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JNTU 2007-08 IV Year I Sem B.Pharmacy - BIOPHARMACEUTICS AND PHARMACOKINETICS
Posted Date: 29 Dec 2007 Resource Type: Articles/Knowledge Sharing Category: Syllabus
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Posted By: India Member Level: Diamond
Rating:  Points: 1
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JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY
HYDERABAD
IV Year B. Pharmacy I-Semester T P C
3+1* 0 3
(R7602) BIOPHARMACEUTICS AND PHARMACOKINETICS
UNIT-I
Introduction to Biopharmaceutics and Pharmacokinetics and their role in formulation development and clinical setting
UNIT-II
Biopharmaceutics: Passage of drugs across biological barrier (passive diffusion, active transport, facilitated diffusion and pinocytosis) factors influencing absorption – physiochemical, physiological and pharmaceutical.
UNIT-III
Drug distribution in the body, Factors influencing distribution.
UNIT-IV
Plasma protein binding, binding sites, factors influencing protein binding
UNIT-V
Pharmacokinetics
Significance of plasma drug concentration measurement.
Compartment model: Definition and scope.
Pharmacokinetics of drug absorption – Zero order and first order absorption rate constant using Wagner Nelson and Loo-riegelman method.
Volume of distribution and distribution coefficient.
Comparative kinetics : One compartment and two compartment models. Determination of Pharmacokinetic parameters from plasma and urine data after drug administration by oral parenteral and other routes.
Curve fitting (Method of Residuals) Regression procedures.
Clearance concept, Mechanism of Renal clearance, clearance ratio, determination of renal clearance.
Non-linear pharmacokietics with special reference to one compartment model after I.V.Drug administration, Michales Mente Equation, detection of non-linearity (Saturation mechanism).
UNIT-VI
Clinical pharmacokinetics
Definition and scope
Dosage adjustment in patients with and without renal and hepatic failure.
Pharmakokinetic drug interactions and its significance in combination therapy.
UNIT-VII
Bioavailability and bioequivalance.
Measures of bioavailability, C-max, T-max and Area Under the Curve (AUC)
Design of single dose bioequivalance study and relevant statistics.
Overview of regulatory requirements for conduction of bio-equivalence studies.
UNIT-VIII
Bio availability and bio equivalence including evaluation testing protocols.
g. In vitro dissolution studies for solid dosage forms methods, interpretation of dissolution data in vitro, in vivo correlations.
h. Bioavailability testing protocol and procedures.
i. In vivo methods of evaluation – statistical treatment.
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Responses
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| Author: India 29 Dec 2007 | Member Level: Diamond Points : 5 | TEXT BOOKS
1. Venkateshulu, Fundamentals of Biopharmaceutics and Pharmacokinetics, Pharma Book Syndicate.
2. Milo Gibaldi, Biopharmaceutics and clinical pharmacokinetics 4/Edn. Pharma Book Syndicate.Hyderabad
3. DM Brahmankar and SB Jaiswal, biophamaceutics and pharmacokinetics- a treatise, vallabh prakasham, Delhi,
4. P.L. Madan, Biopharmaceuticas and Pharmacokinnetics, Jaypee Bros.
REFERENCES
1. Remington’s pharmaceutical sciences, Mac Pub. Co., Easton Pensylvania.
2. Modern pharmaceutics by banker Marcel Dekker Inc., NY
3. L. lachman, H.A.Lieberman, JL. Kanig, the theory aad practice of industrial pharmacy, Varghese publ house, Mumbai.
4. AR. Gennerio Remington: the science andpractice of pharmacy, vol 1 &2 Lippincott Williams & wilkins, Philadelphia, 2004.
5. Robert E notary, Biopharmaceutics and pharmacokinetics – an introduction, arcel dekker inc., NY
6. L. Shargel and ABC Yu, textbook of applied biopharmaceutics & pharmacokinetics, 4th edn, Appleton – centuary – crofts, Connecticut, 2004.
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