GANDHI INSTITUTE OF TECHNOLOGY AND MANAGEMENT (GITAM)

(Deemed to be University)
VISAKHAPATNAM * HYDERABAD * BENGALURU

Accredited by NAAC with A+ Grade

REGULATIONS AND SYLLABUS

OF

MASTER OF PHARMACY (M. Pharm. Pharmaceutics)

(w.e.f. 2020-21 admitted batch)

A University Committed to Excellence

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 MASTER OF PHARMACY (M. Pharm. Pharmaceutics)
REGULATIONS as per PCI
(w.e.f. 2020-2021 admitted batch)

1.0 ADMISSIONS
1.1 Admissions into the M. Pharmacy programme of GITAM University are governed by
GITAM University admission regulations.

2.0 MINIMUM QUALIFICATION FOR ADMISSION

A Pass in the following examinations
2.1 B. Pharm. Degree examination of an Indian University established by law in India
from an institution approved by Pharmacy Council of India (PCI) and has scored not less than
50 % of the maximum marks (aggregate of 4 years of B. Pharm.)
2.2 Every student, selected for admission to post graduate pharmacy programme in any
PCI approved institution should have obtained registration with the State Pharmacy Council
or should obtain the same within one month from the date of his/her admission, failing which
the admission of the candidate shall be cancelled.
2.3 Admissions into M. Pharm. will be based on the All India Entrance Test (GAT -
PGP) conducted by GITAM University and the rule of reservation is followed wherever
applicable.
Note: It is mandatory to submit a migration certificate obtained from the respective
University where the candidate had passed his/her qualifying degree (B. Pharm.)

3. DURATION OF THE PROGRAMME

The programme of study for M. Pharm. shall extend over a period of four semesters (two
academic years).

4. MEDIUM OF INSTRUCTION AND EXAMINATIONS

Medium of instruction and examination shall be in English.

5. WORKING DAYS IN EACH SEMESTER

Each semester shall consist of not less than 100 working days. The odd semesters shall be
conducted from the month of June/July to November/December and the even semesters shall
be conducted from the month of November/December to April/May in every calendar year.

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6. ATTENDANCE AND PROGRESS
A candidate is required to put in at least 80% attendance in individual courses considering
theory and practical separately. The candidate shall complete the prescribed course
satisfactorily to be eligible to appear for the respective examinations.

7. PROGRAMME/COURSE CREDIT STRUCTURE

As per the philosophy of Credit Based Semester System, certain quantum of academic work
viz. theory classes, practical classes, seminars, assignments, etc. are measured in terms of
credits. On satisfactory completion of the courses, a candidate earns credits. The amount of
credit associated with a course is dependent upon the number of hours of instruction per week
in that course. Similarly the credit associated with any of the other academic,
co/extracurricular activities is dependent upon the quantum of work expected to be put in for
each of these activities per week/per activity.
7.1. Credit assignment
7.1.1. Theory and Laboratory courses
Courses are broadly classified as Theory and Practical. Theory courses consist of lecture (L)
and Practical (P) courses consist of hours spent in the laboratory. Credits (C) for a course is
dependent on the number of hours of instruction per week in that course, and is obtained by
using a multiplier of one (1) for lecture and a multiplier of half (1/2) for practical (laboratory)
hours. Thus, for example, a theory course having four lectures per week throughout the
semester carries a credit of 4. Similarly, a practical having four laboratory hours per week
throughout semester carries a credit of 2. The contact hours of seminars, assignments and
research work shall be treated as that of practical courses for the purpose of calculating
credits. i.e. the contact hours shall be multiplied by 1/2. Similarly, the contact hours of
journal club, research work presentations and discussions with the supervisor shall be
considered as theory course and multiplied by 1.
7.2. Minimum credit requirements
The minimum credit points required for the award of M. Pharm. degree is 95. These credits
are divided into theory courses, practical, seminars, assignments, research work, discussions
with the supervisor and journal club over the duration of four semesters. The credits are
distributed semester-wise as shown in Table 8. Courses generally progress in sequence,
building competencies and their positioning indicates certain academic maturity on the part of
the learners. Learners are expected to follow the semester-wise schedule of courses given in
the syllabus.
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8. ACADEMIC WORK
A regular record of attendance both in theory, practical, seminar, assignment, journal club,
discussion with the supervisor, research work presentation and dissertation shall be
maintained by the department / teaching staff of respective courses.

9. COURSE OF STUDY

The course of study for M. Pharm. specialization shall include semester wise theory &
practical as given in Table –1 to 3. The number of hours to be devoted to each theory and
practical course in any semester shall not be less than that shown in Table –1 to 3.

Table – 1: Course of study for M. Pharm. (Pharmaceutics)

Credi
Course t Credit
Course Hrs./wk Marks
Code Hour Points
s
Semester I

Modern Pharmaceutical Analytical

MPH 101T 4 4 4 100
Techniques
MPH 102T Drug Delivery Systems 4 4 4 100
MPH 103T Modern Pharmaceutics 4 4 4 100
MPH 104T Regulatory Affairs 4 4 4 100
MPH 105P Pharmaceutics Practical – I 12 6 12 150
MPH 106P Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II

Molecular Pharmaceutics (Nano

MPH 201T 4 4 4 100
Technology and Targeted DDS)
Advanced Biopharmaceutics &
MPH 202T 4 4 4 100
Pharmacokinetics
Computer Aided Drug Delivery
MPH 203T 4 4 4 100
System
MPH 204T Cosmetic and Cosmeceuticals 4 4 4 100
MPH 205P Pharmaceutics Practical – II 12 6 12 150
MPH 206P Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Table – 2: Course of study for M. Pharm. III Semester

Course Course Credit Credit

Code Hours points
MRM 301T Research Methodology and Biostatistics* 4 4

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 MPR 301T Journal club 2 2
Discussion/Presentation
MPR 302T 2 2
(Proposal presentation)
Research Work
MPR 303P (Proposed project work, Literature survey, 28 14
Plan of work, Methodology)
Total 36 22
* Non University Exam
Table – 3: Course of study for M. Pharm. IV Semester
Course Course Credit Credit
Code Hours points
Discussion/ Final Presentation
MPR 401T (Presentation of work, communication 3 3
skills, question and answers)
Research work and colloquium
(Objective(s) of the work done,
MPR 402P 36 18
Methodology adopted, Results &
Discussions, Conclusions & Outcomes)
Total 39 21

Table – 4: Semester wise credits distribution

Semester Credit points

I 26
II 26
III 22
IV 21
Total Credit Points 95

10. PROGRAMME COMMITTEE

1. The M. Pharm. programme shall have a Programme Committee constituted by the Head of
the institution in consultation with all the Heads of the departments.
2. The composition of the Programme Committee shall be as follows: A teacher at the cadre
of Professor shall be the Chairperson; One Teacher from each M. Pharm. specialization and
four student representatives (two from each academic year), nominated by the Head of the
institution.
3. Duties of the Programme Committee:
i. Periodically reviewing the progress of the classes.
ii. Discussing the problems concerning curriculum, syllabus and the conduct of classes.
iii. Discussing with the course teachers on the nature and scope of assessment for the course
and the same shall be announced to the students at the beginning of respective semesters.
iv. Communicating its recommendation to the Head of the institution on academic matters.

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v. The Programme Committee shall meet at least twice in a semester preferably at the end of
each sessional exam and before the end semester exam.

11. EXAMINATIONS/ASSESSMENTS
The schemes for internal assessment and end semester examinations are given in Table –5 to
6.
11.1. End semester examinations
The End Semester Examinations for each theory and practical course through semesters I to
IV shall be conducted by the respective University except for the subject with asterix symbol
(*) in table 6 for which examinations shall be conducted by the subject experts at college
level and the marks/grades shall be submitted to the University.

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 Table – 5: Schemes for internal assessments and end semester (Pharmaceutics – MPH)

Internal Assessment End Semester Exams

Course Total
Course
code Continuous Sessional Exams Marks
Total Marks Duration
mode Marks Duration
Semester I
Modern Pharmaceutical Analytical
MPH 101T 10 15 1 Hr 25 75 3 Hr 100
Techniques
MPH 102T Drug Delivery Systems 10 15 1 Hr 25 75 3 Hr 100
MPH 103T Modern Pharmaceutics 10 15 1 Hr 25 75 3 Hr 100
MPH 104T Regulatory Affairs 10 15 1 Hr 25 75 3 Hr 100
MPH 105P Pharmaceutics Practical – I 20 30 6 Hr 50 100 6 Hr 150
MPH 106P Seminar/Assignment - - - - 100 - 100
Total 650
Semester II
MPH 201T Molecular Pharmaceutics (Nano Technology
10 15 1 Hr 25 75 3 Hr 100
and Targeted DDS)
MPH 202T Advanced Biopharmaceutics &
10 15 1 Hr 25 75 3 Hr 100
Pharmacokinetics
MPH 203T Computer Aided Drug Delivery System 10 15 1 Hr 25 75 3 Hr 100
MPH 204T Cosmetic and Cosmeceuticals 10 15 1 Hr 25 75 3 Hr 100
MPH 205P Pharmaceutics Practical – II 20 30 6 Hr 50 100 6 Hr 150
MPH 206P Seminar/Assignment - - - - 100 - 100
Total 650

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 Table – 6: Schemes for internal assessments and end semester examinations
(Semester III & IV)
End
Total
Internal Assessment Semester
Course Marks
Course Exams
code Sessional Exams
Continuou
Total Marks Duration
s mode Marks Duration

Semester III
Research Methodology and
MRM 301T 10 15 1 Hr 25 75 3 Hr 100
Biostatistics*
MPR 301T Journal club - - - 100 - - 100
Discussion/Presentation
MPR 302T - - - 100 - - 100
(Proposal presentation)
Research Work
(proposed project work,
MPR 303P - - - - 100 1 Hr 100
Literature survey, Plan of
work, Methodology)
Total 400
Semester IV
Discussion/ Presentation
(Presentation of work,
MPR 401T - - - 100 - - 100
communication skills,
question and answers)
Research Work and
colloquium
(Objective(s) of the work
MPR 402P - - - - 100 1 Hr 100
done, Methodology adopted,
Results & Discussions,
Conclusions & Outcomes)
Total 200
* Non University Examination
11.2. Internal assessment: Continuous mode
The marks allocated for Continuous mode of Internal Assessment shall be awarded as
follows.
Table – 7: Scheme for awarding internal assessment: Continuous mode
Criteria Maximum Marks
Theory
Attendance (Refer Table -5) 8
Student – Teacher interaction 2
Total 10
Practical
Attendance (Refer Table – 5) 10
Based on Practical Records, Regular viva voce, etc. 10

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Total 20

Table – 8: Guidelines for allotment of marks for attendance

Percentage of Attendance Theory Practical
95 – 100 8 10
90 – 94 6 7.5
85 – 89 4 5
80 – 84 2 2.5
Less than 80 0 0

11.2 Sessional Exams

Two sessional exams shall be conducted for each theory / practical course as per the schedule
fixed by the college(s). The scheme of question paper for theory and practical sessional
examinations is given in the tables 5 – 6. The average marks of two sessional exams shall be
computed for internal assessment as per the requirements given in tables.

12. PROMOTION AND AWARD OF GRADES

A student shall be declared PASS and eligible for getting grade in a course of M. Pharm.
programme if he/she secures at least 50% marks in that particular course including internal
assessment.

13. CARRY FORWARD OF MARKS

In case a student fails to secure the minimum 50% in any Theory or Practical course as
specified in 12, then he/she shall reappear for the end semester examination of that course.
However his/her marks of the Internal Assessment shall be carried over and he/she shall be
entitled for grade obtained by him/her on passing.

14. IMPROVEMENT OF INTERNAL ASSESSMENT

A student shall have the opportunity to improve his/her performance only once in the
sessional exam component of the internal assessment. The re-conduct of the sessional exam
shall be completed before the commencement of next end semester theory examinations.

15. REEXAMINATION OF END SEMESTER EXAMINATIONS

Reexamination of end semester examination shall be conducted as per the schedule given in
table 9. The exact dates of examinations shall be notified from time to time.

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 Table – 9: Tentative schedule of end semester examinations

Semester For Regular candidates For Failed Candidates

I and III November/December April/May
II and IV April/May November/December

16. ALLOWED TO KEEP TERMS (ATKT):

No student shall be admitted to any examination unless he/she fulfills the norms given in 6.
ATKT rules are applicable as follows:
A student shall be eligible to carry forward all the courses of I and II semesters till the III
semester examinations. However, he/she shall not be eligible to attend the courses of IV
semester until all the courses of I, II and III semesters are successfully completed. A student
shall be eligible to get his/her CGPA upon successful completion of the courses of I to IV
semesters within the stipulated time period as per the norms.
Note: Grade AB should be considered as failed and treated as one head for deciding ATKT.
Such rules are also applicable for those students who fail to register for examination(s) of any
course in any semester.

17. GRADING OF PERFORMANCES

17.1. Letter grades and grade points allocations:
Based on the performances, each student shall be awarded a final letter grade at the end of the
semester for each course. The letter grades and their corresponding grade points are given in
Table – 10.
Table – 10: Letter grades and grade points equivalent to Percentage of marks and
performances

Percentage of
Letter Grade Grade Point Performance
Marks Obtained
90.00 – 100 O 10 Outstanding
80.00 – 89.99 A 9 Excellent
70.00 – 79.99 B 8 Good
60.00 – 69.99 C 7 Fair
50.00 – 59.99 D 6 Average
Less than 50 F 0 Fail
Absent AB 0 Fail

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A learner who remains absent for any end semester examination shall be assigned a letter
grade of AB and a corresponding grade point of zero. He/she should reappear for the said
evaluation/examination in due course.
18. THE SEMESTER GRADE POINT AVERAGE (SGPA)
The performance of a student in a semester is indicated by a number called ‘Semester Grade
Point Average’ (SGPA). The SGPA is the weighted average of the grade points obtained in
all the courses by the student during the semester. For example, if a student takes five courses
(Theory/Practical) in a semester with credits C1, C2, C3 and C4 and the student’s grade
points in these courses are G1, G2, G3 and G4, respectively, and then students’ SGPA is
equal to:

The SGPA is calculated to two decimal points. It should be noted that, the SGPA for any
semester shall take into consideration the F and AB grade awarded in that semester. For
example, if a learner has a F or AB grade in course 4, the SGPA shall then be computed as:

19. CUMULATIVE GRADE POINT AVERAGE (CGPA)

The CGPA is calculated with the SGPA of all the IV semesters to two decimal points and is
indicated in final grade report card/final transcript showing the grades of all IV semesters and
their courses. The CGPA shall reflect the failed status in case of F grade(s), till the course(s)
is/are passed. When the course(s) is/are passed by obtaining a pass grade on subsequent
examination(s) the CGPA shall only reflect the new grade and not the fail grades earned
earlier. The CGPA is calculated as:

where C1, C2, C3, …. is the total number of credits for semester I, II, III,… and S1, S2, S3,
…. is the SGPA of semester I, II, III, …. ……….

20. DECLARATION OF CLASS

The class shall be awarded on the basis of CGPA as follows:
First Class with Distinction = CGPA of. 7.50 and above

First Class = CGPA of 6.00 to 7.49

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 Second Class = CGPA of 5.00 to 5.99

21. PROJECT WORK

All the students shall undertake a project under the supervision of a teacher in Semester III to
IV and submit a report. 4 copies of the project report shall be submitted (typed & bound copy
not less than 75 pages).
The internal and external examiner appointed by the University shall evaluate the project at
the time of the practical examinations of other semester(s).

22. AWARD OF RANKS

Ranks and Medals shall be awarded on the basis of final CGPA. However, candidates who
fail in one or more courses during the M. Pharm. programme shall not be eligible for award
of ranks. Moreover, the candidates should have completed the M. Pharm. programme in
minimum prescribed number of years, (two years) for the award of Ranks.

23. AWARD OF DEGREE

Candidates who fulfill the requirements mentioned above shall be eligible for award of
degree during the ensuing convocation.

24. DURATION FOR COMPLETION OF THE PROGRAMME OF STUDY

The duration for the completion of the programme shall be fixed as double the actual duration
of the programme and the students have to pass within the said period, otherwise they have to
get fresh registration.

25. REVALUATION/RETOTALING OF ANSWER PAPERS

There is no provision for revaluation of the answer papers in any examination. However, the
candidates can apply for retotaling by paying prescribed fee.

26. RE-ADMISSION AFTER BREAK OF STUDY

Candidate who seeks re-admission to the programme after break of study has to get the
approval from the University by paying a condonation fee.

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27. PROGRAMME EDUCATIONAL OBJECTIVES (PEO)

PEO1: To provide a comprehensive and advanced pharmaceutical education leading to M.

Pharm. Degree.

PEO2: To integrate pharmacy knowledge and skills with pharmaceutical research.

PEO3: To develop pharmacists to contribute effectively in the social health care system.

PEO4: To provide hands on training through state of art infrastructure to inculcate research
aptitude in pharmaceutical sciences.

PEO5: To inculcate leadership and entrepreneurship capabilities in future pharmacy

professionals.

28. PROGRAM OUTCOMES (PO)

PO1: With the in-depth knowledge of novel drug delivery systems and selection of drugs
and polymers for the development of drug & cosmeceutical products the graduates will excel
in the field.
PO2: Knowledge on various preformulation elements, industrial management and GMP
considerations, Pilot Plant Scale Up Techniques, Stability testing, sterilization and packaging
of dosage forms, the graduate students are competent to meet the challenges of the industry.
PO3: Mastering the regulatory affairs, gain advanced knowledge and skills required to learn
the concept of generic drugs and their development, various regulatory filings in different
countries, different phases of clinical trials and submitting regulatory documents: filing
process of IND, NDA and ANDA will make the graduates versatile pharmaceutical
professionals..
PO4: Mastering the data analysis and interpretation skills with respect to dose calculations,
dose adjustments and apply biopharmaceutics theories in practical problem solving and the
pharmacokinetic models, bioequivalence and clinical pharmacokinetics make them
competent to meet the challenges.
PO5: Required training is imparted on computer applications, Pharmacoinformatics, in drug
development in Computational modeling, Preclinical development, clinical development,
Artificial Intelligence.
PO6: Appreciable knowledge and exercise is imparted on Biostatistics and Research
Methodology to make the students well versed with statistical analysis of the biological data.

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29. PROGRAM SPECIFIC OUTCOMES (PSO)
PSO1: It helps in development of new medications, pharmaceutical formulations by using
the latest technologies and processes.
PSO2: Professional Training to the students to work on drug compounds and develop new
medications based on research. In this, students learn to test medications for efficiency and
safety, oversee the production process to ensure medications are produced accurately,
conduct clinical drug trials and evaluate the drug's effectiveness and to determine potential
risks or side effects.
PSO3: Students are trained to collaborate with various pharmaceutical companies and a
variety of health care professionals to ensure clinical drug trials are conducted safely as per
regulatory guidelines for the testing of drugs.
PSO4: To create a talent pool by involving students in research projects and to make students
undertake research projects under faculty guidance for publication and patenting and to foster
ambitious desire among students to undertake higher studies and career growth.

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 SEMESTER – I

PHARMACEUTICS (MPH)

MPH 101T. MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES

Hours per week: 4L End Examination: 75 Marks

Credit: 4 Midsem: 25 Marks

Course Description: This course is designed to provide the student with basic information
about various instrumental techniques covering spectroscopy, chromatography and thermal
analysis. During the course the student will be learning the concepts and applications of
various absorption (UV-Visible, IR) and emission (Spectrofluorimetry, Flame photometry)
spectroscopic techniques along with X-ray crystallography, NMR and Mass spectroscopy.
The student will also gain knowledge on the significance of various basic to complex
chromatographic (TLC, HPLC, GC, Affinity chromatography) and electrophoresis (Gel,
Moving boundary) techniques.

Course objectives: This subject deals with various advanced analytical instrumental
techniques for identification, characterization and quantification of drugs. Instruments
dealt are NMR, Mass spectrometer, IR, HPLC, GC etc.

UNIT – I 12 Hrs
a. UV-Visible spectroscopy: Introduction, Theory, laws, instrumentation associated with UV-
Visible spectroscopy, choice of solvents and solvent effect and applications of UV-Visible
spectroscopy, difference/ derivative spectroscopy.
b. IR spectroscopy: Theory, modes of molecular vibrations, sample handling, instrumentation
of dispersive and Fourier Transform IR spectrometer, factors affecting vibrational
frequencies and applications of IR spectroscopy, data interpretation.
c. Spectrofluorimetry: Theory of fluorescence, factors affecting fluorescence (characteristics
of drugs that can be analyzed by fluorimetry), quenchers, instrumentation and applications of
fluorescence spectrophotometer.
d. Flame emission spectroscopy and Atomic absorption spectroscopy: Principle,
instrumentation, interferences and applications.

UNIT – II 12 Hrs
NMR spectroscopy: Quantum numbers and their role in NMR, principle, instrumentation,
solvent requirement in NMR, relaxation process, NMR signals in various compounds,
chemical shift, factors influencing chemical shift, spin-spin coupling, coupling constant,
nuclear magnetic double resonance, brief outline of principles of FT-NMR and 13C NMR.
Applications of NMR spectroscopy.

UNIT – III 12 Hrs

Mass Spectroscopy: Principle, theory, instrumentation of mass spectroscopy, different types
of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI.
Analyzers of quadrupole and time of flight, mass fragmentation and its rules, meta stable
ions, isotopic peaks and applications of mass spectroscopy.

UNIT – IV 12 Hrs

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Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors
affecting resolution, isolation of drug from excipients, data interpretation and applications of
the following:
a. Thin layer chromatography
b. High performance thin layer chromatography
c. Ion exchange chromatography
d. Column chromatography
e. Gas chromatography
f. High performance liquid chromatography
g. Ultra high performance liquid chromatography
h. Affinity chromatography
i. Gel chromatography

UNIT – V 12 Hrs
a. Principle, instrumentation and applications of gel electrophoresis and moving boundary
electrophoresis
b. X ray Crystallography: Production of X rays, different X ray methods, Bragg’s law,
rotating crystal technique, X ray powder technique, types of crystals and applications of X-
ray diffraction
c. Thermal Techniques:
Differential Scanning Calorimetry (DSC): Principle, thermal transitions and instrumentation
(Heat flux and power-compensation and designs), modulated DSC, hyper DSC, experimental
parameters (sample preparation, experimental conditions, calibration, heating and cooling
rates, resolution, source of errors) and their influence, advantage and disadvantages,
pharmaceutical applications.
Differential Thermal Analysis (DTA): Principle, instrumentation and advantage and
disadvantages, pharmaceutical applications, derivative differential thermal analysis (DDTA).
Thermogravimetric Analysis (TGA): Principle, instrumentation, factors affecting results,
advantage and disadvantages, pharmaceutical applications.

Course Outcomes: After completion of course student is able to know,

● The analysis of various drugs in single and combination dosage forms
● Theoretical and practical skills of the instruments

References
1. Spectrometric Identification of Organic compounds - Robert M Silverstein, 6th edition,
John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A.
Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – A H Beckett and J B Stenlake, Vol II, 4th edition,
CBS Publishers, New Delhi, 1997.
5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd edition, CBS
Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol 11, Marcel.
Dekker Series
8. Spectroscopy of Organic Compounds, 2nd edition, P.S/Kalsi, Wiley Eastern Ltd., Delhi.
9. Textbook of Pharmaceutical Analysis, K A Connors, 3rd edition, John Wiley & Sons, 1982.

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 MPH 102T. DRUG DELIVERY SYSTEMS

Hours per week: 4L End Examination: 75 Marks

Credit: 4 Midsem: 25 Marks

Course Description
Drug Delivery System is an important course for the M.Pharm (Pharmaceutics) students. It is
a core course of pharmaceutics, which trains the students in different novel drug delivery
system, and formulation strategies involved in it. This course includes principles,
formulations, stability and production aspects of SR/CR formulation, Gastro-Retentive,
ocular, transdermal, Protein and Peptide drug delivery systems. This course develops
research approach in M.Pharm students specially in the area of formulation and development.

Corse objectives: This course is designed to impart knowledge on the area of advances in
novel drug delivery systems.

UNIT – I 12 Hrs
SR/CR formulation: Introduction & basic concepts, advantages/ disadvantages, factors
influencing, physicochemical & biological approaches for SR/CR formulation, mechanism of
drug delivery from SR/CR formulation. Dosage forms for personalized medicine:
Introduction, definition, pharmacogenetics, categories of patients for personalized medicines.
Customized drug delivery systems, bioelectronic medicines, 3D printing of pharmaceuticals,
telepharmacy.

UNIT – II 12 Hrs
Rate Controlled Drug Delivery Systems: Principles & fundamentals, types, activation;
modulated drug delivery systems; mechanically activated, pH activated, enzyme activated,
and osmotic activated drug delivery systems, feedback regulated drug delivery systems;
Principles & fundamentals.
Polymers: Introduction, definition, classification, properties and application

UNIT – III 12 Hrs

Gastro-Retentive Drug Delivery Systems: Principle, concepts, advantages and disadvantages,
modulation of GI transit time approaches to extend GI transit.
Buccal Drug Delivery Systems: Principle of muco adhesion, advantages and disadvantages,
mechanism of drug permeation, methods of formulation and its evaluations.

UNIT – IV 12 Hrs
Occular Drug Delivery Systems: Barriers of drug permeation,
Methods to overcome barriers.
Transdermal Drug Delivery Systems: Structure of skin and barriers, penetration enhancers,
Transdermal Drug Delivery Systems, formulation and evaluation.

UNIT – V 12 Hrs
Protein and Peptide Delivery: Barriers for protein delivery.
Formulation and Evaluation of delivery systems of proteins and other macromolecules.
Vaccine delivery systems: Vaccines, uptake of antigens, single shot vaccines, mucosal and
transdermal delivery of vaccines.

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Course Outcomes: Upon completion of the course, student shall be able to understand
● The various approaches for development of novel drug delivery systems.
● The criteria for selection of drugs and polymers for the development of delivering
system
● The formulation and evaluation of Novel drug delivery systems.

References
1. Y. W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel
Dekker, Inc., New York, 1992.
2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker, Inc.,
New York, 1992.
3. Encyclopedia of controlled delivery, Editor - Edith Mathiowitz, Published by Wiley
Interscience Publication, John Wiley and Sons, Inc., New York! Chichester/Weinheim
4. N. K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New
Delhi, 1st edition 1997 (reprint in 2001).
5. S. P. Vyas and R. K. Khar, Controlled Drug Delivery - concepts and advances, Vallabh
Prakashan, New Delhi, First edition 2002

Journals
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian drugs (IDMA)
3. Journal of controlled release (Elsevier Sciences) desirable
4. Drug Development and Industrial Pharmacy (Marcel & Decker) desirable

MPH 103T. MODERN PHARMACEUTICS

Hours per week: 4L End Examination: 75 Marks

Credit: 4 Midsem: 25 Marks

Course Description

Modern Pharmaceutics is an important course for the M.Pharm (Pharmaceutics) students. It

is a core course of pharmaceutics, which trains the students different concepts related to
Preformulation, Dissolution, Theories of dispersion, Large and small volume parenterals,
Compression and Consolidation, cGMP & Industrial Management and different parameters
related to validation and optimization techniques

Course objectives: Course designed to impart advanced knowledge and skills required to
learn various aspects and concepts at pharmaceutical industries

UNIT – I 12 Hrs
Preformation Concepts – Drug excipient interactions - different methods, kinetics of stability,
stability testing.
Dissolution: Dissolution mechanisms, kinetic models for drug release - zero order, first order,
Hixson Crowell’s, Higuchi, Peppas, various compendial dissolution apparatus, dissolution
profiles comparison- difference factor (f1), similarity factor (f2).

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UNIT – II 12 Hrs
Theories of dispersion and pharmaceutical dispersion (emulsion and suspension, SMEDDS)
preparation and stability.
Large and small volume parenterals – physiological and formulation consideration,
manufacturing and evaluation.

UNIT – III 12 Hrs

Compression and Consolidation: Physics of tablet compression, consolidation, effect of
friction, force distribution, force – volume distribution, Heckel plots, decompression, energy
involved in compression

UNIT – IV 12 Hrs
cGMP & Industrial Management: Objectives and policies of current good manufacturing
practices, layout of buildings, services, equipments and their maintenance.
Production management: Production organization, materials management, handling and
transportation, inventory management and control, production and planning control, Sales
forecasting, budget and cost control, industrial and personal relationship.
Concept of Total Quality Management.

UNIT – V 12 Hrs
Validation: Introduction to Pharmaceutical Validation, Scope & merits of validation,
validation and calibration of master plan, ICH & WHO guidelines for calibration and
validation of equipment, validation of specific dosage form, types of validation. Government
regulation, manufacturing process model, URS, DQ, IQ, OQ & PQ. of facilities.
Optimization techniques in Pharmaceutical Formulation: Concept and parameters of
optimization, optimization techniques in pharmaceutical formulation and processing.
Statistical design, response surface method, contour designs, factorial designs and application
in formulation.

Course Outcomes: Upon completion of the course, student shall be able to understand
● The elements of preformulation studies.
● The active pharmaceutical ingredients and generic drug product development
● Industrial management and GMP considerations.
● Optimization techniques & pilot plant scale up techniques
● Stability testing, sterilization process & packaging of dosage forms.

References
1. Theory and Practice of Industrial Pharmacy by Lachmann and Libermann
2. Pharmaceutical dosage forms: Tablets Vol. 1-3 by Leon Lachmann.
3. Pharmaceutical Dosage forms: Disperse systems, Vol, 1-2; by Leon Lachmann.
4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; by Leon Lachmann.
5. Modern Pharmaceutics; By Gillbert and S. Banker.
6. Remington’s Pharmaceutical Sciences.
7. Advances in Pharmaceutical Sciences Vol. 1-5; by H. S. Bean & A. H. Beckett.
8. Physical Pharmacy; by Alfred martin
9. Bentley’s Textbook of Pharmaceutics – by Rawlins.
10.Good manufacturing practices for Pharmaceuticals: A plan for total quality control,
Second edition; by Sidney H. Willig.
11. Quality Assurance Guide; by Organization of Pharmaceutical producers of India.

19
12. Drug formulation manual; by D. P. S. Kohli and D. H. Shah. Eastern publishers, New
Delhi.
13. How to practice GMPs; by P. P. Sharma. Vandhana Publications, Agra.
14. Pharmaceutical Process Validation; by Fra. R. Berry and Robert A. Nash.
15. Pharmaceutical Preformulations; by J. J. Wells.
16. Applied production and operations management; by Evans, Anderson, Sweeney and
Williams.
17. Encyclopaedia of Pharmaceutical technology, Vol I – III.

MPH 104T. REGULATORY AFFAIRS

Hours per week: 4L End Examination: 75 Marks

Credit: 4 Midsem: 25 Marks

Course Description:

The course helps to provide a comprehensive education in the important aspects of

Regulatory and Quality Compliance in the pharmaceutical industry. which trains the students
in approval process of various regulatory filings in different countries, different phases of
clinical trials and submitting regulatory documents, Pharmacovigilance and process of
monitoring in clinical trials

Course objectives: Course designed to impart advanced knowledge and skills required to
learn the concept of generic drug and their development, various regulatory filings in different
countries, different phases of clinical trials and submitting regulatory documents: filing
process of IND, NDA and ANDA
● To know the approval process of
● To know the chemistry, manufacturing controls and their regulatory importance
● To learn the documentation requirements for
● To learn the importance and

UNIT – I 12 Hrs
Documentation in the pharmaceutical industry: Master formula record, DMF (Drug Master
File), distribution records. Generic drugs product development introduction, Hatch- Waxman
act and amendments, CFR (CODE OF FEDERAL REGULATION), drug product
performance, in-vitro, ANDA regulatory approval process, NDA approval process, BE and
drug product assessment, in–vivo, scale up process approval changes, post marketing
surveillance, outsourcing BA and BE to CRO.

UNIT – II 12 Hrs
Regulatory requirement for product approval: API, biologics, novel, therapies obtaining
NDA, ANDA for generic drugs ways and means of US registration for foreign drugs

UNIT – III 12 Hrs

CMC, post approval regulatory affairs. Regulation for combination products and medical
devices. CTD and ECTD format, industry and FDA liaison.
ICH - Guidelines of ICH- Q, S, E, M. Regulatory requirements of EU, MHRA, TGA and
ROW countries.

UNIT – IV 12 Hrs

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Non clinical drug development: Global submission of IND, NDA, ANDA. Investigation of
medicinal products dossier, dossier (IMPD) and investigator brochure (IB).

UNIT – V 12 Hrs
Clinical trials: Developing clinical trial protocols. Institutional review board/ independent
ethics committee formulation and working procedures informed. Consent process and
procedures. HIPAA - new requirement to clinical study process, pharmacovigilance safety
monitoring in clinical trials.

Course Outcomes: Upon completion of the course, it is expected that the students will be
able to understand
● The Concepts of innovator and generic drugs, drug development process
● The Regulatory guidance and guidelines for filing and approval process
● Preparation of Dossiers and their submission to regulatory agencies in different
countries
● Post approval regulatory requirements for actives and drug products
● Submission of global documents in CTD/ eCTD formats
● Clinical trials requirements for approvals for conducting clinical trials
● Pharmacovigilance and process of monitoring in clinical trials.

References
1.Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and
IsaderKaufer, Marcel Dekker series, Vol.143
2.The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert
P.Martin, Drugs and the Pharmaceutical Sciences, Vol.185, Informa Health care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations by Richard A Guarino,
MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. by John Wiley &Sons.Inc.
5.FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics/edited by Douglas J. Pisano, David Mantus.
6. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance by Fay
A.Rozovsky and Rodney K. Adams
7. www.ich.org/
8. www.fda.gov/
9. europa.eu/index_en.htm
10. https://www.tga.gov.au/tga-basics

MPH 105P. PHARMACEUTICS PRACTICALS – I

Hours per week: 12 End Examination: 100 Marks

Credit: 6 Midsem: 50 Marks

1.Analysis of pharmacopoeial compounds and their formulations by UV-Vis

spectrophotometer
2.Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3. Experiments based on HPLC
4. Experiments based on Gas Chromatography

21
5. Estimation of riboflavin/quinine sulphate by fluorimetry
6. Estimation of sodium/potassium by flame photometry
7. To perform In-vitro dissolution profile of CR/ SR marketed formulation
8. Formulation and evaluation of sustained release matrix tablets
9. Formulation and evaluation osmotically controlled DDS
10. Preparation and evaluation of floating DDS- hydro dynamically balanced DDS
11. Formulation and evaluation of Mucoadhesive tablets.
12. Formulation and evaluation of transdermal patches.
13. To carry out preformulation studies of tablets.
14. To study the effect of compressional force on tablet disintegration time.
15. To study micromeritic properties of powders and granulation.
16. To study the effect of particle size on dissolution of a tablet.
17. To study the effect of binders on dissolution of a tablet.
18. To plot Heckal plot, Higuchi and peppas plot and determine similarity factors.

SEMESTER – II

MPH 201T. MOLECULAR PHARMACEUTICS

(NANO TECHNOLOGY & TARGETED DDS) (NTDS)

Hours per week: 4L End Examination: 75 Marks

Credit: 4 Midsem: 25 Marks

Course description: This course is designed to impart knowledge on the area of advances in
novel drug delivery systems.It describes various approaches for development of novel drug
delivery systems.The criteria for selection of drugs and polymers for the development of
NTDS and the formulation and evaluation of novel drug delivery systems.Gives complete
knowledge about Targeted Drug Delivery Systems and concepts events and biological process
involved in drug targeting tumor targeting and brain specific delivery.

Course objectives: This course is designed to impart knowledge on the area of advances in
novel drug delivery systems.

UNIT – I 12 Hrs
Targeted Drug Delivery Systems: Concepts, events and biological process involved in drug
targeting. Tumor targeting and brain specific delivery.

UNIT – II 12 Hrs
Targeting Methods: Introduction, preparation and evaluation.
Nano Particles & Liposomes: Types, preparation and evaluation.

UNIT – III 12 Hrs

Micro Capsules/Micro Spheres: Types, preparation and evaluation, monoclonal antibodies;
preparation and application, preparation and application of niosomes, aquasomes,
phytosomes, electrosomes.

UNIT – IV 12 Hrs
Pulmonary Drug Delivery Systems: Aerosols, propellents, container types, preparation and
evaluation

22
Intra Nasal Route Delivery systems; Types, preparation and evaluation.

UNIT –V 12 Hrs
Nucleic acid based therapeutic delivery system: Gene therapy, introduction (ex-vivo & in-
vivo gene therapy). Potential target diseases for gene therapy (inherited disorder and cancer).
Gene expression systems (viral and nonviral gene transfer). Liposomal gene delivery
systems.
Biodistribution and Pharmacokinetics. Knowledge of therapeutic antisense molecules and
aptamers as drugs of the future.

Course Outcomes: Upon completion of the course student shall be able to understand
● The various approaches for development of novel drug delivery systems.
● The criteria for selection of drugs and polymers for the development of NTDS
The formulation and evaluation of novel drug delivery systems.

References
1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel
Dekker, Inc., New York, 1992.
2. S. P. Vyas and R. K. Khar, Controlled Drug Delivery - concepts and advances,
VallabhPrakashan, New Delhi, First edition 2002.
3. N. K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New
Delhi, First edition 1997 (reprint in 2001).

MPH 202T. ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS

Hours per week: 4L End Examination: 75 Marks

Credit: 4 Midsem: 25 Marks

Course description: This course is designed to impart knowledge and skills necessary for
dose calculations, dose adjustments and to apply biopharmaceutics theories in practical
problem solving.The basic concepts in biopharmaceutics and pharmacokinetics and the use of
raw data and derive the pharmacokinetic models and parameters the best describe the
process of drug absorption, distribution, metabolism and elimination.This course also
describes about the critical evaluation of biopharmaceutical studies involving drug product
equivalency. This subject also describes potential clinical pharmacokinetic problems and
application of basics of pharmacokinetics.

Course objectives: This course is designed to impart knowledge and skills necessary for dose
calculations, dose adjustments and to apply biopharmaceutics theories in practical problem
solving. Basic theoretical discussions of the principles of biopharmaceutics and
pharmacokinetics are provided to help the students to clarify the concepts.

UNIT – I 12 Hrs
Drug Absorption from the Gastrointestinal Tract: Gastrointestinal tract, mechanism of drug
absorption, factors affecting drug absorption, pH–partition theory of drug absorption.
Formulation and physicochemical factors: Dissolution rate, dissolution process, Noyes–
Whitney equation and drug dissolution, factors affecting the dissolution rate. Gastrointestinal

23
absorption: role of the dosage form: Solution (elixir, syrup and solution) as a dosage form,
suspension as a dosage form, capsule as a dosage form, tablet as a dosage form, dissolution
methods, formulation and processing factors, correlation of in vivo data with in vitro
dissolution data. Transport model: Permeability-solubility-charge state and the pH partition
hypothesis, properties of the gastrointestinal tract (GIT), pH microclimate intracellular pH
environment, tight-junction complex.

UNIT – II 12 Hrs
Biopharmaceutic considerations in drug product design and in vitro drug product
Performance: Introduction, biopharmaceutic factors affecting drug bioavailability, rate-
limiting steps in drug absorption, physicochemical nature of the drug formulation factors
affecting drug product performance, in vitro: dissolution and drug release testing,
compendial methods of dissolution, alternative methods of dissolution testing, meeting
dissolution requirements, problems of variable control in dissolution testing performance of
drug products. In vitro–in vivo correlation, dissolution profile comparisons, drug product
stability, considerations in the design of a drug product.

UNIT – III 12 Hrs

Pharmacokinetics: Basic considerations, pharmacokinetic models,
Compartment modeling: one compartment model- IV bolus, IV infusion, extra-vascular.
Multi compartment model: two compartment - model in brief,
Non-linear pharmacokinetics: cause of non-linearity, Michaelis – Menten equation,
estimation of kmax and vmax.
Drug interactions: introduction, the effect of protein-binding interactions, the effect of tissue-
binding interactions, cytochrome p450-based drug interactions, drug interactions linked to
transporters.

UNIT – IV 12 Hrs
Drug Product Performance, In Vivo: Bioavailability and bioequivalence: drug product
performance, purpose of bioavailability studies, relative and absolute availability. Methods
for assessing bioavailability, bioequivalence studies, design and evaluation of bioequivalence
studies, study designs, crossover study designs, evaluation of the data, bioequivalence
example, study submission and drug review process. Biopharmaceutics classification system,
methods. Permeability: In-vitro, in-situ and in-vivo methods. Generic biologics (biosimilar
drug products), clinical significance of bioequivalence studies, special concerns in
bioavailability and bioequivalence studies, generic substitution.

UNIT – V 12 Hrs
Application of Pharmacokinetics: Modified-release drug products, targeted drug delivery
systems and biotechnological products. Introduction to pharmacokinetics and
pharmacodynamic, drug interactions. Pharmacokinetics and pharmacodynamics of
biotechnology drugs. Introduction, proteins and peptides, monoclonal antibodies,
oligonucleotides, vaccines (immunotherapy), gene therapies.

Course Outcomes: Upon completion of this course it is expected that students will be able
understand,
● The basic concepts in biopharmaceutics and pharmacokinetics.
● The use raw data and derive the pharmacokinetic models and parameters the best
describe the process of drug absorption, distribution, metabolism and elimination.

24
● The critical evaluation of biopharmaceutical studies involving drug product
equivalency.
● The design and evaluation of dosage regimens of the drugs using pharmacokinetic and
biopharmaceutic parameters.
● The potential clinical pharmacokinetic problems and application of basics of
pharmacokinetic

References
1.Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th edition,Philadelphia,
Lea and Febiger, 1991
2. Biopharmaceutics and Pharmacokinetics, A. Treatise, D. M. Brahmankar and Sunil B.
Jaiswal., VallabPrakashan, Pitampura, Delhi
3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC, 2nd edition,
Connecticut Appleton Century Crofts, 1985
4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R. Hiremath,
Prism Book
5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker Inc.,New
York, 1982
6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J, Lea and
Febiger, Philadelphia, 1970
7. Clinical Pharmacokinetics, Concepts and Applications 3rd edition by Malcolm Rowland
and Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995
8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack PublishingCompany,
Pennsylvania 1989
9. Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th edition, revised and
expanded by Robert. E. Notari, Marcel Dekker Inc, New York and Basel, 1987.
10. Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and
M.Pemarowski, 1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971.
11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.
Boylan, Marcel Dekker Inc, New York, 1996.
12. Basic Pharmacokinetics, 1st edition, Sunil S Jambhekarand Philip J Breen, Pharmaceutical
press, RPS Publishing, 2009.
13. Absorption and Drug Development - Solubility, Permeability and Charge State, Alex
Avdeef, John Wiley & Sons, Inc, 2003.

MPH 203T. COMPUTER AIDED DRUG DEVELOPMENT

Hours per week: 4L End Examination: 75 Marks

Credit: 4 Midsem: 25 Marks

Course description: This course is designed to impart knowledge about computers in

pharmaceutical research and development.Usage of computational modeling of drug
disposition and computers in preclinical development. Different optimization techniques in
pharmaceutical formulation and usage of computers in market analysis and clinical
development.Recent advances in Artificial intelligence (AI) and robotics in pharmaceutical
research and development .

Course objectives: This course is designed to impart knowledge and skills necessary for
computer Applications in pharmaceutical research and development who want to understand
the application of computers across the entire drug research and development process. Basic

25
theoretical discussions of the principles of more integrated and coherent use of computerized
information (informatics) in the drug development process are provided to help the students
to clarify the concepts.

UNIT – I 12 Hrs
a. Computers in Pharmaceutical Research and Development: A general overview. History of
computers in pharmaceutical research and development. Statistical modeling in
pharmaceutical research and development: Descriptive versus mechanistic modeling,
statistical parameters, estimation, confidence regions, nonlinearity at the optimum, sensitivity
analysis, optimal design, population modeling.
b. Quality-by-Design in pharmaceutical development: Introduction, ICH Q8 guideline,
regulatory and industry views on QbD, scientifically based QbD - examples of application.

UNIT – II 12 Hrs
Computational Modeling of Drug Disposition: Introduction, modeling techniques: Drug
absorption, solubility, intestinal permeation, drug distribution, drug excretion, active
transport; P-gp, BCRP, nucleoside transporters, hPEPT1, ASBT, OCT, OATP, BBB-choline
transporter.

UNIT – III 12 Hrs

Computer-aided formulation development: Concept of optimization, optimization parameters,
factorial design, optimization technology & screening design. Computers in pharmaceutical
formulation: development of pharmaceutical emulsions, microemulsion drug carriers. Legal
protection of innovative uses of computers in R&D, the ethics of computing in
pharmaceutical research, computers in market analysis.

UNIT – IV 12 Hrs
a.Computer-aided biopharmaceutical characterization: Gastrointestinal absorption simulation.
Introduction, theoretical background, model construction, parameter sensitivity analysis,
virtual trial, fed vs. fasted state, in vitro dissolution and in vitro- in vivo correlation,
Biowaiver considerations.
b.Computer Simulations in Pharmacokinetics and Pharmacodynamics: Introduction,
Computer simulation: Whole organism, isolated tissues, organs, cell, proteins and genes.
c.Computers in Clinical Development: Clinical data collection and management, regulation
of computer systems

UNIT – V 12 Hrs
Artificial Intelligence (AI), Robotics and Computational fluid dynamics: General overview,
pharmaceutical automation, pharmaceutical applications, advantages and disadvantages.
current challenges and future directions.

Course Outcomes: Upon completion of this course it is expected that students will be able
to understand,
• History of computers in pharmaceutical research and development
• Computational modeling of drug disposition
• Computers in preclinical development
• Optimization techniques in pharmaceutical formulation
• Computers in market analysis

26
• Computers in clinical development
• Artificial intelligence (AI) and robotics
• Computational fluid dynamics (CFD)

References
1. Computer Applications in Pharmaceutical Research and Development, Sean Ekins, 2006,
John Wiley & Sons.
2. Computer-Aided Applications in Pharmaceutical Technology, 1st edition, Jelena Djuris,
Woodhead Publishing
3. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G. Boylan,
Marcel Dekker Inc, New York, 1996.

MPH 204T. COSMETICS AND COSMECEUTICALS

Hours per week: 4L End Examination: 75 Marks

Credit: 4 Midsem: 25 Marks

Course description: This course describes the fundamental need for cosmetic and
cosmeceutical products.This course describes the key ingredients used in cosmetics and
cosmeceuticals and key building blocks for various formulations.Recent technologies in the
market for designing of cosmetics and cosmeceuticals and various key ingredients and basic
science to develop cosmetics and cosmeceuticals.It also describes the scientific knowledge to
develop stable, safe and effective cosmetics and cosmeceuticals.

Course objectives: This course is designed to impart knowledge and skills necessary for the
fundamental need for cosmetic and cosmeceutical products.

UNIT – I 12 Hrs
Cosmetics – Regulatory: Definition of cosmetic products as per Indian regulation. Indian
regulatory requirements for labeling of cosmetics regulatory provisions relating to import of
cosmetics. Misbranded and spurious cosmetics. Regulatory provisions relating to
manufacture of cosmetics – conditions for obtaining license, prohibition of manufacture and
sale of certain cosmetics, loan license, offenses and penalties.

UNIT – II 12 Hrs
Cosmetics - Biological aspects: Structure of skin relating to problems like dry skin, acne,
pigmentation, prickly heat, wrinkles and body odor. Structure of hair and hair growth cycle.
Common problems associated with oral cavity. Cleansing and care needs for face, eye lids,
lips, hands, feet, nail, scalp, neck, body and under-arm.

UNIT – III 12 Hrs

Formulation Building blocks: Building blocks for different product formulations of
cosmetics/cosmeceuticals.
Surfactants – Classification and application. Emollients, rheological additives: classification
and application.
Antimicrobial used as preservatives, their merits and demerits. Factors affecting microbial
preservative efficacy.

27
Building blocks for formulation of a moisturizing cream, vanishing cream, cold cream,
shampoo and toothpaste.
Soaps and syndet bars.
Perfumes; Classification of perfumes. Perfume ingredients listed as allergens in EU
regulation.
Controversial ingredients: Parabens, formaldehyde liberators, dioxane.

UNIT – IV 12 Hrs
Design of cosmeceutical products: Sun protection, sunscreens classification and regulatory
aspects. Addressing dry skin, acne, sun-protection, pigmentation, prickly heat, wrinkles, body
odor, and dandruff. Dental cavities, bleeding gums, mouth odor and sensitive teeth through
cosmeceutical formulations.

UNIT – V 12 Hrs
Herbal Cosmetics: Herbal ingredients used in hair care, skin care and oral care. Review of
guidelines for herbal cosmetics by private bodies like cosmos with respect to preservatives,
emollients, foaming agents, emulsifiers and rheology modifiers. Challenges in formulating
herbal cosmetics.

Course Outcomes: Upon completion of the course, the students shall be able to understand
● Key ingredients used in cosmetics and cosmeceuticals.
● Key building blocks for various formulations.
● Current technologies in the market
● Various key ingredients and basic science to develop cosmetics and cosmeceuticals
● Scientific knowledge to develop cosmetics and cosmeceuticals with desired safety,
stability, and efficacy.

References
1. Harry’s Cosmeticology. 8th edition.
2. Poucher's Perfumes cosmetics and soaps, 10th edition.
3. Cosmetics - Formulation, Manufacture and quality control, P. P. Sharma, 4th edition
4. Handbook of cosmetic science and Technology A. O. Barel, M. Paye and H. I. Maibach.
3rd edition
5. Cosmetic and Toiletries recent suppliers’ catalogue.
6. CTFA directory.

MPH 205P. PHARMACEUTICS PRACTICALS – II

Hours per week: 12 End Examination: 100 Marks

Credit: 6 Midsem: 50 Marks

1. To study the effect of temperature change, non solvent addition, incompatible polymer
addition in microcapsules preparation.
2. Preparation and evaluation of Alginate beads
3. Formulation and evaluation of gelatin /albumin microspheres
4. Formulation and evaluation of liposomes/niosomes
5. Formulation and evaluation of spherules
6. Improvement of dissolution characteristics of slightly soluble drug by Solid dispersion
technique.
7. Comparison of dissolution of two different marketed products /brands

28
8. Protein binding studies of a highly protein bound drug & poorly protein bound drug
9. Bioavailability studies of paracetamol in animals.
10. Pharmacokinetic and IVIVC data analysis by Winnoline® software.
11. In vitro cell studies for permeability and metabolism
12. DoE using Design Expert® Software
13. Formulation data analysis using Design Expert® Software
14. Quality-by-Design in pharmaceutical development
15. Computer simulations in pharmacokinetics and pharmacodynamics
16. Computational modeling of drug disposition
17. To develop clinical data collection manual
18. To carry out sensitivity analysis, and population modeling.
19. Development and evaluation of creams.
20. Development and evaluation of shampoo and toothpaste base.
21. To incorporate herbal and chemical actives to develop products.
22. To address dry skin, acne, blemish, wrinkles, bleeding gums and dandruff.

● The concept of calibration, qualification and validation.

1. Qualification of pharmaceutical testing equipment (Dissolution testing apparatus,
friability apparatus, disintegration tester)
2. Check list for bulk pharmaceutical chemicals vendors
3. Check list for tableting production.
4. Check list for sterile production area
5. Check list for water for injection.
6. Design of plant layout: Sterile and non-sterile
7. Case study on application of QbD
8. Case study on application of PAT

SEMESTER – III

MRM 301T. RESEARCH METHODOLOGY & BIOSTATISTICS

Hours per week: 4L End Examination: 75 Marks
Credit: 4 Midsem: 25 Marks

Course Description: This introductory course of research methodologies and biostatistics

will give students an overview of the many study designs and statistical tests that are used
in the medical industry to answer research issues. This course focuses on the CPCSEA
guidelines and prerequisites for performing animal experiments, categorising research
projects, developing a study, experimental design, measuring and interpreting data, and
conducting ethical research.

Course objectives: Impart knowledge on statistical principles that can be applied to design
experiments and help in the interpretation of the results.

UNIT – I 12 Hrs
General Research Methodology: Research, objective, requirements, practical difficulties,
review of literature, study design, types of studies, strategies to eliminate errors/bias,
controls, randomization, crossover design, placebo, blinding techniques.

29
UNIT – II 12 Hrs
Biostatistics: Definition, application, sample size, importance of sample size, factors
influencing sample size, dropouts.
Measures of central tendency: Computation of means, median and mode from grouped and
ungrouped data. Measure of dispersion: Computation of variance, standard deviation,
standard error and their coefficients.

UNIT – III 12 Hrs

Regression and correlation: Method of least squares, Correlation Coefficient, rank correlation
and multiple regressions.
Probability rules: Binomial, poison and normal distribution.

UNIT – IV 12 Hrs
Tests of significance: Testing hypotheses- principle and applications of Z, t-, F- ratio and chi-
square tests in pharmaceutical and medical research. Analysis of Variance: 1-way, 2-way and
3-way classification. Non-parametric tests: Sign test, Wilcoxon signed rank test, Wilcoxon
rank sum test, Kruskal Wallis test, run test and median tests.

UNIT – V 12 Hrs
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal hygiene, location of animal
facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal
husbandry, record keeping, SOPs, personnel and training, transport of lab animals.
Declaration of Helsinki: History, introduction, basic principles for all medical research, and
additional principles for medical research combined with medical care.

Course Outcomes: Upon completion of the course the student is able to select appropriate
statistical methods required for a particular research design and develop appropriate research
hypothesis for a research project. Develop appropriate framework for research studies. Gain
knowledge regarding CPCSEA guidelines and prerequisites for conducting animal
experiments.

References
1. Santosh Gupta: “Research Methodology and Statistical Techniques”, Deep & Deep
Publication, 2001
2. C. R. Kothari: “Research Methodology – Methods & Techniques”, 2nd edition, Wishwa
Prakashan, 2000.
3. K. P. C. Swain:“A Text book of Research Methodology”, 1st edition, Kalyani Publishers,
2007.
4. “Research Methodology and Statistical Techniques” Indira Gandhi National Open
University.
5. M. N. Ghosh: “Fundamentals of Experimental Pharmacology”, 2nd edition, Scientific
Book Agency, Calcutta, India, 1984.
6. H. G. Vogel: “Drug Discovery and Evaluation-Pharmacological Assays”, 2nd edition,
Springer Verlag, Berlin, Germany, 2002.

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