JNTUK B.Tech Biopharmaceutics & Pharmacokinetics gives you detail information of Biopharmaceutics & Pharmacokinetics R13 syllabus It will be help full to understand you complete curriculum of the year.
UNIT – I
Introduction to Biopharmaceutics and Pharmacokinetics and their role in formulation development and clinical setting
Biopharmaceutics: Passage of drugs across biological barrier (passive diffusion, active transport, facilitated diffusion and pinocytosis) factors influencing absorption – physiochemical, physiological and pharmaceutical.
LO : To understandBiopharmaceutics, Pharmacokinetics and their applications –absorption mechanisms, factors, their application with examples.
UNIT – II
Drug distribution in the body, Factors influencing distribution. Plasma protein binding, binding sites, factors influencing protein binding
LO : To understand drug distribution, protein binding – factors.
UNIT – III : 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.
LO : To understand the significance of plasma drug concentrations, compartment models – kinetics, parameters.
UNIT – IV : 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, MichalesMente Equation, detection of non-linearity (Saturation mechanism).
LO : To understand pharmacokinetic models, Linear and Non-Linear kinetics, mechanisms and method of assessments.
UNIT – V : 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.
LO : To understand clinical pharmacokinetics and their significance, drug interactions – Adjustment of dose.
UNIT – VI : 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. Bio availability and bio equivalence including evaluation testing protocols.
a. In vitro dissolution studies for solid dosage forms methods, interpretation of dissolution data in vitro, in vivo correlations.
b. Bioavailability testing protocol and procedures.
c. In vivo methods of evaluation – statistical treatment.
LO : To understand bioavailability, bioequivalence, concepts, assessments, design, regulation, invitro dissolution methods, Invitro-invivo correlation.
TEXT BOOKS
- Venkateshulu, Fundamentals of Biopharmaceutics and Pharmacokinetics, Pharma Book Syndicate.
- Milo Gibaldi, Biopharmaceutics and clinical pharmacokinetics 4/Edn. Pharma Book Syndicate.
- DM Brahmanka and SB Jaiswal, biophamaceutics and pharmacokinetics- a treatise, vallabhprakasham, Delhi.
- P.L. Madan, Biopharmaceuticas and Pharmacokinnetics, Jaypee Bros.
REFERENCES
- Remington’s pharmaceutical sciences, Mac Pub. Co., Easton Pensylvania.
- Modern pharmaceutics by banker Marcel Dekker Inc., NY
- L. lachman, H.A.Lieberman, JL. Kanig, the theory aad practice of industrial pharmacy, Varghese publ house, Mumbai.
- AR. Gennerio Remington: the science andpractice of pharmacy, vol 1 & 2 Lippincott Williams &wilkins, Philadelphia, 2004.
- Robert E notary, Biopharmaceutics and pharmacokinetics – an introduction, arceldekkerinc., NY
- L. Shargel and ABC Yu, textbook of applied biopharmaceutics& pharmacokinetics, 4thedn, Appleton – centuary – crofts, Connecticut, 2004.
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