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PHARMACEUTICAL BIOTECHNOLOGY THEORY PY-704 I PY-704 SYLLABUS I RGTU PHARMACY 7TH SEM SYLLABUS I RGTU PY-704 PHARMACEUTICAL BIO TECHNOLOGY SYLLABUS I PY-704 PAPERS I RGTU PHARMACY 7TH SEM SYLLABUS I RGPV B.PHARMACY 7TH SEM PREVIOUS YEAR PAPERS I RGTU PHARMACY 7TH SEM SYLLABUS I PHARMACY LAST 5 YEAR PAPERS

PHARMACEUTICAL BIOTECHNOLOGY THEORY PY-704

Historical Development :
Immunology and Immunological Preparations :

• Principles,Antigens and antibodies,Antigen-antibody reactions and their applications, Immune system.Cellular humoral immunity,Immunological tolerance,Hyper sensitibity, Immunological and diagnostic preparations: Methods of their preparation, standardization and storage.

Enzyme Immobilization –

• Techniques of Immobilization of enzymes, Kinetics and factors affecting enzymes kinetics,Enzymes based sensors, Study of enzymes such as Hyaluronidase, Penicillinase, Strepto-Kinase, Amylases etc. Immobilization of bacteria and plant cells, Applications of Immobilization.

Genetic Recombination :

• Transformation,Conjugation,Transduction,Protoplast fusion,Gene cloning and their applications,Monoclonal antibodies and hybridoma technology, Recombinant DNA technology: Concepts, Methodology and Pharmaceutical applications. Study of drugs produced by biotechnology such as Activase, Humulin, Humatrope, Introne A, Monoclate, Orthoclone OKT3, Referon-A, Recombivax HB etc.Drug delivery systems in Gene therapy.

Microbiological Transformation –

• Introduction,Type of reactions mediated by micro organisms.Design of bio- transformation processes, Selection of organism, Bio transformation processes and its improvements with special reference to steroids.

Industrial Biotechnology –

• Historical development, Fermenter and its design, Control of different parameters in fermentation process, Isolation of mutants, Use of mutagenic agents, Factors in influencing rate of mutation. Design of fermentation process, Fermentative, production of Alcohol, Acetic acid, Penicillin, Streptomycin, Riboflavin, Vitamin B12.

LIST OF PRACTICALS: 

• Detect the presence of the amylase enzyme in saliva.

• Isolate the DNA from cauliflower.

• Perform VDRL test for the given sample of blood.

• Isolate the phospholipid from egg yolk .

• Perform WIDAL test for the given sample of blood.

• Perform DOT ELISA test of the given sample of blood.

• Isolate the total RNA from yeast tablet.

• Immobilize the given enzyme by adsorption method using calcium alginate beads.

• Perform titre value of antibody in given blood sample.

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PHARMACEUTICS-X(BIO PHARMACEUTICS & PHARMACEUTICS) PY-702 I PY-702 SYLLABUS I BIO-PHARMACEUTICS SYLLABUS I RGTU B.PHARMACY 7TH SEM PY-702 SYLLABUS I BIO-PHARMACEUTICS PREVIOUS YEAR PAPERS I PHARMACY 7TH SEM COMPLETE SYLLABUS I PHARMACY 7TH SEMESTER SYLLABUS I RGTU PHARMACY 7TH SEM SYLLABUS I PHARMACY PREVIOUS YEAR PAPERS I PHARMACY 7TH SEM CURRENT SYLLABUS

PHARMACEUTICS-X(BIO PHARMACEUTICS & PHARMACEUTICS) PY-702

Introduction to biopharmaceutics & pharmacokinetics development and their role in drug formulation.
Bio pharmaceutics:
Definition,passage of drugs across biological barrier,Physio-chemical,Biological and Pharmaceutical factors influencing biopharmaceutical performance of drugs.

• 1.Gastrointestinal absorption of drugs: Passage of drugs across biological membranes, nature of biological membranes, gastrointestinal absorption mechanisms.

• 2. Factors affecting drug absorption : Physiological factors, dietary factors,physiochemical factors, pH partition hypothesis, dosage form factors.

• 3. Methods of studying gastrointestinal absorption: In vitro and in vivo methods.

• 4. Drug disposition: Distribution in blood, cellular distribution, plasma protein binding, tissue protein binding.Drug Excretion: Routes of drug excretion, renal excretion of drugs, factors affecting renal excretion, biliary and salivary excretion of drugs. Drug biotransformation: Pathways of drug metabolism, drug metabolizing enzymes, factors affecting drug metabolism and drug response, inhibition and stimulation of drug metabolism.

Pharmacokinetics
Absorbtion, distribution metabolism and excretion of drugs, fluid compartment and circulatory system, protein binding, significance of plasma drug concentration measurement.

Compartment Models
Model selection criteria,alaika information criterian,one – compartment and two compartment models,
Wagner- Nelson and loo Riegelman methods for estimation of absorption constants. Curve fittings,regression procedure and area under blood level curves.

Clinical Pharmacokinetics:
Urinary excretions, computation of pharmacokinetic parameters from urine data, haepetic clearance,biliary excretion,excretion ratio,dosage regimen adjustment in patients with and without renal failure,pharmacokinetic drug interaction and their significance in combination therapy.

Biovailability and Bioequivalance:
Biovailability and Bio-equivalance,Federal requirements,Methods of determination of bio- availability using blood level and urinary excretion data, design and evaluations, bioavailability assessment.

BOOKS RECOMMENDED : 

• Gibaldi, M.and Perrier d, Pharmacokinetics, 4th edn. Pharma mid press, Hydrabad

• Notari, R.E., Biopharmaceutics and pharmacokinetics-An Introduction, marcel Decker New York.

• Jaiswal , Brahmankar Biopharmaquality and pharmacokinetics.

• Leepeter I.D., Pharmacokinetic analysis

• Niazi Textbook of Biopharmacokinetics and clinical pharmacokinetics.

• Venkaateshwaru v , Biopharmaceutics and pharmacokinetics, phared puss, Hydrabad.

• Wagner-pharmacokinetics for the pharmastudies.

• Dhachinamoorthi D: Biopharmaceutics and pharmacokinetics : A practical mannd

• Shargel : pharmacokinetics & Biopharmacokinetics & Biopharmaceutics

LIST OF PRACTICALS:

• Determine the percentage protein binding of the given drug.

• Determine oral bioavailability of the given drug/formulation by urinary excretion method using animal model.

• Perform bioequivalence study of two different brands of the marketed tablets of the given drug using animal model.

• Determine the rate of in-vitro absorption of the given drug using everted intestinal sack.

• Determine the effect of different pH condition on solubility of a weekly acidic or basic drug and study PH partition hypothesis.

• Establish IVIVC for the given sample of drug.

• Calculate elimination rate constant and elimination half life of given excretion data by sigma minus method.

• Calculate elimination rate constant and elimination half life of the given drug data administered by i.v. bolus injection represented by one compartment model.

• Calculate various pharmacokinetic parameters from the given data generated after single extra vascular administration of drug represented by one compartment model.

• Calculate various pharmacokinetic parameters from the given data obtained by using two compartment open model.

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