluation. b. Sterilization, different methods, validation of sterilization methods & equipment.

8. Sterility testing of all pharmaceutical products.

9. Immunity, primary and secondary, defensive mechanisms of the body, microbial resistance, interferon.

10. Microbial assays of antibiotics, vitamins & amino acids.

Practical

Experiments devised to prepare various types of culture media, subculturing of common aerobic and anaerobic bacteria, fungus and yeast, various staining methods, various methods of isolation and identification of microbes, sterilization techniques and their validation, evaluation of antiseptics and disinfectants, testing the sterility of pharmaceutical products as per I.P. requirements, microbial assay of antibiotics and vitamins, etc.

Subject: Pharmacognosy - III

Theory

1. Study of the biological sources, cultivation, collection, commercial varieties, chemical constituents, substitutes, adulterants, uses, diagnostic macroscopic and microscopic features and specific chemical tests of following groups of drugs containing glycosides : (i) Saponins : Liquorice, ginseng, dioscorea, sarsaparilla, and senega. (ii) Cardioactive sterols: Digitalis, squill, strophanthus and thevetia. (iii) Anthraquinone cathartics: Aloe, senna, rhubarb and cascara. (iv) Others: Psoralea, Ammi majus, Ammi visnaga, gentian, saffron, chirata, quassia.

2. Studies of traditional drugs, common vernacular names, botanical sources, morphology, chemical nature of chief constituents, pharmacology, categories and common uses and marketed formulations of following indigenous drugs: Amla, Kantkari, Shatavari, Tylophora, Bhilawa, Kalijiri, Bach, Rasna, Punamava, Chitrack, Apamarg, Gokhru, Shankhapushpi, Brahmi, Adusa, Atjuna, Ashoka, Methi, Lahsun, Palash, Guggal, Gymnema, Shilajit, Nagarmotha and Neem.

3. The holistic concept of drug administration in traditional systems of medicine. Introduction to ayurvedic preparations like Arishtas, Asvas, Gutikas, Tailas, Chumas, Lehyas and Bhasmas.

Practical

1. Identification of crude drugs listed in theory.

2. Microscopic study of some important glycoside containing crude drugs as outlined above. Study of Powdered drugs.

3. Standardization of some traditional drug formulations.

Subject: Pathophysiology of Common Diseases

Theory

1. Definition and Scope

2. Prescription: Handling of prescription, source of errors in prescription, care required in dispensing procedures including labeling of dispensed products.

3. General dispensing procedures including labeling of dispensed products

4. Pharmaceutical calculations: Posology, calculation of doses for infants, adults and elderly patients; Enlarging and reducing recipes percentage solutions, allegation, alcohol dilution, proof spirit, isotonic solutions, displacement value etc.

5. Principles involved and procedures adopted in dispensing of : Typical prescriptions like mixtures, solutions, emulsions, creams, ointments, powders, capsules, pastes, jellies, suppositories, ophthalmics, pastilles, lozenges, pills, lotions, liniments, inhalations, paints sprays tablet triturates, etc.

6. Incompatibilities: Physical and chemical incompatibilities, inorganic incompatibilities including incompatibilities of metals and their salts, non-metals, acids, alkalis, organic incompatibilities. Purine bases, alkaloids, pyrazolone derivatives, amino acids, quaternary ammonium compounds, carbohydrates, glycosides, anesthetics, dyes, surface active agents, correction of incompatibilities. Therapeutic incompatibilities.

7. Community Pharmacy: Organization and structure of retail and wholesale drugstore-types of drug store and design, legal requirements for establishment, maintenance and drug store-dispensing of proprietary products, maintenance of records of retail and wholesale, patient counseling, role of pharmacist in community health care and education.

Practical

1. Dispensing of prescriptions falling under the categories : Mixtures, solutions, emulsions. creams, ointments, powders, suppositories, ophthalmics, capsules, pastes, jellies, pastille, lozenges, pills, tablet triturates, lotions, liniments, inhalations, paints, etc.

2. Identification of various types of incompatibilities in prescription, correction thereof and dispensing of such prescriptions.

3. Dispensing procedures involving pharmaceuticals calculations, pricing of prescriptions and dosage calculations for pediatric and geriatric patients.

4. Dispensing of prescriptions involving adjustment of tonicity.

5. Categorization and storage of pharmaceutical products based on legal requirements of labeling and storage.

6. Project report on visit to the nearby Community for counseling on the rational use of drugs and aspects of health care
Semester 5

Subject: Pharmaceutical Chemistry –V (Biochemistry)

Theory

1. Biochemical organization of the cell and transport processes across cell membranes.

2. The concept of free energy, determination of change in free energy - from equilibrium constant and reduction potential, bioenergetics, production of ATP and its biological significance.

3. Enzymes: Nomenclature, enzyme kinetics and its mechanism of action, mechanism of inhibition, enzymes and iso-enzymes in clinical diagnosis.

4. Coenzymes: Vitamins as coenzymes and their significance. Metals as coenzymes and their significance.

5. Carbohydrate Metabolism: Conversion of polysaccharide to glucose-I-phosphate, Glycolysis and fermentation and their regulation, Gluconeogenesis and glycogenolysis, Metabolism of galactose and galactosemia, Role of sugar nucleotides in biosynthesis, and Pentose Phosphate pathway.

6. The Citric Acid Cycle: Significance, reactions and energetic of the cycle, Amphibolic role of the cycle, and Glyoxylic acid cycle.

7. Lipids Metabolism : Oxidation of fatty acids, ~-oxidation & energetic, oxidation, c.o-oxidation, Biosynthesis of ketone bodies and their utilization. Biosynthesis of saturated and unsaturated fatty acids, Control of lipid metabolism, Essential fatty acids & eicosanoids (prostaglandins, thromboxanes and leukotrienes), phospholipids, and sphingolipids.

8. Biological Oxidation : Redox-potential, enzymes and co-enzymes involved in oxidation reduction & its control, The respiratory chain, its role in energy capture and its control, Energetics of oxidative phosphorylation, Inhibitors of respiratory chain and oxidative phosphorylase Mechanism of oxidative phosphorylation.

9. Nitrogen & Sulphur Cycle : Nitrogen fixation. ammonia assimilation, nitrification and nitrate assimilation, Sulphate activation. sulfate reduction. Incorporation of sulfur in organic compounds, Release of sulfur from organic compounds.

10. Metabolism of Ammonia and Nitrogen Containing Monomers : Nitrogen balance. Biosynthesis of amino acids. Catabolism of amino acids. Conversion of amino acids to specialized products, Assimilation of ammonia. Urea. cycle, metabolic disorders of urea cycle. Metabolism of sulfur containing amino acids. Porphyrin biosynthesis. formation of bile pigments. hyperbilirubinemia. Purine biosynthesis. Purine nucleotide interconversion. Pyrimidine biosynthesis. and Formation of deoxyribonucleotides.

11. Biosynthesis of Nucleic Acids: Brief introduction of genetic organization of the mammalian genome, alteration and rearrangements of genetic material, Biosynthesis of DNA and its replication. Mutation. Physical & chemical mutagenesis / carcinogenesis. DNA repair mechanism. Biosynthesis of RNA.

12. Genetic Code and Protein Synthesis: Genetic code. Components of protein synthesis. and Inhibition of protein synthesis. Brief account of genetic engineering and polymerase chain reactions.

13. Regulation of gene expression.

Practical

1. Preparation of standard buffers (citrate, phosphate and carbonate) and measurement of pH.

2. Titration curve for amino acids.

3. Separation of amino acids by two dimensional paper chromatography and gel electrophoresis.

4. The separation of lipids by TLC.

5. Separation of serum proteins by electrophoresis on cellulose acetate.

6. Quantitative estimation of amino acids.

7. Quantitative estimation of proteins.

8. The identification of c-terminal amino acids of a protein.

9.The determination of glucose by means of the enzyme glucose. Oxidase.

10. The isolation and assay of glycogen from the liver and skeletal muscle of rats.

11 Enzymatic hydrolysis of glycogen by. alpha- and beta-amylases.

12. The isolation and determination of RNA and DNA.

13. Effect of temperature on the activity of alpha - amylase.

14. Estimation of SGOT, SGPT, ALP and BRN in the serum.

Subject: Pharmaceutics - V (Pharmaceutical Technology I)

Theory

1. Liquid Dosages Forms: Introduction, types of additives used in formulations, Vehicles, stabilizers, preservatives, suspending agents, emulsifying agents, solubilizer, colors, flavors and others, manufacturing packaging and evaluation of clear liquids, suspensions and emulsions official in pharmacopeia.

2. Semisolid Dosage Forms: Definitions, types, mechanisms of drug penetration, factors influencing penetration, semisolid bases and their selection. General formulation of semisolids, clear gels manufacturing procedure, evaluation and packaging.

3. Suppositories: Ideal requirements, bases, manufacturing procedure, packaging and evaluation.

4. Extraction and Galenical Products : Principle and method of extraction, preparation of infusion, tinctures, dry and soft liquid extracts.

5. Blood Products and Plasma Substitutes: Collection, processing and storage of whole human blood, concentrated human RBCs, dried human plasma, human fibrinogen, human thrombin, human normal immunoglobulin, human fibrin, foam plasma substitutes, -ideal requirements, PVP, dextran etc. for control of blood pressure as per I.P.

6. Pharmaceutical Aerosols : Definition, propellants, general formulation, manufacturing and packaging methods, pharmaceutical applications.

7. Ophthalmic Preparations: Requirements, formulation, methods of preparation, containers, evaluation.

8. Cosmeticology and Cosmetic Preparations: Fundamentals of cosmetic science, structure and functions of skin and hair. Formulation, preparation and packaging of cosmetics for skin, hair, dentifrice and manicure preparations like nail polish, Lipsticks, eye lashes, baby care products etc.

Practical

1. Preparation, evaluation and packaging of liquid orals like solutions, suspensions and emulsions, ointments, suppositories, aerosols, eye drops, eye ointments etc.

2. Preparation of pharmacopoeial extracts and galenical products utilizing various methods of Extraction.

3. Collection, processing, storage and fractionation of blood

4. Formulation of various types of cosmetics for skin, hair, dentifrices and manicure preparations.

Subject: Pharmacology I

Theory

1. General Pharmacology: Introduction to Pharmacology, Sources of drugs, Dosage forms and routes of administration, mechanism of action, Combined effect of drugs, Factors modifying drug action, tolerance and dependence, Pharmacogenetics. Absorption, Distribution, Metabolism and Excretion of drugs, Principles of Basic and Clinical pharmacokinetics, Adverse Drug Reactions and treatment of poisoning, ADME drug interactions, Bioassay of Drugs and Biological Standardization, Discovery and development of new drugs.

2. Pharmacology of Peripheral Nervous System: a. Neurohumoral transmission (autonomic and Somatic) b. Parasympathomimetics, Parasympatholytics, Sympathomimetics, Adrenergic Receptor and neuron blocking agents, Ganglionic, stimulants and blocking agents. c. Neuromuscular blocking Agents. d. Local anesthetic Agents

3. Pharmacology of Central Nervous System: a) Neurohumoral transmission in the C.N.S. b) General Anesthetics. c) Alcohol and disulfiram. d) Sedatives, hypnotics, Anti-anxiety agents and Centrally acting muscle relaxaNts. e) Psychopharmacological agents (anti-psychotics) antidepressants, maniacs and hallucinogens. t) Antiepileptics drugs. g) Anti-Parkinsonian Drugs. h) Analgesics, Antipyretics, Anti-inflammatory and Anti-gout drugs. i) Narcotic analgesics and antagonists. J) C.N .S. stimulants k) Drug Addiction and Drug Abuse.

Practical

1. Introduction to Experimental Pharmacology : Preparation of different solutions for experiments. Drug dilutions, use of molar and w/v solutions in experimental pharmacology. Common laboratory animals and anesthetics used in animal studies. Commonly used instruments in experimental pharmacology. some common and standard techniques. Bleeding and intravenous injection, intragastric administration. Procedures for rendering animals unconscious-stunning of rodents, pithing of frogs, chemical euthanasia.

2. Experiments on intact preparations Study of different routes of administration of drugs in mice/rats. To study the effect of hepatic microsomal enzyme inhibitors and induction on the pentobarbitone sleeping time in mice.

3. Experiments on Central Nervous system: Recording of spontaneous motor activity, stereotypy, analgesia, anticonvulsant activity, anti- inflammatory activity, and muscle relaxant activity of drugs using simple experiments. .

4. Effects of autonomic drugs on rabbit's eye.

5. Effects of various agonists and antagonists and their characterization using isolated preparations like frog's rectus abdominis muscle " and isolated ileum preparations of rat, guinea pig and rabbit.

Subject: Pharmacognosy - IV

Theory

1. Systematic study of source, cultivation, collection, processing, commercial varieties, chemical constituents, substitutes, adulterants, uses, diagnostic macroscopic and microscopic features and specific chemical tests of following alkaloid containing drugs: a) Pyridine - piperidine: Tobacco, areca and lobelia. b) Tropane: Belladonna, hyoscyamus, datura, duboisia, coca and withania c) Quinoline and isoquinoline : Cinchona, ipecac, opium. d) Indole : Ergot, rauwolfia, catharanthus, nux-vomica and physostigma e) Imidazole: Pilocarpus f) Steroidal: Veratrum and kurchi g) Alkaloidal amine: Ephedra and colchicum. h) Glycoalkaloid: Solanum. i) Purines: Coffee, tea and cola.

2. Role of medicinal and aromatic plants in the national economy.

3. Biological sources, preparation, identification tests and uses of the following enzymes: Diastase, papain, pepsin, trypsin, pancreatin.

4. General techniques of biosynthetic studies and basic metabolic pathways. Brief introduction to biogenesis of secondary metabolites of pharmaceutical importance.

5. Plant bitters and sweeteners

6. Introduction, classification and study of different chromatographic methods and their applications in evaluation of herbal drugs.

Practical

i) Identification of crude drugs listed above.

ii) Microscopic study of characters of eight - selected drugs given in theory in entire and powdered form.

iii) Chemical evaluation of powdered drugs and enzymes.

iv) Chromatographic studies of some herbal constituents

Subject: Pharmaceutics VI (Hospital Pharmacy)

Theory

1. Organization and Structure : Organization of a hospital and hospital pharmacy, Responsibilities of a hospital pharmacist, Pharmacy and therapeutic committee, Budget preparation and Implementation.

2. Hospital Formulary : Contents, preparation and revision of hospital formulary.

3. Drug Store Management and Inventory Control: (a) Organization of drug store, Types of materials stocked, storage conditions. (b) Purchase and Inventory Control principles, purchase procedures, Purchase order, Procurement and stocking.

4. Drug distribution Systems in Hospitals: (a) Out-patient dispensing, methods adopted. (b) Dispensing of drugs to in-patients. Types of drug distribution systems. Charging policy, labeling. (c) Dispensing of drugs to ambulatory patients. (d) Dispensing of controlled drugs.

5. Central Sterile Supply Unit and their Management: Types of materials for sterilization, Packing of materials prior to sterilization, sterilization equipment, Supply of sterile materials.

6. Manufacture of Sterile and Nonsterile Products: Policy making of manufacturable items, demand and costing, personnel requirements, manufacturing practice, Master formula Card, production control, Manufacturing records.

7. Drug Information Services: Sources of Information on drugs, disease, treatment schedules, procurement of information, Computerized services (e.g., MEDLINE), Retrieval of information, Medication error.

8. Records and Reports: Prescription filling, drug profile, patient medication profile, cases on drug interaction and adverse reactions, idiosyncratic cases etc.

9. Nuclear Pharmacy: Introduction to Radio- pharmaceuticals, radio-active halflife, Units of radio-activity Production of radio-pharmaceuticals, methods of isotopic tagging, preparation of radio-isotopes in laboratory using radiation dosimetry, radio-isotope generators, Permissible radiation dose level, Radiation hazards and their prevention, specifications for radio-active laboratory.

Practical

1. Experiments based on sterilization of various types of materials used in Hospitals.

2. Practicals designed on the use of computers in Drug Information Centre, prescription filling, documentation of information on drug interaction.

3. Experiments to illustrate handling of radiopharmaceutical products, measurement of radioactivity
Semester 6

Subject: Pharmaceutical Chemistry - [V (Medicinal Chemistry - I)

Theory

1. Basic Principles of Medicinal Chemistry: Physico-chemical aspects (Optical, geometric and bioisosterism) of drug molecules and biological action, Drugreceptor interaction including transduction mechanisms.

2. Principles of Drug Design (Theoretic~fll Aspects) : Traditional analog (QSAR) and mechanism based approaches (Introduction 00' graph theory, applications of quantum mechanics, Computer Aided Drug Designing (CADD) andro molecular modeling

3. Synthetic procedures of selected drugs, mode of action, uses, structure activity relationship including physicochemical properties of the following classes of drugs: A.Drugs acting at Synaptic and neuro-effector junction sites: i. Cholinergics and Anticholinesterases ii. Adrenergic drugs iii. Antispasmodic and anti ulcer drugs iv. Neuromuscular blocking agents. B.Autacoids i. Antihistamines ii. Eicosanoids iii. Analgesic-antipyretics, anti-inflammatory (non-steroidal) agents. C.Drugs affecting uterine motility Oxytocics (including oxytocin, ergot alkaloids and prostaglandins' Biochemical approaches in drug designing wherever applicable should be discussed.

Practical

1. Exercises based on QSAR: Hansch & Free-Wilson methods.

2. Synthesis of selected drugs from the course content.

3. Spectral analysis of the drugs synthesized

4. Establishing the pharmacopoeial standards of the drugs synthesized.

5. Determination of partition coefficient, dissociation constant and molar refractivity of compounds for QSAR analysis.

Subject: Pharmaceutical Jurisprudence & Ethics

Theory

1. Introduction a. Pharmaceutical Legislations - A brief review. b. Drugs & Pharmaceutical Industry - A brief review. c. Pharmaceutical Education - A brief review.

2. An elaborate study of the following a. Pharmaceutical Ethics b. Pharmacy Act 1948. c. Drugs and Cosmetics Act 1940 and Rules 1945. d. Medicinal & Toilet Preparations (Excise Duties) Act 1955. e. Narcotic Drugs & Psychotropic Substances Act 1985 & Rules. f. Drugs Price Control Order.

3. A brief study of the following with special reference to the main provisions. a. Poisons Act 1919 b. Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 c. Medical Termination of Pregnancy Act 1970 & Rules 1975. d. Prevention of Cruelty to Animals Act 1960. e. States Shops & Establishments Act & Rules. f. Insecticides Act 1968. g. AICTE Act 1987. h. Factories Act 1948. j. Minimum Wages Act 1948. k Patents Act 1970.

4. A brief study of the various Prescription/Non-prescription Products, Medical /Surgical accessories, Diagnostic aids, appliances available in the market. Note: The teaching of all the Acts should cover the latest amendments.

Subject: Pharmaceutics VII (Biopharmaceutics & Pharmacokinetics)

Theory

1. Introduction to Biopharmaceutics and Pharmacokinetics and their role in formulation development and clinical setting.

2. Biopharmaceutics 2.1. Passage of drugs across biological barriers (passive diffusion, active transport, facilitated diffusion and pinocytosis). 2.2. Factors influencing absorption - Physicochemical, physiological and pharmaceutical. 2.3. Drug distribution in the body, plasma protein binding

3. Pharmacokinetics : 3.1. Significance of plasma drug concentration measurement. 3.2. Compartment model-Definition and Scope. 3.3. Pharmacokinetics of drug absorption - Zero order and first order absorption rate constant using Wagner - Nelson and Loo- Reigelman method. 3.4. Volume of distribution and distribution coefficient. 3.5. Compartment kinetics - One compartment and two compartment models. Determination of pharmacokinetic parameters from plasma and urine data after drug administration by intravascular and oral route. 3.6. Curve fitting (method of Residuals), regression procedures. 3.7. Clearance concept, Mechanism of renal clearance, clearance ratio, determination of renal clearance. 3.8. Extraction ratio, hepatic clearance, biliary excretion, Extrahepatic circulation. 3.9. Non-linear pharmacokinetics with special reference to one compartment model after 1. V drug administration, Michaelis Menten Equation, detection of nonlinearity (Saturation mechanism)

4. Clinical Pharmacokinetics: 4.1. Definition and scope 4.2. Dosage adjustment in patients with and without renal and hepatic failure. 4.3. Design of single dose bioequivalence study and relevant statistics. 4.4. Pharmacokinetic drug interactions and their significance in combination therapy.

5. Bioavailability and bioequivalence : 5.1. Measures of bioavailability, Cmax, t max, and Area Under the Curve (AUe). 5.2. Design of single dose bioequivalence study and relevant statistics. 5.3. Review of regulatory requirements for conduction of bioequivalence studies

Practical

1. Experiments designed for the estimation of various pharmacokinetic parameters with given data.

2. Analysis of biological specifications for drug content and estimation of the pharmacokinetic parameters

3. In vitro evaluation of different dosage forms for drug release.

4. Absorption studies - in- vitro and in -situ.

5. Statistical treatment of pharmaceutical data.

Subject: Pharmacology - II

Theory

1. Pharmacology of Cardiovascular System: a) Digitalis and cardiac glycosides. b) Antihypertensive drugs. c) Antianginal and Vasodilator drugs, including calcium channel blockers and beta adrenergic antagonists. d) Antiarrhythmic drugs e) Antihyperlipidemic drugs f) Drugs used in the therapy of shock.

2 Drugs Acting on the Hematopoietic System: a) Hematinics. b) Anticoagulants, Vitamin K and hemostatic agents. c) Fibrinolytic and antiplatelet drugs. d) Blood and plasma volume expands.

3. Drugs acting on urinary system: a) Fluid and electrolyte balance b) Diuretics

4. Autacoids : a) Histamine, 5-HT and their antagonists. b) Prostaglandins, thromboxanes and leukotrienes. c) Pentagastrin, Cholecystokinin, Angiotensin, Bradykinin and Substance P. 5. Drugs Acting on the Respiratory System: a) Anti-asthmatic drugs including bronchodilators. b) Antitussives and expectorants. c) Respiratory stimulants.

Practical

1. Experiments on Isolated Preparations: a) To record the concentration response curve (CRC) of acetylcholine using rectus abdominis muscle preparation of frogs.

b) To study the effects of physostigmine and d-tubocurarine on the CRC of acetylcholine using rectus abdominis muscle preparation of frogs.

c) To record the CRC of 5-HT on rat fundus preparation.

d) To record the CRC of histamine on guinea pig ileum preparation.

e) To record the CRC of noradrenaline on rat anococcygeus muscle preparation.

f) To record the CRC of oxytocin using rat uterus preparation.

2. Pharmacology of Cardiovascular System: a) To study the ionotropic and chronotropic effects of drugs on isolated frog hearts. b) To study the effects of drugs on normal and hypodynamic frog hearts.

3. Blood Pressure of anesthetized Dog/Cat/Rat : To demonstrate the effects of various drugs on the B.P. and respiration including the Vasomotor Reversal of Dale and nicotinic action of acetylcholine
Semester 7

Semester 7

Subject: Pharmacognosy - V (Chemistry of Natural Products)

Theory

1. Chemical and spectral approaches to simple molecules of natural origin

2. Concept of stereoisomerism taking examples of natural products.

3. Chemistry, biogenesis and pharmacological activity of medicinally important monoterpenes, sesquiterpenes, diterpenes, and triterpenoids.

4. Carotenoids: α-carotenoids, β-carotenes, vitamin A, Xanthophylls of medicinal importance.

5. Glycosides : Chemistry and biosynthesis of digitoxin, digoxin, hecogenin, sennosides, diosgenin and sarsasapogenin.

6. Alkaloids: Chemistry, biogenesis and pharmacological activity of atropine and related compounds; quinine, reserpine, morphine, papaverine, ephedrine, ergot and vinca alkaloids.

7. Chemistry and biogenesis of medicinally important lignans and quassinoids, flavonoids.

8. Chemistry and therapeutic activity of penicillin, streptomycin and tetracyclines

Practical

i) Laboratory experiments on isolation, separation, purification of various groups of chemical constituents of pharmaceUtical significance.

ii) Exercises on paper and thin layer chromatographic evaluations of herbal drug constituents.

Subject: Pharmaceutical Biotechnology

Theory

1. Immunology and Immunological Preparations : Principles, antigens and haptens, immune system, cellular humoral immunity, immunological tolerance, antigen-antibody reactions and their applications. Hypersensitivity, Active and passive immunization; Vaccines- their preparation, standardization and storage.

2. Genetic Recombination : Transformation, conjugation, transduction, protoplast fusion and gene cloning and their applications. Development of hybrid om a for monoclonal antibodies. Study of drugs produced by biotechnology such as Activase, Humulin, Humatrope, HB etc.

3. Antibiotics: Historical development of antibiotics. Antimicrobial spectrum and methods used for their standardization. Screening of soil for organisms producing antibiotics, fermenter, its design, control of different parameters. Isolation of mutants, factors influencing rate of mutation. Design of fermentation process. Isolation of fermentation products with special reference to penicillins, streptomyces tetracyclines and vitamin B12•

4. Microbial Transformation : Introduction, types of reactions mediated by microorganisms, design of biotransformation processes, selection of organisms, biotransformation process and its improvements with special reference to steroids.

5. Enzyme immobilization: Techniques of immobilization, factors affecting enzyme kinetics. Study of enzymes such as hyaluronidase, penicillinase, streptokinase and streptodornase, amylases and proteases etc. Immobilization of bacteria and plant cells.

Subject: Pharmaceutics - VIII (Pharmaceutical Technology II)

Theory

1. Capsules: Advantages and disadvantages of capsule dosage form, material for production of hard gelatin capsules, size of capsules, method of capsule filling, soft gelatin, capsule shell and capsule content, importance of base absorption and minimum/gm factors in soft capsules, quality control, stability testing and storage of capsule dosage forms.

2. Micro-encapsulation: Types of microcapsules, importance of microencapsulation in pharmacy, microencapsulation by phase separation, coacervation, multi orifice, spray drying, spray congealing, polymerisation complex emulsion, air suspension technique, coating pan and other techniques, evaluation of microcapsules.

3. Tablets: a) Formulation of different types of tablets, granulation, technology on large-scale by various techniques, physics of tablet making, different types of tablet compression machinery and the equipment employed, evaluation of tablets. b) Coating of Tablets : Types of coating, film forming materials, formulation of coating solution, equipment for coating, coating process, evaluation of coated tablets. c) Stability kinetics and quality assurance.

4. Parenteral Products: a) Preformulation factors, routes of administration, water for injection, pyrogenicity, non aqueous vehicles, isotonicity and methods of its adjustment b) Formulation details, containers and closures and selection. c) Prefilling treatment, washing of containers and closures, preparation of solution and suspensions, filling and closing of ampoules, vials, infusion fluids, lyophilization & preparation of sterile powders, equipment for large scale manufacture and evaluation of parenteral products. d) Aseptic Techniques-source of contamination and methods of prevention, Design of aseptic area, Laminar flow bench services and maintenance. e) Sterility testing of pharmaceuticals.

5. Surgical products : Definition, primary wound dressing, absorbents, surgical cotton, surgical gauzes etc., bandages, adhesive tape, protective cellulosic hemostatics, official dressings, absorbable and nonabsorbable sutures, ligatures and catguts. Medical prosthetics and organ replacement materials.

6. Packaging of Pharmaceutical Products: Packaging components, types, specifications and methods of evaluation, stability aspects of packaging. Packaging equipment, factors influencing choice of containers, legal and other official requirements for containers, package testing.

Practical

1. Experiments to illustrate preparation, stabilization, physical and biological evaluation of pharmaceutical products like powders, capsules, tablets, parenterals, micro capsules, surgical dressing etc.

2. Evaluation of materials used in pharmaceutical packaging.

Subject: Pharmaceutical Industrial Management

Theory

1. Concept of Management : Administrative Management (Planning, Organizing, Staffing, Directing and Controlling), Entrepreneurship development, Operative Management (Personnel, Materials, Production, Financial, Marketing, Time/space, Margin/Morale). Principles of Management (Coordination, Communication, Motivation, Decision-making, leadership, Innovation, Creativity, Delegation of Authority / Responsibility, Record Keeping). Identification of key points to give maximum thrust for development and perfection

2. Accountancy: Principles of Accountancy, Ledger posting and book entries, preparation of trial balance, columns of a cash book, Bank reconciliation statement, rectification of errors, Profits and loss account, balance sheet, purchase, keeping and pricing of stocks, treatment of cheques, bills of exchange, promissory notes and hundies, documentary bills.

3. Economics: Principles of economics with special reference to the laws of demand and supply, demand schedule, demand curves, labor welfare, general principles of insurance and inland and foreign trade, procedure of exporting and importing goods

4. Pharmaceutical Marketing : Functions, buying, selling, transportation, storage, finance, feedback, information, channels of distribution, wholesale, retail, departmental store, multiple shop and mail order business.

5. Salesmanship: Principles of sales promotion, advertising, ethics of sales, merchandising, literature, detailing. Recruitment, training, evaluation, compensation to the pharmacist.

6. Market Research: (a) Measuring & Forecasting Market Demands-Major concept in demand measurement, Estimating current demand, Geodemographic analysis, Estimating industry sales, Market share & Future demand. (b) Market Segmentation & Market Targeting

7. Materials Management: A brief exposure or basic principles of materials management-major areas, scope, purchase, stores, inventory control and evaluation of materials management.

8. Production Management: A brief exposure of the different aspects of Production Management-Visible and Invisible inputs, Methodology of Activities, Performance Evaluation Technique, Process-Flow, Process Knowhow, Maintenance Management.

Subject: Pharmacology - III

Theory

1.Drugs Acting on the Gastrointestinal Tract: (a) Antacids, AntiSecretory and Antiulcer drugs. (b) Laxatives and antidiarrheal drugs. (c) Appetite Stimulants and Depressants (d) Emetics and antiemetics. (e) Miscellaneous-Carminatives, demulcents, protectives, adsorbents, astringents, digestants, enzymes and mucolytics.

2.Pharmacology of Endocrine System: (a) Hypothalamic and pituitary hormones (b) Thyroid hormones and anti thyroid drugs, parathormone, calcitonin and Vitamin D. (c) Insulin, oral hypoglycemic agents & glucagon. (d) ACTH and corticosteroids. (e) Androgens and anabolic steroids. (f) Estrogens, progesterone and oral contraceptives. (g) Drugs acting on the uterus.

3.Chemotherapy: (a) General Principles of Chemotherapy. (b) Sulfonamides and cotrimoxazole. (c) Antibiotics-Penicillins, Cephalosporins, Chloramphenicol Erythromycin, Quinolones and Miscellaneous Antibiotics. (d) Chemotherapy of tuberculosis, leprosy, fungal diseases, viral diseases, urinary tract infections and sexually transmitted diseases. (e) Chemotherapy of malignancy and Immunosuppressive Agents.

4.Principles of Toxicology : (a) Definition of poison, general principles of treatment of poisoning with particular reference to barbiturates, opioids, organophosphorus and atropine poisoning. (b) Heavy metals and heavy metal antagonists.

Practical

1.Experiments on Isolated Preparations: (a) To calculate the pA2 value of atropine using acetylcholine as an agonist on rat ileum preparation. (b) To calculate the pA2 value of mepyramine or chlorpheniramine using histamine as agonist on guinea pig ileum. (c) To estimate the strength of the test sample of agonist/drug (e.g. Acetylcholine, Histamine, 5 -HT, Oxytocin, etc) using a suitable isolated muscle preparation employing Matching bioassay, Bracketing assay, Three point assay and Four point bioassay.

2. Pharmacology of the Gastrointestinal Tract: To study the Anti- secretary and anti-ulcer activity using pylorus

3.Clinical pharmacology : To determine the effects of certain clinically useful drugs on human volunteers like: (a) Antihistamines (b) Anti-anxiety and sedative drugs (c) Analgesics (d) Beta blockers.

Subject: Pharmaceutical Chemistry - VII (Medicinal Chemistry - II)

Theory

1.Synthetic procedures of selected drugs, mode of action, uses, structure activity relationship including Physico-Chemical properties of the following classes of drugs. 1. Steroids and related drugs : Steroidal nomenclature and stereochemistry, androgens and anabolic agents, estrogens, and progestational agents, adrenocorticoids.

2. Drugs acting on the Central Nervous System: General Anesthetics, Local Anesthetics, Hypnotics and Sedatives, Opioid analgesics, antitussives, anticonvulsants, Antiparkinsonism drugs, CNS stimulants, Psychopharmacological agents (neuroleptics, antidepressants, anxiolytics).

3. Diuretics, Cardiovascular drugs, Anticoagulant and Antiplatelet drugs

Practical

1. Workshop on stereomodel use of some selected drugs.

2. Synthesis of selected drugs from the course content involving two or more steps and their spectral analysis.

3. Establishing the Pharmacopoeial standards of the drugs synthesized
Semester 8

Semester 8

Subject: Pharmaceutics IX (Dosage Form Design)

Theory

1. Preformulation studies: a) Study of physical properties of drugs like physical form, particle size, shape, density, wetting dielectric constant. Solubility, dissolution and organoleptic properties and their effect on formulation, stability and bioavailability. b) Study of chemical properties of drugs like hydrolysis, oxidation, reduction, racemization, polymerization etc., and their influence on formulation and stability of products. c) Study of prodrugs in solving problems related to stability, bioavailability and elegance of formulations.

2. Design, development and process validation methods for pharmaceutical operations involved in the production of pharmaceutical products with special reference to tablets, suspensions

3. Stabilization and stability testing protocol for various pharmaceutical products

4. Performance evaluation methods a) In-vitro dissolution studies for solid dosage forms methods, interpretation of dissolution data. b) Bioavailability studies and bioavailability testing protocol and procedures. c) In-vivo methods of evaluation and statistical treatment.

5. GMP and quality assurance, Quality audit

6. Design, development, production and evaluation of controlled release formulations.

Practical

1. Preformulation studies including drug-excipient compatibility studies, effect of stabilizers, preservatives etc. in dosage form design.

2. Experiments demonstrating improvement in bioavailability through prodrug concept.

3. Stability evaluation of various dosage forms and their expiration dating.

4. Dissolution testing and data evaluation for oral solid dosage forms.

5. In -vivo bioavailability evaluation from plasma drug concentration and urinary excretion curves.

6. Design, development and evaluation of controlled release formulations.

Subject: Pharmaceutical Analysis – III

Theory

A. Quality assurance: 1. GLP, ISO 9000, TQM, Quality Review and Quality Documentation.

2. Regulatory control, regulatory drug analysis, interpretation of analytical data.

3. Validation, quality audit: quality of equipment, validation of equipment, validation of analytical procedures. B. The theoretical aspects, basic instrumentation, elements of interpretation of spectra, and applications of the following analytical techniques should be discussed : 1. Ultraviolet and visible spectrophotometry 2. Fluorimetry. 3. Infrared spectrophotometry. 4. Nuclear Magnetic Resonance spectroscopy including 13c NMR. 5. Mass Spectrometry. 6. Flame Photometry. 7. Emission Spectroscopy. 8. Atomic Absorption Spectroscopy. 9. X -ray Diffraction. 10. Radio immunoassay.

Practical

1. Quantitative estimation of at least ten formulations containing a single drug or more than one drug, using instrumental techniques.

2. Estimation of Na+, K+, Ca++ ions using flame photometry.

3. IR of samples with different functional groups (-COOH, -COOR. _ CONHR; - NH2, -NHR, -OH, etc.).

4. Workshop to interpret the structure of simple organic compounds using UV, IR. NMR and MS

Subject: Pharmaceutical Chemistry - VIII (Medicinal Chemistry III)

Theory

1. Drug metabolism and Concepts of Prodrugs. 3. Amino acids, peptides, nucleotides and related drugs a. Thyroid and Anti thyroid drugs b. Insulin and oral hypoglycemic agents. c. Peptidomimetics and nucleotidomimetics. vi. Diagnostic agents. vii. Pharmaceutical Aids

2. Synthetic procedures of selected drugs, mode of action, uses, structure activity relationship (including physicochemical aspects) of the following classes of drugs. (Biochemical approaches in drug designing wherever applicable should be discussed). i) Antimetabolites (including sulfonamides). ii) Chemotherapeutic agents used in Protozoal, Parasitic and other infection iii) Antineoplastic agents iv Antiviral including anti - HIVagents. v) Immunosuppressants and immunostimulants.

3. Amino acids, peptides, nucleotides and related drugs a. Thyroid and Anti thyroid drugs b. Insulin and oral hypoglycemic agents. c. Peptidomimetics and nucleotidomimetics. vi. Diagnostic agents. vii. Pharmaceutical Aid

Practical

1. Experiments designed on drug metabolism: a. Preparation of S9 and microsomes from tissue homogenates and standardization of protein.

b. Effect of phenobarbital pretreatment on microsomal cytochrome p-450, cytochrome b5, and NADPH-Cytochrome C-reductase and comparison of microsomes from control.

c. Determination of microsomal aminopyrine demethylase and p_ nitroanisole odemethylase activities.

d. Determination of microsomal azo- and nitroreductase activities.

2. Synthesis of selected drugs.

3. Establishing pharmacopoeial standards and spectral studies.

Subject: Pharmacognosy – VI

Theory

1. World-wide trade in medicinal plants and derived products with special reference to diosgenin (dioscorea), taxol (Taxus sps) digitalis, tropane alkaloid containing plants, Papain, cinchona, Ipecac, Liquorice, Ginseng, Aloe, Valerian, Rauwolfia and plants containing laxatives

2. A brief account of plant based industries and institutions involved in work on medicinal and aromatic plants in India. Utilization and production of phytoconstituents such as quinine, calcium sennosides, podophyllotoxin, diosgenin, solasodine, and tropane alkaloids.

3. Utilization of aromatic plants and derived products with special reference to sandalwood oil, mentha oil, lemongrass oil, vetiver oil, geranium oil and eucalyptus oil.

4. Historical development of plant tissue culture, types of cultures,. nutritional requirements, growth and their maintenance. Applications of plant tissue culture in pharmacognosy.

5. Chemotaxonomy of medicinal plants.

6. Marine pharmacognosy, novel medicinal agents from marine sources.

7. Natural allergens and photosensitizing agents and fungal toxins.

8. Herbs are healthy foods.

9. Herbal cosmetics.

Practical

1.Isolation of some selected phytoconstituents studied in theory.

2.Extraction of volatile oils and their chromatographic profiles.

3. Some experiments in plant tissue culture

Subject: Pharmacology - IV (Clinical Pharmacy and Drug Interaction)

Theory

1.Introduction to Clinical Pharmacy.

2.Basic Concepts of Pharmacotherapy. a) Clinical Pharmacokinetics and individualization of Drug Therapy. b) Drug Delivery Systems and their Biopharmaceutic & Therapeutic Considerations. c) Drug Use During Infancy and in the Elderly (Pediatrics & Geriatrics). d) Drug use during Pregnancy. c) Drug induced Diseases. d) The Basics of Drug Interactions. g) General Principles of Clinical Toxicology" h) Interpretation of Clinical Laboratory Tests

3. Important Disorders of Organ Systems and their Management: a) Cardiovascular Disorders-Hypertension, Congestive Heart Failure, Angina, Acute Myocardial Infarction, Cardiac arrhythmias. b) CNS Disorders: Epilepsy, Parkinsonism, Schizophrenia, Depression. c) Respiratory Disease-Asthma. d) Gastrointestinal Disorders-Peptic ulcer, Ulcerative colitis, Hepatitis, Cirrhosis. c) Endocrine Disorders-Diabetes mellitus and Thyroid Disorders. t) Infectious Diseases-Tuberculosis, Urinary Tract Infection, Enteric Infections, Upper Respiratory Infections. g) Hematopoietic Disorders-Anemias. h) Joint and Connective Tissue Disorders-Rheumatic Diseases, Gout and Hyperuricemia. i) Neoplastic Diseases- Acute Leukaemias, Hodgkin's disease.

4. Therapeutic Drug Monitoring

5. Concept of Essential Drugs and Rational Drug use
Complementary Module 1: Soft Skills Development
- Business communication
- Preparation for the Interview
- Presentation Skills
Complimentary Module 2: Resume Writing

Resume Writing

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