Fourth Professional, Second Semester, Pharmaceutics

PHARMACEUTICS-X (Biopharmaceutics-II)
(Theory)

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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)

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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.

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)


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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)

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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.

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)


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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)

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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.

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.