PHARMACEUTICS-XVIII (Pharmaceutical Technology-I)
(Theory)
Cr. Hr. 03
1. PRINCIPLES OF PHARMACEUTICAL FORMULATION AND
DOSAGE FORM DESIGN: Product Formulation, Need for Dosage Form
and Preformulation Studies.
2. FORMULATION DEVELOPMENT: Pharmaceutical Aerosoles,
Ophthalmic Preparations, and Parenteral Preparations.
3. ADVANCED FORMULATION TECHNIQUES: Development of a
formualtion methodology and flow plan for the new product. New
technologies in drug delivery system.
4. NOVEL DRUG DELIVERY SYSTEMS:
a) Introduction to the Drug Carrier: Liposomes, Niosomes and
Biodegradable polymers.
b) Active & Passive Drug Delivery System.
c) Other Novel GIT Systems.
PHARMACEUTICS-XVIII (Pharmaceutical Technology-I)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the
basis of the above mentioned theoretical topics and availability of the
requirements, e.g. Various techniques to develop the formulation,
Granulation technology, Study of drug delivery systems, Biotechnological
aspect of product development, In-vitro Quality Control
of various dosage forms.
Recommended Books
1. Anya M Hellery, Drug delivery and targeting, Taylor & Francis, London, 2001.
2. Joseph R Robinson Controlled drug delivery, Marcel & Dakker Inc, New York, 2nd Ed., 1987.
3. T V Ramabhadran, Pharmaceutical design and development, Ellis Horwood, New York, 1994.
4. M E Aulton, Pharmaceutics: Science of Dosage Forms Design, ELBS/Churchill Livingstone, London, 1998.
5. Banker, Modern pharmaceutics, Marchell Dakker Inc, New York, 1990.
6. John A Bontempo, Development of biopharmaceutical parenteral dosage forms, Marchell Dakker Inc, New York, 1997.
7. N K Jain, Controlled and Novel drug delivery, CBS Publishers & Distributers, New Dehi, 1997.
8. Ansel, Pharmaceutical Dosage Form in Drug Delivery System, Lee & Febiger, London, 1990.
9. Attaurahman and M I Chaudry, Bioassay techniques for drug development, CRC Press, LLC, USA, 2001.
10. Pramod K Gupta, Inject able drug development, CRC Press, LLC, USA, 1999.
11. H John Smith, Introduction to the principals of drug design and action, CRC Press, LLC, USA, 1998
12. Rong Liu, Water Insoluble Drug Formulations, CRC Press, LLC, USA, 2000.
13. Peter Blaisdell, Twenty First Century Pharmaceutical Development. CRC Press, LLC, USA, 2000.
14. Lachman L, Theory and Practice of Industrial Pharmacy, Lee & Febiger, Philadelphia, 3rd Ed., 1986.
Thursday, March 3, 2011
Fifth Professional, First Semester, Pharmaceutics
PHARMACEUTICS-XVII (Clinical Pharmacy-III)
(Theory)
Cr. Hr. 03
1. RATIONAL USE OF DRUGS: Rational Presribing, Rational Dispensing,
Problems of Irrational Drug Use, Learning about drug use problem,
Sampling to study drug use, Indicators of drug use.
2. INTRODUCTION TO ESSENTIAL DRUGS: Criteria for selection,
Usage and Advantages.
3. DRUG UTILZATION EVALUATION & DRUG UTILIZATION
REVIEW (DUE/DUR): Development of protocol of use of few very low
therapeutic index drug groups like Steroids, Vancomycin and Cimetidine.
4. DRUG ABUSE and; MISUSE.
5. PRACTICAL PHARMACOKINETICS: Therapeutic Drug Monitoring of
Digoxin, Theophyline, Gentamycin, Lithium, Phenytoin, Cabamazepine,
Phenobarbitone, Primidone, Walparic Acid, Cyclosporins and
Vancomycin.
6. PHARMACOECONOMIC STUDIES.
PHARMACEUTICS-XVII (Clinical Pharmacy-III)
(Laboratory)
Cr. Hr. 01
Clerkship in the Clinical setting. A project related to Clinical Pharmacy
Practices will be completed by the students and will be evaluated by the
external examiner.
Recommended Books
1. Roger Walker, Clinical Pharmacy & Therapeutics, Churchill Levingstone, London, 3rd Ed., 2003.
2. Guard Paul, A Behavioral Approach to Pharmacy Practice, Black Well, USA, 2000.
3. Herfindal Gourley, Clinical Pharmacy & Therapeutics, William & Willkins, London, 1992.
4. A J Winfield, Pharmaceutical Practice, Churchill Levingstone, London, 2nd Ed., 1998.
5. Kavin Taylor, Pharmacy Practice, Taylor & Francis, New York, 1998.
6. Deborah Rosenbaun, Clinical Research Coordinator Hand Book, 2nd Ed., Sarrison, Inc, North Carolina, USA.
7. Simon Cook, Clinical Studies Management, a Practical Guide to Success, Sue Horwood Publishing limited, West Sussex, UK.
8. Joseph T Dipiro, Encyclopedia of Clinical Pharmacy. Marcel Dekker, Publishing, 2003.
9. Joseph T Dipiro, Encyclopedia of Pharmacy. Marcel Dekker Publishing, 2002.
10. Mellainie J Rantucci, Pharmacist Talking with Patients, 1997.
11. Smith GDG and Aronson J K, Oxford Text Book of Clinical Pharmacology and Drug Therapy, Oxford University Press, UK, 1990.
12. Hansten P and Horn J, Drug interactions. Lee & Febiger, Philadelphia, USA, 1989.
(Theory)
Cr. Hr. 03
1. RATIONAL USE OF DRUGS: Rational Presribing, Rational Dispensing,
Problems of Irrational Drug Use, Learning about drug use problem,
Sampling to study drug use, Indicators of drug use.
2. INTRODUCTION TO ESSENTIAL DRUGS: Criteria for selection,
Usage and Advantages.
3. DRUG UTILZATION EVALUATION & DRUG UTILIZATION
REVIEW (DUE/DUR): Development of protocol of use of few very low
therapeutic index drug groups like Steroids, Vancomycin and Cimetidine.
4. DRUG ABUSE and; MISUSE.
5. PRACTICAL PHARMACOKINETICS: Therapeutic Drug Monitoring of
Digoxin, Theophyline, Gentamycin, Lithium, Phenytoin, Cabamazepine,
Phenobarbitone, Primidone, Walparic Acid, Cyclosporins and
Vancomycin.
6. PHARMACOECONOMIC STUDIES.
PHARMACEUTICS-XVII (Clinical Pharmacy-III)
(Laboratory)
Cr. Hr. 01
Clerkship in the Clinical setting. A project related to Clinical Pharmacy
Practices will be completed by the students and will be evaluated by the
external examiner.
Recommended Books
1. Roger Walker, Clinical Pharmacy & Therapeutics, Churchill Levingstone, London, 3rd Ed., 2003.
2. Guard Paul, A Behavioral Approach to Pharmacy Practice, Black Well, USA, 2000.
3. Herfindal Gourley, Clinical Pharmacy & Therapeutics, William & Willkins, London, 1992.
4. A J Winfield, Pharmaceutical Practice, Churchill Levingstone, London, 2nd Ed., 1998.
5. Kavin Taylor, Pharmacy Practice, Taylor & Francis, New York, 1998.
6. Deborah Rosenbaun, Clinical Research Coordinator Hand Book, 2nd Ed., Sarrison, Inc, North Carolina, USA.
7. Simon Cook, Clinical Studies Management, a Practical Guide to Success, Sue Horwood Publishing limited, West Sussex, UK.
8. Joseph T Dipiro, Encyclopedia of Clinical Pharmacy. Marcel Dekker, Publishing, 2003.
9. Joseph T Dipiro, Encyclopedia of Pharmacy. Marcel Dekker Publishing, 2002.
10. Mellainie J Rantucci, Pharmacist Talking with Patients, 1997.
11. Smith GDG and Aronson J K, Oxford Text Book of Clinical Pharmacology and Drug Therapy, Oxford University Press, UK, 1990.
12. Hansten P and Horn J, Drug interactions. Lee & Febiger, Philadelphia, USA, 1989.
Fifth Professional, First Semester, Pharmaceutical Chemistry
PHARMACEUTICAL CHEMISTRY-V (Medicinal Chemistry-I)
(Theory)
Cr. Hr. 03
Note: The topics will be taught with special reference to their Pharmaceutical Applications.
1. INTRODUCTION TO MEDICINAL CHEMISTRY: Chemical constitution and biological activity: (Receptor, Theory, Structure Activity Relationships (SAR) and Drug Metabolism).
2. CLASSIFICATION OF SYNTHETIC DRUGS: Drug Design and recent approaches to the synthesis of drugs (a brief concept of methods and reactions of synthesis of various drugs).
3. GENERAL PROPERTIES, CHEMISTRY (General methods of determination, the structure & isolation from natural source), BIOLOGICAL ACTION, STRUCTURE ACTIVITY RELATIONSHIP AND THERAPEUTIC APPLICATIONS OF THE FOLLOWING:
e) Anaesthetics: Local anaesthetics (Procaine, Lignocaine, Eucaine, Cocaine and Benzocaine), General anaesthetics (Cyclopropane, Halothane, Nitrous oxide, Chloroform, Thiopental Sodium, Ketamine, Methohexital, Thioamylal Sodium, Fantanyl Citrate, Tribromo ethanol).
f) Analgesics and Antipyretics: Paracetamol, Salicylic acid analogues, Quinolines derivatives, Pyrazolone and Pyrazolodiones, Narylanthranilic acids, Aryl and heteroaryl acetic acid derivatives.
d) Sedatives and Hypnotics: Benzodiazepines, Barbiturates, Paraldehyde, Glutethimide, Chloral hydrate, and alcohols.
a) Vitamins: Water Soluble Vitamins (B1, B2, B6, B12, Folic acid, Nicotinic acid, Biotin, Pantothenic acid and Ascorbic acid) Fat Soluble Vitamins (A, D, E, and K).
b) Hormones: Steroidal Hormones (Testosterone, Progesterone, Estrogen, Aldosteron and Cortisol), Proteinous Hormones (Insulin, Glucagon, Oxytocin and Vassopressin).
c) Anti-neoplastic Agents: Tamoxifen, Fluorouracil, Mercapturine, Methotrexate and Vincristine.
PHARMACEUTICAL CHEMISTRY-V (Medicinal Chemistry-I)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g.
1. Estimation of functional groups; Carboxylic, Hydroxy, Amino and Nitro groups; Determination of Molecular weights of Organic Compounds.
2. Synthesis of Paracetamol, Salicylic Acid, Methyl salicylate, Azobenzene, Benzoic Acid, 5-Hydroxy-1,3-benzoxazol-2-one, Aspirin, P-nitrosophenol, 3-nitrophthalic acid, o-Chloro-benzoic acid.
Recommended Books
1. Martin and Cook, Remington Practice of Pharmaceutical Science, Mack Publishing Company, USA, 2001
2. Foye W O, Principles of Medicinal Chemistry, Verghese Publising House, Bomby, 1995.
3. Tyagi, Text Book of Synthetic Drugs, Anmol Publications, Delhi, 1990. 4. Alferd Burger, Medicinal Chemistry, Jhon Willey & Sons, New York, 1996.
4. Block, Roche, Soine and Wilson, Inorganic and Medicinal Pharmaceutical Chemistry, Verghese Publishing House, Bombay, 1986.
5. Block, Roche, Soine and Wilson. Inorganic and Medicinal Pharmaceutical Chemistry, Lee & Febiger, Philadelphia, USA, 1983.
(Theory)
Cr. Hr. 03
Note: The topics will be taught with special reference to their Pharmaceutical Applications.
1. INTRODUCTION TO MEDICINAL CHEMISTRY: Chemical constitution and biological activity: (Receptor, Theory, Structure Activity Relationships (SAR) and Drug Metabolism).
2. CLASSIFICATION OF SYNTHETIC DRUGS: Drug Design and recent approaches to the synthesis of drugs (a brief concept of methods and reactions of synthesis of various drugs).
3. GENERAL PROPERTIES, CHEMISTRY (General methods of determination, the structure & isolation from natural source), BIOLOGICAL ACTION, STRUCTURE ACTIVITY RELATIONSHIP AND THERAPEUTIC APPLICATIONS OF THE FOLLOWING:
e) Anaesthetics: Local anaesthetics (Procaine, Lignocaine, Eucaine, Cocaine and Benzocaine), General anaesthetics (Cyclopropane, Halothane, Nitrous oxide, Chloroform, Thiopental Sodium, Ketamine, Methohexital, Thioamylal Sodium, Fantanyl Citrate, Tribromo ethanol).
f) Analgesics and Antipyretics: Paracetamol, Salicylic acid analogues, Quinolines derivatives, Pyrazolone and Pyrazolodiones, Narylanthranilic acids, Aryl and heteroaryl acetic acid derivatives.
d) Sedatives and Hypnotics: Benzodiazepines, Barbiturates, Paraldehyde, Glutethimide, Chloral hydrate, and alcohols.
a) Vitamins: Water Soluble Vitamins (B1, B2, B6, B12, Folic acid, Nicotinic acid, Biotin, Pantothenic acid and Ascorbic acid) Fat Soluble Vitamins (A, D, E, and K).
b) Hormones: Steroidal Hormones (Testosterone, Progesterone, Estrogen, Aldosteron and Cortisol), Proteinous Hormones (Insulin, Glucagon, Oxytocin and Vassopressin).
c) Anti-neoplastic Agents: Tamoxifen, Fluorouracil, Mercapturine, Methotrexate and Vincristine.
PHARMACEUTICAL CHEMISTRY-V (Medicinal Chemistry-I)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g.
1. Estimation of functional groups; Carboxylic, Hydroxy, Amino and Nitro groups; Determination of Molecular weights of Organic Compounds.
2. Synthesis of Paracetamol, Salicylic Acid, Methyl salicylate, Azobenzene, Benzoic Acid, 5-Hydroxy-1,3-benzoxazol-2-one, Aspirin, P-nitrosophenol, 3-nitrophthalic acid, o-Chloro-benzoic acid.
Recommended Books
1. Martin and Cook, Remington Practice of Pharmaceutical Science, Mack Publishing Company, USA, 2001
2. Foye W O, Principles of Medicinal Chemistry, Verghese Publising House, Bomby, 1995.
3. Tyagi, Text Book of Synthetic Drugs, Anmol Publications, Delhi, 1990. 4. Alferd Burger, Medicinal Chemistry, Jhon Willey & Sons, New York, 1996.
4. Block, Roche, Soine and Wilson, Inorganic and Medicinal Pharmaceutical Chemistry, Verghese Publishing House, Bombay, 1986.
5. Block, Roche, Soine and Wilson. Inorganic and Medicinal Pharmaceutical Chemistry, Lee & Febiger, Philadelphia, USA, 1983.
Fourth Professional, Second Semester, Pharmaceutics
PHARMACEUTICS-XVI (Pharmaceutical Quality Managements-II)
(Theory)
Cr. Hr. 03
1. BIOLOGICAL ASSAYS: Biological methods, Standard praprations and units of activity, Bioassay of antibiotics, Bioassay of insulin injection, Assay of prepared digitalis and Assay of Vitamin D.
2. ALCOHOL DETERMIANTION: Alcoholometric methods, Problem during distillation of alcohol, Method for liquids containing less than 30% or more than 30% alcohol and special treatment before distillation.
3. ALKALOIDAL DRUG ASSAY: Weighing for assay, Extraction of drugs, Maceration, Percolation, Continuous extraction, Puriifcation of Alkaloids and determination of alkaloids.
4. MISCELLANEOUS DETERMINATIONS AND TESTS: Determiantion of weight/ml, Water/Moisture content, Loss on Drying, Toxicity tests & Identification tests, Evaluation of Ointments, Ash contents and Alkalinity of Glass.
5. GENERAL KNOWLEDGE OF APPENDICES ATTACHED TO B.P., BPC, AND USP.
6. STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING MANUFACTURING PROCESSES.
PHARMACEUTICS-XVI (Pharmaceutical Quality Managements-II)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g. Sterility test, Determiantion of Ash contents, Determination of Moisture contents, Determination of total solids, Determination of viscosity of syrups, gels, etc., Determination of emulsion types.
Recommended Books
1. A H Beckett and J B Stennlake, Practical Pharmaceutical Chemistry, Part-I and II, The Alton Press, London.
2. A M Knevel and F E Digangi, Jenkin’s Quantitative Pharmaceutical chemistry, McGraw-Hill Book Company, New York.
3. K A Connors, A Text Book of Pharmaceutical Analysis, John — Wiley and Sons, New York.
4. A Braithwaite and F J Smith, Chromatographic Methods, Chapman and Hall, London.
5. G D Christian, Analytical Chemistry, John Wiley and Sons, New York.
6. Karamt A Javaid, Pharmaceutical Quality Assurance in Class, Industry and Market, Aziz Publishers, Lahore-Pakistan (1993).
7. Gil Bismuth and Shosh Neumann, Cleaning Validation, A practical approach. CRC Press, LLC, USA, 2003.
8. J T Carstersen and C T Rhodes, Drug Stability: Principles and Practices, 3rd Ed. (revised and expanded) Mercel Dekker, New York, 2000.
9. Sydney H Willig, Good Manufacturing Practices for Pharmaceuticals, Marcel Dekker Publishing.
10. Bryant R, The pharmaceutical Quality Control Hand Book, Aster Publishing Corporation, Eugene, 1989.
11. Braun R E, Introduction to Instrumental Analysis, McGraw-Hill Book Co, NY, 1987.
(Theory)
Cr. Hr. 03
1. BIOLOGICAL ASSAYS: Biological methods, Standard praprations and units of activity, Bioassay of antibiotics, Bioassay of insulin injection, Assay of prepared digitalis and Assay of Vitamin D.
2. ALCOHOL DETERMIANTION: Alcoholometric methods, Problem during distillation of alcohol, Method for liquids containing less than 30% or more than 30% alcohol and special treatment before distillation.
3. ALKALOIDAL DRUG ASSAY: Weighing for assay, Extraction of drugs, Maceration, Percolation, Continuous extraction, Puriifcation of Alkaloids and determination of alkaloids.
4. MISCELLANEOUS DETERMINATIONS AND TESTS: Determiantion of weight/ml, Water/Moisture content, Loss on Drying, Toxicity tests & Identification tests, Evaluation of Ointments, Ash contents and Alkalinity of Glass.
5. GENERAL KNOWLEDGE OF APPENDICES ATTACHED TO B.P., BPC, AND USP.
6. STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING MANUFACTURING PROCESSES.
PHARMACEUTICS-XVI (Pharmaceutical Quality Managements-II)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g. Sterility test, Determiantion of Ash contents, Determination of Moisture contents, Determination of total solids, Determination of viscosity of syrups, gels, etc., Determination of emulsion types.
Recommended Books
1. A H Beckett and J B Stennlake, Practical Pharmaceutical Chemistry, Part-I and II, The Alton Press, London.
2. A M Knevel and F E Digangi, Jenkin’s Quantitative Pharmaceutical chemistry, McGraw-Hill Book Company, New York.
3. K A Connors, A Text Book of Pharmaceutical Analysis, John — Wiley and Sons, New York.
4. A Braithwaite and F J Smith, Chromatographic Methods, Chapman and Hall, London.
5. G D Christian, Analytical Chemistry, John Wiley and Sons, New York.
6. Karamt A Javaid, Pharmaceutical Quality Assurance in Class, Industry and Market, Aziz Publishers, Lahore-Pakistan (1993).
7. Gil Bismuth and Shosh Neumann, Cleaning Validation, A practical approach. CRC Press, LLC, USA, 2003.
8. J T Carstersen and C T Rhodes, Drug Stability: Principles and Practices, 3rd Ed. (revised and expanded) Mercel Dekker, New York, 2000.
9. Sydney H Willig, Good Manufacturing Practices for Pharmaceuticals, Marcel Dekker Publishing.
10. Bryant R, The pharmaceutical Quality Control Hand Book, Aster Publishing Corporation, Eugene, 1989.
11. Braun R E, Introduction to Instrumental Analysis, McGraw-Hill Book Co, NY, 1987.
Fourth Professional, Second Semester, Pharmaceutics
PHARMACEUTICS-X (Biopharmaceutics-II)
(Theory)
Cr. Hr. 03
1. INTRODUCTION TO PHARMACOKINETICS: Determination through plasma drug level studies. Application of pharmacokinetics in clinical situations.
2. CONCEPT OF COMPARTMENT (S) MODELS: One compartment open model. Two compartment open model. Three compartment open model and Non-compartmental method of analysis.
3. BIOLOGICAL HALF-LIFE AND VOLUME OF DISTRIBUTION:
Concept and Methods of Determination.
4. DRUG CLEARANCE:
Mechanism, determination and relationship of clearance with half-life.
5. ELIMINATION OF DRUGS:
a) Hepatic Elimination. Percent of Drug Metabolized, Drug Biotransformation reactions, (Phase-I reactions and phase-II reactions), First pass effect, Hepatic clearance of protein bound drugs and Biliary excretion of drugs.
b) Renal Excretion of Drugs: Renal clearance, Tubular Secretion and Tubular Reabsorption.
c) Elimination of Drugs through other organs: Pulmonary excretion, Salivary excretion, Mammary excretion, Skin excretion and Genital excretion.
6. PROTEIN BINDING:
Determination of plasma protein binding and Clinical significance of drug-protein binding.
7. APPLICATIONS OF PHARMACOKINETICS AND BIOAVAILABILITY IN CLINICAL SITUATIONS.
8. APPLICATIONS OF PHARMACOKIENTICS IN DISEASE STATES.
PHARMACEUTICS-X (Biopharmaceutics-II)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g.
1. Plasma level-time curve: Determination of Pharmacokinetic parameters.
2. Determination of plasma protein binding.
3. Urinary sampling techniques.
4. In Laboratory animals. In humans. Renal excretion of drugs or drug disposition.
Recommended Books
1. Leon Shargel, Applied Pharmacokinetics and Biopharmaceutics, Appleton & Lange, New York, 4th Ed., 1999.
2. Malcoln Rouland, Thomous N Tozer, Clinical Pharmacokinetics, William & Willkins, London, 1995.
3. Milo Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics, Marchel & Dakker Inc, New York, 1982.
4. Gibbson and Skett, Introduction to Drug Metabolism, Champ & Hall, London, 1986.
5. Robert E Notari, Biopharmaceutics and Clinical Pharmacokinetics, Marchel & Dakker Inc, New York, 1988.
6. Stephen H Curry, Drug disposition and pharmacokinetics, Black Well Scientific Publishing, Oxford, 1977.
7. Avraham Yacobi, Toxicokinetics and New Drug Development, Paramount Press, New York, 1989.
8. Sarfraz Niazi, Text Book of Biopharmaceutics and Clinical Pharmacokinetics. Appleton-Century-Crofts, New York, 1985.
9. P Macheras, C Reppas and J B Dressman, Biopharmaceutics of orally administered drugs, Ellis Horwood Limited, London (1995).
10. Albert P Li, Invitro approaches for evaluation of drug efficacy and toxicity, CRC Press, LLC, USA, 2004.
11. Ronald D Schoenwald, Pharmacokinetics in drug discovery and Development, CRC Press, LLC, USA, 2002.
(Theory)
Cr. Hr. 03
1. INTRODUCTION TO PHARMACOKINETICS: Determination through plasma drug level studies. Application of pharmacokinetics in clinical situations.
2. CONCEPT OF COMPARTMENT (S) MODELS: One compartment open model. Two compartment open model. Three compartment open model and Non-compartmental method of analysis.
3. BIOLOGICAL HALF-LIFE AND VOLUME OF DISTRIBUTION:
Concept and Methods of Determination.
4. DRUG CLEARANCE:
Mechanism, determination and relationship of clearance with half-life.
5. ELIMINATION OF DRUGS:
a) Hepatic Elimination. Percent of Drug Metabolized, Drug Biotransformation reactions, (Phase-I reactions and phase-II reactions), First pass effect, Hepatic clearance of protein bound drugs and Biliary excretion of drugs.
b) Renal Excretion of Drugs: Renal clearance, Tubular Secretion and Tubular Reabsorption.
c) Elimination of Drugs through other organs: Pulmonary excretion, Salivary excretion, Mammary excretion, Skin excretion and Genital excretion.
6. PROTEIN BINDING:
Determination of plasma protein binding and Clinical significance of drug-protein binding.
7. APPLICATIONS OF PHARMACOKINETICS AND BIOAVAILABILITY IN CLINICAL SITUATIONS.
8. APPLICATIONS OF PHARMACOKIENTICS IN DISEASE STATES.
PHARMACEUTICS-X (Biopharmaceutics-II)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g.
1. Plasma level-time curve: Determination of Pharmacokinetic parameters.
2. Determination of plasma protein binding.
3. Urinary sampling techniques.
4. In Laboratory animals. In humans. Renal excretion of drugs or drug disposition.
Recommended Books
1. Leon Shargel, Applied Pharmacokinetics and Biopharmaceutics, Appleton & Lange, New York, 4th Ed., 1999.
2. Malcoln Rouland, Thomous N Tozer, Clinical Pharmacokinetics, William & Willkins, London, 1995.
3. Milo Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics, Marchel & Dakker Inc, New York, 1982.
4. Gibbson and Skett, Introduction to Drug Metabolism, Champ & Hall, London, 1986.
5. Robert E Notari, Biopharmaceutics and Clinical Pharmacokinetics, Marchel & Dakker Inc, New York, 1988.
6. Stephen H Curry, Drug disposition and pharmacokinetics, Black Well Scientific Publishing, Oxford, 1977.
7. Avraham Yacobi, Toxicokinetics and New Drug Development, Paramount Press, New York, 1989.
8. Sarfraz Niazi, Text Book of Biopharmaceutics and Clinical Pharmacokinetics. Appleton-Century-Crofts, New York, 1985.
9. P Macheras, C Reppas and J B Dressman, Biopharmaceutics of orally administered drugs, Ellis Horwood Limited, London (1995).
10. Albert P Li, Invitro approaches for evaluation of drug efficacy and toxicity, CRC Press, LLC, USA, 2004.
11. Ronald D Schoenwald, Pharmacokinetics in drug discovery and Development, CRC Press, LLC, USA, 2002.
Fourth Professional, Second Semester, Pharmaceutics
PHARMACEUTICS-IX (Industrial Pharmacy-II)
(Theory)
Cr. Hr. 03
1. EMULSIONS:
Mechanical Equipments, Specific formulation Considerations and Emulsion stability.
2. SUSPENSIONS: Formulation of suspensions, Equipment used in preparation and test methods for pharmaceutical suspensions.
3. SEMISOLIDS:
Equipment used for Ointments, Pastes, Gels and Jellies. Packaging of ointments.
4. STERILE PRODUCTS:
Sterile area and its Classification, Ophthalmic ointments, Preparation of praenterals (Building, Equipment), Complete Sterility (Aseptic area), air control, (Laminar flow etc.), air locks, Environmental monitoring methods, Sterilization, Filling/Packaging (Plastic and glass containers), Added substances (Preservatives, antioxidants, solubilizer, suspending agents, buffers, stabilizers etc.), Inprocess Quality Control of Parenterals (Sterility, leakage, pyrogens, clarity etc.).
5. STANDARDIZATION OF PHARMACEUTICALS: An understanding of quality assurance system adopted in pharmaceutical industry. Good Manufacturing Practices and Current Good Manufacturing Practices.
6. PACKING & PACKAGING:
Influence of Packaging materials, Stability, Packaging Lines, Packaging Area, Packaging Equipment.
7. EQUIPMENTS USED FOR: Patches, Sprays, Implants, Sutures, Plasters and Sachet packing.
8. STUDY TOUR:
A visit to the pharmaceutical industries will be an integral part of the syllabi
PHARMACEUTICS-IX (Industrial Pharmacy-II)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g.
1. Ampoule filling, sealing and sterilization clarity and leakage tests in injectables.
2. Capsule filling by semi automatic machines. Manufacture of sustained action drugs.
3. Tablets Tests like Disintegration. Dissolution. Friability. Hardness and thickness tests. Determination of weight variation in tablets. Density of powder. Particle size analysis.
Recommended Books
1. Lackman, Theory and Practice of Industrial Pharmacy, Verghese Publishing House, Bombay, 1987.
2. Cooper and Gunn’s, Tutorial Pharmacy, CBS Publishers & Distributors, New Delhi, 1986.
3. Bentley’s Pharmaceutical Text Book, CBS Publishers & Distributors, New Delhi, 1986.
4. Remington’s Pharmaceutical Sciences, Mack Publishing Company, USA, 2001.
5. John Sharp, Good Pharmaceutical Manufacturing Practice, Rational and Compliance.
(Theory)
Cr. Hr. 03
1. EMULSIONS:
Mechanical Equipments, Specific formulation Considerations and Emulsion stability.
2. SUSPENSIONS: Formulation of suspensions, Equipment used in preparation and test methods for pharmaceutical suspensions.
3. SEMISOLIDS:
Equipment used for Ointments, Pastes, Gels and Jellies. Packaging of ointments.
4. STERILE PRODUCTS:
Sterile area and its Classification, Ophthalmic ointments, Preparation of praenterals (Building, Equipment), Complete Sterility (Aseptic area), air control, (Laminar flow etc.), air locks, Environmental monitoring methods, Sterilization, Filling/Packaging (Plastic and glass containers), Added substances (Preservatives, antioxidants, solubilizer, suspending agents, buffers, stabilizers etc.), Inprocess Quality Control of Parenterals (Sterility, leakage, pyrogens, clarity etc.).
5. STANDARDIZATION OF PHARMACEUTICALS: An understanding of quality assurance system adopted in pharmaceutical industry. Good Manufacturing Practices and Current Good Manufacturing Practices.
6. PACKING & PACKAGING:
Influence of Packaging materials, Stability, Packaging Lines, Packaging Area, Packaging Equipment.
7. EQUIPMENTS USED FOR: Patches, Sprays, Implants, Sutures, Plasters and Sachet packing.
8. STUDY TOUR:
A visit to the pharmaceutical industries will be an integral part of the syllabi
PHARMACEUTICS-IX (Industrial Pharmacy-II)
(Laboratory)
Cr. Hr. 01
NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g.
1. Ampoule filling, sealing and sterilization clarity and leakage tests in injectables.
2. Capsule filling by semi automatic machines. Manufacture of sustained action drugs.
3. Tablets Tests like Disintegration. Dissolution. Friability. Hardness and thickness tests. Determination of weight variation in tablets. Density of powder. Particle size analysis.
Recommended Books
1. Lackman, Theory and Practice of Industrial Pharmacy, Verghese Publishing House, Bombay, 1987.
2. Cooper and Gunn’s, Tutorial Pharmacy, CBS Publishers & Distributors, New Delhi, 1986.
3. Bentley’s Pharmaceutical Text Book, CBS Publishers & Distributors, New Delhi, 1986.
4. Remington’s Pharmaceutical Sciences, Mack Publishing Company, USA, 2001.
5. John Sharp, Good Pharmaceutical Manufacturing Practice, Rational and Compliance.
Fourth Professional, Second Semester, Pharmaceutics
PHARMACEUTICS-VIII (Clinical Pharmacy-II)
(Theory)
Cr. Hr. 03
1. DRUG INTERACTIONS:
Mechanism, Physiological factors affecting interaction, Types and level of drug interactions, Role of pharmacist in evaluating drug interactions & its management.
2. ADVERSE DRUG REACTIONS: Adverse Drug Reactions and Side Effects: Classification, Excessive pharmacological response, Idiosyncrasy, Secondary pharmacological effects, Allergic drug reactions, General toxicity, Toxicity following drug
Withdrawal, Detection, reporting & Management of ADR.
3. DRUG INDUCED DISEASES.
4. COMPUTERS IN CLINICAL PHARMACY:
5. UTILIZATION OF CLINICAL DRUG LITERATURE: Introduction, Drug literature selection, Drug literature evaluation and Drug literature communication.
PHARMACEUTICS-VIII (Clinical Pharmacy-II)
(Laboratory)
Cr. Hr. 01
Clerkship in the Clinical setting. A project related to Clinical Pharmacy Practices will be completed by the students and will be evaluated by the external examiner.
Recommended Books
1. Roger Walker, Clinical Pharmacy & Therapeutics, Churchill Levingstone, London, 3rd Ed., 2003
2. Guard Paul, A Behavioral Approach to Pharmacy Practice, Black Well, USA, 2000.
3. Herfindal Gourley, Clinical Pharmacy & Therapeutics, William & Willkins, London, 1992.
4. A J Winfield, Pharmaceutical Practice, Churchill Levingstone, London, 2nd Ed., 1998.
5. Kavin Taylor, Pharmacy Practice, Taylor & Francis, New York, 1998.
6. Deborah Rosenbaun, Clinical Research Coordinator Hand Book, 2nd edition, Sarrison, Inc, North Carolina, USA.
7. Simon Cook, Clinical Studies Management, a Practical Guide to Success, Sue Horwood Publishing limited, West Sussex, UK.
8. Joseph. T Dipiro, Encyclopaedia of Clinical Pharmacy. Marcel Dekker Publishing, 2003
9. Joseph T, Dipiro, Encyclopaedia of Pharmacy. Marcel Dekker Publishing, 2002
10. Mellainie J Rantucci, Pharmacist Talking with Patients, 1997.
11. Smith GDG and Aronson J K, Oxford Text Book of Clinical Pharmacology and Drug Therapy, Oxford University Press, UK, 1990.
12. Hansten P and Horn J, Drug interactions. Lee & Febiger, Philadelphia, USA, 1989.
(Theory)
Cr. Hr. 03
1. DRUG INTERACTIONS:
Mechanism, Physiological factors affecting interaction, Types and level of drug interactions, Role of pharmacist in evaluating drug interactions & its management.
2. ADVERSE DRUG REACTIONS: Adverse Drug Reactions and Side Effects: Classification, Excessive pharmacological response, Idiosyncrasy, Secondary pharmacological effects, Allergic drug reactions, General toxicity, Toxicity following drug
Withdrawal, Detection, reporting & Management of ADR.
3. DRUG INDUCED DISEASES.
4. COMPUTERS IN CLINICAL PHARMACY:
5. UTILIZATION OF CLINICAL DRUG LITERATURE: Introduction, Drug literature selection, Drug literature evaluation and Drug literature communication.
PHARMACEUTICS-VIII (Clinical Pharmacy-II)
(Laboratory)
Cr. Hr. 01
Clerkship in the Clinical setting. A project related to Clinical Pharmacy Practices will be completed by the students and will be evaluated by the external examiner.
Recommended Books
1. Roger Walker, Clinical Pharmacy & Therapeutics, Churchill Levingstone, London, 3rd Ed., 2003
2. Guard Paul, A Behavioral Approach to Pharmacy Practice, Black Well, USA, 2000.
3. Herfindal Gourley, Clinical Pharmacy & Therapeutics, William & Willkins, London, 1992.
4. A J Winfield, Pharmaceutical Practice, Churchill Levingstone, London, 2nd Ed., 1998.
5. Kavin Taylor, Pharmacy Practice, Taylor & Francis, New York, 1998.
6. Deborah Rosenbaun, Clinical Research Coordinator Hand Book, 2nd edition, Sarrison, Inc, North Carolina, USA.
7. Simon Cook, Clinical Studies Management, a Practical Guide to Success, Sue Horwood Publishing limited, West Sussex, UK.
8. Joseph. T Dipiro, Encyclopaedia of Clinical Pharmacy. Marcel Dekker Publishing, 2003
9. Joseph T, Dipiro, Encyclopaedia of Pharmacy. Marcel Dekker Publishing, 2002
10. Mellainie J Rantucci, Pharmacist Talking with Patients, 1997.
11. Smith GDG and Aronson J K, Oxford Text Book of Clinical Pharmacology and Drug Therapy, Oxford University Press, UK, 1990.
12. Hansten P and Horn J, Drug interactions. Lee & Febiger, Philadelphia, USA, 1989.
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