Master of Pharmacy (Pharmaceutics)

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Study & Evaluation Scheme of Master of Pharmacy (Pharmaceutics) [Applicable w.e.f. Academic Session 2011-12 till revised] TEERTHANKER MAHAVEER UNIVERSITY N.

1 Study & Evaluation Scheme of Master of Pharmacy (Pharmaceutics) [Applicable w.e.f. Academic Session till revised] TEERTHANKER MAHAVEER UNIVERSITY N.H.-24, Delhi Road, Moradabad, Uttar Pradesh Website: ( ) Page 1 of 16

2 TEERTHANKER MAHAVEER UNIVERSITY (Established under Govt. of U. P. Act No. 30, 2008) Delhi Road, Bagarpur, Moradabad (U.P) Study & Evaluation Scheme of MASTER OF PHARMACY SUMMARY Programme : M. Pharm. (Pharmaceutics) Duration : Two years full time Medium : English Minimum Required Attendance : 75 % Credit Maximum Credits Minimum credits required for degree : 95 : 90 Assessment Internal External Total : Internal Evaluation (Theory Papers) : Clas s Test I Clas s Test II Clas s Test III Continuou s Evaluatio n Semin ar Total Theory Practical Duration of Examination : External Internal External Internal 3 hrs. 1.5 hrs. 4 hrs. 4 hrs. To qualify the course a student is required to secure a minimum of 40% marks in aggregate in the end semester examination and teachers continuous evaluation (i.e. both internal and external). A candidate who secures less than 40% of marks in a course shall be deemed to have failed in that course. The student should have overall 50% marks in a semester to clear the semester. In case a student has more than 40% in each course but less than 50% overall in a semester he/she shall re-appear in one or two course(s) to improve the percentage. There will be three Class Tests in a semester and an average of the marks obtained in best two tests will be computed (cumulatively) for the final result. The class tests would comprise of five questions. Student shall have to answer three questions out of which one question will be compulsory. Each question would be of five marks. Question Paper Structure: 1. The question paper shall consist of eight questions. Out of which first question shall be of short answer type (not exceeding 50 words) and will be compulsory. Question No. 1 shall contain 8 parts representing all units of the syllabus and students shall have to answer any five (weightage 4 marks each). 2. Out of the remaining seven questions, a student shall be required to attempt any five questions. There will be minimum one and maximum two questions from each unit of the syllabus. The weightage of Question No. 2 to 8 shall be 10 marks each. ( ) Page 2 of 16

3 Study & Evaluation Scheme Programme: M. Pharm. Semester I Course Subject Periods Evaluation Scheme S.N. Code L T P C Internal External Total 1 MPA101 Modern Analytical Techniques MPU101 Pharmaceutical Biostatics and Computer Application 3 MPU102 Product Development MPA151 Modern Analytical Techniques (MAT) Lab 5 MPU152 Product Development Lab Total Semester II Course Subject Periods Credits Evaluation Scheme S.N. Code L T P Internal External Total 1 MPU201 Pharmaceutical Production Management 2 MPU202 Recent Advances in Drug Delivery System 3 MPU203 Bio-pharmaceutics & Pharmacokinetics 4 MPU251 Research Project Synopsis MPU252 Recent Advances in Drug Delivery System Lab 6 MPU253 Bio-pharmaceutics & Pharmacokinetics Lab Total Semester III Course Subject Periods Credits Evaluation Scheme S.N. Code L T P Internal External Total 1 MPU351 Research Project Phase -I Total Semester IV Course Subject Periods Credits Evaluation Scheme S.N. Code L T P Internal External Total 1 MPU451 Research Project Phase -II (Thesis compilation and Viva-Voce) Total Research Project shall be carried out in different stages. It will commence with submission and approval of synopsis in second semester. The experimental work shall be carried out in two phases i.e. in III & IV semesters. Note: L Lecture T- Tutorial P- Practical C- Credits 1L = 1Hr 1T= 1 Hr 1P=1 Hr 1C =1Hr of Theory paper = 2Hrs of Practical ( ) Page 3 of 16

4 M. Pharm. Semester I MODERN ANALYTICAL TECHNIQUE Course Code: MPA101 L-4, T-2, P-0, C-5 Objective: The basic objective of this course is to get familiar with Principle, theory & instrumentation of sophisticated pharmaceutical analysis instruments and the interpretation of their spectra. Unit - 1 Principle, theory & instrumentation of UV-Visible spectroscopy, it s utility in structural qualitative and quantitative analysis of drug molecules, Woodward Fischer rules and use of Shiff s reagents for elucidation of structure. Unit 2 Infrared spectroscopy, I.R radiation and its interaction with organic molecules, vibrational mode of bonds, instrumentation and application, effect of hydrogen bonding and conjugation on absorption bands, interpretation of IR Spectra, FTIR and ATR. Unit 3 Nuclear magnetic resonance spectroscopy: chemical shift concept, isotopic nuclei, reference standards and solvents. 1 H NMR spectra, coupling constants, interpretation of spectra, decouplingdouble resonance and shift reagent methods. Principles of FT-NMR with reference to 13 C NMR, free induction decay. Spin-spin and spin-lattice relaxation phenomenon. Nuclear overhauser enhanced 13 C NMR spectra, their interpretation and application. Unit 4 Mass spectrometry: Basic principles and brief outline of instrumentation. Ion formation, molecular ion, metastable ion, fragmentation process in relation to molecular structure and functional groups. Relative abundance of isotopes, chemical ionization, GC-MS and LC/MS. Interpretation of spectra of simple molecules. Unit 5 Chromatographic techniques: Principles of separation and application of Column, Paper, Thin layer and Gas chromatography, HPLC, HPTLC, Electrophoresis. Instrumentation of HPLC, Reverse phase columns. Pharmaceutical evaluation of drug in biological fluids- bioassays. Radioimmunoassay. Recommended Books 1. Willard, H.H., Merrit, L.L., Dean, J.A., Settle, P.A., Instrumental Methods of Analysis, Van Nostrand. 2. Skoog, D.A., Heller, F.J., Nieman, T.A., Principles of Instrumental Analysis, WB Saunders. 3. Haswell, S.J., ed. Atomic Absorption Spectroscopy, Elsevier. 4. Ardrey, R.E., Pharmaceutical Mass Spectra, Pharmaceutical Press, London. 5. Sethi, P.D., Quantitative Analysis of Pharmaceutical Formulations, CBS Publishers, New Delhi. 6. Kalsi, P.S., Spectroscopy of Organic Compounds, New Age Publishers, New Delhi. 7. Gross J.H., Mass Spectrometry, Springer Berlin, Heidelberg. 8. Haffmann D. H., Advances in Chromatography, Marcel Dekker. 9. Robert D. Braun, Introduction to Instrumental Analysis, McGraw-Hill. 10. Wilfried, M.A. Niessen- Liquid Chromatography-Mass Spectrometry, Marcel Dekker. *Latest editions of all the suggested books are recommended. ( ) Page 4 of 16

5 Semester I PHARMACEUTICAL BIOSTATICS AND COMPUTER APPLICATIONS Course Code: MPU101 L-4, T-2, P-0, C-5 Objective: The basic objective of this course is to get familiar with pharmaceutical biostatics and computer applications. Unit - 1 Methods of collection of data, classifications and graphical representation of data. Binomial and normal probability distribution. Polygon, histogram, measure of central tendency. Significance of statistical methods, probability, degree of freedom, measures of variation - Standard deviation, Standard error. Unit - 2 Sampling, sample size and power. Statistical inference and hypothesis. Tests for statistical significance: student t-test, Chi-square test, confidence level, Null hypothesis. Unit - 3 Linear regression and correlation. Analysis of Variance (one way and two way). Factorial designs (including fraction factorial design). Theory of probability, Permutation and Combination, Ratios, Percentage and Proportion. Two way ANOVA and Multiple comparison procedures. Unit - 4 Non-parametric tests, Experimental design in clinical trials, Statistical quality control, Validation, Optimization techniques and Screening design. Correlation and regression, least square method, significance of coefficient of correlation, nonlinear regression. Unit - 5 Bioassays-calculations of doses response relationships, LD 50, ED 50. Applications of software for statistical calculation viz. SPSS, foxtron. Recommended Books 1. Bolton, Pharmaceuticals Statistics- Practical & Clinical Applications, Marcel & Dekker, New York. 2. Fisher, R.A., Statistical Methods for Research Works, Oliver & Boyd, Edinburgh. 3. Chow, Statistical Design and Analysis of Stability Studies, Marcel Dekker, New York. 4. Buncher, Statistics in the Pharmaceutical Industry, Marcel Dekker, New York. 5. Finney, D.J., Statistical Methods in Biological Assays, Hafner, New York. 6. Montgomery, D.C., Introduction to Statistical Quality Control, Willy. 7. Lipschutz, Introduction to Probability and Statistics, McGraw-Hill. 8. Li wan Po, Statistics for Pharmacist, Wiley-Blackwell. * Latest editions of all the suggested books are recommended. ( ) Page 5 of 16

6 Semester I PRODUCT DEVELOPMENT Course Code: MPU102 L-4, T-2, P-0, C-5 Objective: The basic objective of this course is to get familiar with product development. Unit-1 PREFORMULATION STUDIES Timings and goals of Preformulation. pre-formulation methodology, solid stat properties, partition coefficient, solubility, dissolution, crystal from the stability, compatibility tests, dissolution of drug substances and dosage forms, Pediatric & geriatric aspects of formulation. Unit -2 PHARMACEUTICAL PROCESS VALIDATION Regulatory basis, validation of sterile products, solid dosage forms, process. Drug additive interaction. Unit-3 STABILITY Theoretical considerations, Degradative pathways, Stability indicating assays, Influence of packaging components on dosage form stability, Stabilization of Pharmaceutical formulations (solid, liquid and semi solid formulations). Unit-4 Evaluation of Pharmaceutical formulations in vitro and in vivo studies and their correlation. Levels and types of IV-IVC. Unit -5 POLYMERS Types, Pharmaceutical Application, Molecular Weight Determination, Conformation of dissolved linear macromolecules, Polymer solutions, Polymer in solid state, Fabrication. PACKAGING DEVELOPMENT- Packaging materials, Types, Labeling, Preformulation screening of packaging components. Recommended Books 1. Bannker G.S., & Rhodes C.T., Modern Pharmaceutics, Marcel Dekker, New York. 2. Liberman H.A. et al, Pharmaceutical Dosage Forms-Tablets, Marcel Dekker, New York. 3. Lachman L, Lieberman H.A. & Kanig J.L. The Theory & Practice of Industrial Pharmacy. Varghese Publishing Home. 4. Aulton M.E., Pharmaceutics-The Science of Dosage form Design, Churchill Livingstone. 5. Liberman H.A. et al, Pharmaceutical Dosage Forms-Parenterals, Marcel Dekker, New York. 6. Carstensen J.T., Drug Stability-Principles & Practice, Marcel Dekker, New York. 7. Malmsten M., Surfactants and Polymers in Drug Delivery, Marcel Dekker, New York. 8. Ansel H.A. - Pharmaceutical Dosage Forms, Lippincott Williams & Wilkins. 9. Sarfaraz K. Niazi, Handbook of Preformulations: Chemical, Biological and Botanical Drugs, CRC Press. *Latest editions of all the suggested books are recommended ( ) Page 6 of 16

7 Semester I MODERN ANALYTICAL TECHNIQUE (MAT) LAB Course Code: MPA151 L-0, T-0, P-8, C-4 Objective: The basic objective of this course is to get familiar with different analytical instruments. Based on the Course Code: MPA101 ( ) Page 7 of 16

8 Semester I PRODUCT DEVELOPMENT LAB Course Code: MPU152 L-0, T-0, P-8, C-4 Objective: The basic objective of this course is to get familiar with product development practicals. Based on Course Code MPU103 ( ) Page 8 of 16

9 Semester II PHARMACEUTICAL PRODUCTION MANAGEMENT Course Code: MPU201 L-4, T-2, P-0, C-5 Objective: The basic objective of this course is to get familiar with pharmaceutical production management. Unit-1 Status of Pharmaceutical industry with special reference to post GATT scenario. Project planning and implementation. Transfer of Technology. Unit-2 Master formula generation and SOP. Pilot plant scale up techniques. Unit-3 Factory layout, Material Management: Unit-4 Process optimization and automation in pharmaceutical manufacturing. Unit-5 Inventory control. Different Systems of inventory control. Import and Export regulations laws and methods to obtain I & E licenses, I and E regulations USA, EU and Japanese perspectives. Recommended Books 1. Banker G.S., & Rhodes C.T., Modern Pharmaceutics, Marcel Dekker, New York. 2. Remington, The Science & Practice of Pharmacy, Lippincott. William & Wilkins. 3. Lachman L, Lieberman H.A. & Kanig J.L., The Theory & Practice of Industrial Pharmacy, Varghese Publishing Home. 4. Aulton M.E., Pharmaceutics The Science of Dosage form Design, Churcill Livingstone. 5. Levin M.A., Pharmaceutical Process Scale up, Marcel Dekker, New York. 6. Dutta A.K., Material Management, Prentice Hall India. 7. Chary S.N., Production and Operative Management, Tata-Mcgraw Hill, India. 8. Kennedy T., Pharmaceutical Project Management, Marcel Dekker, New York. * Latest editions of all the suggested books are recommended ( ) Page 9 of 16

10 Semester II RECENT ADVANCES IN DRUG DELIVERY SYSTEM Course Code: MPU202 L-4, T-2, P-0, C-5 Objective: The basic objective of this course is to get familiar with novel techniques and advances in drug delivery system. Unit-1 Formulation considerations with special emphasis on release patterns. Sustained and Controlled release- oral, dental, nasal, ocular & parenteral systems. Unit-2 Fast Release- Introduction, formulation & evaluation. Unit-3 Transdermal Drugs Delivery System- Factors influencing transdermal delivery, formulation & evaluation including Iontophoresis and Ionophoresis. Unit-4 Target Oriented Drug Delivery Systems- prodrugs, Liposome, Niosome, nanoparticles Microspheres and microparticles. Lipoproteins Activated Carbons, Cellular Carriers, Antibodies, DNA, And Low Molecular Weight Proteins. Hormones, Dextran & Polysaccharides, Synthetic Polymers, Nanoparticles, Microparticles fabrication techniques (Latest Advances). Unit-5 Nutraceuticals- introduction & scope. Recommended Books 1. Chien Y.W., Novel Drug Delivery Systems-Fundamentals, Developmental Concepts. Biomedical Assessment, Marcel Dekker, New York. 2. Chien Y.W., ed., Transdermal Controlled Systemic Medications, Marcel Dekker, New York. 3. Schreyer, H., Drug Targeting Technology Physical, Chemical & Biological Methods, Marcel Dekker, New York. 4. Banker G.S. & Rhodes C.T., Modern Pharmaceutics, Marcel Dekker, New York. 5. Gennaro A.R., Remington, The Science & Practice of Pharmacy, Lippincott. Williams & Wilkins. 6. Lachman L., Lieberman B.A & Kanig I.L., The Theory & Practice of Industrial Pharmacy, Varghese Publishing Home. 7. Aulton M.E., Pharmaceutics-The Science of Dosage form Design, Churchill Livingstone. 8. Potts R.O. & Guy R.H., Mechanism of Trans dermal Drug Delivery, Marcel Dekker, New York. * Latest editions of all the suggested books are recommended. ( ) Page 10 of 16

11 Semester II BIO-PHARMACEUTICS & PHARMACOKINETICS Course Code: MPU203 L- 4, T-2, P-0, C-5 Objective: The basic objective of this course is to get familiar with bio-pharmaceutics & pharmacokinetics. Unit-1 Drug Absorption Distribution & Disposition. Unit-2 Pharmacokinetics. Open one compartment, two compartment & three compartment models & their limitations. Non-compartmental pharmacokinetics. Graphical methods of calculating pharmacokinetic parameters. Unit-3 Factors influencing bio-availability, evaluation of bioavailability, bio-equivalence with reference to BCS. Unit-4 Dosage Regimens, Repetitive dosing and dose adjustments in renal and hepatic failure, individualization of dosage regimen. Unit-5 Pharmacokinetic applications in Clinical practice. Principles of clinical trial. Recommended Books 1. Notari, R.E., Biopharmaceutics and Pharmacokinetics An introduction, Marcel Dekker Inc. N.Y. 2. Rowland M., and Tozer T.N., Clinical Pharmacokinetics, Lea and Febriger, N.Y. 3. Wagner J.G., Fundamentals of Clinical Pharmacokinetics, Drugs Intelligence Publishers, Hamilton. 4. Wagner J.G., Pharmacokinetics for the Pharmaceutical Scientist, Technomic Publishing A.G. Basel, Switzerland. ( ) Page 11 of 16

12 Semester II RESEARCH PROJECT SYNOPSIS Course Code: MPU251 L-0, T-2, P-0, C-1 Objective: The basic objective of this course is to get familiar with the method, instrumentation and the technology of the topic that is selected for the dissertation. Guidelines: 1. The course will comprise of preparation of synopsis for the proposed research work to be done during third and fourth semester courses. 2. The allotted supervisor will provide guidelines and determine the topic of the research work based on thorough literature reviews. 3. The final presentation will be evaluated by the supervisor(s) concerned for 25 marks. 4. A committee of senior faculty of the institute including supervisor(s), will finally evaluates the quality of the proposed work and its relevance in the pharmaceutical field (out of 75 marks). ( ) Page 12 of 16

13 Semester II RECENT ADVANCES IN DRUG DELIVERY SYSTEM LAB Course Code MPU252 L-0, T-0, P-8, C-4 Objective: The basic objective of this course is to get familiar with practicals related novel techniques and advances in drug delivery system. Based on the Course Code: MPU202 ( ) Page 13 of 16

14 Semester II BIO-PHARMACEUTICS & PHARMACOKINETICS LAB Course Code: MPU253 L- 0, T-0, P-8, C-4 Objective: The basic objective of this course is to get familiar with pharmacokinetic practicals. Based on the Course Code: MPU203 ( ) Page 14 of 16

15 Semester III RESEARCH PROJECT (PHASE-I) (TO BE CONTINUED IN SEMESTER-IV) Course Code: MPU351 L- 0, T-0, P-48, C-24 Objective: The basic objective of this course is to represent the findings of the project that has been done in the dissertation. Guidelines: 1. The course will comprise of the confirmation of the proposed research work based on the initial experimentation to confirm the feasibility of the work. 2. The allotted supervisor(s) will provide guidelines with exploration of the line of action with recent trends of research in the related field and confirm global acceptability with regards to industry and academic problems. 3. The continuous literature survey and modification of experimental pathway will be taken in to practice with regular monitoring. 4. The candidate s performance will be evaluated by the supervisor(s) and the internal committee of at least three senior faculties in addition to the allotted supervisor(s). There will be atleast two seminars to be presented before the committee in this semester consisting of the progress of the research work. 5. Each seminar will be of 50 marks. ( ) Page 15 of 16

16 Semester IV RESEARCH PROJECT (PHASE II) (THESIS COMPILATION & VIVA-VOCE) Course Code: MPU451 L-0, T-0, P-48, C-24 Objective: The basic objective of this course is to present the findings of the project that has been carried out in different phases. Guidelines: 1. The progress of research work will be continuously evaluated by the supervisor(s) concerned. 2. There will be at least two presentations in this semester and each will be evaluated out of 25 marks by the internal committee of at least three senior faculties beside the allotted supervisor(s). 3. The external examiner appointed by the university will finally evaluate the thesis by way of viva- voce and presentation by the candidate out of the remaining 50 marks. ( ) Page 16 of 16

Master of Pharmacy (Pharmacology) [Applicable w.e.f. Academic Session till revised]

Study & Evaluation Scheme of Master of Pharmacy (Pharmacology) [Applicable w.e.f. Academic Session 2011-12 till revised] TEERTHANKER MAHAVEER UNIVERSITY N.H.-24, Delhi Road, Moradabad, Uttar Pradesh-244001