Ch. Bansi Lal University, Bhiwani · Theory Practical Total Theory Practical Total Internal Assessment Theory Practical MIP-101 Modern Analytical Techniques-I (MAT-I) C.M.C 04 --

Session: 2016-17

1

Schemes of Examinations

&

Syllabi

of

M. Pharmacy

for

Industrial Pharmacy (Pharmaceutics)

(2016-2017)

Ch. Bansi Lal University, Bhiwani

Session: 2016-17

2

Ch. Bansi Lal University, Bhiwani

Scheme of Examination for M. Pharmacy Industrial Pharmacy (Pharmaceutics)

Semester-I Credits: 34 Marks: 750

Paper

Code

Subjects

Type

of

Course

Contact Hours Per Week Credits Examination Scheme Total

Theory Practical Total Theory Practical Total Internal

Assessment

Theory Practical

MIP-101 Modern Analytical

Techniques-I (MAT-I)

C.M.C 04 -- 04 04 -- 04 20 80 100

MIP-102 Dosage Forms Design

and Development

C.C 04 -- 04 04 -- 04 20 80 100

MIP-103 Advances in Drug

Delivery-I

C.C 04 -- 04 04 -- 04 20 80 100

MIP-104 Advanced

Pharmacokinetics and

Biopharmaceutics-I

C.C 04 -- 04 04 -- 04 20 80 100

MIP-105 Biostatistics I.D.C 04 -- 04 04 -- 04 20 80 100

MIP-106 Practical (MAT-I) C.M.C - 06 (6X1) 06 -- 03 03 -- - 100 100

MIP-107 Pharmaceutics Practical

(MIP 102- 104)

C.C - 18 (6X3) 18 -- 09 09 -- - 100 100

MIP-108 Seminar/ Journal Club C.C 03 -- 03 -- -- 01 -- -- -- 25

MIP-109 Self-study Paper C.C -- -- -- -- -- 01 -- -- -- 25

Total 23 24 47 20 12 34 100 400 200 750

C.C = Core Course I.D.C = Inter Disciplinary Course E.C= Elective Course C.M.C= Complimentary Course

Session: 2016-17

3

Scheme of Examination for M. Pharmacy Industrial Pharmacy (Pharmaceutics)

Semester-II Credits: 34 Marks: 750

Paper

Code

Subjects

Type

of

Course

Contact Hours Per Week Credits Examination Scheme Total

Theory Practical Total Theory Practical Total Internal

Assessment

Theory Practical

MIP-201 Modern Analytical

Techniques-II

(MAT-II)

C.M.C 04 -- 04 04 -- 04 20 80 100

MIP-202 Advances in Drug

Delivery-II

C.C 04 --- 04 04 04 20 80 100

MIP-203 Advanced

Pharmacokinetics and

Biopharmaceutics-II

C.C 04 -- 04 04 -- 04 20 80 100

MIP-204 Pharmaceutical

Technology and

Biotechnology

C.C 04 -- 04 04 -- 04 20 80 100

MIP-205 Intellectual Property

Rights

C.C 04 - 04 04 -- 04 20 80 - 100

MIP-206 Practical (MAT-II) C.M.C 06 (6X1) 06 -- 03 03 -- -- 100 100

MIP-207 Pharmaceutics

Practical (MIP 201-

MIP 203)

C.C -- 18 (6X3) 18 -- 09 09 -- -- 100 100

MIP-208 Seminar/ Journal Club/

Synopsis

C.C 03 - 3 - - 01 - - - 25

MIP-209 Self-study Paper

-- - -- - - 01 - - 25

Total 23 24 47 20 12 34 100 400 200 750

C.C = Core Course I.D.C = Inter Disciplinary Course E.C= Elective Course C.M.C= Complimentary Course

Session: 2016-17

4

Scheme of Examination for M. Pharmacy Industrial Pharmacy (Pharmaceutics) 3

rd Semester Credits: 23 Marks: 225

PART-I (DISSERTATION WORK)

Paper Code Subject Contact

Hours

Credits

Examination Marks Max. Marks

Internal External

MIP-301 Pharmaceutical Entrepreneurship 04 04 20 80 100

MIP-302 Midterm Evaluation/ Presentation/ Viva

voce

-- -- -- 100 100

MIP-303 Journal Club

(One Research Paper Per Student) 02 1 25 - 25

MIP-304 Research Work 36 18 - - -

Total 42 23 45 180 225

4th

Semester Credits: 23 Marks: 250

PART-II (DISSERTATION WORK)

Paper Code Subject Contact

Hours

Credits

Examination Marks Max. Marks

Internal External

MIP-401 Communication Skills 04 04 20 80 100

MIP-402 Journal Club

(One Research Paper Per Student)

02 01 25 25

MIP-403 Research Work 36 18

MIP-404 Dissertation Evaluation by External

Examiner

- - - 100 100

MIP-405 Dissertation/Final Presentation & Viva

voce

- 50 50

Total 42 23 45 230 275

Duration- 02 years (04 semesters) Total Marks- 2000

Total Credits- 114

Session: 2016-17

5

M. Pharmacy (Industrial Pharmacy)

Semester 1

MIP-101

Modern Analytical Techniques -I (MAT- I)

Maximum Marks: 100

Theory Examination: 80

Internal Assessment: 20

Time: 3 hrs

Note: There shall be nine questions in all. Question no. 1 shall be compulsory, consisting of

eight short answer type questions covering the entire syllabus. Two questions will be asked

from each unit. Student will have to attempt one question from each unit. Each question shall

carry equal marks.

UNIT-I

UV-Visible spectroscopy: Brief review of electromagnetic spectrum, UV-Visual range, energy-

wavelength colour relationships. Interaction of electro - magnetic radiation (UV-Vis) and matter and

its effects, Chromophores and their interaction with EMR, Woodward-Fieser rule, Absorption

spectra of organic compounds and complexes illustrating the phenomenon and its utilization in

qualitative and quantitative studies of drugs, Beer-Lambert‟s law, Shifts and their interpretation

(including solvent effects). Multi component analysis, derivative spectroscopy.

Spectrofluorimerty: Fluorescence, Phosphorescence, Chemiluminescence-Theory, instrumentation

and Applications (9 Lectures)

UNIT-II

Infra-Red Spectroscopy: Nature of Infra-red radiation, Interaction of IR radiation with organic

molecules and effects on bonds, Molecular or infra-red spectra, Brief outline of classical IR

instrumentation and interpretation of spectra, including sample preparation for spectroscopy,

Qualitative interpretation of IR Spectra, Influence of substituents, ring size, hydrogen bonding

vibrational coupling and field effect on frequency, Quantitative methods, FT-NIR and applications.

Recent advances in IR Spectroscopy.

Raman spectroscopy- Principle, Instrumentation and Applications

Laser Spectroscopy: Introduction, principle, instrumentation and applications. (9 Lectures)

UNIT-III

Chromatographic Techniques: Introduction and classification

High performance TLC –Principle, adsorbents, retention and separation parameters, detection

methods, quantitative and quantitative HPTLC.

Gas Chromatography: Introduction, principles, Instrumentation, carrier gas, types of columns,

columnselection- liquid stationary phases, column efficiency parameters, the Van Deemter equation,

Resolution, Derivatisation methods, Detectors. A critical comparison of sensitivity, selectivity and

field of applications of these detectors. Applications of GC in Pharmaceutical sciences.

(9 Lectures)

Unit-IV Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile

phase selection, efficiency parameters, resolution and optimization of chromatographic parameters.

Detectors in HPLC: Comparison of sensitivity selectivity and field of applications of these

detectors. Modes of HPLC-Ion pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-

permeation, Flash chromatography. Applications of liquid chromatography. UPLC

Emission Spectrometry (Atomic Absorption Spectrometry, Flame Photometry). (9 Lectures)

Session: 2016-17

6

Reference books:

1. Principles of Instrumental Analysis, 5th Ed., D.A. Skoog, F.J. Holler and T. A. Nieman.

2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler & Morril 5th

Ed., 1991.

3. Instrumental Methods of Analysis, H.H. Willard, L.L Merritt, J.A. Dean, F.A. Settle, 7th Ed.

4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol. -2.

5. Drugs & Pharma, Sciences Series, Marcel Dekker Inc.

6. “Applications of absorption spectroscopy of organic compounds” by John R. Dyer.

7. “Contemporary practice of chromatography” by Poole, Colin F. and Sheila A. Schuette.

8. Ewing‟s Analytical Instrumentation Handbook, edited by Jack Cazes, CRC press.

9. “Practical HPLC method development” by L. R. Snyder Willey Interscience, Second Ed.

10. Aldrich FT-IR Spectral Library.

11. “Pharmaceutical Analysis” by David C. Lee Blackwell Publisher.

Session: 2016-17

7


Semester 1

MIP-106

Practical (MAT-I)

Maximum Marks: 100

Time: 06 hrs/week

1. Use of UV Vis spectrophotometer for analysis of Pharmacopoeial compounds and their

formulations.

2. Simultaneous estimation of multi component containing formulations by UV

spectrophotometry.

3. Effect of pH and solvent on UV spectrum of certain drugs.

4. Experiments on factors affecting the absorbance/fluorescence in UV spectroscopy/

Fluorimetry.

5. Interpretation of IR spectra

6. Experiments based on various chromatography techniques for separation of mixture of

compounds.

7. Any other practical based on aforementioned theory.

Reference books:


2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler & Morril

5th Ed., 1991.


4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol. -2.

5. Drugs & Pharma, Sciences Series, Marcel Dekker Inc.







Session: 2016-17

8


Semester 1

MIP-102

DOSAGE FORM DESIGN AND DEVELOPMENT

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Preformulation Studies

Introduction, goals of preformulation, physicochemical properties, criteria for selection of drug and

excipients, compatibility tests.

Solid State Pharmaceutics

Crystalinity, crystal habit, polymorphism, amorphous state, solvates and hydrates and analytical

techniques for characterization.

Stability Testing

Stress testing and stability assessment protocols, photostability, packing influence on stability, New

drug summations specific stability issues and general approaches for the improvement of stability of

finished products. (9 Lectures)

UNIT-II

Solubility and Solubilisation

Development of theoretical relationships of prognostic relevance, techniques of solubilisation of

drugs including surfactant systems, co-solvents, solid state manipulations, complexation and

chemical modifications.

Partition Coefficient

Pharmaceutical significance of partition coefficient, correlation with in-vivo performance,

techniques to estimate log P values, shake flask method, choice of solvent systems,

chromatographic determination, theoretical computation using Hansch & Leo/Rekker principle,

effect of various variants like temperature, pH etc. on partition coefficient.

(9 Lectures)

UNIT-III

Complexation

Metal and organic molecular complexes, inclusion complexes with reference to cyclodextrins, types

of cyclodextrins, their pharmaceutical applications.

Rheology

Concepts of rheology, viscoelastic analysis of semisolids, applications and practice of rheology,

viscometers. (9 Lectures)

UNIT-IV

Optimization in Pharmaceutical Process and Formulations

Design of experiments- Basic terminology, Advantages, scope of experimental design in

pharmaceutical formulations with special emphasis on factorial designs and central composite

design, with suitable example. (9 Lectures)

Session: 2016-17

9

Reading Material Recommended:

1. Wells J.I. Pharmaceutical Prefomulation: The Physicochemical Properties of Drug

Substances. Ellis Horwood, Chiechester, U. K. Latest Edition.

2. Yalkowsky S.H. Techniques of Solubilisation of Drugs. Marcel Dekker, New York. Latest

Edition.

3. Doornbos C. and Hann P. Optimization Techniques in Formulation and Processing. In

Encyclopedia of Pharmaceutical Technology. Swarbrick J. and Boylan J.C. Eds., Vol. II,

Marcel Dekker, New York. 1995.

4. Lewis G.A. Optimization Methods. In Encyclopedia of Pharmaceutical Technology. Vol.

IV, Informa Healthcare, New York. 2007.

5. Swarbrick J. and Boylan J.C. Eds., Encyclopedia of Pharmaceutical Technology. Vol. I,

Marcel Dekker, New York. Latest Edition.

6. Singh B. and Ahuja A. Response Surface Optimization of Drug Delivery Systems. In

Controlled and Novel Drug Delivery Systems, Jain N.K. Ed., CBS, New Delhi. Latest

Edition.

7. Carstensen J.T. Drug Stability: Principles and Practices. Marcel Dekker, New York. Latest

Edition.

Session: 2016-17

10


Semester 1

MIP-103

ADVANCES IN DRUG DELIVERY-I

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Polymers in drug delivery Polymer classifications, biodegradable and non-biodegradable polymers and their Properties,

applications of polymers in controlled release. Smart polymers: types, classification, properties,

purpose of use with examples, biopolymers: properties, advantages and applications of biopolymers

in dosage form design.

Fundamentals of Controlled Release (CR) Drug Delivery

Rationale of sustained/controlled drug delivery; Physicochemical and biological factors influencing

design and performance of CR products, therapeutic status of CDDS. Pharmacokinetic/

pharmacodynamic basis of controlled drug delivery. (9 Lectures)

UNIT-II

Design and fabrication of Oral CR systems Strategies and design of oral controlled release delivery systems, oral systems based on dissolution,

diffusion and dissolution, ion-exchange resins, pH-independent formulations, altered density

formulations. Bucco/ mucoadhesive systems. Osmotic controlled oral drug delivery.

Parenteral CDD System

Parenteral systems, biopharmaceutic considerations, design and development. Implantable

therapeutic systems, biocompatibility of polymers and carriers; Intrauterine devices and intra

vaginal devices. (9 Lectures)

UNIT-III

Transdermal Drug Delivery System Transdermal therapeutic systems, Drug absorption through skin, permeation enhancers, basic

components of TDDS, approaches to development and evaluation; iontophoresis, sonophoresis and

electroporation. Heat assisted TDDS. (9 Lectures)

UNIT-IV

Novel ocular drug delivery systems Ocular therapeutics and constraints to effective delivery, formulation considerations to improve the

ocular bioavailibility, ocular inserts including insoluble and soluble inserts, non-corneal routes and

their use for systemic drug delivery.

Nasal drug delivery systems Advantage, factor effecting nasal drug delivery system. (9 Lectures)

Session: 2016-17

11


1. Robinson J.R. and Lee VHL. Controlled Drug Delivery - Fundamentals and Applications.


2. Chien Y.W. Transdermal Controlled Systemic Medications, Marcel Dekker, New York.

Latest Edition.

3. Bruck S.D. Controlled Drug Delivery. Vol. I (Basic Concepts), CRC Press, Florida. Latest

Edition.

4. Bruck S.D. Controlled Drug Delivery. Vol. II (Clinical Applications), CRC Press, Florida.

Latest Edition.

5. Tyle P. and Ram B. Targeted Therapeutic Systems, Marcel Dekker, New York. Latest

Edition.

6. Prescott LF and Nimmo WS. Novel Drug and its Therapeutic Applications, John Wiley and

Sons. Chichester. Latest Edition.

Session: 2016-17

12


Semester 1

MIP-104

ADVANCED PHARMACOKINETICS AND BIOPHARMACEUTICS-I

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Compartmental Pharmacokinetics

Review of fundamentals, terminology, basics of kinetics following single dose administration

through instantaneous and non-instantaneous routes (like i.v. bolus, i.v. infusion, peroral) using

serum and urine levels, one and multi-compartmental kinetics, multiple dose administration,

superposition rule. (9 Lectures)

UNIT-II

Noncompartmental Pharmacokinetic Modeling Approach

Pitfalls of compartmental techniques and advantages of model-independent approaches, definition

and significance of stochastic approach, statistical moments, AUC, AUMC, determination of AUC

& AUMC using techniques like trapezoidal, logtrapezoidal, spline, and hybrid approaches, MRT

and its significance in pharmacokinetics, computation of statistical moments from plasma and urine

data, cut off error, MDT, MIT, MAT and bioavailability. (9 Lectures)

UNIT-III

Non-linear Pharmacokinetics

Definition, significance and applications with literature examples, recognition of nonlinearity,

computation of non-linear pharmacokinetic parameters (Vm, Km, AUC, etc.) from the time course

and AUC of a drug in body being eliminated by single Michaelis Menten kinetics, computation of

pharmacokinetic parameters (Vm, Km, K, AUC, etc.) from the time course of a drug being

eliminated by Michaelis Menten kinetics and by a blend of Michaelis Menten kinetics and first-

order kinetics.

Protein Binding

Theory of plasma protein binding and implications, elements of Scatchard, Klotz and Rosenthal

analyses for computation of binding parameters, experimental techniques to determine protein

binding with their merits and limitations, factors influencing protein binding, effect of binding on

drug pharmacokinetics.

(9 Lectures)

UNIT-IV

Physiologically Based Pharmacokinetic (PBPK) Models

Basic concepts of PBPK models, development of a PBPK model, limitations with respect to

classical compartmental approaches, permeation limited versus diffusion limited models,

interspecies scaling, applications.

Pharmacokinetic and Pharmacodynamic (PK/PD) Models Basic concepts of PK/PD modeling, methodology including linear, log-linear, Emax, maxsigmoidal

models, non-steady state and time-dependant models, biphasic distribution model, tolerance and

signal transduction models, biomarkers, non-linear mixed effect modeling, Naive pool approach,

hysteresis of pharmacodynamics response, applications. (9 Lectures)

Session: 2016-17

13


1. Wagner JG. Fundamentals of Clinical Pharmacokinetics, Drug Intelligence Publication,

Hamilton. Latest Edition.

2. Wagner JG. Pharmacokinetics for the Pharmaceutical Scientist, Technomic, Pennsylvania.

Latest Edition.

3. Shargel L, Yu ABC and Wu-pong S. Applied Biopharmaceutics and Pharmacokinetics

McGraw- Hill Medical Publishers, New Delhi. Latest Edition.

4. Gibaldi M. and Perrier D. Pharmacokinetics. Informa Healthcare, New York. Latest Edition.

5. Gibaldi M. Biopharmaceutics and Clinical Pharmacokinetics, Lea & Febiger, Philadelphia.

Latest Edition.

6. Dressman B and Lennernas H. Oral Drug Absorption: Prediction & Assessment, Marcel

Dekker, New York. Latest Edition.

7. Garett ER and Hitz JL. Drug, Fate and Metabolism, Vol. 4, Marcel Dekker, New York.

Latest Edition.

Session: 2016-17

14


Semester 1

MIP-105

BIOSTATISTICS

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

Unit I

Probability and Descriptive Statistics Scientific notation: significant digits, rounding off, scientific

notation, Error analysis; Counting and Probability: Addition rules; Permutations; Combinations;

Inclusion-exclusion rule; Sampling with and without replacement; Conditional probability: Bayes‟

theorem; Independence; Descriptive statistics and Random variables; Measures of central tendency:

mean, median, mode; Expectation; Measures of spread: range, percentile, standard deviation;

Higher moments: kurtosis, skew, Displaying data: Histograms, stemand-leaf plots, box plots,

frequency distributions; Discrete random variables: Bernoulli, Binomial, Poisson; Geometric

distributions; Continuous random variables: Normal; Exponential distributions; Standard normal

distribution. (9 Lectures)

Unit II

Inferential statistics and one sample hypothesis testing Samples and populations: Random,

stratified and cluster sampling; Single- and Double-blind experiments; Point and interval estimates;

Sampling distributions: t, chi-square, F distributions; Hypothesis testing: null and alternative

hypotheses, decision criteria, critical values, type I and type II errors, Meaning of statistical

significance; Power of a test; One sample hypothesis testing: Normally distributed data: z, t and chi-

square tests; Binomial proportion testing. (9 Lectures)

Unit III

Multi-sample and nonparametric hypothesis testing two sample hypothesis testing; Nonparametric

methods: signed rank test, rank sum test; Kruskal-Wallis test; Analysis of variance: One-way

ANOVA. (9 Lectures)

Unit IV

Curve fitting Regression and correlation: simple linear regression; Least squares method; Analysis

of enzyme kinetic data; Michaelis-Menten; Lineweaver-Burk and the direct linear plot; Logistic

Regression; Polynomial curve fitting.

Design of Experiments Single factor experiments; Randomized block design; Lackett-Burman

Design; Comparison of k treatment means; Factorial designs; Blocking and confounding; Response

surface methodology. (9 Lectures)

Texts/References

1. Bernard Rosner, Fundamentals of Biostatistics, 5th Edition, Thomson Brooks/Cole, 2000.

2. Richard A. Johnson, Probability and Statistics for Engineers, 6th Edition, Prentice Hall,

2000.

3. Morris H. DeGroot, Mark J. Schervish, Probability and Statistics, 3rd Rev. Edition,

Addison-Wesley, 2002.

4. E. Kreyszig, Advanced Engineering Mathematics, 9th Edition, John Wiley, 2006.

Session: 2016-17

15


Semester 1

MIP-107

PRACTICAL INDUSTRIAL PHARMACY (MIP-102-104) Maximum Marks: 100

Time: 18 hrs

Experiments in Pharmaceutics

1. Accelerated stability studies on formulations or drugs with respect to

a) Temperature dependent.

b) Effect of buffer/ pH dependent.

2. Preparation and evaluation of diclofenac sodium gels containing two different gel bases.

3. Determination of rate and order of decomposition of drugs like aspirin, acetanilide, ascorbic

acid etc (2 exp.).

4. Study of effect of various binding agents on the properties of tablets.

5. Formulation and evaluation of semi- solid dosage form using different bases and drugs of

current interest.

6. Formulation and comparative evaluation of coated and uncoated tablets (marketed) of

various categories.

7. Formulation and evaluation of stability of reconstituted dry syrups of amoxicillin or

ampicillin etc.

8. Evaluation of packaging materials.

9. Preparation and comparative evaluation with marketed products of efficiency of neutralizing

property of antacid suspensions.

10. Preparation of injectable formulation.

11. Preparation of eye drops.

12. Preparation of ear drops.

13. Product development and protocol preparation for

a) Liquid antacid preparation.

b) Multivitamin tablet/capsule.

c) Skin ointments.

d) Injection containing antibiotics.

e) Sustained release preparations.

14. Validation of sterilization.

15. Effluent treatment testing.

16. Calibration of UV.

17. Study of drug-drug/excipient interaction using DSC.

18. Study of polymorphs using DSC.

19. Experiment based on HPTLC technique.

20. Comparison of the regulatory issues of formulation and development of new formulations in

different regulatory bodies.

21. Improvement of dissolution characteristics of drugs by different methods.

22. Comparison of dissolution of different marketed products/brands.

23. Influence of polymorphism on solubility and dissolution.

24. Protein binding of drugs.

25. Calculation of bioavailability from urinary excretion data.

Session: 2016-17

16

26. Bioavailability studies of paracetamol or any other drug by salivary data.

27. Study of drug absorption through everted rat gut method-influence of different variables like

pH and drug concentration.

28. Calculation of Ka, Ke, t1/2 and Tmax from the given data.

29. Calculation of AUC and bioequivalence from the given data.

30. Preparation of albumin microspheres by heat stabilisation technique and their particle size

characterization.

31. Study on the diffusion of drugs through various polymer membranes.

32. Preparation and study on the in-vitro dissolution of various sustained action products and

comparison with marketed products.

33. Preparation of resealed erythrocytes from blood, loading of various drugs and study on the

release pattern.

34. Preparation of matrix tablets using various polymers like PVP etc. and studying their release

pattern.

35. Preparation and evaluation of microcapsules by different microencapsulation techniques

like:

a) Simple coacervation technique: Gelatin-Water-Ethanol.

b) Coacervation by temperature change: Ethylcellulose in cyclohexane for

phenobarbitone.

c) Coacervation by nonsolvent addition: Cellulose acetate butyrate in methyl ethyl

ketone using isopropyl ether as nonsolvent. (1 exp. in each)

36. Preparation and evaluation of wax embedded microspheres of diclofenac sodium and

theophylline.

37. Preparation and evaluation of reservoir type devices (e.g.) PEG, ethylcellulose in

chloroform/dichloromethane as the coating material and the drugs like salicylic acid and

caffeine.

38. Preparation of polymer film containing different drugs and studying the film characteristics

and release patterns.

39. Preparation and evaluation of albumin microspheres


41. Preparation and evaluation of matrix tablets using various polymers

42. Study of diffusion of drugs through various polymeric membranes

43. Preparation and in vitro evaluation of buccal mucoadhesives

44. Preparation and evaluation of transdermal films

45. Preparation and evaluation of hydrodynamically balanced tablets

46. Study of in vitro dissolution of various sustained release formulations of marketed products

Session: 2016-17

17


Semester 2

MIP-201

Modern Analytical Techniques-II (MAT-II)

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR (Magnetic

Properties of nuclei, applied field and precession, absorption and transition frequency). Chemical

shift concept, Isotopic nuclei, Reference standards, proton magnetic spectra, their characteristics,

presentation, terms used in describing spectra and their interpretation (signal no., position,

intensity), Brief outline of instrumental arrangements and some practical details, Signal multiplicity

phenomena in high resolution PMR, Spin-spin coupling, Application of Signal Splitting and

coupling constant data to interpretation of spectra, Decoupling and shift reagent methods.

Quantitative NMR. Brief outline of principles of 13

C NMR. Introduction to 2-D NMR Techniques.

Applications of NMR technique in Pharmaceutical sciences. (9 Lectures)

UNIT-II

Mass Spectrometry: Basic principles and brief outline of instrumentation. Ion formation and types,

molecularion, meta stable ions, fragmentation processes, Fragmentation patterns and fragment

characteristics in relation to parent structure and functional groups, Relative abundances of isotopes

and their contribution to characteristic peaks, Mass spectrum, its characteristics, presentation and

interpretation, Chemical ionisation mass spectrometry, ESI, Ion-trap. FAB mass spectroscopy.

Applications of mass spectrometry. (9 Lectures)

UNIT-III

X-Ray Diffraction Methods: Elementary crystallography, X-Ray diffraction, Bragg‟s law, X-Ray

powder diffraction, X-Ray powder diffractometer- interpretation of data.

Thermal Analysis: Principles and applications of thermogravimetric analysis (TGA), Differential

thermal analysis (DTA) and Differential scanning Calorimetry (DSC). (9 Lectures)

Unit-IV

Electrophoresis: Principle, techniques, instrumentation including detection strategies and

applications

Hyphenated techniques: Brief introduction (LC-MS, GC-MS, GC-IR, LC-NMR and GC-NMR)

and applications.

Radioimmunoassay Assay and ELISA: Principle, instrumentation and applications. (9 Lectures)

Session: 2016-17

18

Reference books:


2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler & Morril 5th

Ed., 1991.


4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol -2.

5. Drugs &Pharma, Sciences Series, Marcel Dekker Inc.







Session: 2016-17

19


Semester 2

MIP-207

Practical (MAT-II)

Maximum Marks: 100

Time: 06 hrs/week

1. Interpretation of NMR and Mass spectra.

2. Experiments Based on flame photometry.

3. Any other practical based on aforementioned theory.

Reference books:


2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler & Morril

5th Ed., 1991.


4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol -2.

5. Drugs &Pharma, Sciences Series, Marcel Dekker Inc.







Session: 2016-17

20

M. Pharmacy Industrial Pharmacy (Pharmaceutics)

Semester 2

MIP-202

ADVANCES IN DRUG DELIVERY –II

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Colloidal and supramolecular delivery systems -I:

Closed bi-layered system: Historical background, structural aspects, preparation, characterization,

evaluation and applications of liposomes, specialized liposomes like Pharmacosomes and

Niosomes.

Nanoparticles and microspheres: Method of preparation, characterization, evaluation and

pharmaceutical applications. (9 Lectures)

UNIT-II Multiple w/o/w emulsions as drug vehicles, composition of the multiple emulsion and stability,

influence of the nature of oily phase, methods for stabilizing w/o/w multiple emulsions.

(9 Lectures)

UNIT-III

Colloidal and supramolecular delivery systems -II

Microemulsions: Introduction, structure of microemulsions, solubilization and formulation of

microemulsions, Self-emulsifying drug delivery systems (SEDDS), transport properties and

pharmaceutical applications of emulsions. (9 Lectures)

UNIT-IV

Protein and peptide drug delivery Considerations in the physiological delivery of therapeutic proteins; carrier-mediated transport of

peptides and peptide analogues, problems associated with the delivery of protein and peptides.

Targeted drug delivery History, concept, types and key elements; ideal carrier system and approach with special reference

to organ targeting (e.g. brain, tumor, lung, liver and lymphatics); Basics of temperature, pH and

magnetically induced targeting. (9 Lectures)


1. Robinson JR and Lee VHL. Controlled Drug Delivery - Fundamentals and Applications.


2. Bruck SD. Controlled Drug Delivery. Vol. I (Basic Concepts), CRC Press, Florida. Latest

Edition.

3. Bruck SD. Controlled Drug Delivery. Vol. II (Clinical Applications), CRC Press, Florida.

Latest Edition.

4. Tyle P and Ram B. Targeted Therapeutic Systems, Marcel Dekker, New York. Latest Edition.

5. Vyas SP and Khar RK. Targeted and Controlled Drug Delivery. CBS, New Delhi. Latest

Edition.

6. Jain NK. Advances in Controlled and Novel Drug Delivery. CBS, New Delhi. Latest Edition.

Session: 2016-17

21


Semester 2

MIP-203

ADVANCED PHARMACOKINETICS AND BIOPHARMACEUTICS-II

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Clinical Pharmacokinetics

Introduction, pharmacokinetic relationships, duration of response, kinetics of pharmacological

response, explanation of clinical response via pharmacokinetics, monitoring plasma concentrations

of drugs during clinical use including problems encountered in clinical investigations, analysis of

clinical relevance of kinetic studies, turnover concepts, individualization of dosage and dosage

regimen, variability, genetics, age, weight, disease, interacting drugs, use of creatinine clearance,

problem solving. (9 Lectures)

UNIT-II

Biopharmaceutics

Review of physicochemical, pharmaceutical and physiological variables affecting absorption.

Bioavailability and bioequivalence concepts, assessment of bioavailability from serum and urine

level data, crossover design and analysis of bioequivalence trials, biowaivers, federal perspectives,

problem solving. (9 Lectures)

UNIT-III

In vitro and In vivo of correlations (IVIVC)

Concept, biopharmaceutical classification scheme, various IVIVC approaches with applications and

limitations, dissolution as a surrogate to bioavailability for immediate release and extended release

formulations, A-D levels, validation, IVIVR, IVIVM, federal perspectives.

Pharmacokinetic Simulations and Allied Pharmacokinetic Approaches

Pharmacokinetic simulations using pharmacokinetic parameters, simple problem solving. Basics of

chronopharmacokinetics, toxicokinetics, population pharmacokinetics. (9 Lectures)

UNIT-IV

Use of Computers in Pharmacokinetics

Introduction, strategy for model building, selection and application of suitable pharmacokinetic,

statistical and variance models, function minimization for maximization of goodness of fit, iterative

and non-iterative techniques, weighting schemes for non-linear regression, AIC, SC, MSC, digital

versus analog computers, law of parsimony, literature review on computer software on

compartmental, noncompartmental and clinical pharmacokinetic analysis and simulation, and

biopharmaceutics. (9 Lectures)

Session: 2016-17

22


1. Wagner JG. Fundamentals of Clinical Pharmacokinetics, Drug Intelligence Publication,

Hamilton. Latest Edition.

2. Wagner JG. Pharmacokinetics for the Pharmaceutical Scientist, Technomic, Pennsylvania.

Latest Edition.

3. Shargel L, Yu ABC and Wu-pong S. Applied Biopharmaceutics and Pharmacokinetics

McGraw-Hill Medical Publishers, New Delhi. Latest Edition.

4. Gibaldi M and Perrier D. Pharmacokinetics. Informa Healthcare, New York. Latest Edition.

5. Gibaldi M. Biopharmaceutics and Clinical Pharmacokinetics, Lea & Febiger, Philadelphia.

Latest Edition.

6. Dressman B and Lennernas H. Oral Drug Absorption: Prediction & Assessment, Marcel

Dekker, New York. Latest Edition.

7. Bourne DEA. Mathematical Modelling of Pharmacokinetic Data. Technomic, Pennsylvania.

Latest Edition.

8. Welling PG and Tse FLS. Pharmacokinetics: Regulatory, Industrial and Academic

Perspectives, Marcel Dekker, New York. Latest Edition.

9. Gibaldi M and Prescott L. Handbooks of Clinical Pharmacokinetics, ADIS, New York.

Latest Edition.

10. Rowland M and Tozer TN. Clinical Pharmacokinetics: Concepts and Applications,

Lippincott Williams & Wilkins. New York. Latest Edition.

Session: 2016-17

23


Semester 2

MIP-204

PHARMACEUTICAL TECHNOLOGY AND BIOTECHNOLOGY

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Pharmaceutical Technology

Tablet production systems: Benefits, production, process design considerations, materials handling,

processing step combination and elimination, unit operation improvement, tablet production

equipments.

Tablet production: Layout of facilities, materials flow, quality assurance procedures, design of

facilities, construction considerations, equipment consideration, environmental consideration,

materials management and inventory control. (9 Lectures)

UNIT-II

Processing of small volume parenterals (SVP‟s) and related sterile products: Planning and

scheduling, material and personnel management, documentation control. Facilities - AHU's,

humidity and temperature controls, air filtration systems, dust collectors. Manufacturing including

various aspects of preparing SVP solutions, suspensions, powders/freeze dried powders for

reconstitution, filling, sealing, inspection and labelling.

Manufacture of LVP‟s: Raw materials including water, stability, storage and inventory control,

batch mixing, clarification by membrane filters and support systems. (9 Lectures)

UNIT-III

GMP of Pharmaceuticals : Current GMP in manufacturing, processing, packaging of drugs. GMP

for finished products. General provision, organization and personnel, building and facilities,

equipment, control of components and drug product, container and closures, production and

process, packaging and labeling, laboratory and control of records and reports.

Pharmaceutical Process Validation : Basic concept, definition and regulatory basis of validation.

Benefits of validation. Phases of quipment validation such as pre-purchase,post-purchase (IQ,OQ

and PQ) and qualification of established /in-use equipment. Types of process validation.

Retrospective, Prospective, Concurrent Validation, Validation of tablets and sterile products.

Validation of steam, dry heat, gaseous, radiation and filtration sterilization processes. Analytical

Validation. (9 Lectures)

UNIT-IV

Recombinant DNA technology: Types of genetic recombination, genetic transformation,

transduction, plasmids and their biological significance, conjugation, transposons, various cloning

vectors including plasmids and bacteriophages, host for cloning vectors, expression vectors,

practical applications of genetic recombination.

Monoclonal antibodies: Production of monoclonal antibodies, diagnostic therapeutic and analytical

applications. An introduction to their role in drug targeting.

Gene Therapy: An introduction to genetic disorders, approaches used, viral and non-viral mediated

gene therapy, safety and ethical considerations. (9 Lectures)

Session: 2016-17

24


1. Lieberman HA and Lachman L. Pharmaceutical Dosage Forms: Tablets. Vol. I, II and III,

Marcel Dekker, New York. Latest Editions.

2. Avis KE, Lachman L and Lieberman HA, Pharmaceutical Dosage Forms: Parenterals.

Volume I and II, Marcel Dekker, New York. Latest Edition.

3. Prescott LM, Harley JP and Klein DA. Microbiology. Wm. C. Brown Publishers, England.

Latest Edition.

4. Vyas SP and Dixit VK. Pharmaceutical Biotechnology. CBS, New Delhi. Latest Edition.

5. Remington JP, Science and Practice of Pharmacy. Lippincot Williams and Wilkins, New

York. Latest Edition.

Session: 2016-17

25


Semester 2

MIP-205

INTELLECTUAL PROPERTY RIGHTS Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Intellectual Property Rights

Concepts and fundamentals: The emergence and growth of the concepts regarding intellectual

property (IP), intellectual property protection (IPP) and intellectual property rights (IPR); economic

importance, copyright, trademarks; role of IP in pharmaceutical industry; global ramifications and

financial implications.

Ethical issues in IPR/IPP (9 Lectures)

UNIT-II

Trade Related Aspects of Intellectual Property Rights

Intellectual property and international trade, concept behind WTO, WIPO, GATT, TRIPs, TRIMS

and GATS, status in India and other developing countries. (9 Lectures)

UNIT-III

Indian Patent Act. 1970 and its amendements: WTO and modifications under TRIPS, filing of a

patent application, precautions before patenting-disclosures/non-disclosures, publication-

article/thesis, prior art search – published patents search, internet search, patent sites, specialized

service search requests, costs, patent application forms and guidelines, fee structure, time frames,

jurisdiction aspects. (9 Lectures)

UNIT-IV

Technology Development/Transfer Commercialization Related Aspects Technology

developmentTypes of patent applications provisional, non-provisional, PCT and convention patent

applications, international patenting requirement procedures and costs. Patent infringement:

Meaning, scope, litigation, drug related patents infringements, case studies and examples, patenting

by research students. (9 Lectures)

Reading Material Recommended

1. Treece DJ. Managing Intellectual Capital: Organizational, Strategic and Policy Dimension.

Oxford University Press, England. Latest Edition.

2. Wadedhra BL. Law Relating to Patents, Trademarks, Copyright Design and Geographical

Indications. Universal Law Publishing, New Delhi. Latest Edition.

3. Bansal P. IPR Handbook for Pharma Students and Researchers, Pharma Book Syndicate,

Hyderabad. Latest Edition.

4. Copyright Protection in India [website: http:copyright.gov.in].

5. Information on Orange Book [website: www.fda.gov/cder/ob/default.htm].

http://www.fda.gov/cder/ob/default.htm

Session: 2016-17

26


Semester 2

MIP-207 (MIP 202-204)

PRACTICAL INDUSTRIAL PHARMACY (PHARMACEUTICS)

Maximum Marks: 100

Time: 18 hrs

Formulation, Development and Optimization

1. Preformulation studies of various drugs and dosage forms.

2. Accelerated stability studies of drug and its formulations.

3. Practicals related to calculation of Shelf life and overages.

4. Practicals relating to specialized formulations.

5. In-vitro dissolution studies of drugs and dosage forms.

6. Practicals relating to statistical optimization of dosage forms.

Advances in Biopharmaceutics and Pharmacokinetics

1. Calculations related to Fundamentals of zero-order and first-order pharmacokinetics

2. Determination of various pharmacokinetics parameters from Plasma concentration time data for

One compartment and Multi compartment model for intravenous and extra venous

administrations.

3. Determinations of Pharmacokinetics parameters from Urinary Excretion Data

4. Calculations related to Non-Linear Pharmacokinetics

5. Dose Adjustment calculations in clinical pharmacokinetics

6. Demonstration of various pharmacokinetic softwares.

7. In-vivo pharmacokineic study on animal.

8. Preparation and evaluation of albumin microspheres


10. Preparation and evaluation of matrix tablets using various polymers

11. Study of diffusion of drugs through various polymeric membranes

12. Preparation and in vitro evaluation of buccal mucoadhesives

13. Preparation and evaluation of transdermal films

14. Preparation and evaluation of hydrodynamically balanced tablets

15. Study of in vitro dissolution of various sustained release formulations of marketed products

Session: 2016-17

27


Semester 3

MIP-301

PHARMACEUTICAL ENTREPRENEURSHIP

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Accounting and Finance

Taking decision on starting a venture; Assessment of feasibility of a given venture/new venture;

Approach a bank for a loan; Sources of financial assistance; Making a business proposal/Plan for

seeking loans from financial institution and Banks; Funds from bank for capital expenditure and for

working; Statutory and legal requirements for starting a company/venture; Budget planning and

cash flow management; Basics in accounting practices: concepts of balance sheet, P&L account,

and double entry bookkeeping; Estimation of income, expenditure, profit, income tax etc.

UNIT-II

Marketing

Assessment of market demand for potential product(s) of interest; Market conditions, segments;

Prediction of market changes; Identifying needs of customers including gaps in the market,

packaging the product; Market linkages, branding issues; Developing distribution channels;

Pricing/Policies/Competition; Promotion/ Advertising; Services Marketing

UNIT-III

Negotiations/Strategy With financiers, bankers etc.; With government/law enforcement authorities; With

companies/Institutions for technology transfer; Dispute resolution skills; External

environment/changes; Crisis/ Avoiding/Managing; Broader vision–Global thinking

Information Technology How to use IT for business administration; Use of IT in improving business performance; Available

software for better financial management; E-business setup, management.

UNIT-IV

Human Resource Development (HRD) Leadership skills; Managerial skills; Organization structure, pros & cons of different structures;

Team building, teamwork; Appraisal; Rewards in small scale set up.

Fundamentals of Entrepreneurship Support mechanism for entrepreneurship in India

Role of knowledge centre and R&D Knowledge centres like universities and research institutions; Role of technology and upgradation;

Assessment of scale of development of Technology; Managing Technology Transfer; Regulations

for transfer of foreign technologies; Technology transfer agencies.

Session: 2016-17

28

Case Study 1. Candidates should be made to start a „mock paper company‟, systematically following all

the procedures.

• The market analysis developed by them will be used to choose the product or services.

SEMESTER - IV 25 M.Sc (General Biotechnology)

• A product or service is created in paper and positioned in the market. As a product or

services available only in paper to be sold in the market through the existing links. At this

juncture, the pricing of the product or the service needs to be finalized, linking the

distribution system until the product or services reaches the end consumer.

• Candidates who have developed such product or service could present the same as a

project work to the Panel of Experts, including representatives from industry sector. If the

presented product or service is found to have real potential, the candidates would be exposed

to the next level of actual implementation of the project.

2. Go to any venture capital website (like sequoiacap.com) and prepare a proposal for funding

from

SUGGESTED READINGS:

1. Dynamics of Entrepreneurial Development & Management, Vasant Desai – Himalaya

Publishing House

2. Entrepreneurship Development –Poornima M. Charantimath – Small Business Enterprises –

Pearson Education – 2006 (2 & 4)

3. Entrepreneurship Development – S. S. Khanka – S. Chand & Co

Session: 2016-17

29


Semester 4

MIP-401

COMMUNICATION SKILLS

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

Unit-I Human Communication (Theoretical perspective): Its uniqueness, its nature, models of

communication, Types of Human communication, Language, non-verbal communication, logic and

reasoning, lateral thinking. The concept of facilitating: factors, barriers and filters in

communication; the seven C‟s of effective communication. Preparing for interviews, CV/Biodata.

(9 Lectures)

Unit -II

Self-communication, interpersonal communication, dyadic communication, small group

communication. Public communication. Mass Communication. Reliability of communication. Input

and Evaluation Processes (Practice): Listening (process, comprehension, evaluation). Reading

(process, comprehension, evaluation). Watching (process, comprehension, evaluation). Email Do‟s

and Don‟ts. (9 Lectures)

Unit-III Output and Interaction Processes (Practice): Speech (conversation, interview, group discussion,

public speech). Writing (spontaneous writing, guided writing, creative writing). Organizing ideas

(noting, summary, flow charts, concept maps). Correspondence (personal, business). (9 Lectures)

Unit-IV Science/ Scientific Writing (Theory and practice): Goals and Objectives. Ethics in writing. Structure

of documents. Language and grammar. Illustrations and aids. Writing proposals and instructions.

Making presentations. Formatting documents. Drafts and revisions. Editing. Writing popular

science/ journal article. (9 Lectures)

Suggested Texts and References:

1. Communicating a social and career focus, K. M. Berko, Andrew D. Wolvyn and Darlyn R.

2. Wolvyn, Houghton Mifflin Co., Boston (1977)

3. The Craft of Scientific Writing (3rd Edition), Michael Alley, Springer, New York (1996)

4. Science and Technical Writing – A Manual of Style (2nd Edition), Philip Reubens (General

editor), Routledge, New York (2001)

5. Writing Remedies – Practical Exercises for Technical Writing Edmond H. Weiss, Universities

Press (India) Ltd., Hyderabad (2000)

6. Effective Technical Communication, M. Ashraf Rizvi, Tata Mc Graw – Hill Publishing Co. Ltd.,

New Delhi (2005)

Documents

Ch. Bansi Lal University, Bhiwani · Theory Practical Total Theory Practical Total Internal Assessment Theory Practical MIP-101 Modern Analytical Techniques-I (MAT-I) C.M.C 04 --