SEMESTER III nBP301T. PHARMACEUTICAL ORGANIC CHEMISTRY -Il (Theory) 45 Hours Scope: This subject deals with general methods of preparation and reactions of some organic compounds. Reactivity of organic compounds are also studied here. The syllabus emphasizes on mechanisms and orientation of reactions. Chemistry of fats and oils are also included in the syllabus. Object write the structure, name and the type of isomerism of the organic compound Upon completion of the course the student shall be able to write the reaction, name the reaction and orientation of reactions 3. account for reactivity/stability of compounds, 4. prepare organic compounds Course Content: General methods of preparation and reactions of compounds superscripted with asterisk (*) to be explained ‘To emphasize on definition, types, classifi and differences UNIT I 10 Hours © Benzene and its derivatives ‘A. Analytical, synthetic and other evidences in the derivation of structure of benzene, Orbital picture, resonance in benzene, aromatic characters, Huckel’s rule B. Reactions of benzene - nitration, sulphonation, halogenation- reactivity, Friedelerafts —alkylation- reactivity, limitations, Friedelerafts acylation C. Substituents, effect of substituents on reactivity and orientation of mono substituted benzene compounds towards _ electrophilic substitution reaction D. Structure and uses of DDT, Saccharin, BHC and Chloramine UNIT IL 10 Hours © Phenols* - 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 ba and synthetic uses of aryl diazonium salts © Aromatic Acids* ~Acidity, effect of substituents on acidity and important reactions of benzoic acid. UNIT IT 10 Hours © Fats and Oils a. Fatty acids ~ reactions. ion, principles/mechanisms, applications, examples Bb. Hydrolysis, Hydrogenation, Saponification and Ranei oils ¢. Analytical constants — Acid value, Saponification value, Ester value, Iodine value, Acetyl value, Reichert Meissl (RM) value ~ signi principle involved in their determination. UNIT IV 08 Hours + Polynuclear hydrocarbons: a, Synthesis, reactions b. Structure and medicinal uses of Naphthalene, Phenanthrene, Anthracene, Diphenylmethane, Triphenylmethane and their derivatives UNIT V 07 Hours * 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 y of oils, Drying 74BP305P. PHARMACEUTICAL ORGANIC CHEMISTRY -II (Practical) 4 Hrs/week 1 Experiments involving laboratory techniques © Recrystallization © Steam distillation I Determination of following oil values (including standardization of reagents) © Acid value © Saponification value © Iodine value IIL Preparation of compounds © Benzanilide/Phenyl benzoate/Acetanilide from Aniline/ Phenol /Aniline by acylation reaction. 4,6-Tribromo aniline/Para bromo acetanilide from Aniline/ ‘* Acetanilide by halogenation (Bromination) reaction, -Nitro salicylic acid/Meta di nitro benzene from Salicylic acid / Nitro benzene by nitration reaction. ‘© Benzoic acid from Benzyl chloride by oxidation reaction. ‘* Benzoic acid Salicylic acid from alkyl benzoate/ alkyl salicylate by hydrolysis reaction. ‘© L-Phenyl azo-2-napthol from Aniline by diazotization and coupling reactions. © Benzil from Benzoin by oxidation reaction. ‘© Dibenzal acetone from Benzaldehyde by Claison Schmidt reaction © Cinnammic acid from Benzaldehyde by Perkin reaction © P-lodo benzoic acid from P-amino benzoic acid Recommended Books (Latest Editions) Organic Chemistry by Morrison and Boyd Organic Chemistry by LL. Finar , Volume-1 Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl Organic Chemistry by P.L.Soni Practical Organic Chemistry by Mann and Saunders. Vogel’s text book of Practical Organic Chemistry ‘Advanced Practical organic chemistry by N.K. Vishnoi. NOve ye 758. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz. BP302T. PHYSICAL PHARMACEUTICS-I (Theory) 45Hours Scope: The course deals with the various physica and physicochemical properties, and principles involved in dosage forms/formulations. Theory and practical components of the subject help the student to get a better insight into various areas of formulation research and development, and stability studies of pharmaceutical dosage forms. Object pon the completion of the course student shall be able to 1. Understand various physicochemical properties of drug molecules in the designing the dosage forms 2. Know the principles of chemical kinetics & to use them for stability testing nad determination of expiry date of formulations 3. Demonstrate use of physicochemical properties development and evaluation of dosage forms. the formulation Course Content: UNIT-I 10 Hours 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. Partially miscible liquids, Critical solution temperature and applications. Distribution law, its limitations and applications UNIT-IL 10Hours 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, solid- crystalline, amorphous & polymorphism. Physicochemical properties of drug molecules: Refractive index, optical rotation, dielectric constant, dipole moment, dissociation constant, determinations and applications UNIT-IIL 08 Hours 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. 76UNIT-IV O8Hours Complexation and protein binding: Introduction, Classification of Complexation, Applications, methods of analysis, protein binding, Complexation and drug action, crystalline structures of complexes and thermodynamic treatment of stability constants. UNIT-V 07 Hours PH, buffers and Isotonic solutions: Sorensen’s pH scale, pH determination (clectrometric and calorimetric), applications of butfers, buffer equation, buffer capacity, buffers in pharmaceutical and biological systems, buffered isotonic solutions. 7BP306P. PHYSICAL PHARMACEUTICS - I (Practical) 4 Hrs/week 1, Determination the solubility of drug at room temperature 2. Determination of pKa value by Half Neutralization’ Henderson Hasselbaleh equation, 3. Determination of Partition co- efficient of benzoic acid in benzene and water 4, Determination of Partition co- efficient of Iodine in CCl, and water 5. Determination of % composition of NaC! in a solution using phenol-water system by CST method 1 of surface tension of given liquids by drop count and drop weight Determination of HLB number of a surfactant by saponification method 8. Determination of Freundlich and Langmuir constants using activated char coal 9. Determination of critical micellar concentration of surfactants 10. Determination of stability constant and donor acceptor ratio of PABA-Caffeii complex by solubility method LL. Determination of stability constant and donor acceptor ratio of Cupric-Glycine complex by pH titration method Recommended Books: (Latest Editions) Physical Pharmacy by Alfred Martin Experimental Pharmaceutics by Eugene, Parott. Tutorial Pharmacy by Cooper and Gunn. Stocklosam J. Pharmaceutical Calculations, Lea &Febiger, Philadelphia. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3, MarcelDekkar Inc. Liberman H.A, Lachman C, Pharmaceutical Dosage forms. Disperse systems, volume 1, 2, 3. Marcel Dekkar Inc. 7. Physical Pharmaceutics by Ramasamy C and Manavalank. yeepe 2 8. Laboratory Manual of Physical Pharmaceutics, C.V.S, Subramanyam, J Thimma settee 9. Physical Pharmaceutics by C.V.S. Subramanyam 10. Test book of Physical Phramacy, by Gaurav Jain & Roop K. Khar 78BP 303 T. PHARMACEUTICAL MICROBIOLOGY (Theory) 45Hours Scope: ‘* Study of all categories of microorganisims especially for the production of alchol antibiotics, vaccines, vitamins enzymes etc. Objectives: Upon completion of the subject student shall be able to; 1. Understand methods of identificat various microorganisms 2. To understand the importance and implementation of sterlization in pharmaceutical processing and industry 3. Learn sterility testing of pharmaceutical products. 4. Carried out microbiological standardization of Pharmaceuticals. 5. Understand the cell culture technology and its applications in pharmaceutical industries. n, cultivation and preservation of Course content: Unit 1 10 Hours Introduction, history of microbiology, its branches, importance. Introduction to Prokaryotes and Eukaryotes Study of ultra-structure and morphological classification of bacteria, nutritional requirements, raw materials used for culture media and physical parameters for growth, growth curve, isolation and preservation methods for pure cultures, cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable count). Study of different types of phase constrast microscopy, dark field microscopy and electron microscopy. Unit 11 10 Hours cope and its 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. 79Equipments employed in large scale sterilization, Sterility indicators. Unit Study of morphology, classification, reproduction/replication and cultivation of Fungi and Viruses Classification and mode of action of disinfectants Factors influencing disinfection, antiseptics and their evaluation. For bacteriostatic and bactericidal actions Evaluation of bactericidal & Bacteriostatic. Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP. Unit 1V. Designing of aseptic area, laminar flow equipments; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification. Principles and methods of different microbiological assay. Methods for standardization of antibiotics, vitamins and amino acids. Assessment of a new antibiotic. Unit V 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. ation of cell cultures in pharmaceutical industry and research, 80 10 Hours 08 Hours 07HoursBP 307P.PHARMACEUTICAL MICROBIOLOGY (Practical) 4 Hrs/week 1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator, laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator, microscopes used in experimental microbiology. 2. Sterilization of glassware, preparation and sterilization of media, 3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations. 4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with practical) 5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other techniques. Microbiological assay of antibiotics by cup plate method and other methods, Motility determination by Hanging drop method, Sterility testing of pharmaceuticals. Bacteriological analysis of water |. Biochemical test yeas s Recommended Books (Latest edition) 1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications, Oxford London. 2. Prescott and Dunn., Industrial Microbiology, 4" edition, CBS Publishers & Distributors, Delhi. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology. Rose: Industrial Microbiology. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan Cooper and Gunn's: Tutorial Pharmacy, CBS Publisher and Distribution. Peppler: Microbial Technology. . LP., B.P., U.S.P.- latest editions. 10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai 1. Edward: Fundamentals of Microbiology. 12. N.K Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi 13. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company Yer awe » 81BP 304 T. PHARMACEUTICAL ENGINEERING (Theory) 45 Hours Scope: This course is designed to impart a fundamental knowledge on the art and science of various unit operations used in pharmaceutical industry. Objectives: Upon completion of the course student shall be able: To know various unit operations used in Pharmaceutical industries. 2. To understand the material handling techniques. 3. To perform various processes involved in pharmaceutical manufacturing process. 4. To carry out various test to prevent environmental pollution. 5. To appreciate and comprehend significance of plant lay out design for optimum use of resources. 6. To appreciate the various preventive methods used for corrosion control in Pharmaceutical industries. Course content: UNIT- 10 Hours ‘+ Flow of fluids: Types of manometers, Reynolds number and its significance, Bernoulli's theorem and its applications, Energy losses, Orifice meter, Venturimeter, Pitot tube and Rotometer. ‘* Size Reduction: Objectives, Mechanisms & Laws governing size reduction, factors affecting size reduction, principles, construction, working, uses, merits and demerits of Hammer mill, ball mill, fluid energy mill, Edge runner mill & end runner mill. * Size Separation: Objectives, applications & mechanism of size separation, official standards of powders, sieves, size separation Principles, construction, working, uses, merits and demerits of Sieve shaker, cyclone separator, Air separator, Bag filter & elutriation tank. UNIT-IT 10 Hours Heat Transfer: Objectives, applications & Heat transfer mechanisms. Fourier’s law, Heat transfer by conduction, convection & radiation. Heat interchangers & heat exchangers. 82‘* 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 lation & molecular distillation UNIT- 11 08 Hours © 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, planetary mixers, Propellers, Turbines, Paddles & Silverson Emulsifier, UNIT-IV 08 Hours «Filtration: Objectives, applications, Theories & Factors influencing filtration, filter aids, filter medias. Principle, Construction, Working, Uses, Merits and demerits of plate & frame filter, filter leaf, rotary drum filter, Meta filter & Cartridge filter, membrane filters and Seidtz filter. ‘* Centrifugation: Objectives, principle & applications of Centrifugation, principles, construction, working, uses, merits and demerits of Perforated basket centrifuge, Non-perforated basket centrifuge, semi continuous centrifuge & super centrifuge. UNIT- V 07 Hours + 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Recommended Books: (Latest Editions) Introduction to chemical engineering — Walter L Badger & Julius Banchero, Latest edition, Solid phase extraction, Principles, techniques and applications by Nigel J.K. Simpson- Latest edition. Unit operation of chemical engineering ~ Meabe Smith, Latest edition. Pharmaceutical engineering principles and practices ~ C.V.S Subrahmanyam ef al., Latest edition. Remington practice of pharmacy- Martin, Latest edition. Theory and practice of industrial pharmacy by Lachmann., Latest edition. Physical pharmaceuties- C.V.S Subrahmanyam et al., Latest edition, Cooper and Gunn’s Tutorial pharmacy, S.J. Carter, Latest edition,WV. v. VL BP308P - PHARMACEUTICAL ENGINEERING (Practical) 4 Hours/week Determination of radiation constant of brass, iron, unpainted and painted glass. Steam distillation — To calculate the efficiency of steam distillation. To determine the overall heat transfer coefficient by heat exchanger. Construction of drying curves (for calcium carbonate and starch), Determination of moisture content and loss on drying. Determination of humidity of air ~ i) From wet and dry bulb temperatures ~use of Dew point method. VIL. Description of Construction working and application of Pharmaceutical VIIL Size analysis by sieving — To evaluate size distribution of tablet granulatio x. XL and Thickness! viscosity Machinery such as rotary tablet machine, fluidized bed coater, fluid energy mill, de humidifier. Construction of various size frequency curves including arithmetic andlogarithmic probability plots. reduction: To verify the laws of size reduction using ball mill and determining Kicks, Rittinger’s, Bond’s coefficients, power requirement and critical speed of Ball Mill. Demonstration of colloid mill, planetary mixer, fluidized bed dryer, freeze dryer and such othermajor equipment. Factors affecting Rate of Filtration and Evaporation (Surface area, Concentration XIL To study the effect of time on the Rate of Crystallization XI. To calculate the uniformity Index for given sample by using Double Cone Blender. 85