HOSPITAL AND COMMUNITY PHARMACY

1. Hospital pharmacy - Definition, hospital organization, pharmacy organization and personnel, location and layout of a hospital pharmacy unit in a hospital, responsibilities of a hospital pharmacist.
2. Pharmacy and therapeutics commitee, hospital formulay, dispensing to inpatients (a) floor stock system, (b) Individual prescription order system, (c) combination of (a) and (b), dispensing to out patients.
3. Purchase and inventory control in hospitals and in community pharmacy, storage of drugs.
4. Drug info ration center, central sterile supply, intravenous drugs admixture, unit dosage dispensing, prepackaging in the hospital
5. Manufacturing - Bulk and sterile handling of controlled drugs, current state of hospital pharmacy in India.
6. Community pharmacy: (1) drug house management - selection of site, space, lay-out, and legal requirements, structure of pharmacy organization.
7. Sales promotion: Market research-salesmanship, qualities of a salesman, advertising and window display.
8. Recruitment finance: Capital requirements, sources of pharmacy capital, risk management and insurance.
9. Pharmacy finance: Capital requirements, sources of pharmacy capital, risk management and insurance.

Suggested books:
1. Merchant and qadry's text book of hospital pharmacy revised by Dr.Ramesh K Goyal and RK Parikh; BS Shah Prakashan Publications.
2. Hospital pharmacy by William E Hassan.
3. Pharmacy management for students and practioners, by C.Patrick Tharp and Pedro J Lecca.
4. Remington's Pharmaceutical Sciences.

CLINICAL PHARMACY & THERAPEUTICS PRACTICALS

1. Calculation of elimination t1/2 of a drug from a given data.
2. Calculation of absorption t1/2 of a drug from a given data.
3. Calculation of pediatric dose from adult dose.
4. Prediction of drug interaction from a given set of drugs.
5. Prediction of drug interaction from a given set of drugs.
6. Prediction of drug interaction from a given set of drugs.
7. Dosage schedule of important drugs used fro TB.
8. Dose and Dosage schedule of digoxin.
9. Dosage adjustment of drugs in renal failure.
10. Adverse effects of selected drugs.
11. Drugs not to be used in pregnancy.
12. Care to be taken by lactating mothers in drug use.

Suggested books:
1. Clinical pharmacy and therapuetics: Roger Walker and Clive Edwards.
2. Contemporary perspectives on clinical pharmacotherapuetics: Kamlesh.Kholi

CLINICAL PHARMACY & THERAPEUTICS THEORY

General concept: Clinical pharmacokinetics, drug interactions, adverse drug reactions, parental nutrition, pharmacoeconomics, pharmacogenomics, pharmacovigilance, therapeutic drug monitoring, neutraceuticals, essential drugs and rational drug usage. Age related drug therapy: concept of posology, drug therapy for neonates, pediatrics and geriatrics. Drugs used in pregnancy and lactation.
Drug therapy in gastrointestinal, hepatic, renal, cardiovascular and respiratory disorders.
Drug therapy for neurological and psychological disorders.
Drug therapy in infections of respiratory system, urinary system, infective miningitis, TB, HIV, malaria and filaria.
Drug therapy for thyroid and parathyroid disorders, diabetes mellitus, menstrual cycle disorders, menopause and male sexual dysfunction.
Drug therapy for malignant disorders like leukemia, lymphoma and solid tumors.
Drug therapy for rheumatic, eye and skin disorders.

BIOPHARAMCEUTICS AND NOVEL DRUG DELIVERY SYSTEMS - PRACTICAL

1. Evaluation of dissolution rate of commercial brands (at least two brands) of paracetamol tablets as per IP/BP/USP.
2. Evaluation of dissolution rate of commercial brands (at least two brands) of Indomethacin Conventional and SR capsules as per IP/BP/USP
3. To study the effect of surfactant on the dissolution rate of poorly soluble drugs.
4. Preparation and Evaluation of solid dispersions of insoluble drugs in PVP/PEG/Mannitol ( with at least two drugs)
5. Preparation and Evaluation of Matrix Tablets for sustained release ( with at least two drugs)
6. Determination of Kel and t1/2 of at least one drug.
7. Determination of Vd and renal clearance.
8. Determination of Ka and AUC.
9. Analysis of pharmacokinetic data as per one compartment model (I. V).
10. Analysis of pharmacokinetic data as per one compartment model (oral).

BIOPHARAMCEUTICS AND NOVEL DRUG DELIVERY SYSTEMS

1. Biopharmaceutics: Introduction, fate of drug after administration, routes of drug administration, drug absorption, drug absorption and disposition. Drug absorption: Oral, Percutaneous, rectal, factors involved, mechanisms and kinetics - a detailed study of physiochemical, biological and dosage form considerations in drug absorption.
2. Drug dissolution and bioavailability: Concepts, definitions, factors involved, assassment, official methods, applications and significance.
3. Drug distribution: Localization and protein binding - enterohepatic cycling - first pass effect. Drug elimination: Metabolism, hepatic metabolism, microsomal and non microsomal metabolism, enzyme induction and inhibition and their influence on drug activity, drug excretion through urine, bile, lungs and skin - renal clearance. Significance of Biopharmaceutics in product formuation and developmant.
4. Pharmacokinetics: Introduction, compartment models, blood level curves, pharmacokinetic parameters, biological half - life, apparent volume of distribution, renal clearance, absorption rate, AUC - their significance, kinetics of blood levels following IV, oral, single and repeated administration. Introduction to dosage regimens.
5. Novel drug delivery systems: Introduction, basic concepts in controlled release - Mechanisms and basic techniques used. Advantages and disadvantages of controlled release products. A brief study of the following types of controlled release systems.
(i) Oral controlled release: Matrix tablets, coated pellets, OROS.
(ii) Parental controlled release: Microspheres, emulsions and suspensions.
(iii) Transdermal therapeutic systems (TTS): Basic concepts, limitations, design for TTS.
(iv) Implants and implantable devices: An introduction to osmotically controlled drug delivery systems.
(v) A study of Liposomes, Released Erythrocytes, Nanoparticles and their applications.

Applications:
1. Theory and practice of Industrial Pharmacy by Leon Lachman, Lieberman and Kanig;
2. Remington's Practice of Pharmaceutical Sciences;
3. Biopharmaceutics and clinical pharmacokinetics by Milo Gibaldi
4. Biopharmaceutics and pharmacokinetics byBrahmankar;
5. Modern pharmaceutics by Banker.
6. Oral drug delivery technology by Aukunaru Jithan published by Pharma book syndicate.

PHARMACEUTICAL CHEMISTRY-VI (MEDICINAL-II) PRACTICALS

1. Preparation of synthetic drugs involving two or three steps such as benzocaine, barbituric acid, methaqualone, cinchopen, phenolphthalein.
2. Identification of drugs.
3. Analysis of formulations containing drugs studied in theory such as chloroquine phosphate, metronizadole, diethyl carbamazine, pentobarbitone, dapsone, isoniazid, tolbutamide, sulpha drugs.

Text books:
1. Wilson and Gisvold, textbook of organic, medicinal and pharmaceutical chemisrty.
2. Bently and Drivers Textbook of Pharmaceutical Chemistry
3. Remington's Practice of pharmaceutical sciences.

Reference books:
1. Organic Chemistry, Vol.I. by I.L.Finar
2. Essentials of medicinal chemistry by Karlkovas
3. Medicinal Chemistry, Vol.I, II and III. by A.Burger
4. Indian Pharmacopoeia

PHARMACEUTICAL CHEMISTRY-VI (MEDICINAL-II)

1. Physico-chemical properties and biological activity: Influence of partition coefficient, covalent bonding, hydrogen bonding, surface activity, redox potentials, chelation, enantiomers, and geometrical isomerism an biological activity.
2. Factors affecting adsorption, transport, distribution and elimination of drugs, protein binding of drugs.
3. Introduction to the concepts of prodrug, soft drugs and targeted drugs
4. Introduction to principles of chemotherapy, chemotherapeutic index, drug resistance, super infection.
A study of the classification, mode of action, uses and synthesis of specified members in each of the following categories.
5. Antiinfective agents: a) Ectoparasiticides: Lindane, pyrethrins, sulfurated compounds, benzyl benzoate (b) Antiseptics and disenfectants: alcohol, formaldehyde, recorcinol, hydrogen peroxide, benza;konium chloride, gentian violet, methyline blue and furazolidone.
6. Sulphonamides: sulfisoxazole, sulphamethazole and sullphathiozole.
7. Antimycobacterial agents: a) Antitubercular agents: PASA, isoniazid b) antileprotic agents: dapsone
8. Antihelmintics: diethyl carbamazine citrate, mebendazole, tinidazole, thiobendazole and pyrantel pamoate
9. Antimalarials: Chloroquine, primaquine, mefloquine, and pyremetnamine.
10. Antiamoebic agents: metronizadole, diloxanide, furoate, and carbarsone.
11. Antifungal agents: clotrimazole, Ketocanazole and tolnaftate.
12. Antiviral agents: acyclovir, zidovudine, idoxuridine and adamantine
13. Cytostatic agents: chlorambucil, cyclophospamide, lomustine, methotrexate, 5-flouro uracil and mercaptourine
14. Adrenergic drugs: Biosynthesis and metabolism of catecholamines, direct and indirect sympathomimetics, mode of action and structure activity relations, adrenergic blocking agents, synthesis of amphetamine, phenyl ethylamine and isoproterneol.
15. Cholinergic agents and anticholinesterases: Structural features of acetylcholine, cholinergic agonists, anticholinesterases, synthesis of carbachol, physostigmine, neostigmine and dicyclomine.
16. Diuretics: acetazolamide, furosemide, ethacrynic acid and hydrochlorthiazide.
17. Antihypertensives: methyl dopa, amlodipine, prazocin and propranolol.

PROJECT

Project is in the VIIth semester. along with ohter subjects in the VII th semester.

GMP AND VALIDATION

1. CGMP: A detailed study of GMP as prescribed in schedule M of Drugs and Cosmetic act and Rules. Requirements regarding premises, sanitations, personnel, equipment and buiding, documentation and records and processes.
2. Control of production procedures: Manufacturing control - In - Process quality Control for solids, liquids, semisolids and parental products - packaging control.
3. Control of Finished Products: Tablets, Capsules, Parentals, Semi solids and Liquid orals.
4. Validations: Types and protocols of validation - A study of process Validation. Validation of Equipments, Cleaning, Analytical Method Validation-Procedures and examples.
5. Quality control and Quality assurance: Principles and general concepts-Duties and responsibilities of Quality control and Quality assurance departments in a modern pharmaceutical concern - Sources of Quality Variation - Control of quality variation. Raw material control - Quality assurance before start-up and at start-up; Manufacturing control - Packaging materials and Labels control.
6. Concept of statistical quality control - Quality control charts - sampling and sampling plans.

Books:
1. The Theory and practice of Industrial Pharmacy by Leon Lachman. H.A. Libermen and Joseph L. Kanig, 3rd edition.
2. Tablets - Vol. I, II and III by Leon Lachman et al.
3. Modern Pharmaceuticals by Banker.
4. Quality assurance of pharmaceuticals Vol.I and Vol. II published by pharma books syndicate.

PHARMACOGNOSY AND PHYTOCHEMISRTY - II PRACTICAL

1. Identification of powdered crude drugs and their combinations with the help of organoleptic, microscopic, and chemical tests;
2. Determination of leaf constants such as stomatal index, stomatal number, vein islet number and palisade ratio;
3. Thin layer chromatographic studies of extracts from crude drugs.

Recommended books:
1. Pharmacopoeia of India, 1985;
2. Practical Pharmacognosy, 3rd edition, by Kokate, C.K.;
3. Practical Pharmacognosy byLala, P.K., Lina, Calcutta, 198.

PHARMACOGNOSY AND PHYTOCHEMISRTY - II

General Pharmacognocy: Advantages and disadvantages of obtaining drugs from cultivated and wild plants. Variability of drug constituents due to exogenous and endogenous factors like altitude, temperature, rainfall, light, propagation by seed vegetative means, mutation, hybridization; Deterioration of crude drugs during storage of crude drugs. Methods of storage.

Evaluation of crude drugs: Identity, purity and quality of crude drugs by organoleptic microscopic, physical, chemical and biological evaluation; Methods of adulteration, detection and identification of adulterants types and significance of standards for crude drugs included in I.P. and B.P. Quantitative pharmacognosy.
A detailed study of the following drugs, their classification methods of preparation, commercial varieties, active principles, their chemical nature, identification, tests and uses; Roots and rhizomes: Male fern, valerin, rhubarbm podophyllum, liquorice, turmeric, ginger, ipecac, rauwolfia, aconite and jalap; Unorganised drugs: opium, aloes, kino, gambier, agar, alginates, gelatin.
Resins, gum resins, oleoresins-colophony, benzoin, shellac, myrr, galbanum, asafetida, tyrpentine, balsam or Tolu, balsam of Peru and storax; Glands and glandular secretions-thyroid, pitutary, adrenal, pancreas and musk; Gums and saccharin subatances: acacia, tragacanth and honey.

Chromatography and some related terms. Classification and a study of various chromatographic methods. Column, paper, thin layer and gas chromatography, HPLC and their applications to natural products. Biogenesis; Pathways leading to formation of plant products; Historical development of plant tissue culture, types of cultures, nutritional requirements, growth and their maintenance, applications of plant tissue culture in production of pharmaceutically important secondary metabolites.

Recommended books:
1. Atal CK and Kapoor BM. Cultivation and utilization of aromatic plants. CSIR Publications.
2. Tyler, VC, Brady, LR and Robers, JE.Pharmacognasy., 11th to 14th Editions;
3. Wallis. TE. Textbook of pahrmacognacy., 5th edition, J & A, Churchill Limited, U.K
Kokate, CK.Purohit, A.P. and Ghokale, SB.Pharmacognosy;
5. Ross, MF. and Brain,KR. An introduction to phytopharmacy, Pitamn Medical-Kent;
Deinvert, J. and BajajYPS. Applied and fundamental aspects of Plant cell, Tissue and Organ culture, Berlin.

PHARMACOLOGY - II PRACTICAL

1. Action of drugs adrenaline, ach on isolated smooth muscle (Physiological antagonism)
2. Action of atropine and ach (receptor antagonism) on isolated smooth muscle of rabbit intestine.
3. Action of histamine and antihistamine (receptor antagonism) on isolated smooth muscle.
4. Drug antagonism studies on isolated smooth muscle strips Adrenaline x Propanolol (receptor antagonism) of rabbit intestine
5. Two point Bioassay of acetylcholine on frog uterus abdominis muscle.
6. Three point bioassay of acetyl choline on frog uterus abdominis muscle.
7. Bioassay of histamine on guinea pig ileum.
8. Action of drugs on rabbit eye (local anaesthetics).
9. Action of drugs on mice (CNS stimulants)
10. Action of drugs on mice (CNSdepressants)
11. Test for pyrogens (rabbit method)
12. Insulin hypoglycaemic action in rabbits

PHARMACOLOGY - II THEORY

1. Chemotherapy: Sulphonamides, antibiotics, antiviral, antifungal agents and antineoplastics.
2. Drug treatment in tuberculosis, leprosy, veneral diseases, malaria, filaria, leishmaniasis, trypnasomiasis, amoebiasis and helmenthiasis.
3. Vitamins and hormones: vitamins, thyroid, parathyroid, adrenal cortex, insulin and oral antidiabetic drugs.
4. Pharmacology of drugs acting on sex organs: oral contraceptives, oxytocic agents and uterine relaxants.
5. Immunity and biological standardization: Vaccines and immune sera, immunosupressive agents.
6. Methods of biological assay, principles of bioassays, fundamentals of biometric analysis. Detailed study of the official bioassay methods of adrenaline, posterior pituitary, insulin, gonadotrophic hormones, cholera vaccine and diptheria antitoxin.
7. Pharmacology of local anaesthetics.
8. Drugs acting on respiratory system: cough supressants, bronchodilatory, drugs used in asthma.
9. Miscellaneous: chelating agents, demuclents, counter-irritants, diagnostic agents.
10. Drugs acting on GI tract: digestants, antispasmodics, anti-diahrrhoeal agents, cathartics, emetics, antimetics, drugs used in inflammatory bowl syndrome, antacids and drugs used in gastric ulcers.

Text books:
1. Textbook of pharmacology by Rang and Dale
2. Essentials of medical pharmacology - K.D Tripathi
3. Lippincort's illustrated pharmacology
4. Pharmacology and pharmacotherapeutics by Satoshkar and Bandarkar.

Suggested books:
1. Pharmacological basis of therapeutics by Goodman and Gillman.
2. Text book of clinical pharmacology - Bertram.C.Katzung
3. Indian Pharmacopoeia

PHARMACEUTICAL CHEMISTRY-V (NATURAL PRODUCTS) PRACTICAL

1. Determination of acid value
2. Determination of saphonification value
3. Determination of iodine value
4. Determination of unsaponifiable matter
5. Determination of Eugenol in clove oil
6. Estimation of cineole in eucalyptus oil.
7. Estimation of citral in lemon grass oil.
8. Determination of aminophylline
9. Determination of caffeine citrate
10. Estimation of strychnine hydrochloride
11. Tests for absence of arachis oil, cottonseed oil and sesame oil in other oils
12. Reactions of carbohydrates, glycosides, alkaloids, aminoacids (including xanthine alkaloids), sterols and vitamins
13. Identification of selected natural products
14. Preparation of caffeine from tea dust
15. Preparatioin of caseine and estimation of nitrogen
16. Soxhelt extraction of a crude drug
17. Assay of tincture Nuxvomica/Tincture Belladona

Suggested Books:
1. Organic chemistry, Vol.II. By I.L.Finar
2. Wilson and Gisvold, Textbook of Organic, Medicinal and pharmaceutical chemistry
3. Bently and Driver's Textbook of Pharmaceutical chemistry
4. Remington's Practice of Pharmaceutical sciences.
5. Indian Pharmacopoeia

PHARMACEUTICAL CHEMISTRY-V (NATURAL PRODUCTS)

1. Carbohydrates: Classification and general properties. Knowledge of structure including stereochemistry of glucose, fructose, and sucrose. General treatment of pharmaceutically important carbohydrates-maltose, lactose, starch, cellulose, dextrin, and glycosides.

2. Amino acids and proteins: Classification and general reactions of amino acids and their relationship to proteins and polypeptides. Methods of preparation of aminoacids, classification and general reactions of proteins, degradation of proteins-hydrolysis and end group analysis-protein hormones, oxytocin.

3. Purines and xanthine derivatives: Structure and synthesis of uric acid, Theo bromine, theophylline, and caffeine. General aspects of nucleoproteins and nucleic acids.

4. Lipids: Fixed oils and fats. Fatty acids: chemistry and analysis of oils and fats.

5. Terpenes: Occurence, general methods of isolation and classification, chemistry of citral, limonene, alpha-terpeneiol, carvone, camphor and menthol. Preparation, general composition, properties and analysis of essential oils of I.P.

6. Alkaloids: Classification, general methods of isolation, chemical tests for alkaloids, chemistry and uses of ephedrin, nicotine, papaverine and atropine.

7. Vitamins: Classification, chemistry, physiological role and uses of thiamine, riboflavin and ascorbic acid. Skeletal structures of vitamins official in I.P.

8. Steroids: Nomenclature and skeletal structures of ergosterol, stigmasterol, cholesterol and bile acids. Chemical tests for steroids. Calciferols and Sapogenins-diosgenin, hecogenin.

9. Hormones: Sex hormones, structure and physiological properties of testerone, progesterone, estrone, estriol and estradiol. Their synthesis from cholesterol or diosgenin. Synthetic estrogens. Introduction to oral contraceptives. Cortisones; prednisolone, aldosterone, synthesis of cortisone. Steroidal anti-inflammatory drugs: structures and their therapeutic uses.

10. Glycosides: Enzymatic and hydrolysis reactions of glycosides, mechanism of action, SAR, therapeutic uses and toxicity of glycosides. Cardiac glycosides of digitalis, bufa and squill. Structure of salicin, hesperidin and rutin.

11. Antibiotics: A general study of antibiotics, isolation or synthesis, chemistry and uses of penicillin, chloramphenicol and streptomycin, general introduction to tetracycline and other antibiotics included in I.P.

12. Spectroscopy and structure: an introductory treatment of U.V., I.R. and NMR spectroscopy in structure determination.

PHARMACEUTICAL ANALYSIS - II (PRACTCAL)

1. Separation of plant materials by column chromatography
2. Separation and identification of flavanoids/sulphonamides by paper chromatography
3. Separation and identification of sulphonamides by paper chromatography
4. Separation and identification of amino acids by TLC methods
5. Separation and identification of barbiturates by TLC methods
6. Determination of λ max, (KMnO4 and methylene blue solutions)
7. Demonstration experiments in HPLC and GLC
8. Assay of sulphadiazine tablets by visible spectrophotometry
9. Assay of sulphadiazine tablets by UV spectrophotometry
10. Demonstration experiments in IR spectrometry including interpretation of given spectra.
11. Fluorimetric estimation of quinine sulphate in formulations
12. Fluorimetric estimation of riboflavin in formulations
13. Flame photometric estimation of sodium and potassium ions
14. Potentiometric analysis a) Determination of pH of two solutions b) Titration of strong acid against strong base c) Titration of strong base against weak acid d) Simultaneous determination of strong acid and weak acid in a mixture e) Potentiometric assay of any two formulations from I.P.
15. Conductometric titration of NaOH with HCl
16. Polarographic estimation of drug official in I.P.
17. Determination of concentration of sugar solution by polarimetry
18. Determination of critical micellar concentration (butyric acid in water using abbe refractometer)
19. Demonstration experiments in detection of polymorphism and pseudo polymorphism in pharmaceuticals by DTA and DSC
20. Assay of an ointment and cream official in I.P.
21. Complete testing and assay of any two drugs as per I.P. monograph.

Reference books:
1. A text book of pharmaceutical analysis by K.A.Connors (John Wiley)

PHARMACEUTICAL ANALYSIS - II (THEORY)

Physiochemical chemical aspects of analytical chemistry with special reference to pharmaceutical analysis.

Chromatographic methods-1: Principles, theories, instrumentation and applications involved in a) column chromatography b) Paper chromotography c) Thin layer chromatography and HPTLC d) Ion exchange and gel filtration techniques
Chromatographic methods-II: Principles, theories, instrumentation and applications involved in a) Gas chromatography (GC) b) High performance liquid chromatography (HPLC)

Spectrophotometric analysis: A discussion of basic principles including interaction of matter with electro-magnetic radiation, absorption, emission, luminescence and scattering phenomena, units of measurement and definition of terms: a) absorptiometry: quantitative consideration of absorption phenomena including Beer and Lambert's laws and their mathematical expression, deviations from the laws and methods used in absorption spectrophotometry (visible, UV and IR) including sources, monochromators, detectors, preparation of calibration curves and pharmaceutical applications. Sources of errors and their correction and validation of spectrophotometric methods. B) Basic principles, equipment and methods used and pharmaceutical applications of flame photometry, photofluorimetry, turbidimetry and nephlometry.

Electrochemical analysis: A discussion of basic principles involved in electrochemical analysis, electrochemical cells and half-cells, electrodes, electrode reactions and electrode potentials: a) Potentiometry: basic principles involved in measurement of EMF and pH, Nernst equation, typical equipment and their construction, factors influencing EMF of cells, portable, stationary and online equipment for pH measurement, applications b) Potentiometric titrations including principles involved, methods for detection of end point including dead stop mend point, applications in neutralization, redox and precipitation titrations, equipment used, exploration of titration curves obtained with acids and bases of different strength and mixture of acids. c) Conductometric titrations: basic principles, titrations, equipment and applications.
d) Polarography: basic principles, titrations, equipment and applications in qualitative and quantitative analysis. e) amperometric titrations: basic principles, titrations, equipment and applications.
Basic principles, definition of terms, equipment and their working and applications of NMR and Mass spectrometry. Thermal methods of analyses and radioimmunoassay.

Textbooks:
1. Practical pharmacology chemistry by A.H.Beckett and J.B.Stenlake
2. Indian Pjarmacopoeia

Reference books:
1. Pharmaceutical chemistry by L.G.Chattern (Marcel Dekker)
2. A text book of pharmaceutical analysis by K.A.Connors (John Willey)
3. Pharmaceutical analysis- modern methods by J.W.Munson (Marcel Dekker)
4. Instrumental methods of analysis by Willard, Merritt, Dean and Settle (CBS Publishers)
5. Text book of analytical chemistry, by Y.Anjaneyulu, K.Chandra sekhar and Valli manickam.
6. Introduction to instrumental analysis by Robert D.Braun published by pharma book syndicate.