PY-701 PHARMACEUTICS VIII
(PHARMACEUTICAL TECHNOLOGY I)
Formulation considerations, technology involved, equipment (machine) employed, problems to be encountered, packaging evaluation and CMP (India, WHO & USFDA) requirements of the following dosage
forms.
1. Solid Dosage Forms- Tablets, Tablet coatings and Capsules.
2. Liquid Dosage Forms- Liquid Orals, Dry Syrups.
3. Semisolid Dosage Forms- ointments, Creams, Suppositories, Gels.
4. Sterile Dosage Forms- Parenteral ( Small Volume Parenterals & Large Volume Parenterals ) and ophthalmic Preparations.
5. Pharmaceutical Aerosols
Blood Products and Plasma Substitutes:
Collection, processing and storage of whole human blood, concentrated human RBC, dried human plasma, human normal immunoglobulin, plasma substitutes, ideal requirements, PVP, Dextran, etc. for control of blood pressure,
Surgical products:
Definition, surgical cotton, surgical gauzes, bandages, adhesive tapes, absorbable and non absorbable sutures, ligatures and catguts, Medical prosthetics and organ replacement materials.
Books Recommended
1. Rawlins, E.A., Text Book Of Pharmaceutics, Bailliere Tindall.
2. Lachman, L. , Liberman, H.A. and Kanig, J.L., The Theory and Practice of Industrial Pharmacy,
Lea and Febiger, Philadelphia.
3. Liberman, H.A., lachman, L. and Ker Inc. New York.
4. Pharmacopoeia Of India, Ministry of Health and family Welfare, Govt. of India, New Delhi.
5. Avis, K.E., Lachman, L. and Liberman, H.A., Pharmaceutical Dosage Forms-Parenteral
Medication Vol.1-2, Marcel Decker Inc., New York.
6. Banker G.S. and Rhode C.T., Modern Pharmaceutics, Marcell Decker Inc., New York.
7. Bean, H.S., Beckett, A.H. and Carless, A.H., Advances in Pharmaceutical Sciences, Vol.1-4,
Academic Press, London.

PY-701:Pharmaceutics-VIII Pharmaceutical Technology –I
List of Practicals
1. Prepare and evaluate Paracetamol Compressed Tablets.
2. Prepare and evaluate Effervescent Tablets of Aspirin.
3. Prepare and evaluate Dispersible tablets of Diclofenac Sodium.
4. Perform the Sugar Coating on the given sample of Tablets.
5. Perform the Film Coating on the given sample of Tablets.
6. Perform the Enteric Coating coating on the given sample of Tablets.
7. Prepare and evaluate Tetracycline HCL Capsules.
8. Prepare and evaluate Antacid Suspension.
9. Prepare and evaluate B-Complex Syrup.
10. Prepare and evaluate Amoxicillin Dry Syrup.
11. Prepare and evaluate Castor Oil Emulsion.
12. Prepare and evaluate Diclofenac Sodium Suppositories.
13. Prepare and evaluate Vaporizing Ointment.
14. Prepare and evaluate Non-Staining Iodine Ointment containing Methyl Salicylate.
15. Prepare and evaluate Antiseptic Cream.
16. Prepare and evaluate Diclofenac Gel.
17. Prepare and evaluate Ciprofloxacin Eye Drop.
18. Prepare and evaluate Water for Injection.
19. Prepare and evaluate Oxytetracycline Injection.
20. Perform the Sability Studies of given sample of Paracetamol Tablets.
21. Prepare and evaluate an aqueous injection of a poorly water – soluble drug using hydrotropic solubilization technique.
PY702 : Pharmaceutics-X
(Biopharmaceutics and Pharmacokinetics)
Introduction to biopharmaceutics and pharmacokinetics development and their role in drug formulation.
Biopharmaceutics
Definition , passage of drugs across biological barrier , Physiochemical , Biological and Pharmacaceutical
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 bioavailability using blood level and urinary excretion data, design and evaluations, bioavailability assessment.
Books recommended
1. Gibaldi, M.and Perrier d, Pharmacokinetics, 4th edn. Pharma mid press, Hydrabad
2. Notari, R.E., Biopharmaceutics and pharmacokinetics-An Introduction, marcel Decker New York.
3. Jaiswal , Brahmankar Biopharmaquality and pharmacokinetics.
4. Leepeter I.D., Pharmacokinetic analysis
5. Niazi Textbook of Biopharmacokinetics and clinical pharmacokinetics.
6. Venkaateshwaru v , Biopharmaceutics and pharmacokinetics, phared puss, Hydrabad.
7. Wagner-pharmacokinetics for the pharmastudies.
8. Dhachinamoorthi D: Biopharmaceutics and pharmacokinetics : A practical mannd
9. Shargel : pharmacokinetics & Biopharmacokinetics & Biopharmaceutics


PY 702 : Pharmaceutics – X
(Biopharmaceutics & pharmacokinetics ) practicals
List of Practicals
1. Determine the percentage protein binding of the given drug.
2. Determine oral bioavailability of the given drug/formulation by urinary excretion method using animal
model.
3. Perform bioequivalence study of two different brands of the marketed tablets of the given drug using
animal model.
4. Determine the rate of in-vitro absorption of the given drug using everted intestinal sack.
5. Determine the effect of different pH condition on solubility of a weekly acidic or basic drug and study PH partition hypothesis.
6. Establish IVIVC for the given sample of drug.
7. Calculate elimination rate constant and elimination half life of given excretion data by sigma minus method.
8. Calculate elimination rate constant and elimination half life of the given drug data administered by i.v. bolus injection represented by one compartment model.
9. Calculate various pharmacokinetic parameters from the given data generated after single extra
vascular administration of drug represented by one compartment model.
10. Calculate various pharmacokinetic parameters from the given data obtained by using two compartment open model.

PY703 :PHARMACEUTICAL CHEMISTRY VIII
(MEDICINAL CHEMISTRY-III)
The synthesis of the selected drugs, mode of action, classification, uses, SAR of the following category of drugs:
A) Steroids and related drugs. Steroidal nomenclature and stereochemistry, androgen and anabolic agents, estrogens and progestational agents adrenocorticoids.
B) Diuretics and cardiovascular drugs.
C) Chemotherapeutic Agents-: Anti metabolites(Including Sulpha durgs) Anti viral & Anti HIV, Antineoplastic, Anti malarials, Anti tuberarlar, Anti biatics, Immuno- suppresive
D) Amino acids, Protiens and peptide hormones.
E) Thyroid and Antithyroid Drugs.
F) Insulin and Oral hypoglycemic agents.
G) Drugs affecting uterine motility, oxytocins (including prostoglandins and Ergot alkaloids).
Books Recommended:
1. Foye, W.C., Principles of Medicinal Chemistry, Lea and Febiger, Philadelphia.
2. Wolff , M.E. Ed., Burger’s Medicinal Chemistry, John Wiley and Sons, New York.
3. Hansch, C., Comprehensive Medicinal Chemistry, Pergarnon Press, Oxford
4. Delagado, J.N. and Remers, W.A.R, Wilson and Giswold’s Text Book of Organic,Medicianl and Pharmaceutical Chemistry, J.Lippincott Co., Philadelphia.
5. Nogrady, T., Medicinal Chemistry-A Biochemical Approach, Oxford University Press, New York, Oxford.
6. Kar, A., Medicinal Chemistry, Willey Eastern Ltd., New Delhi.
7. Patrick, G., An Introduction to Medicinal Chemistry, Scientific Distributors, Mumbai.
8. Malone, Dyson and Purey, May’s Chemistry of Synthetic Drugs.
9. Parimoo, P., Text Book of Medicinal Chemistry, CBS Publishers and Distributors, New Delhi.
10. Thomas, G., Introduction to medicinal Chemistry, CBS Publishers and Distributors, New Delhi.
11. Sten lake B.J. medicinal and pharm. Chemistry pharma mid press, Hyderabad
PY704 :Pharmaceutical Biotechnology Theory
Historical Development :Immunology and Immunological Preparations :
Principles, Antigens and antibodies, Antigen-antibody reactions and their applications,Immune system.Cellular humoral immunity, Immunological tolerance, Hypersensitibity,
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 –
Intoduction, Types of reactions mediated by micro organisms. Design of biotransformation
processes, Selection of organism, Biotransformation processes and its improvements with special refrence 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.
B.Pharm. Semester- VII
PY 704 Pharmaceutical Biotechnology Practical
List of Practicals
1. Detect the presence of the amylase enzyme in saliva.
2. Isolate the DNA from cauliflower.
3. Perform VDRL test for the given sample of blood.
4. Isolate the phospholipid from egg yolk .
5. Perform WIDAL test for the given sample of blood.
6. Perform DOT ELISA test of the given sample of blood.
7. Isolate the total RNA from yeast tablet.
8. Immobilize the given enzyme by adsorption method using calcium alginate beads.
9. Perform titre value of antibody in given blood sample.

Syllabus for GPAT-2010 Examination

Syllabus for GPAT-2010 Examination

Natural Products :
Pharmacognosy & Phytochemistry - Chemistry, tests, isolation, characterization and estimation of phytopharmaceuticals belonging to the group of Alkaloids, Glycosides, Terpenoids, Ster oids, Bioflavanoids, Purines, Guggul lipids. Pharmacognosy of crude drugs that contain the above constituents. Standardization of raw materials and herbal products. WHO guidelines. Quantitative microscopy including modern techniques used for evaluation. Biotechnological principles and techniques for plant development, Tissue culture.
Pharmacology :
General pharmacological principles including Toxicology. Drug interaction. Pharmacology of drugs acting on Central nervous system, Cardiovascular system, Autonomic nervous system, Gastro intestinal system and Respiratory system. Pharmacology of Autocoids, Hormones, Hormone antagonists, chemotherapeutic agents including anticancer drugs. Bioassays, Immuno Pharmacology. Drugs acting on the blood & blood forming organs. Drugs acting on the renal system.
Medicinal Chemistry :
Structure, nomenclature, classification, synthesis, SAR and metabolism of the following category of drugs, which are official in Indian Pharmacopoeia and British Pharmacopoeia. Introduction to drug design. Stereochemistry of drug molecules. Hypnotics and Sedatives, Analgesics, NSAIDS, Neuroleptics, Antidepressants, Anxiolytics, Anticonvulsants, Antihistaminics, Local Anaesthetics, Cardio Vascular drugs - Antianginal agents Vasodilators, Adrenergic & Cholinergic drugs, Cardiotonic agents, Diuretics, Anti-hypertensive drugs, Hypoglycemic agents, Antilipedmic agents, Coagulants, Anticoagulants, Antiplatelet agents. Chemotherapeutic agents - Antibiotics, Antibacterials, Sulphadrugs. Antiprotozoal drugs, Antiviral, Antitubercular, Antimalarial, Anticancer, Antiamoebic drugs. Diagnostic agents. Preparation and storage and uses of official Radiopharmaceuticals, Vitamins and Hormones. Eicosanoids and their application.
Pharmaceutics :
Development, manufacturing standards Q.C. limits, labeling, as per the pharmacopoeial requirements. Storage of different dosage forms and new drug delivery systems. Biopharmaceutics and Pharmacokinetics and their importance in formulation. Formulation and preparation of cosmetics - lipstick, shampoo, creams, nail preparations and dentifrices. Pharmaceutical calculations.
Pharmaceutical Jurisprudence :
Drugs and cosmetics Act and rules with respect to manufacture, sales and storage. Pharmacy Act. Pharmaceutical ethics.
Pharmaceutical Analysis :
Principles, instrumentation and applications of the following: Absorption spectroscopy (UV, visible & IR). Fluorimetry, Flame photometry, Potentiometry. Conductometry and Polarography. Pharmacopoeial assays. Principles of NMR, ESR, Mass spectroscopy. X-ray diffraction analysis and different chromatographic methods.
Biochemistry :
Biochemical role of hormones, Vitamins, Enzymes, Nucleic acids, Bioenergetics. General principles of immunology. Immunological. Metabolism of carbohydrate, lipids, proteins. Methods to determine, kidney & liver function. Lipid profiles.
Microbiology :
Principles and methods of microbiological assays of the Pharmacopoeia. Methods of preparation of official sera and vaccines. Serological and diagnostics tests. Applications of microorganisms in Bio Conversions and in Pharmaceutical industry.


Clinical Pharmacy :
Therapeutic Drug Monitoring Dosage regimen in Pregnancy and Lactation, Pediatrics and Geriatrics. Renal and hepatic impairment. Drug - Drug interactions and Drug - food interactions, Adverse Drug reactions. Medication History, interview and Patient counseling.

People’s Institute of Pharmacy & Research Centre

People’s Institute of Pharmacy & Research Centre
Bhanpur, By-Pass road,
Bhopal-462037 (M.P.)

The aim of the People’s Institute of Pharmacy & Research Centre is committed to quality of education. Demand for well-qualified Pharmacy manpower is increasing day by day with the proliferation of many new companies and a greater demand for competent candidates in the Pharmaceutical sector is generated. Job opportunities for Pharmacy professionals have increased in India and abroad. Keeping this in view, the members of SJPN (Charitable Trust) have proposed to start People’s Institute of Pharmacy & Research Centre (PIP&RC) at Bhanpur, Bhopal, approx. 5.5 km from the Railway Station as well as Airport.

ABHINAMDAN

Amrit Singh

Complexometric

These titrations are based on complexation reactions.
Most often used reagent is EDTA - EthyleneDiamineTetraAcetic acid. There are also other similar chelating agents (EGTA, CDTA and so on) used. In some of other methods Ag+ is used as a titrant for determining cyanides and Hg2+ as a titrant in Cl- determination.
Changing property of the solution is usually the concentration of the complexed substance, although in some cases it can be much more convenient to express results in terms of titrant concentration. As its concentration changes by many orders of magnitude, and is almost always smaller than 1, we use negative logarithmic scale, similar to that used in pH definition.
In the case of determination of metals detection of the endpoint is mainly based on substances that change color when creating complexes with determined metals. One of these indicators is eriochrome black T, substance that in pH between 7 and 11 is blue when free, and black when forms a complex with metal, other examples are pyrocatechin violet and murexide. It is important that formation constant for these complexes is low enough, so that titrant reacts with complexed ions first.

Iodometry

Iodometry

Iodometry is one of the most important redox titration methods. Iodine reacts directly, fast and quantitively with many organic and inorganic substances. Thanks to its relatively low, pH independent redox potential, and reversibility of the iodine/iodide reaction, iodometry can be used both to determine amount of reducing agents (by direct titration with iodine) and of oxidizing agents (by titration of iodine with thiosulfate). In all cases the same simple and reliable method of end point detection, based on blue starch complex, can be used.
Reversible iodine/iodide reaction mentioned above is
2I- ↔ I2 + 2e-
and obviously whether it should be treated as oxidation with iodine or reduction with iodides depends on the other redox system involved.
Second important reaction used excesivelly in iodometry is reduction of iodine with thiosulfate:
2S2O32- + I2 → S4O62- + 2I-
In the case of both reactions it is better to avoid low pH. Thiosulfate is unstable in the presence of acids, and iodides in low pH can be oxidized by air oxygen to iodine. Both processes can be source of titration errors.
Iodine is very weakly soluble in the water, and can be easily lost from the solution due to its volatility. However, in the presence of excess iodides iodine creates I3- ions. This lowers free iodine concentration and such solutions are stable enough to be used in lab practice. Still, we should remember that their shelf life is relatively short (they should be kept tightly closed in dark brown bottles, and standardized every few weeks). Iodine solutions are prepared dissolving elemental iodine directly in the iodides solution. Elemental iodine can be prepared very pure through sublimation, but because of its high volatility it is difficult to weight. Thus use of iodine as a standard substance, although possible, is not easy nor recommended. Iodine solutions can be easily normalized against arsenic (III) oxide (As2O3) or sodium thiosulfate solution.
It is also possible to prepare iodine solutions mixing potassium iodide with potassium iodate in the presence of strong acid:
5I- + IO3- + 6H+ → 3I2 + 3H2O
Potassium iodate is a primary substance, so solution prepared this way can have exactly known concentration. However, this approach is not cost effective and in lab practice it is much better to use iodate as a primary substance to standardize thiosulfate, and then standardize iodine solution against thiosulfate.

end point detection with starch

Iodine in water solutions is usually colored strong enough so that its presence can be detected visually. However, close to the end point, when the iodine concentration is very low, its yellowish color is very pale and can be easily overlooked. Thus for the end point detection starch solutions are used.
Iodine gets adsorbed on the starch molecule surface and product of adsortion has strong, blue color. Exact mechanism behind adsorption and color change is not known, see for example this explanation of starch as an indicator usage.
In the presence of small amounts of iodine adsorption and desorption are fast and reversible. However, when the concentration of iodine is high, it gets bonded with starch relatively strong, and desorption becomes slow, which makes detection of the end point relatively difficult. Luckily high concentrations of iodine are easily visible, so if we are using thiosulfate to titrate solution that initially contains high iodine concentration, we can titrate till the solution gets pale and add starch close to the end point. In the case of titration with iodine solution we can add starch at the very beginning, as high iodine concentrations are not possible before we are long past the end point.
At the elevated temperatures adsorption of the iodine on the starch surface decreases, so titrations should be done in the cold.
Finally, it is worth of noting that starch solutions, containing natural carbohydrate, have to be either prepared fresh, or conserved with antibacterial agent like mercuric iodide HgI2.

Solutions used in iodometric titrations

Two most important solutions used in iodometric titrations are solution of iodine and solution of sodium thiosulfate. Both substances can be easily obtained in a pure form, but their other characteristics (volatility, hard to control amount of water of crystallization) make them difficult to use as a primary standards.
It is also worth of mentioning that both solutions are not quite stable and they can not be stored for a prolonged period of time. Iodine can be lost from the solution due to its volatility, while thiosulfate slowly decomposes giving off elemental sulfur. The latter process is easily visible, as thiosulfate solutions become slightly cloudy with time.
Iodine solution
It is not difficult to prepare high purity iodine through sublimation, but - due to its volatility - iodine is difficult to weight accurately, as it tends to run away. To minimize losses it should be weight in closed weighing bottle. Iodine should be kept in a closed bottles also because it is highly corrosive and it vapor can damage delicate mechanism of analytical balance.
Commonly used solutions are 0.05M (0.1 normal).
To find out amounts of substances required to prepare the solution for a needed volume use ChemBuddy concentration calculator. Download the iodine solution preparation file. Open it with the free trial version of the concentration calculator. After opening the file enter solution volume and click on the Show recipe button. Read amounts of the substances, but don't follow the general directions. It is better to use as small initial volume of the solution as possible, that is, dissolve potassium iodide in about 1/100th of the final volume of water, before adding iodine.
To minimalize losses it is important to transfer iodine to the solution as fast as possible, or even to weight a 1% excess. Solution should be kept in dark glass bottle with grinded glass stopper and standardized every few weeks or before use.
Sodium thiosulfate solution
Sodium thiosulafte can be realtively easily obtained in a pure form, but it is quite difficult to obtain samples with known amount of water of crystallization, as the exact composition of the solid is very temperature and humidity dependent. Thus solution has to be standardized against potassium iodate KIO3 or potassium dichromate.
Commonly used solutions are 0.1M (0.1 normal).
To prepare the recipe for a needed volume of the solution use ChemBuddy concentration calculator. Download the sodium thiosulfate solution preparation file. Open it with the free trial version of the concentration calculator. After opening the file enter solution volume and click on the Show recipe button.
Small amount of carbonate added helps keep solution pH above 7, which slows down thiosulfate decomposition. Some sources also call for addition of 0.5 mL chloform per liter of the solution, to stop possible growth of bacteria that can speed up decomposition process.
Starch solution
Starch solution is used for end point detection in iodometric titration.
To prepare starch indicator solution, add 1 gram of starch (either corn or potato) into 10 mL of distilled water, shake well, and pour into 100 mL of boiling, distilled water. Stir thoroughly and boil for a 1 minute. Leave to cool down. If the precipitate forms, decant the supernatant and use as the indicator solution. To make solution long lasting add a pinch of mercury iodide or salicylic acid, otherwise it can spoil after a few days.
2% sodium bicarbonate
This solution is used for neutralization of sodium arsenite, before it is titrated with iodine solution during iodine solution standardization.

0.05M iodine standardization against arsenic trioxide
Chemical characteristics of the arsenic trioxide As2O3 make it a good candidate for a standard substance in many potentiometric methods, however, because of its toxicity it is used less and less frequently.
Arsenic oxide is dissolved in sodium hydroxide, producing sodium arsenite, which is a good reducing agent. In iodometry it is quantitatively oxidized by iodine to arsenate:
Na3AsO3 + I2 + H2O → Na3AsO4 + 2I- + 2H+
Direction of this reaction depends on pH - in acidic solutions As(V) is able to oxidize iodides to iodine. To guarantee correct pH of the solution we will add solution of sodium bicarbonate NaHCO3.
Interestingly, when using As2O3 as a standard substance in other types of redox titrations, we often add small amount of iodide or iodate to speed up the reaction. For obvious reasons in the case of iodometric titration we don't have to.
Procedure to follow:
Weight exactly about 0.15-0.20g of dry arsenic trioxide and transfer it to Erlenmayer flask.
Add 10 mL of 1M sodium hydroxide solution and dissolve solid.
Add a drop of phenolphthalein solution.
Neutralize with 0.5M sulfuric acid, adding several drops of excess acid after solution loses its color.
Add slowly (to not cause the solution to foam up) 50 mL of 2% NaHCO3 solution.
Add 5 mL of the starch solution.
Titrate swirling the flask, until a blue color persists for 20 seconds.
To calculate iodine solution concentration use EBAS - stoichiometry calculator. Download iodine standardization against arsenic trioxide reaction file, open it with the free trial version of the stoichiometry calculator.
Note, that to be consistent with the use of arsenic trioxide and its molar mass, reaction equation is not the one shown above, but
As2O3 + 2I2 + 5H2O → 2AsO43- + 4I- + 10H+
These are equivalent. Enter arsenic troxide mass in the upper (input) frame in the mass edit field above As2O3 formula. Click n=CV button below iodine in the output frame, enter volume of the solution used, read solution concentration