<<<<<<< HEAD rgpv syllabus BPharm Lateral Entry 0th Semester Syllabus110817111925-21403a05


SEMESTER V

PY 501. MEDICINAL CHEMISTRY – II (Theory)

45 Hours

Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry and therapeutic value of drugs. The subject emphasizes on structure activity relationships of drugs, importance of physicochemical properties and metabolism of drugs. The syllabus also emphasizes on chemical synthesis of important drugs under each class.

Objectives: Upon completion of the course the student shall be able to

  1. Understand the chemistry of drugs with respect to their pharmacological activity

  2. Understand the drug metabolic pathways, adverse effect and therapeutic value of drugs

  3. Know the Structural Activity Relationship of different class of drugs

  4. Study the chemical synthesis of selected drugs


Course Content:


Study of the development of the following classes of drugs, Classification, mechanism of action, uses of drugs mentioned in the course, Structure activity relationship of selective class of drugs as specified in the course and synthesis of drugs superscripted (*)


UNIT- I 10 Hours

Antihistaminic agents: Histamine, receptors and their distribution in the humanbody

H1–antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamines cuccinate, Clemastine fumarate, Diphenylphyraline hydrochloride, Tripelenamine hydrochloride, Chlorcyclizine hydrochloride, Meclizine hydrochloride, Buclizine hydrochloride, Chlorpheniramine maleate, Triprolidine hydrochloride*, Phenidamine tartarate, Promethazine hydrochloride*, Trimeprazine tartrate, Cyproheptadine hydrochloride, Azatidine maleate, Astemizole, Loratadine, Cetirizine, Levocetrazine Cromolyn sodium


H2-antagonists: Cimetidine*, Famotidine, Ranitidin.


Gastric Proton pump inhibitors: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole


Anti-neoplastic agents:

Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan,

Chlorambucil, Busulfan, Thiotepa

Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine, Cytarabine, Methotrexate*, Azathioprine

Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate Miscellaneous: Cisplatin, Mitotane.

UNIT – II 10 Hours

Anti-anginal:

Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbide dinitrite*, Dipyridamole.

Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.


Diuretics:

Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide, Dichlorphenamide.

Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide, Cyclothiazide,

Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid. Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride. Osmotic Diuretics: Mannitol

Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril, Benazepril hydrochloride, Quinapril hydrochloride, Methyldopate hydrochloride,* Clonidine hydrochloride, Guanethidine monosulphate, Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine, Hydralazine hydrochloride.


UNIT- III 10 Hours

Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride, Disopyramide phosphate*, Phenytoin sodium, Lidocaine hydrochloride, Tocainide hydrochloride, Mexiletine hydrochloride, Lorcainide hydrochloride, Amiodarone, Sotalol.


Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine and Cholestipol


Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*, Anisindione, clopidogrel


Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide, Bosentan, Tezosentan.

UNIT- IV 08 Hours


Drugs acting on Endocrine system

Nomenclature, Stereochemistry and metabolism of steroids

Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol, Oestrione, Diethyl stilbestrol.

Drugs for erectile dysfunction: Sildenafil, Tadalafil.

Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol

Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone, Dexamethasone

Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine, Propylthiouracil, Methimazole.


UNIT – V 07 Hours

Antidiabetic agents:

Insulin and its preparations

Sulfonyl ureas: Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride. Biguanides: Metformin.

Thiazolidinediones: Pioglitazone, Rosiglitazone. Meglitinides: Repaglinide, Nateglinide.

Glucosidase inhibitors: Acrabose, Voglibose.


Local Anesthetics: SAR of Local anesthetics

Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine, Cyclomethycaine, Piperocaine.

Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*, Butacaine, Propoxycaine, Tetracaine, Benoxinate.

Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine.

Miscellaneous: Phenacaine, Diperodon, Dibucaine.*


Recommended Books (Latest Editions)

  1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.

  2. Foye’s Principles of Medicinal Chemistry.

  3. Burger’s Medicinal Chemistry, Vol I to IV.

  4. Introduction to principles of drug design- Smith and Williams.

  5. Remington’s Pharmaceutical Sciences.

  6. Martindale’s extra pharmacopoeia.

  7. Organic Chemistry by I.L. Finar, Vol. II.

  8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1to 5.

  9. Indian Pharmacopoeia.

  10. Tex​t book of practical organic chemistry- A.I.Vogel.

    PY 502. Industrial PharmacyI (Theory)

    45 Hours

    Scope: Course enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product.


    Objectives: Upon completion of the course the student shall be able to

    1. Kn​ow the various pharmaceutical dosage forms and their manufacturing techniques.

    2. Kn​ow various considerations in development of pharmaceutical dosage forms

    3. Fo​rmulate solid, liquid and semisolid dosage forms and evaluate them for their quality


      Course content:

      3 hours/ week

      UNIT-I 07 Hours

      Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.

      1. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism

      2. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization BCS classification of drugs & its significant

      Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.


      UNIT-II 10 Hours

      Tablets:

      1. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipments and tablet tooling.

      2. Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating.

      3. Quality control tests: In process and finished product tests


        Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia

        UNIT-III 08 Hours

        Capsules:

        1. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.

        2. Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance of base adsorption and minim/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.

      Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets


      UNIT-IV 10 Hours

      Parenteral Products:

      1. Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity

      2. Production procedure, production facilities and controls, aseptic processing

      3. Formulation of injections, sterile powders, large volume parenterals and lyophilized products.

      4. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests of parenteral products.

        Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations

        UNIT-V 10 Hours

        Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.

        Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.

        Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influencing choice of containers, legal and official requirements for containers, stability aspects of packaging materials, quality control tests.

        Industrial Pharmacy I (Practical)


        1. Preformulation studies on paracetamol/asparin/or any other drug

        2. Preparation and evaluation of Paracetamol tablets

        3. Preparation and evaluation of Aspirin tablets

        4. Coating of tablets- film coating of tables/granules

        5. Preparation and evaluation of Tetracycline capsules

        6. Preparation of Calcium Gluconate injection

        7. Preparation of Ascorbic Acid injection

        8. Qulaity control test of (as per IP) marketed tablets and capsules

        9. Preparation of Eye drops/ and Eye ointments

        10. Preparation of Creams (cold / vanishing cream)

        11. Evaluation of Glass containers (as per IP)


      4 Hours/week


      Recommended Books: (Latest Editions)

      1. Ph​armaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman &J.B.Schwartz

      2. Ph​armaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman

      3. Ph​armaceutical dosage form disperse system VOL-1 by Liberman & Lachman

      4. Mo​dern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition

      5. Re​mington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science (RPS)

      6. Th​eory and Practice of Industrial Pharmacy by Liberman & Lachman

      7. Ph​armaceutics- The science of dosage form design by M.E.Aulton, Churchill livingstone, Latest edition

      8. In​troduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger, Philadelphia, 5thedition, 2005

      9. Dr​ug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel Dekker Series, Vol 107.

        PY 503. PHARMACOLOGY-II (Theory)

        45 Hours


        Scope: This subject is intended to impart the fundamental knowledge on various aspects (classification, mechanism of action, therapeutic effects, clinical uses, side effects and contraindications) of drugs acting on different systems of body and in addition,emphasis on the basic concepts of bioassay.


        Objectives: Upon completion of this course the student should be able to

        1. Un​derstand the mechanism of drug action and its relevance in the treatment of different diseases

        2. De​monstrate isolation of different organs/tissues from the laboratory animals by simulated experiments

        3. De​monstrate the various receptor actions using isolated tissue preparation

        4. Ap​preciate correlation of pharmacology with related medical sciences

Course Content:

UNIT-I 10hours

  1. Pharmacology of drugs acting on cardio vascular system

    1. Introduction to hemodynamic and electrophysiology of heart.

    2. Drugs used in congestive heart failure

    3. Anti-hypertensive drugs.

    4. Anti-anginal drugs.

    5. Anti-arrhythmic drugs.

    6. Anti-hyperlipidemic drugs.


UNIT-II 10hours

  1. Pharmacology of drugs acting on cardio vascular system

    1. Drug used in the therapy of shock.

    2. Hematinics, coagulants and anticoagulants.

    3. Fibrinolytics and anti-platelet drugs

    4. Plasma volume expanders

  2. Pharmacology of drugs acting on urinary system

    1. Diuretics

    2. Anti-diuretics.


      UNIT-III 10hours

  3. Autocoids and related drugs

    1. Introduction to autacoids and classification

    2. Histamine, 5-HT and their antagonists.

    3. Prostaglandins, Thromboxanes and Leukotrienes.

    4. Angiotensin, Bradykinin and Substance P.

    5. Non-steroidal anti-inflammatory agents

    6. Anti-gout drugs

    7. Antirheumatic drugs

UNIT-IV 08hours

  1. Pharmacology of drugs acting on endocrine system

    1. Basic concepts in endocrine pharmacology.

    2. Anterior Pituitary hormones- analogues and their inhibitors.

    3. Thyroid hormones- analogues and their inhibitors.

    4. Hormones regulating plasma calcium level- Parathormone, Calcitonin and Vitamin-D.

d. Insulin, Oral Hypoglycemic agents and glucagon.

e. ACTH and corticosteroids.


UNIT-V 07hours

  1. Pharmacology of drugs acting on endocrine system

    1. Androgens and Anabolic steroids.

    2. Estrogens, progesterone and oral contraceptives.

    3. Drugs acting on the uterus.

  2. Bioassay

    1. Principles and applications of bioassay.

    2. Types of bioassay

    3. Bioassay of insulin, oxytocin, vasopressin, ACTH,d-tubocurarine,digitalis, histamine and 5-HT

      PHARMACOLOGY-II (Practical)

      4Hrs/Week


      1. Introduction to in-vitro pharmacology and physiological salt solutions.

      2. Effect of drugs on isolated frog heart.

      3. Effect of drugs on blood pressure and heart rate of dog.

      4. Study of diuretic activity of drugs using rats/mice.

      5. DRC of acetylcholine using frog rectus abdominis muscle.

      6. Effect of physostigmine and atropine on DRC of acetylcholine using frog rectus abdominis muscle and rat ileum respectively.

      7. Bioassay of histamine using guinea pig ileum by matching method.

      8. Bioassay of oxytocin using rat uterine horn by interpolation method.

      9. Bioassay of serotonin using rat fundus strip by three point bioassay.

      10. Bioassay of acetylcholine using rat ileum/colon by four point bioassay.

      11. Determination of PA2 value of prazosin using rat anococcygeus muscle (by Schilds plot method).

      12. Determination of PD2 value using guinea pig ileum.

      13. Effect of spasmogens and spasmolytics using rabbit jejunum.

      14. Anti-inflammatory activity of drugs using carrageenan induced paw-edema model.

      15. Analgesic activity of drug using central and peripheral methods


Note: All laboratory techniques and animal experiments are demonstrated by simulated experiments by softwares and videos


Recommended Books (Latest Editions)

  1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology, Churchil Livingstone Elsevier

  2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc Graw-Hill.

  3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics

  4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott Williams & Wilkins.

  5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews- Pharmacology.

  6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical Publishers (P) Ltd, New Delhi.

  7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher

  8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert.

  9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.

  10. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan.

    PY 504. PHARMACOGNOSY AND PHYTOCHEMISTRY II (Theory)

    45Hours Scope: The main purpose of subject is to impart the students the knowledge of how the secondary metabolites are produced in the crude drugs, how to isolate and identify and produce them industrially. Also this subject involves the study of producing the plants and phytochemicals through plant tissue culture, drug interactions and basic principles of traditional system of medicine

    Objectives: Upon completion of the course, the student shall be able

    1. to know the modern extraction techniques, characterization and identification of the herbal drugs and phytoconstituents

    2. to understand the preparation and development of herbal formulation.

    3. to understand the herbal drug interactions

    4. to carryout isolation and identification of phytoconstituents


Course Content:

UNIT-I 7 Hours

Metabolic pathways in higher plants and their determination

  1. Brief study of basic metabolic pathways and formation of different secondary metabolites through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.

  2. Study of utilization of radioactive isotopes in the investigation of Biogenetic studies.


    UNIT-II 14 Hours

    General introduction, composition, chemistry & chemical classes, biosources, therapeutic uses and commercial applications of following

    secondary metabolites:


    Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,

    Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta

    Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis

    Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander,

    Tannins: Catechu, Pterocarpus

    Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony

    Glycosides: Senna, Aloes, Bitter Almond

    Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids

    UNIT-III 06 Hours

    Isolation, Identification and Analysis of Phytoconstituents


    1. Terpenoids: Menthol, Citral, Artemisin

    2. Glycosides: Glycyrhetinic acid & Rutin

    3. Alkaloids: Atropine,Quinine,Reserpine,Caffeine

    4. Resins: Podophyllotoxin, Curcumin


      UNIT-IV 10 Hours

      Industrial production, estimation and utilization of the following phytoconstituents: Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine, Taxol, Vincristine and Vinblastine


      UNIT V 8 Hours

      Basics of Phytochemistry

      Modern methods of extraction, application of latest techniques like Spectroscopy, chromatography and electrophoresis in the isolation, purification and identification of crude drugs.

      PHARMACOGNOSY AND PHYTOCHEMISTRY II (Practical)

      4 Hours/Week


      1. Morphology, histology and powder characteristics & extraction & detection of: Cinchona, Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander

      2. Exercise involving isolation & detection of active principles

        1. Caffeine - from tea dust.

        2. Diosgenin from Dioscorea

        3. Atropine from Belladonna

        4. Sennosides from Senna

      3. Separation of sugars by Paper chromatography

      4. TLC of herbal extract

      5. Distillation of volatile oils and detection of phytoconstitutents by TLC

      6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii) Colophony (iv) Aloes (v) Myrrh


Recommended Books: (Latest Editions)

  1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co., London, 2009.

  2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution, New Delhi.

  3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition, Nirali Prakashan, New Delhi.

  4. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.

  5. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi, 2007

  6. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.

  7. A.N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi, 2005.

  8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.

  9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VE Tylor.

  10. The formulation and preparation of cosmetic, fragrances and flavours.

  11. Remington’s Pharmaceutical sciences.

  12. Text Book of Biotechnology by Vyas and Dixit.

  13. Text Book of Biotechnology by R.C. Dubey.

PY 505. PHARMACEUTICAL JURISPRUDENCE (Theory)


Scope: This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in India.


45 Hours

Objectives: Upon completion of the course, the student shall be able to understand:

  1. The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals.

  2. Various Indian pharmaceutical Acts and Laws

  3. The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals

  4. The code of ethics during the pharmaceutical practice

Course Content:


UNIT-I 10 Hours


Drugs and Cosmetics Act, 1940 and its rules 1945:

Objectives, Definitions, Legal definitions of schedules to the Act and Rules

Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties.

Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,

Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.


UNIT-II 10 Hours


Drugs and Cosmetics Act, 1940 and its rules 1945.

Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA) Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties

Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties.

Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling authorities, Drugs Inspectors


UNIT-III 10 Hours



Recommended books: (Latest Edition)

  1. Forensic Pharmacy by B. Suresh

  2. Text book of Forensic Pharmacy by B.M. Mithal

  3. Hand book of drug law-by M.L. Mehra

  4. A text book of Forensic Pharmacy by N.K. Jain

  5. Drugs and Cosmetics Act/Rules by Govt. of India publications.

  6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.

  7. Narcotic drugs and psychotropic substances act by Govt. of India publications

  8. Drugs and Magic Remedies act by Govt. of India publication

  9. Bare Acts of the said laws published by Government. Reference books (Theory)

======= rgpv syllabus BPharm Lateral Entry 0th Semester Syllabus110817111925-21403a05


SEMESTER V

PY 501. MEDICINAL CHEMISTRY – II (Theory)

45 Hours

Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry and therapeutic value of drugs. The subject emphasizes on structure activity relationships of drugs, importance of physicochemical properties and metabolism of drugs. The syllabus also emphasizes on chemical synthesis of important drugs under each class.

Objectives: Upon completion of the course the student shall be able to

  1. Understand the chemistry of drugs with respect to their pharmacological activity

  2. Understand the drug metabolic pathways, adverse effect and therapeutic value of drugs

  3. Know the Structural Activity Relationship of different class of drugs

  4. Study the chemical synthesis of selected drugs


Course Content:


Study of the development of the following classes of drugs, Classification, mechanism of action, uses of drugs mentioned in the course, Structure activity relationship of selective class of drugs as specified in the course and synthesis of drugs superscripted (*)


UNIT- I 10 Hours

Antihistaminic agents: Histamine, receptors and their distribution in the humanbody

H1–antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamines cuccinate, Clemastine fumarate, Diphenylphyraline hydrochloride, Tripelenamine hydrochloride, Chlorcyclizine hydrochloride, Meclizine hydrochloride, Buclizine hydrochloride, Chlorpheniramine maleate, Triprolidine hydrochloride*, Phenidamine tartarate, Promethazine hydrochloride*, Trimeprazine tartrate, Cyproheptadine hydrochloride, Azatidine maleate, Astemizole, Loratadine, Cetirizine, Levocetrazine Cromolyn sodium


H2-antagonists: Cimetidine*, Famotidine, Ranitidin.


Gastric Proton pump inhibitors: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole


Anti-neoplastic agents:

Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan,

Chlorambucil, Busulfan, Thiotepa

Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine, Cytarabine, Methotrexate*, Azathioprine

Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate Miscellaneous: Cisplatin, Mitotane.

UNIT – II 10 Hours

Anti-anginal:

Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbide dinitrite*, Dipyridamole.

Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.


Diuretics:

Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide, Dichlorphenamide.

Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide, Cyclothiazide,

Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid. Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride. Osmotic Diuretics: Mannitol

Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril, Benazepril hydrochloride, Quinapril hydrochloride, Methyldopate hydrochloride,* Clonidine hydrochloride, Guanethidine monosulphate, Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine, Hydralazine hydrochloride.


UNIT- III 10 Hours

Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride, Disopyramide phosphate*, Phenytoin sodium, Lidocaine hydrochloride, Tocainide hydrochloride, Mexiletine hydrochloride, Lorcainide hydrochloride, Amiodarone, Sotalol.


Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine and Cholestipol


Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*, Anisindione, clopidogrel


Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide, Bosentan, Tezosentan.

UNIT- IV 08 Hours


Drugs acting on Endocrine system

Nomenclature, Stereochemistry and metabolism of steroids

Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol, Oestrione, Diethyl stilbestrol.

Drugs for erectile dysfunction: Sildenafil, Tadalafil.

Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol

Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone, Dexamethasone

Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine, Propylthiouracil, Methimazole.


UNIT – V 07 Hours

Antidiabetic agents:

Insulin and its preparations

Sulfonyl ureas: Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride. Biguanides: Metformin.

Thiazolidinediones: Pioglitazone, Rosiglitazone. Meglitinides: Repaglinide, Nateglinide.

Glucosidase inhibitors: Acrabose, Voglibose.


Local Anesthetics: SAR of Local anesthetics

Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine, Cyclomethycaine, Piperocaine.

Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*, Butacaine, Propoxycaine, Tetracaine, Benoxinate.

Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine.

Miscellaneous: Phenacaine, Diperodon, Dibucaine.*


Recommended Books (Latest Editions)

  1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.

  2. Foye’s Principles of Medicinal Chemistry.

  3. Burger’s Medicinal Chemistry, Vol I to IV.

  4. Introduction to principles of drug design- Smith and Williams.

  5. Remington’s Pharmaceutical Sciences.

  6. Martindale’s extra pharmacopoeia.

  7. Organic Chemistry by I.L. Finar, Vol. II.

  8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1to 5.

  9. Indian Pharmacopoeia.

  10. Tex​t book of practical organic chemistry- A.I.Vogel.

    PY 502. Industrial PharmacyI (Theory)

    45 Hours

    Scope: Course enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product.


    Objectives: Upon completion of the course the student shall be able to

    1. Kn​ow the various pharmaceutical dosage forms and their manufacturing techniques.

    2. Kn​ow various considerations in development of pharmaceutical dosage forms

    3. Fo​rmulate solid, liquid and semisolid dosage forms and evaluate them for their quality


      Course content:

      3 hours/ week

      UNIT-I 07 Hours

      Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.

      1. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism

      2. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization BCS classification of drugs & its significant

      Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.


      UNIT-II 10 Hours

      Tablets:

      1. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipments and tablet tooling.

      2. Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating.

      3. Quality control tests: In process and finished product tests


        Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia

        UNIT-III 08 Hours

        Capsules:

        1. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.

        2. Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance of base adsorption and minim/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.

      Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets


      UNIT-IV 10 Hours

      Parenteral Products:

      1. Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity

      2. Production procedure, production facilities and controls, aseptic processing

      3. Formulation of injections, sterile powders, large volume parenterals and lyophilized products.

      4. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests of parenteral products.

        Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations

        UNIT-V 10 Hours

        Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.

        Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.

        Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influencing choice of containers, legal and official requirements for containers, stability aspects of packaging materials, quality control tests.

        Industrial Pharmacy I (Practical)


        1. Preformulation studies on paracetamol/asparin/or any other drug

        2. Preparation and evaluation of Paracetamol tablets

        3. Preparation and evaluation of Aspirin tablets

        4. Coating of tablets- film coating of tables/granules

        5. Preparation and evaluation of Tetracycline capsules

        6. Preparation of Calcium Gluconate injection

        7. Preparation of Ascorbic Acid injection

        8. Qulaity control test of (as per IP) marketed tablets and capsules

        9. Preparation of Eye drops/ and Eye ointments

        10. Preparation of Creams (cold / vanishing cream)

        11. Evaluation of Glass containers (as per IP)


      4 Hours/week


      Recommended Books: (Latest Editions)

      1. Ph​armaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman &J.B.Schwartz

      2. Ph​armaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman

      3. Ph​armaceutical dosage form disperse system VOL-1 by Liberman & Lachman

      4. Mo​dern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition

      5. Re​mington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science (RPS)

      6. Th​eory and Practice of Industrial Pharmacy by Liberman & Lachman

      7. Ph​armaceutics- The science of dosage form design by M.E.Aulton, Churchill livingstone, Latest edition

      8. In​troduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger, Philadelphia, 5thedition, 2005

      9. Dr​ug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel Dekker Series, Vol 107.

        PY 503. PHARMACOLOGY-II (Theory)

        45 Hours


        Scope: This subject is intended to impart the fundamental knowledge on various aspects (classification, mechanism of action, therapeutic effects, clinical uses, side effects and contraindications) of drugs acting on different systems of body and in addition,emphasis on the basic concepts of bioassay.


        Objectives: Upon completion of this course the student should be able to

        1. Un​derstand the mechanism of drug action and its relevance in the treatment of different diseases

        2. De​monstrate isolation of different organs/tissues from the laboratory animals by simulated experiments

        3. De​monstrate the various receptor actions using isolated tissue preparation

        4. Ap​preciate correlation of pharmacology with related medical sciences

Course Content:

UNIT-I 10hours

  1. Pharmacology of drugs acting on cardio vascular system

    1. Introduction to hemodynamic and electrophysiology of heart.

    2. Drugs used in congestive heart failure

    3. Anti-hypertensive drugs.

    4. Anti-anginal drugs.

    5. Anti-arrhythmic drugs.

    6. Anti-hyperlipidemic drugs.


UNIT-II 10hours

  1. Pharmacology of drugs acting on cardio vascular system

    1. Drug used in the therapy of shock.

    2. Hematinics, coagulants and anticoagulants.

    3. Fibrinolytics and anti-platelet drugs

    4. Plasma volume expanders

  2. Pharmacology of drugs acting on urinary system

    1. Diuretics

    2. Anti-diuretics.


      UNIT-III 10hours

  3. Autocoids and related drugs

    1. Introduction to autacoids and classification

    2. Histamine, 5-HT and their antagonists.

    3. Prostaglandins, Thromboxanes and Leukotrienes.

    4. Angiotensin, Bradykinin and Substance P.

    5. Non-steroidal anti-inflammatory agents

    6. Anti-gout drugs

    7. Antirheumatic drugs

UNIT-IV 08hours

  1. Pharmacology of drugs acting on endocrine system

    1. Basic concepts in endocrine pharmacology.

    2. Anterior Pituitary hormones- analogues and their inhibitors.

    3. Thyroid hormones- analogues and their inhibitors.

    4. Hormones regulating plasma calcium level- Parathormone, Calcitonin and Vitamin-D.

d. Insulin, Oral Hypoglycemic agents and glucagon.

e. ACTH and corticosteroids.


UNIT-V 07hours

  1. Pharmacology of drugs acting on endocrine system

    1. Androgens and Anabolic steroids.

    2. Estrogens, progesterone and oral contraceptives.

    3. Drugs acting on the uterus.

  2. Bioassay

    1. Principles and applications of bioassay.

    2. Types of bioassay

    3. Bioassay of insulin, oxytocin, vasopressin, ACTH,d-tubocurarine,digitalis, histamine and 5-HT

      PHARMACOLOGY-II (Practical)

      4Hrs/Week


      1. Introduction to in-vitro pharmacology and physiological salt solutions.

      2. Effect of drugs on isolated frog heart.

      3. Effect of drugs on blood pressure and heart rate of dog.

      4. Study of diuretic activity of drugs using rats/mice.

      5. DRC of acetylcholine using frog rectus abdominis muscle.

      6. Effect of physostigmine and atropine on DRC of acetylcholine using frog rectus abdominis muscle and rat ileum respectively.

      7. Bioassay of histamine using guinea pig ileum by matching method.

      8. Bioassay of oxytocin using rat uterine horn by interpolation method.

      9. Bioassay of serotonin using rat fundus strip by three point bioassay.

      10. Bioassay of acetylcholine using rat ileum/colon by four point bioassay.

      11. Determination of PA2 value of prazosin using rat anococcygeus muscle (by Schilds plot method).

      12. Determination of PD2 value using guinea pig ileum.

      13. Effect of spasmogens and spasmolytics using rabbit jejunum.

      14. Anti-inflammatory activity of drugs using carrageenan induced paw-edema model.

      15. Analgesic activity of drug using central and peripheral methods


Note: All laboratory techniques and animal experiments are demonstrated by simulated experiments by softwares and videos


Recommended Books (Latest Editions)

  1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology, Churchil Livingstone Elsevier

  2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc Graw-Hill.

  3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics

  4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott Williams & Wilkins.

  5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews- Pharmacology.

  6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical Publishers (P) Ltd, New Delhi.

  7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher

  8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert.

  9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.

  10. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan.

    PY 504. PHARMACOGNOSY AND PHYTOCHEMISTRY II (Theory)

    45Hours Scope: The main purpose of subject is to impart the students the knowledge of how the secondary metabolites are produced in the crude drugs, how to isolate and identify and produce them industrially. Also this subject involves the study of producing the plants and phytochemicals through plant tissue culture, drug interactions and basic principles of traditional system of medicine

    Objectives: Upon completion of the course, the student shall be able

    1. to know the modern extraction techniques, characterization and identification of the herbal drugs and phytoconstituents

    2. to understand the preparation and development of herbal formulation.

    3. to understand the herbal drug interactions

    4. to carryout isolation and identification of phytoconstituents


Course Content:

UNIT-I 7 Hours

Metabolic pathways in higher plants and their determination

  1. Brief study of basic metabolic pathways and formation of different secondary metabolites through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.

  2. Study of utilization of radioactive isotopes in the investigation of Biogenetic studies.


    UNIT-II 14 Hours

    General introduction, composition, chemistry & chemical classes, biosources, therapeutic uses and commercial applications of following

    secondary metabolites:


    Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,

    Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta

    Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis

    Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander,

    Tannins: Catechu, Pterocarpus

    Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony

    Glycosides: Senna, Aloes, Bitter Almond

    Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids

    UNIT-III 06 Hours

    Isolation, Identification and Analysis of Phytoconstituents


    1. Terpenoids: Menthol, Citral, Artemisin

    2. Glycosides: Glycyrhetinic acid & Rutin

    3. Alkaloids: Atropine,Quinine,Reserpine,Caffeine

    4. Resins: Podophyllotoxin, Curcumin


      UNIT-IV 10 Hours

      Industrial production, estimation and utilization of the following phytoconstituents: Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine, Taxol, Vincristine and Vinblastine


      UNIT V 8 Hours

      Basics of Phytochemistry

      Modern methods of extraction, application of latest techniques like Spectroscopy, chromatography and electrophoresis in the isolation, purification and identification of crude drugs.

      PHARMACOGNOSY AND PHYTOCHEMISTRY II (Practical)

      4 Hours/Week


      1. Morphology, histology and powder characteristics & extraction & detection of: Cinchona, Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander

      2. Exercise involving isolation & detection of active principles

        1. Caffeine - from tea dust.

        2. Diosgenin from Dioscorea

        3. Atropine from Belladonna

        4. Sennosides from Senna

      3. Separation of sugars by Paper chromatography

      4. TLC of herbal extract

      5. Distillation of volatile oils and detection of phytoconstitutents by TLC

      6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii) Colophony (iv) Aloes (v) Myrrh


Recommended Books: (Latest Editions)

  1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co., London, 2009.

  2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution, New Delhi.

  3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition, Nirali Prakashan, New Delhi.

  4. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.

  5. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi, 2007

  6. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.

  7. A.N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi, 2005.

  8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.

  9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VE Tylor.

  10. The formulation and preparation of cosmetic, fragrances and flavours.

  11. Remington’s Pharmaceutical sciences.

  12. Text Book of Biotechnology by Vyas and Dixit.

  13. Text Book of Biotechnology by R.C. Dubey.

PY 505. PHARMACEUTICAL JURISPRUDENCE (Theory)


Scope: This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in India.


45 Hours

Objectives: Upon completion of the course, the student shall be able to understand:

  1. The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals.

  2. Various Indian pharmaceutical Acts and Laws

  3. The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals

  4. The code of ethics during the pharmaceutical practice

Course Content:


UNIT-I 10 Hours


Drugs and Cosmetics Act, 1940 and its rules 1945:

Objectives, Definitions, Legal definitions of schedules to the Act and Rules

Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties.

Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,

Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.


UNIT-II 10 Hours


Drugs and Cosmetics Act, 1940 and its rules 1945.

Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA) Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties

Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties.

Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling authorities, Drugs Inspectors


UNIT-III 10 Hours



Recommended books: (Latest Edition)

  1. Forensic Pharmacy by B. Suresh

  2. Text book of Forensic Pharmacy by B.M. Mithal

  3. Hand book of drug law-by M.L. Mehra

  4. A text book of Forensic Pharmacy by N.K. Jain

  5. Drugs and Cosmetics Act/Rules by Govt. of India publications.

  6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.

  7. Narcotic drugs and psychotropic substances act by Govt. of India publications

  8. Drugs and Magic Remedies act by Govt. of India publication

  9. Bare Acts of the said laws published by Government. Reference books (Theory)

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