Thursday, March 3, 2011

Fourth Professional, Second Semester, Pharmaceutics

PHARMACEUTICS-VII (Hospital Pharmacy-II)
(Theory)


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1. MANUFACTURING BULK AND STERILE.

2. THE PHARMACY-CENTRAL STERILE SUPPLY ROOM.

3. ASEPTIC DISPENSING

TPN, I/V Admixtures, Cytotoxic Dispensing, Semi-sterile Dispensing (Eye drops, Ear drops) and Hyperailimentation.

4. ROLE OF PHARMACISTS IN SMALL HOSPITALS, NURSING HOMES ETC:

5. PURCHASING, DISTRIBUTION AND CONTROL OF HOSPITAL MEDICINES, MEDICAL & SURGICAL SUPPLIES: Purchasing, Stocking, Stock Control, Inventory Management, Drug Distribution, Relationship between purchasing, Distribution and Clinical

Pharmacy Services.

6. NUCLEAR PHARMACY.

7. THE PHYSICAL PLANT AND ITS EQUIPMENT

8. INVESTIGATIONAL USE OF DRUGS.

9. HEALTH ACCESSORIES.

10. SURGICAL SUPPLIES.

11. INSPECTION OF WARDS WITH REFERENCE TO DRUG STORAGE AND ADMINISTRATION.

12. MANAGEMENT OF ACCIDENT & EMERGENCY PHARMACY (A & E).

13. COMMON KNOWLEDGE OF ABOUT 100 DRUGS REGISTERED BY MINISTRY OF HEALTH, GOVERNMENT OF PAKISTAN.

Recommended Books

1. William Hassan, Hospital Pharmacy, Lee & Febiger, Washington, 5th Ed., 1986.
2. N I Bukhari, Hospital Pharmacy, Aziz Book Depot, Lahore-Pakistan (2000).
3. Martin Stephen, Hospital Pharmacy, Pharmaceutical Press, London, 2003.

Fourth Professional, First Semester, Pharmaceutics

PHARMACEUTICS-XI (Pharmaceutical Quality Management-I)
(Theory)


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1. SCOPE

(a) An understanding of the testing, quality control programme and methods adopted in a pharmaceutical industry, dosage form control, process control, testing program and methods, physical, chemical and biological tests and specifications, statitical quality control.

(b) General understanding of Total Quality Assurance and measures to adopt Quality Assurance

2. QUALITY CONTROL OF SOLID DOSAGE FORMS:

(a) Physical tests: Hardness, Thickness and Diameter, Friability, Disintegration, Weight Variation.

(b) Chemical tests: Content uniformity, Assay of active ingredients and dissolution tests of Powders, Granules, Tablets and Capsules.

3. QUALITY CONTROL OF SYRUPS AND ELIXIRS:

Viscosity, its determiantion and application in the Quality Control of Pharmaceuticals, Weight per ml and Assay of active ingredients.

4. EVALUATION OF SUSTAINED ACTION PRODUCTS (TABLETS & CAPSULES):

Stability of viability rate during storage and In-vitro & In-vivo evaluation of sustaining action.

5. QUALITY CONTROL OF SUPPOSITORIES Disintegration test, Uniformity of weight, Assay of active ingredients, Liqefaction time test and Breaking test.

6. QUALITY CONTROL OF STERILE PRODUCTS (PARENTERALS) Leaker’s test, Clarity test, Pyrogen test for parenterals and other sterile preparations and Assay for active ingredients.

PHARMACEUTICS-XI (Pharmaceutical Quality Management-I)
(Laboratory)

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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. Assay of various spirits, tinctures, extracts, syrups and elixirs, Assay of Ointments and suppositories, Assay of tablets and capsules, Test for alkalinity of glass, Determiantion of alcohol contents in the Pharmaceutical preparations and Pyrogen test.

Recommended Books

1. A H Beckett and J B Stennlake, Practical Pharmaceutical Chemistry, Part-I and II, The Alton Press, London.
2. 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. 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, First Semester, Pharmaceutics

PHARMACEUTICS-X (Biopharmaceutics-I)
(Theory)

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1 DEFINITIONS AND TERMINOLOGY: Biopharmaceutics, Generic Equivalence, Bioavailability, Bioequivalence, Drug Disposition, Therapeutics, Pharmacokinetics, Biotransformation and Therapeutic Equivalents.

2. GASTRO-INTESTINAL ABSORPTION AND PHYSICO-CHEMICAL CONSIDERATIONS. Forces which help in transmembrane movements, pH Partition Theory, Lipid Solubility and Factors affecting Bioavailability.

3. BIOAVAILABILITY STUDIES: Purpose, Relative and Absolute Bioavailability, and Determination of Bioavailability.

4. FACTORS AFFECTING DISSOLUTION IN RESPECT OF BIOAVAILABILITY: Methods of in-vitro and in-vivo determination of rate of dissolution.

5. MULTIPLE DOSAGE REGEMIN.

6. INTRAVENOUS INFUSIONS.

7. BIOPHARMACEUTICAL AND PHARMACOKINETIC ASPECTS IN DEVELOPING A DOSAGE FORM.
PHARMACEUTICS-X (Biopharmaceutics)
(Laboratory)

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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. Blood Sampling Techniques: In Laboratory Animals like dog, rabbits, mice etc. In human beings, In-vitro dissolution studies, Optional dose determination, Measurement of rate of Bioavailability, Determination of relative and absolute bioavailability.

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, First Semester, Pharmaceutics

PHARMACEUTICS-IX (Industrial Pharmacy-I)
(Theory)


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1. MASS TRANSFER.

2. HEAT TRANSFER.

3. DRYING: Theories of drying, Drying of Solids, Classification of dryers, General Methods, Fluidized Bed systems, Pneumatic systems, Spray dryer, Freeze dying.

4. MIXING: Fundamentals, Mechanisms, Mixing Equipment used in Liquid/Liquid, Liquid/Solid and solid/solid mixing, Communition (size reduction), Reasons for size reduction, Factors affecting size reduction, size analysis, Sieving, Energy Mills (Ball Mill. Endrumer, Edge Rumer, Disintegrant, Colloid Mill, Hammer Mill, Cutter Mill, and Fluid Energy Mill etc.).

5. CLARIFICATION AND FILTERATION: Theory, Filter media, Filter aids, Filter selection and Equipment (Leaf filter, Filter press, Melta filters and Rotary filters).

6. EVAPORATION: General principles of Evaporation, Evaporators and Evaporation under reduced pressure.

7. COMPRESSION AND COMPACTION: The solid-air Interface, Angle of Repose, Flow rates, Mass volume relationship, Density, Heckel Plots, Consolidation, Granulation, Friability, Compression (dry method, wet method, slugging), Physics of Tabletting, tabletting machines and other equipment required, problems involved in tabletting, tablet coating,

Capsulation (Hard and Soft gelatin capsules).

8. SAFETY METHODS IN PHARMACEUTICAL INDUSTRY:

(a) Mechanical, chemical and fire hazards problems.

(b) Inflammable gases and dusts.
PHARMACEUTICS-IX (Industrial Pharmacy-I)
(Laboratory)

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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. Manufacture of Tablets by Wet Granulation Method, by Slugging and by Direct Compression. Coating of Tablets (Sugar Coating, Film coatingand Enteric Coating). Clarification of liquids by various processes. Size Reduction. Homogenization.

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.