Scheme of Instruction and Evaluation for M. Pharmacy (Pharmaceutics) I – Semester – Revised-2009
Instruction Hours per week Theory M PCT.T. 1.101 Pharmaceutical Analytical Techniques Industrial pharmacy-I (pharmaceutical production technology) Pharmaceutical Product Development Quality Assurance Pharmaceutical Analytical Techniques Pharmaceutical Product Development Scientific and Technical Writing (SAIL) Seminar Theory 4 Practical --Duration of External Examination 3
Subject / Paper
Theory / Practical
Evaluation Internal 30 External 70
M PCT.T. 1.102
M PCT.T.1.103 M PCT.T. 1.104 M PCT.P. 1.105 M PCT.P. 1.106 M PCT.T. 1.107 M PCT .1.108
Theory Theory Practical Practical Tutorial Theory
4 4 -2 18
----6 6 8 20
30 30 30 30 A/B/C/D 60 240
70 70 70 70 420
3 3 6 6 -
Scheme of Instruction and Evaluation for M. Pharmacy (Pharmaceutics) II– Semester – Revised-2009
Instruction Hours per week Theory M PCT.T. 1.201 M PCT.T. 1.202 M PCT.T. 1.203 M PCT.T. 1.204 M PCT.P. 1.205 M PCT.P. 1.206 M PCT.T. 1.207 M PC. 1.208 IPR & Regulatory Affairs Industrial pharmacy – II (scale up and validation) Biopharmaceutics and Pharmacokinetics Advances in drug delivery system Advances in drug delivery system. Biopharmaceutics and Pharmacokinetics Entrepreneurship Management (SAIL) Seminar Theory Theory Theory Theory Practical Practical Tutorial Theory 18 SAIL: Self assess Instrumentation Learning 4 4 4 4 --2 Practical --------6 6 8 20 Duration of External Examination 3 3 3 3 6 6 -
Subject / Paper
Theory / Practical
Evaluation Internal 30 30 30 30 30 30 A/B/C/D 50 230 External 70 70 70 70 70 70 420
Scheme of Instruction and Evaluation for M. Pharmacy (Pharmaceutics)
Semester III and IV
DISSERTATION – Original research work carried out by the candidate under the guidance of regular teaching faculty/visiting faculty of the department should be submitted in a bound form.
Evaluation of the dissertation shall be done by external and internal examiners appointed by the university.
Dissertation viva-voce Dissertation report
Grade A/B/C/D/F Grade A/B/C/D/F
B. Very good
Dispersive IR spectrophotometers and Fourier transform spectrophotometers.net
. Instrumentation (components and their significance). spin. Gas chromatography: Instrumentation. UNIT – III Mass Spectrometry: Basic principles and instrumentation (components and their significance). fragment ions. normal and reversed phase packing materials. applications in pharmaceutical analysis. Interpretation of PMR spectra. Chemical shifts concept. applications in pharmaceutical analysis. Difference and derivative spectra. instrumentation in HPLC.
www. molecular ion. fragmentation patterns and fragment characteristics in relation to parent structure and functional groups.www.spin coupling. effect of conjugation.net
PHARMACEUTICAL ANALYTICAL TECHNIQUES M PCT. efficiency parameters. solvents. flash chromatography. Absorption spectra of organic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs including multicomponent analysis. Infra-Red Spectroscopy: Interaction of infrared radiation with organic molecules and it’s effects on bonds. chiral chromatography. Woodward-Fieser rules for caculating absortion maximum for unsaturated hydrocarbons. Concept of chromophore and auxochrome.ouworld. column efficiency parameters. column selection. Brief note on ATR. instrumentation (components and their significance). derivatisation methods. Sample handling for IR spectroscopy. Brief introduction about Carbon-13 NMR and 2D NMR Spectroscopy. mobile phase selection. mass spectrum and its characteristics. UNIT – IV Chromatographic Techniques: Classification of chromatographic methods based on mechanism of separation and their basic principles. shielding and deshielding. UNIT – II Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR. solvent and pH. Interpretation of IR spectra. fragmentation processes. spin-spin decoupling. Instrumentation and applications of HPTLC. (Attenuated Total Reflectance). Relative abundances of isotopes and their contribution to characteristic peaks. gel permeation chromatography. T. signal multiplicity phenomena in high resolution PMR.ouworld.101 Sessional: 30 Examinations: 70 Period / Week: 4 Duration of Exam: 3 hrs Nature of Exam: Theory
UNIT – I UV-Visible Spectroscopy: Basic principles. and supercritical fluid chromatography (SFC). metastable ions. Liquid chromatography: Comparison of GC and HPLC. ion exchange chromatography. Instrumentation. interaction of electromagnetic radiation with matter and its effects (electronic transitions).1. Ionization techniques.
5th ed. 25th Ed. 11. isotachphoresis. CBS Publishers & distributors. John Wiley & Sons. instrumentation.. Settle FA. 8.net
UNIT – V Electrophoresis: Principles. 2006. 5. Skoog. New Delhi. Narosa publishing house Pvt Ltd. Instrumental methods of chemical analysis. Singapore. instrumentation and applications of moving boundary electrophoresis.. Holler. 3rd ed. Dean JA. Radio immunoassay and ELISA: Principle. 1986. 6th ed. FJ. 2007.. Ewing. Part I & II. Instrumental methods of chemical analysis. JB.net
. Sharma BK... 2005. SDS gel electrophoresis and blotting techniques.www. GW. continuous electrophoresis (preparative) and capillary electrophoresis. 2004. 2004. Palgrave. New Delhi. I & II. Vol. 2005. 2. Ltd. Florida. 2008. Haryana.
www. Beckett. Stenlake. 4th ed. Practical pharmaceutical chemistry. California. Pavia DL. 9. Modem methods of pharmaceutical analysis. 2000. 2nd ed. 4th ed. 3rd ed. Schirmer... Principles of instrumental analysis. Crouch. Lampman GM. Baba Barkha Nath printers. CBS Publishers & Distributors. Merritt LL. DA. isoelectric focusing (IEF). William Kemp. RM. A Text book of pharmaceutical analysis. Vyvyan JA. 3. Goel Publishing house.. Kriz GS. Webstar.ouworld. CRC Press.. SR.. Instrumental methods of analysis. McGraw Hill Book Company. 7. 2nd ed. 7th ed. Spectrometric identification of organic compounds.
10. New York.. Organic spectroscopy.. Recommended books: 1. RE. Silverstein. zone electrophoresis (ZE). Brookescole publishers. Introduction to spectroscopy. 6. applications and limitations. New Delhi..ouworld. 2006. Meerut. Willard HH. FX. Jag Mohan. 4. Singapore. 1985. AH. Organic spectroscopy: Principles and Applications. 6th ed. New York. John Wiley & Sons (Asia) Pvt. Conners KA.
wall and floor treatment. Lieberman.net
. 4. Avis. Varghese Publ. 2. package printing for different dosage forms. fixtures and machineries. L. UNIT -3 Capsule Production: Production process. 2. DM. continuous and batch mixing. Lyophilization Technology: Principles.1. Parentral medications.E. 3. engineering and maintenance. freeze-drying equipments. fluidized bed coating. application techniques. Recommended books: 1. Disperse Systems Production: Production processes. particle coating. UNIT -5 Air Handling Systems: Study of AHUs. disperse equipments including fine solids dispersion.ouworld. Bombay.T. labeling. Pharmaceutical Dosage Forms. applications of mixers. Water Treatment Process: Techniques and maintenance – RO. equipments. utilities & utilities equipment location. speronizers and marumerisers. machinery. NY. Modern Pharmaceutics by Banker. Lachman. Pharmaceutical Dosage Forms. air filtration systems.ouworld. Problems encountered. Problems encountered. unit operation improvements. personnel flow. Vol 1.www. NY.
www. Coating Technology: Process. WFI. change rooms. humidity & temperature control. UNIT -4 Packaging Technology: Types of packaging materials. mills. dust collectors. The theory & Practice of Industrial Pharmacy. problems encountered. rota granulators. 3 by Lachman. Vol 72. granulation and pelletization equipments.net
INDUSTRIAL PHARMACY-I (PHARMACEUTICAL PRODUCTION TECHNOLOGY) M PCT. NY. 2 by K. improved capsule manufacturing and filling machines for hard and soft gelatin capsules. Layout and problems encountered. Marcel Dekker. Marcel Dekker. and other specialized granulation and drying equipments. ultra – filtration. Marcel Dekker. rapid mixing granulators. process.102 Period / Week: 4 Sessional: 30 Duration of Exam: 3 hrs Examinations: 70 Nature of Exam: Theory UNIT -1 Improved Tablet Production: Tablet production process. UNIT – 2 Parenteral Production: Area planning & environmental control. Vol 1.
by G. Marcel Dekker.net
5.P. Vol 86. NY. 7. Packaging Pharmaceutical and Health Care. Ray. Marcel Dekker. Lieberman. Pharmaceutical Production Facilities. 12.www. Ellis Horwoods. Marcel Dekker.
www. 11.Lockhard. 9. design and applications. UK. NY.C. Quality Control of Packaging Materials in Pharmaceutical Industy. . Pharmaceutical Project Management. Taylor and Francis.ouworld. Vol 96. 8.Kharburn. PR Watt. Product design and testing of polymeric materials by N.Kennedy. NY. Dispersed System Vol 1. 3 by Lachman. L. 6. 2. H.net
. NY. Chezerisionoff. Tablet Machine instrumentation in pharmaceuticals. Cole. T. 10. Marcel Dekker.ouworld. Freeze drying / Lyophilization of Pharmaceuticals & Biological Products.
solid dispersion. Martin's physical pharmacy and pharmaceutical sciences. Factors influencing dissolution and intrinsic dissolution studies.I. salt formation. New Delhi. methods of determination. 2006. 2. UNIT – II Formulation Additives: Study of different formulation additivies. levels of correlations. in-vitro dissolution testing models – sink and non-sink.. determination methods. drug excipient interactions. Schwartz JB. Noida.ouworld. Lieberman HA. solubility techniques to improve solubility and utilization of analytical methods – cosolvency. complexation. new developments in excipient science. dissolution testing for conventional and controlled release products.. mechanisms of dissolution. Dissolution test apparatus – designs. CBS Publishers & distributors. drug-excipient compatibility studies. Ltd.net
PHARMACEUTICAL PRODUCT DEVELOPMENT M PCT. UNIT – V Product Stability: Degradation kinetics. 3rd ed. structure modification. factors influencing their incorporation. Solid state stability and shelf life assignment. powder flow. Sinko PJ. in-vitro and in-vivo correlations. Recommended books: 1.
www. Mumbai 1991.www. crystal morphology and variations. phase-solubility analysis. experimental determination.net
. Biorelevent media.103 Sessional: 30 Examinations: 70 Period / Week: 4 Duration of Exam: 3 hrs Nature of Exam: Theory
UNIT – I Preformulation Studies: Molecular optimization of APIs (drug substances). accelerated stability studies. Design of experiments – factorial design for product and process development. I-III. 2nd ed. Varghese Publishers. interpretation of kinetic data (API & tablets). Publications Pvt. Kanig JL. Lieberman HA. 3. Pharmaceutical dosage forms: tablets Vol. role of formulation development and processing.. 2005. micellar solubilization and hydrotropy. mechanisms.T. Stability protocols. UNIT – IV Dissolution: Theories. factors influencing-media effects and pH effects. Data handling and correction factor. Lachman L. stability testing of drugs and pharmaceuticals. The theory and practice of industrial pharmacy.1.ouworld. reports and ICH guidelines. pH-solubility profile. 5th ed. UNIT – III Solubility: Importance. Lachman L. B.
Marcel Dekker Inc. 13. 15. 9. Vol-12. Stella VJ. Ellis Horwood Ltd. Marcel Dekker Inc. United States Pharmacopoeia. 1981. 8. Stability of drugs and dosage forms.
www. 2003.. Ltd. 2005. 10. 2008. Saurah printer pvt. Mazzo DJ. 7. Kramer J. Sethi PD. Rhodes CT. Part I & II. Dressman J.net
.. 5. Rhodes CT.www. Drug stability principles and practices. New Delhi.. Pharmaceutical dissolution testing. 3rd ed. New York. Beckett AH.ouworld. 2005. British Pharmacopoeia. Inc.. Indian Pharmacopoeia. Controller of Publication. Eastern Press Pvt. Yoshioka S. Banker GS. 2005. W. 2004. England. 1998. British Pharmacopoeia Commission Office. New Delhi. Ltd. New York. Conners KA. New Delhi. 2008.. Modern Pharmaceutics. 1999. CBS Publishers & distributors. Yalkowsky SH. Pharmaceutical preformulation: The physicochemical properties of drug substances. Practical pharmaceutical chemistry. 1996. A Text book of pharmaceutical analysi Wells JI.Stability testing of drug products. 4th ed. Stenlake JB. London. Techniques of solubilization of drugs.. Quantitative analysis of drugs in pharmaceutical formulations. 3rd ed. New Delhi. 14. 4th ed. 2006. New Delhi. USA. 12. Springer (India) Pvt. 16.. Bangalore... United States Pharmacopeial Convention.net
4. Carstensen JT.. Delhi. Ltd.. International stability testing. CBS Publishers & distributors. CBS publications. 6. 11.ouworld. Grimm .
statistical consideration . functions. personnel – desirable qualities of analyst. thickness. basic aspects of crystals. handling. sampling plans. tests for air flow pattern.1. friability. UNIT – 4 Good Laboratory Practices: Scope. content uniformity. lighting. receipt. equipments. Control charts – X charts.net
QUALITY ASSURANCE M PCT. particle size distribution. evaluation of test results. frequency distribution. differential thermal analysis (DTA). reference materials. Facilities. clarity. APIs.net
. reagents. electrical conductivity and content uniformity) and parenterals (pH. sample size. instrumentation and applications of thermogravimetric analysis (TGA).
www. cleaning and maintenance. viscosity. differential scanning calorimetry (DSC). UNIT . labeling & preservation. calibration & handling). miller indices.3 Thermal Methods of Analysis: Principles. suspensions and emulsions (appearance and feel. microbiological monitoring) buildings & facilities (design and construction features. air handling systems. quality assurance for raw materials. X-Ray Diffraction Methods: Origin of X-rays. UNIT – 5 Statistical Quality Control: Scope. retention samples. specification reportory. sanitation & maintenance) equipments (construction. Analysis of data. pressure & humidity control tests. testing facilities operation – systems and procedures in QC lab. organization.2 In-process quality control: Importance. hardness.104 Sessional: 30 Examinations: 70 Period / Week: 4 Duration of Exam: 3 hrs Nature of Exam: Theory
UNIT – 1 Quality Assurance Systems: Basic concept of quality control & quality assurance. packing materials & finished products (specifications.probability. and thermo mechanical analysis (TMA). inspection. volume check.www. production (change control. integrity of seals and particulate matter). volume check. temperature. rotating crystal technique. UNIT . responsibilities of key personnel in the QC lab.ouworld. sources of variation. sampling and certificate of analysis). X-ray crystallography. single crystal diffraction. IPQC tests for tablets (weight variation.ouworld. Sampling procedures. construction materials. structural elucidation and applications. R charts. Safety guidelines in QC lab. test methods. disintegration tests and content uniformity). aseptic process control. analytical worksheet. Test and control articles – incoming samples. Validation of analysis methods. testing. Problems encountered and trouble shooting. powder diffraction. sampling – importance. applications.T.
BP. NY. 5. Latest edition of IP.B. Bolton.Sethi. Petric. Marcel Dekker. UK. Vandana Publ. Vol 78. SH Wllig. New Delhi. Statistical design and analysis in pharmaceutical sciences. D. S. Blackwell Sc. Marcel Dekker. Marcel Dekker.D. 9. New Delhi. Marcel Dekker. 6. Medical Statistics at a Glance. NY.ouworld.net
Recommended books: 1. P. 4. Sethi.www. Vol 80. Good Manufacturing Practices for Pharmaceuticals. NY. Pharmaceutical statistics.ouworld. Vol 69.net
. S. Vandana Publ.D. USP. Quality assurance of Drugs in Pharmaceuticals.A. 7. P. 2. Good Laboratory Practice Regulations. 8. NY. Statistical Methodology in Pharmaceutical Science. Marcel Dekker. NY.Weinberg. Berry. A. How to Practice GLP.
(2 experiments) . Any other relevant experiments based on theory. Interpretation of drugs by IR spectra. Experiments based on the application of derivative spectroscopy. Workshop of spectroscopy: (UV. UV/Visible spectrum scanning of a few organic compounds for UV. 9. Effect of solvents and pH on UV spectrum of drugs (2 experiments). 7. 5.ouworld. 2. IR. P. MASS) structural elucidation of at least 5 compounds (4 experiments). (2 experiments). Separation of protein drug substances by electrophoresis.1. NMR. (2 experiments).net
PHARMACEUTICAL ANALYTICAL TECHNIQUES (PRACTICAL) M PCT. 4.
www. 6. 8.net
. 3. Experiments based on HPLC (Isocratic and Gradient elution) techniques.105 Sessional: 30 Examination: 70 Period / Week: 6 Duration of Exam: 6hrs Nature of Exam: Practical
List of Experiments 1.absorption and correlations of structures (5 compounds) and isosbestic point in case of mixtures.ouworld.www. Estimation of multicomponent formulation by UVSpectrophotometer in
Dissolution of drugs in different pH media for comparison of performance with innovator.net
. (2 experiments). Stability studies of drugs in dosage forms at 25 oC.
www. P. 4. Dissolution methods of transdermal drug delivery systems.106 Sessional: 30 Examination: 70 Period/week: 6 Duration of Exam: 6 hrs Nature of Exam: Practical
1. Test for degradation of compounds using TLC for any two drugs. Effect of pH on the solubility of drugs.(2 experiments).www. Effect of solid dispersion and hydrotropy on the dissolution.1. Product development and protocol preparation using preformulation data for tablets and capsules. Compatibility evaluation of drugs and excipients.net
PHARMACEUTICAL PRODUCT DEVELOPMENT (PRACTICAL) M PCT. Effect of hydrogen peroxide. Dissolution studies of drug in three different biorelevant dissolution media (2 experiments).ouworld. Effect of surfactants on the solubility of drugs. hydrochloric acid and sodium hydroxide solutions on the stability of drugs in solution at elevated temperatures and room temperature. 9. 2. 12.
5. Stability testing of solution and solid dosage forms for photo degradation. 60% RH and 40 oC. 10. 11.ouworld. 3. 75% RH. 7. 8. 6.
.P.Environment scanning – Information.Types of enterprise – Merits and Demerits .Profitability and control measures.107 Periods/week :2 Nature of Exam: Tutorials Grade : A/B/C/D.Concept need and process in entrepreneurship development. sources. enterprise feasibility study. Reference 1.net
ENTREPRENEURSHIP MANAGEMENT Subject Code : M PCT . demands and challenges .T 1.Feedback.Role of enterprise in national and global economy . monitoring and evaluation. . assertiveness.requirements and understanding the process of entrepreneurship development.finance. technology. market assessment. resource mobilisation and implementation.Entrepreneurial motivation – dynamics of motivation.Need for diversification . interpersonal skills. self awareness. Examination : -Exam Duration: --
Course Objectives: • To provide conceptual inputs regarding entrepreneurship management.Project work – Feasibility report.
www.Entrepreneurial competency – Concepts. SWOT Analysis.Concept and dynamics . raw material. UNIT – III: LAUNCHING AND ORGANISING AN ENTERPRISE .M. .Performance appraisal and assessment .Costing and marketing management and quality control.ouworld. problems. .www. co-ordination and feasibility study UNIT – V: PREPARING PROJECT PROPOSAL TO START ON NEW ENTERPRISE . NIESBUD. • To develop management skills for entrepreneurship management.Institutional support in enterprise development and management UNIT – II: THE ENTREPRENEUR . vision strategies . Joint venture. achievement. UNIT – IV: GROWTH STRATEGIES AND NETWORKING .Government policies and schemes for enterprise development . creativity.Future Growth – Techniques of expansion and diversification.Enterprise selection. • To orient and impart knowledge towards identifying and implementing entrepreneurship opportunities.ouworld.net
. Akhauri. .Resource mobilisation . site and manpower.Methods. • To sensitise and motivate the students towards entrepreneurship management. UNIT – I: CONCEPTUAL FRAME WORK . Planning.(1990): Entrepreneurship for Women in India. . . factors affecting entrepreneur'’ role. New Delhi. schemes of assistance. M.Developing Entrepreneurial competencies .
Health & Co.net
2.G.C. 4. C.(1996) The Women Entrepreneurs. etal (1982): Practice of Entrepreneurship. Hisrich.D & Brush. Developing and Managing a New Enterprise.C.
www.www. USA. R. V. Richard D. R. G. D. and Peters.net
. Inwin.(1987): Women Entrepreneurship – Developing New Entrepreneurs. (1995): Entrepreneurship – Starting. Meredith..G. Toranto. Ahmedabad EDII.ouworld.. 5. INC. 3. M. Hisrich. Geneva.D.P. Patel. ILO.ouworld.
Vol 100. SN Katju. international & regional agreements. ammonizing formulation development for global filings. patent processing & application. Fda. Recommended books: 1. salient features. structure. Original laws published by Govt. UNIT – 4 Related Quality Systems: Introduction to ISO series. fundamental principles.
UNIT – 5 Documentation: Types related to pharmaceutical industry.net
IPR & REGULATORY AFFAIRS M PCT.A. Marcel Dekker. protocols. scope. functions.
www. law publ. impact on developing countries. Good Manufacturing Practices for Pharmaceuticals. hc-sc. Das and Gokul Das. NY. Law and Drugs. membership & withdrawal. NDA. UNIT – 2 GATT and WTO: GATT – Historical perspective. scope. CTD.ouworld.gc.Willig. 2. Protection of Industrial Property Rights. P.com. status. ich. Hussain.org.H. UNIT – 3 Regulatory Affairs: Indian context – Requirements and guidelines of GMP. sources of patent information. objectives. Patents. understanding of Drugs and Cosmetic Act 1940 and Rules 1945. S.int. dispute settlement. 4. NY. Marcel Dekker. Laws of drugs in India. New Drug Approval Process. patentlawlinks. Vol 78.1. of India. 7. R.net
.ouworld. WTO – objectives. trade related aspects (TRIPS). copyrights. Guarino. 5.201 Sessional: 30 Examinations: 70 Period / Week: 4 Duration of Exam: 3 hrs Nature of Exam: Theory
UNIT – 1 Patents and Intellectual Property Rights (IPR): Definition. WHO and ICH. India – tasks & challenges.T.
Objectives and guidelines of
USFDA. wipo. U and Y.ca. trademarks.org. impact on globalization. 6. 3.org. dealing with post-approval changes – SUPAC. objectives. ANDA. cder. handling and maintenance including electronic documentation.www. with reference to Schedule M.
PQ for equipments – autoclave. IQ. cleaning validation and vender qualification. raw materials. industrial effluent testing & treatment. compression. UNIT . 3. liquid orals. Monitoring & prevention systems. capsules. cone blender. for tablets. parentrals and semisolid preparations.net
.3 Equipment Qualification: Importance. in-process and finished product specifications. PR Watt. Taylor and Francis.T. stability. drying. parentrals. Nash. equipments. Recommended books: 1.2 Validation: General concepts. facility. Marcel Dekker. JR Berry.A.
www. capsules. problems encountered during transfer of technology. OQ. membrane filter. NY. procedures & protocols. sterilization. NY. semisolids. liquid orals. Vol 57.1. John Wiloy. liquid filling and sealing machine. FBD. Bombay. physical layout. Pharmaceutical Production facilities. chemical and pharmaceutical.www. process scale up for tablets. Pharmaceutical process validation. Marcel Dekker. liquid filling and sealing. The theory & Practice of Industrial Pharmacy. 5. validation of mixing. DHS.5 Industrial safety: Hazards – fire. electrical. mechanical.Kennedy. by GC Cole. tablet coating. tablet compression machine. Technology transfer from R & D to pilot plant to plant scale. H. Control of environmental pollution. granulation. L.202 Sessional: 30 Examinations: 70 Period / Week: 4 Duration of Exam: 3 hrs Nature of Exam: Theory
UNIT – 1 Pilot plant design: Basic requirements for design. Tablet machine instruments in pharmaceuticals. Scale up: Importance. 4. Pharmaceutical project management. 2.4 Process validation: importance. UNIT .ouworld. input. environmental control. types.ouworld.net
INDUSTRIAL PHARMACY – II (SCALE UP AND VALIDATION) M PCT. equipment selection. Vol 86. NDDS products – stress on formula. water process systems. product uniformity. design and applications. VMF. rapid mixer granulator. UNIT .Lieberman. Varghese Publ. Analytical method validation. documentation.Lachman. UNIT . T.
7.Vallabh Prakashan. Vol 1. 2. CVS.ouworld. Dispersed system Vol 1. Vol 1. Marcel Dekker. NY. 3 by Lachman. 8.net
. Tablets. NY. Pharmaceutical dosage forms.
www. Avis. 2. Pharmaceutical production and Management.2007.E. Lieberman.www. 2 by K. Marcel Dekker. Marcel Dekker. 3 by Lachman. Subrahmanyam. 9. NY. Lieberman. Pharmaceutical dosage forms.ouworld. Parentral medications.
IV infusion & extra vascular. Clearance: Concept. factors affecting biotrasformation. UNIT -3 Pharmacokinetcs: Parameters & determination. UNIT -2 Drug Absorption: General consideration. design of dosage forms and novel drug delivery systems.203 Sessional: 30 Examinations: 70 Period / Week: 4 Duration of Exam: 3 hrs Nature of Exam: Theory
UNIT -1 Bioavailability and Bioquiovalence: Objectives. individualization of therapy. & reciprocal). Application of pharmacokinetics in new drug development. determination of rate constants & different plots (direct. mechanism.net
BIOPHARMACEUTICS AND PHARMACOKINETICS M PCT. official bioequivalence protocols & therapeutic equivalence. measurements of bioavailability.T. absorption / drug transport mechanisms. and in-vivo methods. determination.net
. non-renal clearance. different volume of distribution.ouworld. Integration of kinetics.www. multi compartment in IV bolus. Non-linear kinetics: Cause of non-linearity. kinetics. in-situ.ouworld. estimation of various parameters. bioavailability of drugs that follow non-linear kinetics. role factors affecting absorption. % drug metabolized. absorption of drug non-peroral routes. therapeutic drug monitoring. determination.
www. Drug Distribution: Factors affecting. drug & metabolites levels in blood. UNIT – 5 Pharmacokinetics of Multiple Dosing: Various terminology. urine and other biological fluids.4 Drug Disposition and Excretion: Biotransformation. methods of determining absorption-in-vitro. Phase I & Phase-II reactions. protein & tissue binding. renal. enhancing bioavailability. adjustment of dosage in renal & hepatic impairment.1. pharmacokinetic models – one compartment. Chronopharmacokinetics & pharmacokinetics of elderly and infants. concepts of equivalents. UNIT . Scatchard. bioavailability & variations.
Theory & Practice of Industrial Pharmacy.www.ouworld.S.net
. L. Varghese Publ. Philadelphia. Remingtons Pharmaceutical Sciences. Prentice Hall.
www. Clinical Pharmacokinetics.ouworld. Vallabh Prakashan. 4. Swarbrick. Biopharmaceutics & Clinical Pharmacokinetics. 2009. Current concepts in Pharmaceutical Sciences. Lea and Febriger.Lachman. Textbook of Biopharmaceutics and Pharmacokinetics. 8. Vallabh. C. DM Brahmankar. Delhi. Bombay. Delhi. 5. London. Mile Gibaldi. Lea and Febriger. 2. Niazi. 3. 7. Philadelphia. Philadelphia. Lea and Febriger. Biopharmaceutics and Clinical Pharmacokinetics.Subrahmanyam.V. Biopharmaceutics and Clinical Pharmacokinetics. Mack & Co. 6.net
Recommended books: 1. Rowland and Tozer.
2. NY. pharmacokinetic design for DDS – intermittent.1. Nasal System Drug Delivery. Marcel Dekker. Novel Drug Delivery System. formulation & evaluation including iontophoresis and other latest developments in skin delivery systems.www. 4. Su. Y. concept. E. causes of protein destabilization.S.ouworld. liquid sustained release systems. Vol 39. activation modulated & feedback regulated DDS. micro-emulsions. Marcel Dekker.
1. design. formulation. Advances in Drug Delivery: Pulsatile. resealed erythorocytes. delivery techniques. magnetic microspheres. pharmacosomes. formulation & evaluation.ouworld. niosomes. NY. Biotechnology in Drug Delivery Systems: Brief review of major areas-recombinant DNA technology. Marcel Dekker. K. liposomes. effect of system parameters in controlled drug delivery. Mathiowitz. Robinson.E. 3.204 Sessional: 30 Examinations: 70 Period / Week: 4 Duration of Exam: 3 hrs Nature of Exam: Theory
UNIT – 1 Concept & Models for NDDS: Classification of rate controlled drug delivery systems (DDS). biodegradable & natural polymers. Specialized pharmaceutical emulsions – multiple emulsions.5 Protein / Peptide Drug Delivery Systems: Concepts. stability testing. Bioadhesive DDS. polymerization techniques. Carriers for Drug Delivery: Polymers / co-polymers-introduction. Vol 29. Controlled Drug Delivery Systems. Vol 31.W. microspheres. computation of desired release rate and dose for controlled release DDS.T. UNIT -3 Transdermal Drug Delivery Systems: Theory. Chein. NY. Mucoadhesive DDS (buccal. zero order & first order release. characterization.net
ADVANCES IN DRUG DELIVERY SYSTEMS
M PCT. methods in drug targeting – nanoparticles. colon specific. UNIT . design. Vol 98. NY. Marcel Dekker. gene therapy. NY. rate programmed release. 5. Transdermal Controlled Systemic Medications. pulmonary). Vol 50. biological process and events involved in drug targeting. classification. Marcel Dekker.
www. nasal. stability and destabilization.net
. UNIT -2 Study of Various DDS: Concepts. monoclonal antibodies. design. application in CDDS / NDDS. YW Chein. formulation & evaluation of controlled release oral DDS. UNIT – 4 Targeted Drug Delivery Systems: Importance.
10. M. 7.www.ouworld. Pharmaceutical Biotechnology. John Wiley. Marcel Dekker.net
6. Vyas. NY. E.H. Vandamme.J. Tarcha.net
www. CRC Press. P Tyle Marcel Dekker. Delhi. Marcel Dekker. Rubinstein. Protein Formulation & Delivery. NY. McNally. P. Polymers for Controlled Drug Delivery. CBS. NY. Drug Delivery Devices. Vol 32.J.ouworld. 8. E. Biotechnology of Industrial Antibiotics. Vol 99. 11. NY. Drug Targeting.
7. 6. Preparation and evaluation of different polymeric membranes.net
ADVANCES IN DRUG DELIVERY SYSTEMS
M PCT.1. Formulation and evaluation of transdermal films. 5.
.ouworld. 2.205 Sessional: 30 Examinations: 70 Period / Week: 6 Duration of Exam: 6 hrs Nature of Exam: Practicals
1. 3. Study of in-vitro dissolution of various SR products in market.ouworld. 4.P. Formulation and evaluation of mucoadhesive system.www. Formulation and evaluation of sustained release oral matrix tablet. Formulation and evaluation of sustained release oral reservoir system. Formulation and evaluation of microspheres / microcapsules.
Estimation of pharmacokinetic parameters for the given urinary excretion data. 4.206 Sessional: 30 Examinations: 70 Period / Week: 6 Duration of Exam: 6 hrs Nature of Exam: Practicals
1.www.ouworld.ouworld. 3. 6.P. 2. Estimation of creatinine clearance. Effect of pH / particle size on dissolution studies.
www. 7. Comparative dissolution studies on different dosage forms for drugs.net
BIOPHARMACEUTICS AND PHARMACOKINETICS
M PCT. Estimation of pharmacokinetic parameters for the given oral absorption data. Estimation of pharmacokinetic parameters in urine / serum samples. Plasma protein binding studies on different drugs.1. 5.
sources. T 1. Content. . Spanner Head. Results and Discussion Ask questions related to: content.
www.Different forms of scientific and technical writing. Use outline as a starting device. classifying information under fact/opinion.net
SCIENTIFIC AND TECHNICAL WRITING
Subject Code : M PCT.IV: PARTS OF DISSERTATION/RESEARCH REPORT/ARTICLE Introduction. Monographs.net
. summarizing a text and presenting sequence of topics in different forms. sentence outlines and combination of topic and sentence outlines UNIT – III: DRAFTING TITLES.Formatting Tables: Title. Clarity and Grammar Brevity and Precision in writing . conceptual outline. Examination : -Exam Duration: --
Course Objectives: To be able to appreciate and understand importance of writing scientifically. SUB TITLES. TABLES. clarify.Appendices: use and guidelines The Writing process: Getting started.www. validity internal consistency and objectivity during writing each of the above parts. UNIT – I: COLLECTION AND EVALUATION OF INFORMATION Identification. Dissertations.Articles in journals. How to formulate outlines: The reasons for preparing outlines • as a guide for plan of writing • as skeleton for the manuscript Kinds of outline: topic outlines. Body stab. Research notes and reports.Tables as systematic means of presenting data in rows and columns and lucid way of indicating relationships and results. tabulating information. Review articles. searching information. Box Head . Review of Literature. Drafting. Reflecting and Re-reading Checking: Organization.Drafting and Re-drafting based on critical evaluation UNIT . . • To Develop competence in writing and abstracting skills. UNIT – II: WRITING AS A MEANS OF COMMUNICATION .ouworld. Stab Column. Headings. Methodology.ouworld. ILLUSTRATIONS . Bibliographies. • To write either a draft research proposal or a chapter of dissertation.207 Periods/week :2 Nature of Exam : Tutorials
Grade: A/B/C/D. continuity. Column Head.
California: Sage. (1990): Integrating Research: A Guide for Literature Reviews (2nd Edition).www.Available infra-structure and recourses .Presenting pilot study/data . H.M.net
.Clear organization .net
UNIT – V: WRITING FOR GRANTS . Cooper.Clarity.Executive summary References 1. Washington: APA. F.(Ed. Dunn. . APA (1984): Publication Manual of Americal Psychological Association (3rd Edition). 2.
www.ouworld.Outcome of study and its implications .V & Others.Research proposal of method . 3.Rationale and importance of the question being address .Emperial and theoretical conceptualization .Clearly state the question to be addressed . NY:Sage.ouworld.) (1984): Disserninating Research: Changing Practice.Budgeting . specificity of method.