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M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 1 of 20
Study & Evaluation Scheme
of
Master of Pharmacy
(Pharmaceutics) [Applicable w.e.f. Academic Session 2011-12 till revised]
[With amendments in Credit scheme, MPU 251, 351 & 451 vide approval dated 17th
Nov 2012]
TEERTHANKER MAHAVEER UNIVERSITY N.H.-24, Delhi Road, Moradabad, Uttar Pradesh-244001
M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 2 of 20
Website: www.tmu.ac.in
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 : 71 Minimum credits required for degree : 66
Assessment
:
Internal External Total
30 70 100
Internal Evaluation (Theory Papers) :
Clas
s
Test
I
Clas
s
Test
II
Clas
s
Test
III
Continuou
s
Evaluatio
n
Semin
ar
Total
10 10 10 5 5 30
Duration of Examination :
Theory Practical
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.
M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 4 of 20
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. (8 Hours)
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. (8 Hours)
Unit – 3
Nuclear magnetic resonance spectroscopy: chemical shift concept, isotopic nuclei, reference
standards and solvents. 1H NMR spectra, coupling constants, interpretation of spectra, decoupling-double resonance and shift reagent methods.
Principles of FT-NMR with reference to 13C NMR, free induction decay. Spin-spin and spin-lattice
relaxation phenomenon. Nuclear overhauser enhanced 13C NMR spectra, their interpretation and
application. (8 Hours)
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. (8 Hours)
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.
(8 Hours)
Recommended Books
1. Willard, H.H., Merrit, L.L., Dean, J.A., Settle, P.A., Instrumental Methods of Analysis, Van
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.
M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 5 of 20
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. (8 Hours)
Unit - 2
Sampling, sample size and power. Statistical inference and hypothesis. Tests for statistical
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.
M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 6 of 20
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. (8 Hours)
Unit -2
PHARMACEUTICAL PROCESS VALIDATION
Regulatory basis, validation of sterile products, solid dosage forms, process. Drug additive
interaction. (8 Hours)
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). (8 Hours)
Unit-4
Evaluation of Pharmaceutical formulations in vitro and in vivo studies and their correlation. Levels and types of IV-IVC. (8 Hours)
Unit -5
POLYMERS Types, Pharmaceutical Application, Molecular Weight Determination, Conformation of dissolved
linear macromolecules, Polymer solutions, Polymer in solid state, Fabrication.
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
M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 7 of 20
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
M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 8 of 20
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
M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 9 of 20
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. (8 Hours)
Unit-2
Master formula generation and SOP.
Pilot plant scale up techniques. (8 Hours)
Unit-3
Factory layout, Material Management: (8 Hours)
Unit-4 Process optimization and automation in pharmaceutical manufacturing. (8 Hours)
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. (8 Hours)
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
M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) Page 10 of 20
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.