SAVITRIBAI PHULE PUNE UNIVERSITY Faculty of Pharmaceutical


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SAVITRIBAI PHULE PUNE UNIVERSITY
Faculty of Pharmaceutical Science
Syllabus Second Year B. Pharm. Credit System 2015 Course
(With effect from Academic Year 2016 - 17)

2.3.1 T PHYSICAL PHARMACEUTICS-I (Theory) (3 Hrs/Week)
Learning objectives: On completion of following theory topics & laboratory experiments, learner should be able to A. Knowledge: 1. Understand the basics of chemical and physical phenomena that govern the in vivo and invitro actions of pharmaceutical products. 2. Describe the principles of pharmaceutical sciences in the field of pharmaceutics. 3. Explain and apply the key physical pharmacy concepts of solubility and dissolution, partitioning phenomena, surface phenomena, etc. 4. Articulate the interrelationships between the physiochemical properties of a drug, its dosage form, route of administration and bioavailability. 5. Acquire knowledge in Physical principles of states of matter and phase rule. 6. Recognize basic rules and equations regarding physical principles essential for pharmaceutical applications. 7. Compare and contrast between one, two & three component system. 8. Explain various laws and theories of gases and correlate them with formation of aerosols. 9. Know about crystallization as well as various parameters of crystal like crystal forms, habits, lattice angle, methods of crystal analysis, polymorphism. 10. Adapt knowledge of Non-electrolytic and Electrolytic solutions regarding their types and properties mostly colligative properties. 11. Illustrate Solubility and Distribution Phenomenon and apply them in the pharmaceutical practices. 12. Know applications of thermodynamics in the pharmacy. B. Skills: 1. To operate different pharmaceutical laboratory instruments us ed in determining various physical properties such as surface tension, viscosity, adsorption and solubility. 2. To calculate critical solution temperature & effect of addition of electrolyte on CST of phenolwater system. 3. To construct of ternary phase diagram for three-component system. 4. To predict solubility, molecular weight, cell constant, pKa of given compound. 5. To evaluate unknown concentration by conductometric titration.

Topic No. 1 2
03
4 5
6

Name of the topic and contents
SECTION-I Phase Rule a. Gibbs phase rule, one component (Water), two components, and three components system, Pharmaceutical applications Gaseous state of matter a. Basic gas laws, theory & equation of state for ideal gases, Deviation from gas theory, Compressibility factor, Vander Waal equation for real gases, critical constants, b. Liquefaction of gases: Linde’s process, Claude’s process, application of liquefaction to Aerosols i.e. principle of aerosols, two phase and three phase systems. Solution of Non-electrolytes and Electrolyte a. Properties and types of solutions, ideal and real solutions, Raoult’s law and its deviations, boiling point diagram, fractional and steam distillation, b. Colligative properties: relative lowering of vapor pressure, elevation of boiling Point, depression of freezing point, and osmotic pressure, problems involving molecular weight determinations. c. Solution of electrolytes: equivalent and specific conductance, Kohlrauschs law, conductometric titrations, Colligative properties of electrolytes.
SECTION-II a. Introduction to crystallization, Crystal parameters- crystal forms, habits, lattice angle, Methods of crystal analysis: X-Ray Diffraction, Bragg’s equation. b. Polymorphism: Definition, Different shapes of polymorphs, Example and its Pharmaceutical applications, Brief introduction of Detection techniques. Glass transition temperature Solubility and Distribution Phenomenon a. Solute solvent interactions, Definition of solubility, intrinsic and saturation solubility, solubility of gases in liquids, liquid in liquids and solids in liquids, factors affecting solubility, solubility of weak electrolytes, influence of pH, solvents, solubility parameter and combined effect of pH and Solvents. b. Distribution phenomenon: Nernst distribution law and its limitations, Effect of ionic dissociation and association, applications in Pharmacy. c. Brief introduction of BCS classification. Thermodynamics a. Definition of enthalpy, entropy, First and second law of thermodynamics (Statement and equation)

No of Hrs. 04 07
11
08 11
04

2.3.1 P PHYSICAL PHARMACEUTICS-I (Practical) (3 Hrs/Week)

Sr. Topic

Experiment

No

1 Phase Rule

1. Determination of Critical solution temperature of Phenol

water system.

2. Determination of effect of addition of electrolyte on CST

of phenol water system.

3.

Construction of ternary phase diagram for three-

component system [oil-water-surfactant].

2 Solutions of

non- 1. Determination of solubility of substance at different

electrolytes

and temperatures.

electrolytes

2.

Determination of solubility of benzoic acid in different

solvents.

3.

Determination of effect of co solvents on solubility of

benzoic acid in water.

4. Determination of molecular weight by Rast’s camphor

method. e. Determination of unknown concentration by

conductometric titration.

3 Solubility

and 1. Determination of partition coefficient of benzoic a cid

Distribution phenomena between water and benzene.

2. Determination of effect of pH on partition coefficient.

3. Estimation of saturation solubility of given drug in water.

4. Determination of effect of pH on solubility.

4 Thermodynamics

1. Determination of heat of solution of

Salicylic/benzoic/oxalic acid

Recommended Books: 1. Martins Physical Pharmacy and Pharmaceutical Sciences, 5/Ed., Patrick J. Sinka, Lippincott Williams and Wilkins. 2. Essentials of Physical Chemistry by B. S. Bahl, G. D. Tuli, Golden Jubilee Ed., S. Chand and Company. 3. Essentials of Physical Chemistry and Pharmacy, H. J. Arnikar, S. S. Kadam, K. N. Gujar, Orient Longman Pvt. Ltd, India 4. Textbook of Physical Pharmacy, Vol. II, 3/Ed., K. L. Kapoor, McMillan India Ltd 5. Principles of Physical Chemistry 4/Ed., Samuel H. Marlton, Carl F. Frultoon, Oxford and IBH publishing Co. Pvt. Ltd., New Delhi 6. Physical Pharmacy by Dr. U.B. Hadkar, NiraliPrakashan, 8/Ed, Mumbai 7. Essentials of Physical Pharmaceutics by C.V. S. Subramanyam, 2/Ed, Vallabh Prakashan, New Delhi.

8. Textbook of Physical Pharmaceutics by C.V. S. Subramanyam, 2/Ed, Vallabh Prakashan, New Delhi 9. Theory and Practice of Industrial Pharmacy by H A Liebermann, Leon Lachman and J B Schwartz 10. Physical Pharmacy, by Martin, Swarbrick and Cammarata Indian Edition, Varghese Publishing House, Mumbai. 11. Handbook of Practical Physical Pharmacy and Physical Pharmaceutics by U. B. Hadkar, NiraliPrakashan, 4/Ed., 2007, Pune 12. Practical Physical Pharmacy by H.N. More and A. A. Hajare, Career Publication. 1/Ed, 2007, Nashik 13. Practical Physical Pharmacy by Gaud and Gupta, NiraliPrakashan 14. Essentials of Physical Pharmacy, by Madan and Tuli, S. Chand & Company, New Delhi 15. Martin’s Physical Pharmacy and Pharmaceutical Sciences, 5/Ed. by Patric J. Sinka, Lippincott Williams and Wilkins, 2007. 16. Essentials of Physical Chemistry and Pharmacy. H. J. Arnikar, S. S. Kadam, K. N.Gujar, Orient Longman Pvt. Ltd, India,. 17. Practical Physical Pharmacy, Gurtoo and Kapoor.

2.3.2 T PHARMACEUTICAL MICROBIOLOGY (THEORY) (3 Hrs/Week)
Learning objectives: On successful completion of following theory topics & laboratory experiments, learner should be able to A. Knowledge: 1. Define microbiology & classify microbes into various categories 2. Aware about historical developments and contributions of scientists in the field of
microbiology. 3. Know the recent advances in microbiology. 4. Compare and contrast the various structural features, biology & characteristics of microbes. 5. Know the modes of reproduction in bacteria, growth characteristics, requirements. 6. Describe isolation & counting methods of microorganisms. 7. Explain the mechanism of tumour formation. 8. Illustrate use of microorganism in pharmacy. 9. Identify the causes and basis of microbial spoilage. 10. Know the sources & types of microbial contamination. 11. Explain an importance of microbial limit tests, preservative efficacy test & standardization
processes. 12. State mechanism of action and effectiveness of various sterilization processes. 13. Know the Sterility testing as per I.P. and its importance. 14. Classify disinfectants & be able to illustrate mechanism of action & its evaluation. 15. Focus on various basic aspects of immunology. 16. Illustrate types of immunity, basic aspects like antigen, antibody and their various their various
reactions. 17. Know the vaccines, its types and preparation methods. 18. Know the basics behind various reactions of antigen and antibody as well as hypersensitivity
reactions. 19. Describe vaccine manufacturing process.
B. Skills: 1. Explain the principle, construction and working of various instruments and perform their
operations. 2. Handle microscope for observation of microbes. 3. Learn how to prepare and sterilize nutrient broth, nutrient agar, slants, stabs and plates. 4. Adopt the skills required for maintaining strictly aseptic condition & handling inoculating
loop, its sterilization and inoculation procedure. 5. Isolate microorganism by streak plate technique & count them by pour plate technique. 6. Observe motility of bacteria by hanging drop technique.

7. Execute morphology bacteria by simple staining, negative staining & gram staining. 8. Do sterility testing of WFI by direct inoculation method. 9. Determine minimum inhibitory concentration by broth dilution. 10. Do Antibiotic Assay of any antibiotic.

Sr.

Topic

No

No.

of

Hrs

SECTION-I

1 Introduction to Microbiology: Scope and applications to pharmaceuticals,

05

Whittaker’s five kingdom concept, Classification of microbes into bacteria,

rickettsia, actinomycetes, fungi, protozoa, algae and viruses (and their significance

related to pharmacy), Historical developments- contributions of Anton van

Leeuwenhoek, Louis Pasteur, Robert Koch and Paul Ehrlich.

2 Bacteria: Size, shape, structure, cell wall, capsules, spores, flagella, Reproduction- 10

binary fission, Growth, growth curve, Culture media, Counting methods,

Preservation of microbial cultures, Significance of Prebiotics and Probiotics.

3 Yeasts and moulds: Introduction and applications of Saccharomyces cerevisiae,

01

Candida albicans and Penicillium.

4 Viruses: Introduction, general properties, structure of viruses, Human viruses –

03

multiplication and cultivation, Structure Human Immunodeficiency virus.

5 Microbial Limit tests: Viable count, Identification of specific microorganism as

02

per IP

6 Sterilization: Introduction to concept of sterilization, Different methods - dry heat, 03

moist heat, gaseous, radiation and filtration.

SECTION-II

7 Preservation and Disinfection: Chemical classification of different disinfectants

03

with a example, Phenol coefficient test: RW test.

8 Fundamentals of Immunology: Microbial virulence, exotoxins, endotoxins

09

Antigens, Types of Immunity, Defense mechanisms of host – specific and

nonspecific, Mechanism of CMI and HMI, Antibodies-Classification.

9 Antigen - Antibody reactions: Characteristics of Antigen Antibody reaction,

04

Basics of Precipitation, Agglutination (Slide and Tube), Introduction to

complement fixation test, immunofluorescence tests, Radio Immunoassay and

ELISA.

10 Vaccines and sera: Classification of vaccines, General production of Vaccines and 05

sera and their quality control.

2.3.2 P PHARMACEUTICAL MICROBIOLOGY (Practical) (3 Hrs/Week)
1. To study the principle and working of laboratory equipments.(autoclave, hot air oven, colony counter, incubator)
2. Microscopy different parts of compound microscope, resolving power, magnification power, numerical aperture and working distance.
3. Preparation and sterilization of nutrient broth, nutrient agar, slants, stabs and plates. 4. To study different techniques of Inoculation of cultures and aseptic techniques. 5. Isolation of microorganism by streak plate technique. 6. Total Viable Count (TVC) by pour plate technique. 7. Observation of motility of bacteria by hanging drop technique. 8. To study morphology bacteria by simple staining 9. To study morphology bacteria by negative staining. 10. To study morphology bacteria by Gram staining. 11. Sterility testing of WFI by direct inoculation method. 12. MIC (minimum inhibitory concentration) determination by broth dilution. 13. Antibiotic Assay of any one antibiotic as per IP.
Recommended Books for Theory and Practical: 1. Anathnarayan R, Panikar CKJ. Textbook of Microbiology. Eighth Edition, Orient Longman. 2011. 2. Aulton ME. Pharmaceutics-The Science of Dosage Form Design. Churchill Livingstone. 1998. 3. Baird RM, et al. Handbook of Microbiological Quality Control – Pharmaceutical and Medical Devices. Taylor and Francis Inc., London. 2000. 4. Carter SJ. Copper and Gunn’s Tutorial Pharmacy. CBS Publishers and Distributors, Delhi. 1996. 5. Collee JG, et al. Mackie and McCartney Practical Medical Microbiology. Fourteenth Edition, Churchill Livingstone Publications, New York. 1996. 6. Hugo WB, Russell AD. Pharmaceutical Microbiology. Sixth Edition, Blackwell Science. 1998. 7. Kokare CR. Pharmaceutical Microbiology-Principles and Applications. Sixth Edition, Nirali Prakashan, Pune, India. 2008. 8. Indian Pharmacopoeia. Govt. of India, Ministry of Health and Family Welfare. 1996 & 2007. 9. Pelczar MJ et al. Microbiology. Fifth Edition, McGraw Hill, New York. 10. Rawlins EA. Bentley’s Textbook of Pharmaceutics. Eighth Edition, 1992. Bailliere Tindall, London.1986.

11. Akers MJ. Parenteral Quality Control. Second Edition, Marcel Dekker Inc., New York. 1994.
12. Brooks GF, Butel JS, Morse SA. Jawetz, Metrics & Adel bergs Medical Microbiology. Twenty First Edition, Appleton & Lange Publication, United State of America. 1989.
13. Maloy SR, Cronan JE. Microbial Genetics. Second Edition, Narosa Publishing House, New Delhi. 2006.
14. Ingraham JL, Ingraham CA. Introduction to Microbiology. Second Edition, Thomson. Brooks Cole, US. 2000.
15. Wiley M, Sherwood LM, Woolverton CJ. Prescott Harley & Klein’s Microbiology. Seventh Edition, McGraw Hill International Edition. 2008.
16. Frobisher M, HinsDill RD, Crabtrea KT, Good Heart CR. Fundamentals of Microbiology. Ninth Edition, Saunders Company, Japan. 1974.
17. Casida LE. Industrial Microbiology. Seventh Edition, New Age International Publication. 2007.
18. Goldsby RA, Kindt TJ. Kuby Immunology. Fifth Edition, W. H. Freeman and company. 2003.

2.3.3 T PHARMACEUTICAL BIOCHEMISTRY (Theory) (3 Hrs/Week)

Learning objectives: On completion of following theory topics and laboratory experiments, a learner should able to

A. Knowledge: 1. Know the scope of Biochemistry in Pharmacy. 2. Understand role of biochemical processes in cell metabolism. 3. Know the enzyme structures, their functions, mechanism for enzymatic activity and
applications of enzymes. 4. Know the general metabolism process of proteins, lipids, carbohydrates and nucleic acids. 5. Understand chemistry, function, classification, biological importance, qualitative tests &
applications of various bio-molecules. e.g. proteins, carbohydrates, lipids, nucleic acids and vitamins 6. Establish the correlation of metabolism, process, steps involved in metabolism of carbohydrates, lipids, protein and nucleic acid 7. Explain types, their structures, biochemical functions & importance of fat-soluble and water-soluble vitamins.

B. Skills: 1. Identify proteins, amino acids and carbohydrates by various qualitative as well as
quantitative chemical tests. 2. Separate, identify and characterize proteins from various samples like egg, milk, etc and
understand principle behind the technique. 3. Estimate quantity of ascorbic acid in a given sample. 4. Demonstrate action of salivary amylase on starch.

Topic No.
1
2
3

Name of the topic and contents
SECTION-I Introduction to Biochemistry: Scope of the subject in Pharmaceutical Sciences, biochemical reactions, highlights of only eukaryotic cell metabolism. Enzymes: Introduction, classification, co-enzymes, co-factor, active sites, mechanism of enzyme actions, Michaelis-Menten equation, double reciprocal plot, factors affecting enzyme activity, enzyme inhibition (reversible, irreversible, allosteric), applications of enzymes. Biomolecules: i. Amino acids: Introduction, classification, structures, essential and nonessential amino acids, physicochemical properties, peptide bond, end group analysis (Edman’s and Sanger’s method), and medicinally important amino acids. ii. Proteins: Introduction, classification, structural levels of proteins, globular (IgG and haemoglobin) and fibrous protein (keratin and collagen). Acid and enzymatic hydrolysis of proteins. Determination of the amino acid sequence

No of Hrs. 02 07
12

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SAVITRIBAI PHULE PUNE UNIVERSITY Faculty of Pharmaceutical