Section B - DR

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Section B - DR ...



    Sr. No. Subject Theory hours per week Practical hours per

    week 4.1. Dosage form Design 3 3 4.2. Pharmacognosy and Phytochemistry 3 3 4.3. Medicinal Chemistry - II 3 3 4.4. Pharmacology and Bioassay 3 3 4.5. Pharmaceutical Management 3 -- 4.6. Quality Assurance Techniques 3 3 4.7. Pharmaceutical Jurisprudence and 3 --

    Intellectual Property Rights

     Total 21 15

4.1 : Dosage Form Design Theory (Final B. Pharm.) - 3 HRS. / WEEK

    Sr. Topics and contents Hours No.

     SECTION - A

     Preformulation: - 08

     Concept of preformulation,

    1. Organization of preformulation activity,

    Essential information of new drug for preformulation, Principle areas of

    preformulation: - Analytical preformulation, Bulk Characterization, Solubility,

    Stability Analysis.

    2. Solubility and Dissolution: - 10

    Methods of expressing solubility,

    Prediction of solubility

    Physicochemical prediction of solubility

    Solubility Parameters

    Factors affecting on solubility

    Dissolution mechanisms

    Factors affecting dissolution

    Intrinsic dissolution

    Measurement of dissolution rates

    3 Stability: - 10

    Definition: - Expiry date, Shelf life, Order of reaction.

    Environmental factors influencing stability: - pH, Solvent, Solubility, Additives, Light,

    Temperature, Acid Base Catalysis, Ionic Strength

    Modes of drug instability and methods to prevent them: - Chemical and Physical

    Technique of stability prediction, Tentative expiry dating

    Introduction to cGMP guidelines in stability testing and expiry dating(No details)

    Effect of packaging material on stability of drug.

    4 Package Development: - 10

    Structure and composition

    Glass- types, manufacture of glass, glass container, evaluation

    Plastic- definition, material properties (mechanical, electrical and optical),

    physicochemical properties (mass transfer, chemical attack), types-thermoplastic,

    thermoset with example and applications.

    Drug plastic interactions, evaluation of plastics

    Collapsible tubes- metal, plastic, lamination

    Closure: closure types (rubber, plastic), closure liners, tamper resistant packaging,

    film wrappers, blister packing material, strip package, bubble pack, shrink banding,

    pouches, bottle seal, taper seals, breakable caps, tape seals, seal cartons.


    5 Oral Sustained Release and Introduction to NDDS: - 15 Introduction, Terminology

    Biopharmaceutical aspects: - Steady state concepts, Calculation of loading and

    maintenance dose.

    Design of oral SRDF systems: - Biological factors, Physicochemical factors Diffusional systems: - Reservoir system, Lag time, Burst effect

     Matrix system, Effect of porosity and tortuosity Dissolution controlled system, Cube route dissolution equation, Diffusion layer

    controlled dissolution.

    Bioerodible and Combination of diffusion and dissolution systems Evaluation: - Official and unofficial methods of evaluation of SRDF/CRDF system Polymers used in SRDF system

Introduction to NDDS( Novel Drug Delivery System): -

    Osmotically controlled system, osmotic pumps

    Ion exchange system

    Transdermal system

    Occular system

    Intravaginal and intrauterine system

    Injection and implant

    Biomucoadhesive system

    Iontophhoretic system

    Sonophoretic system

    Targeted drug delivery system: - Liposome, Nanoparticles, Prodrugs, Resealed

    erythrocytes, Antibody targeted systems

    6 Scale Up Techniques: - 06 Introduction

    Steps involved in scale up

    General consideration

    Scale up examples of: Solid dosage form

     Liquid dosage forms- Solution, Suspension, Emulsion.

     Semi solid dosage forms- Suppository

    7 Optimization and Experimental Design: - 07 Introduction

    Concepts of optimized drug product

    Various optimization parameters like problem types and variables Optimization techniques: - Classical optimization, Statistical design Optimization methods : Evolutionary, Simplex, Langarian, Search (Introduction only). Experimental design (Introduction to)

    Designing strategy and purpose of experimental design along with pharmaceutical


    Stages in experimental design

    Starting of experimental design- Definition, Important concepts of experimental

    design, Software for designing.

    8 Design of Dosage Form:- 06 Principles of dosage form design (DFD)

    Biopharmaceutical aspects of DFD

    Drug related factors in DFD

    Therapeutic considerations in DFD.


    ? Leon Lachmann, H. Liebermann, “Principles and Practice of Industrial Pharmacy

    ? Banker’s Modern Pharmaceutics ? Pharmaceutical Experimental Design, , M and D series by Lewis Vol-92

    ? Kim, Advanced Pharmaceutics

    ? Aulton, Pharmaceutics.

    ? Rawland, Pharmaceutics.

    th? “Remington’s Science and Practice of Pharmacy”, 20 edition, Vol-I and II

    ? ICH guidelines for stability study

    ? Indian Pharmacopoeia Current Editions ? British Pharmacopoeia Current Editions ? United State Pharmacopoeia Current Editions ? S.P.Vyas, R.K.Khar, Targeted and controlled drug delivery system, CBS Publication

    ? Chein, Controlled Drug Delivery Systems, Marcel Dekkers Publication.

4.1 : Dosage Form Design Practical (Final B. Pharm.) - 3 HRS. / Batch / Week

    1 Compare oxidative degradation of ascorbic acid at pH 2.0 and 8.0. 2 Compare the degradation rate constant of ascorbic acid in presence of cuppric ions. 3 Construction and analysis of Plaquette Burman design to a hypothetical system. 4 Demonstration of fluidised bed processing technique.

    5 Demonstration of mixing performance evaluation of mixer (Sigma/ Planetary/ ribbon/ RMG) 6 Demonstration of Preparation of microcapsules of given sample of drug by extrusion &

    sperodization technique.

    7 Determination of compressibility of given material

    8 Determination of effect of solvent on aspirin solution stability

    9 Determination of F value of given dosage form

    10 Determination of micromeritic properties of given material (MCC/ Starch etc.) 11 Determination of Phase solubility analysis of drug ?-CD complex 12 Determination of solubility of given drug at different pH

    13 Determine the energy of activation of hydrolysis of aspirin/ ascorbic acid solution 14 Determine the optimum dielectric constant for maximum solubility of drug. 15 Evaluate antimicrobial adsorption property of given sample of rubber closure. 16 Fitting of data to linear, log and polynomial system to determine best fit. 17 Perform pharmacopeia test for given sample of glass vial / ampoule. 18 Perform physicochemical test as per pharmacopoeia on given sample of plastic. 19 Preparation of ion exchange complex of given drug sample and evaluation of its release 20 Prepare & evaluate beads of given sample of drug using melt dispersion 21 Prepare & evaluate beads of given sample of drug using polymer coacervation 22 Study of effect of homogenizing time on emulsion globule distribution of liquid paraffin



    ? Leon Lachmann, H. Liebermann, “Principles and Practice of Industrial Pharmacy

    ? Banker’s Modern Pharmaceutics

    ? Pharmaceutical Experimental Design, , M and D series by Lewis Vol-92

    ? Kim, Advanced Pharmaceutics

    ? Aulton, Pharmaceutics.

    ? Rawland, Pharmaceutics.

    ? “Remington’s Science and Practice of Pharmacy”, 20th edition, Vol-I and II

    ? ICH guidelines for stability study

    ? Indian Pharmacopoeia Current Editions

    ? British Pharmacopoeia Current Editions

    ? United State Pharmacopoeia Current Editions

    ? S.P.Vyas, R.K.Khar, Targeted and controlled drug delivery system, CBS Publication

    ? Chein, Controlled Drug Delivery Systems, Marcel Dekkers Publication.

4.2 : Pharmacognosy and Phytochemistry Theory (Final B. Pharm.) - 3 HRS. / Week

    Section A

    1. Phytochemical investigation of crude drugs and it’s importance (1)

    Detail study of each category of drugs under phytochemical scheme including biosynthesis


    Definition composition Chemistry and extraction of volatile oils, biosynthesis, terpeneless

    volatile oils

    Study of drugs containing volatile oils

    a) Monoterpenoids: Rosemary, Anise, Cummin, Celery, Lavender, Gaultheria, Palmarosa,

    Citronella, Thyme, Camphor, Chenopodium, Eucalyptous, Lemongrass, Turpentine,

    Pepprmint oil, Caraway, Cardamom, Coriander, Ajowan, Dill, Fennel, Lemon peel, Orange

    peel, Nutmg, Cassia, Cinnamon, jatamansi, garlic, Sweet basil, Sacred basil, Musk, Civet

    b) Sesquiteerpenoids: Artemisia, Davana, Arnica, Sandalwood, Clove, Hops, Saussurea, Cubeb,

    Valerian, Ferverfew

    c) Diterpenoids: Taxus, Coleus

    d) Triterpenoids: Ambergris

    e) Tetraterpenoids and polyterpenoids: Annatto, Saffron

    Structure determination and elucidation of, Citral, Geraniol, Menthol, Santonin, Beta


    3. ALKALOIDS: (12)

    Definition, distribution, classification, methods of isolation, properties, chemistry and biosynthesis of

    following group of alkaloids

    Study of alkaloid containing drugs,

    1) Tropane: Belladonna, Datura, Hyoscamus, Stramonium, Coca, Duboisa

    2) Indole: Ergot, Nuxvomica, Physostigma, Rauwolfia, Vinca,

    3) Isoquinoline: Opium, Ipecac, berberis, Hydrastis, Curare,

    4) Quinoline; Cichona, and Camptotheca

    5) Pyridine: Lobelia, Areca

    6) Quinazoline: Vasaka

    7) Purine; Coffee, Tea, and Coca

    8) Imidazole; Pilocarpus

    9) Steroidal: Veratrum, Kurchi, Ashwagandha,

    10) Protoalkaloids: Ephedra, Colchicum, Aconite, Gloriosa

    Structure determination and elucidation of, Reserpine, Morphine, Atropine, Caffeine, Ephedrine

    4. MARINE DRUGS: (04) Indroduction, importance, classification of drug molecules from marine organisms

    a) Cytotoxic and antineoplastic agents

    b) Cardiovascular drugs

    c) Marine toxins

    d) Antimicribial drugs

    e) Antibiotic substances

    f) Antiinflammatory and antispasmodics

    g) Miscelleneous pharmacologically active substances

    Section B

    1. Extraction isolation and analysis of phytopharmaceuticals (06)

    ? A detailed study of various methods of extraction and isolation of phytopharmaceuticals

    namely infusion, decoction, digestion, maceration, percolation, successive solvent extraction,

    supercritical fluid extraction, steam distillation, had space techniques, sepbox, selection of

    suitable extraction process

    ? Application of chromatography and spectroscopy to plant drug analysis

    2. Industrial importance and status of herbal drugs (02)

     Role of medicinal and aromatic plants in national economy

     Importance and status of herbal medicines, aromatics and cosmetics

    3. Worldwide trade in medicinal and aromatic plants and their derived products. A brief account of

    plant based industries and institutions involved in work of medicinal and aromatic plants and

    their products in India (02) 4. Details of methods of isolation including industrial identification, chemistry and estimation of, a)

    Quinine b) Ephedrine c) Cardiac glycosides d) Ca sennosides e) Diosgenin f) Glycyrrhizin g) Citrus

    bioflavonoids h) Rutin i) Andrographolides j) Phyllanthin k) Guggulosterol l) Gymnrmic acid m)

    Asiaticoside/ madecassoside n) Withanolides (10) 5. Standardization of herbal drugs: (05)

    i) Importance of standardization of raw materials, extracts and formulation

    ii) problems involved in standardization of herbs

    iii) Standardization of single drug and compound formulation

    iv) Estimation of parameter limits used for standardization

    v) Herbal extracts

    vi) WHO guidelines or quality standardization of herbal formulation


    ? Introduction

    ? Nutraceuticals, Antioxidants, Prebiotics and probiotics, Poluunsaturated fatty acids, (PUFA),

    Dietry fibres

    ? Definition Introduction status, safety quality control and efficacy and brief study of herbs

    such as, Alfalfa, Angelica, Arnica, Apricot, Borage, Bran, Chamomile, Chicory, Colcellana,

    Cucumber, Damiana, Devil’s claw, Fenugreek, Garlic, Onion, Gentian, Ginseng, Ginkgo biloba,

    Hydrocotyl, Golden sal, Hibiscus, Hops, Honey, Kelp, Marigold, Mormontea, Parsley,

    Passiflora, pennyroyal, Soyabeen, Ganoderma fruits, evening primrose, corn oil, Tejpat oil,

    Blessed thistle, Balm lemon foliage and flower

    a. Herbal formulations: (05)

    A comparative study of traditional and modern dosage forms. Classification general

    considerations and different stages of herbal formulations and dosage forms

    b. Herbal cosmetics: (05)

    Definition, classification and role and importance of herbs in cosmetics

    Study of following herbal cosmetics

    i. Shampoo- soapnut

    ii. Conditioner- Amla, Henna, Hibiscus and Tea

    iii. Hair darkners; Amla and Henna

    iv. Skin care: Aloe vera, Turmeric, Sandalwood, Glycyrrhizin

    v. Herbal soap

    vi. Herbal mouthwash

    vii. Herbal hair tonic

    viii. Liquid cream

    ix. Lotion

    c. Patenting of natural products (02)

    Different aspects of obtaining patents in natural products (rules and regulations therein)

    4.2 : Pharmacognosy and Phytochemistry Practical (Final B. Pharm.)-3 Hrs/batch/ Week

    1. Pharmacognostic study excluding histology of following plants:

    Nutmeg, Orange peel, Lemon peel, Jatamansii, Sandalwood, Tulsi, Aconite, Ergot, Colchicum,

    Swertia, Picrorrhiza, Andrographis

    2. Pharmagcognostic study including morphological, histological, powdered drug characteristics of following drugs

    Leaves: Vasaka, Vinca, Neem, Eucalyptus, Datura, Tulsi, Sweet basil,

    Fruits: Fennel, coriander, Anise, Cardamom, Dill,

    Bark: Cinnamon, Kurchi, Ashoka, Arjuna

    Root: Rauwolfia, Ashwagandha, Ipecac, Colchicum

    Stem: Ephedra

    Bud: Clove

    Seed: Nux-vomica

    Entire plant: Picrorrhiza, Andrographis

    3. Extraction of active constituents followed by separation by TLC identification by suitable method (At least 10 from the following list)

    i. Extraction of caffeine from tea ii. Extraction of hesperidin from orange peel iii. Extraction of pectin from any suitable source iv. Extraction of alkaloids from vinca v. Extraction of vasicine from vasaka vi. Extraction of piperine from piper nigrum vii. Extraction of strychnine and brucine from nux vomica viii. Extraction of curccumine from Curcumma longa ix. Extraction of oleoresin from ginger x. Extraction of tannic acid from myrobalan xi. Extraction of hecogenin from agave xii. Extraction of solasodine from suitable source xiii. Extraction of berberine from berberis root xiv. Extraction of nicotine from tobacco leaves xv. Extraction of ammonium glycyrrhizinate from liquorice xvi. Extraction of eucalyptus oil, lemongrass oil, cumin oil, coriander oil and dill oil

    4. Preparation and evaluation of at least two from each category of the following herbal cosmetics categories

    i. Shampoo

    ii. Conditioner

    iii. Hair darkners

    iv. Skin care

    v. Herbal soap

    vi. Herbal mouthwash

    vii. Herbal hair tonic

    viii. Liquid cream

    ix. Lotion


    ? Dr. Pulok Mukherjee, Quality control of Herbal Drugs, Business Horizon G59, Masjid Moth, Gk-2,

    New Delhi

    ? Dr. S S Agrawal, Herbal Drug Technology, Orient Longman Pvt. Ltd.3-6-752 Himayat Nagar

    Hyderabad -29

    ? Ciddi Veeresham Medicinal Plant Biotechnology CBS Publishers & Distributor , New Delhi ? Amritpal Singh Saroyi, Glossary of Medicinal Plant used in Ayurved, Scientific Publishers (India)

    P.O. Box 91 Jodhpur

    ? The Wealth of India Raw Materials (All Volumes) Council of Scientific & Industrial Research, New


    ? Peach K and Tracey M V, Modern Methods of Plant Analysis Vol 1 - 4 , Narosa Publishing House,

    New Delhi

    ? Swain T, Chemical Plant Taxonomy, Academic Press, London

    ? Swain T, Comparative Phytochemstry , Academic Press, London

    ? Wallis T E, Analytical Microscopy ,J A Churchill Ltd. London

    ? Industrial Gums, Polysaccharides and their derivatives.Second Edition Academic Press, New


    ? Iyengar M A, Pharmacognosy Lab Manual, Manipal Power Press, Manipal

    ? Youngken H W Natural Drugs : Morphologic & Taxonomic consideration

    ? Chakrabarty Pharmaconomic An Approach to new drug development

    ? A K Gupta, Neeraj Tandon & Madhu Sharma Quality standards of Indian Medicinal plants Vol -2


    ? Indian Council for Medical Reasearch, Ansari Nagar, New Delhi

    ? Kokate C.K Purohit A.P and Gokhale S.B, Pharmacognosy, Nirali Prakashan. ? Kokate C.K Practical Pharmacognosy, Vallabh Prashan, Delhi.

    ? Atal C.K and Kanpur B.M Cultivation and Utilization of Medicinal Plants, RRL, Jammu. ? Brain K.R and Turner T.T, The Practical Evaluation of Phytopharmaceuticals, Wright-

    Scientechnica, Bristil.

    ? Official Methods of Analysis, Association of Official Analytical Chemists Publications, Washington. ? Swain.T, Comparative Phytochemistry, Academic Press London.

    ? Wallis, T.E Analytical Microscopy, J.A Churchill limited, London.

    ? Wallis, T.E Textbook of Pharmacognosy, J.A Churchill limited, London. nd edition Academic press, ? Whistler R.L, Industrial Gums, Polysaccharides and their Derivatives, 2

    New Delhi.

    ? Tyler, V.E, Brady,R.,Pharmacognosy.

    ? Wagner, S.B., Zgainsky, Plant Drug Analysis.

    st? Poluk Mukherjee, Quality Control Of Herbal Drugs, Business Horizons, Pharmaceutical Press, 1

    Edition, 2001.



    ? National and International Journals- phytochemistry, fitoterapia, journal of natural products,

    Indian journal of natural remedies, journal of ethnopharmacology, phytotherapy research. ? J.S Quadri, Textbook of Pharmacognosy, B.S Shah Prakashan, Ahemdabad,

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