M. Ansari Pharm D, PhD Associate Professor of Pharmaceutics.
M.Pharm (Pharmaceutics) -...
Transcript of M.Pharm (Pharmaceutics) -...
ACADEMIC REGULATIONS, COURSE STRUCTURE
AND DETAILED SYLLABUS
FOR
MASTER PHARMACY TWO YEAR POST GRADUATE COURSE
(Applicable for the batches admitted from 2012-2013)
ANURAG GROUP OF INSTITUTIONS
(AUTONOMOUS)
SCHOOL OF PHARMACY
Venkatapur, Ghatkesar, Hyderabad – 500088
M.Pharm (Pharmaceutics)
2012-2013
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Academic Regulations for M. Pharm (Regular) Degree Course
(Effective for the students admitted into I year from the Academic Year 2012-2013 onwards)
The M.Pharm Degree of Jawaharlal Nehru Technological University
Hyderabad shall be conferred on candidates who are admitted to the program and
fulfill all the requirements for the award of the degree.
1.0 ELIGIBILITY FOR ADMISSIONS:
Admission to the above program shall be made subject to the eligibility,
qualifications and specialization prescribed by the university from time to
time.
Admissions shall be made on the basis of merit rank obtained by the
qualifying candidate at an Entrance Test conducted by the University or on the
basis of any other order of merit approved by the University, subject to
reservations prescribed by the university from time to time.
2.0 AWARD OF M.PHARM DEGREE:
2.1 A student shall be declared eligible for the award of the M.Pharm degree, if
he pursues a course of study and completes it successfully for not less than
two academic years and not more than four academic years.
2.2 A Student, who fails to fulfil all the academic requirements for the award of
the degree within four academic years from the year of his admission, shall
forfeit his seat in M.Pharm course.
2.3 The minimum instruction period for each semester is 90 clear instruction
days.
3.0 COURSE OF STUDY The following specializations are offered at present for the M.Pharm Course
of study.
1. Hospital and Clinical Pharmacy
2. Pharmaceutics
3. Industrial Pharmacy
4. Pharmacology
5. Pharmaceutical Analysis and Quality Assurance
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4.0 ATTENDANCE:
The programs are offered on a unit basis with each subject being considered
as an unit.
4.1 A candidate shall be deemed to have eligibility to write end semester
examinations in a subject if he has put in at least 75% of attendance in the
subject.
4.2 Shortage of attendance up to 10% in any subject (i.e. 65% and above and
below 75%) may be condoned by the college Academic council on genuine
and valid reasons on representation by the candidate with supporting
evidence.
4.3 A candidate shall get minimum required attendance at least in three (3) theory
subjects in the present semester to get promoted to the next semester. In order
to qualify for the award of the M.Pharm Degree, The candidate shall
complete all the academic requirements of the subjects, as per the course
structure.
4.4 Shortage of attendance below 65% shall in no case be condoned
4.5 A stipulated fee shall be payable towards condonation of shortage of
attendance.
5.0 EVALUATION:
The performance of the candidate in each semester shall be evaluated
subject-wise, with a maximum of 100 marks for theory and 100 marks for
practical’s, on the basis of internal evaluation and End semester Examination.
For the theory subjects 60 marks shall be awarded based on the performance in
the End semester Examination, 30 marks shall be awarded based on the internal
evaluation and 10 marks for assignment.
5.1 For theory subjects, during the semester there shall be 2 midterm
examinations. Each midterm examination consists of one subjective paper and
one assignment. The subjective paper is for 30 marks with duration of 2 hours.
Subjective paper of each semester shall contain 2 parts Section-A & Section-B.
Section-A comprises of five (5) short answer type of questions. The student
has to answer all the questions from section-A. Each question carries two
marks. A total of ten marks are allocated to section-A. Section-B consists of
five (5) essay type of questions from which the student has to answer three
questions. Each question carry not more than seven (7) marks. A total of 20
marks are allocated for section-B. The questions in the first midterm
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examination includes the topics of first 2.5 units while the questions in the
second midterm examination includes the topics of remaining 2.5 units. The
assignments should be submitted before the conduct of respective midterm
examinations.
The total marks secured by the student are out of 40 marks (30marks from
midterm examination and 10 marks from assignment) in an internal
examination for a subject. The average of marks secured in two midterm
examinations shall be taken as final marks. If he/she is absent for any test /
assignment, he/she are awarded zero marks for that test / assignment.
5.2 For practical subjects, 60 marks shall be awarded based on the performance in
the End Semester Examinations, 40 marks shall be awarded based on the day-
to-day performance as internal marks.
5.3 There shall be two seminar presentations during I year I semester and II
Semester. For seminar, a student under the supervision of a faculty member,
shall collect the literature on a topic and critically review the literature and
submit it to the department in a report from and shall make an oral presentation
before the departmental committee. The departmental committee consists of
Head of the department, supervisor and two other senior faculty members of
the department. For each seminar there will be only internal evaluation of 50
marks. A candidate has to secure a minimum of 50% to be declared successful.
5.4 There shall be a Comprehensive Viva-Voce in II year I Semester. The
comprehensive Viva-Voce will be conducted by a committee consisting of
Head of the Department and two Senior Faculty members of the Department.
The comprehensive Viva-Voce is aimed to assess the students’ understanding
in various subjects he/she studies during the M.Pharm course of study. The
Comprehensive viva-voce valued for 100 marks by the Committee. There are
no internal marks for the Comprehensive viva-Voce
5.5 A candidate shall be deemed to have secured the minimum academic
requirement in a subject if he secures a minimum of 40% of marks in the End
Examination and a minimum aggregate of 50% of the total marks in the End
Semester Examination and Internal Evaluation taken together.
5.6 In case the candidate does not secure the minimum academic requirement in
any subject (as specified in 4.3) he has to reappear for the End Examination in
that subject. A candidate shall be given one chance to re-register for each
subject provided the internal marks secured by a candidate are less than 50%
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and he has failed in the end examination. In such case candidate must re-
register subject(s) and secure required minimum attendance. Attendance in the
re-registered subject(s) has to be calculated separately to become eligible to
write the end examination in the re-registered subject(s). The attendance of re-
registered subject(s) shall be calculated separately to decide upon the eligibility
for writing the end examination in those subject(s). In the event of taking
another chance, the internal marks and end examination marks obtained in the
previous attempt are nullified.
5.7 In case the candidate secures less than the required attendance in any
subject(s), he shall not be permitted to appear for the End Examination in that
subject(s). He shall re-register the subject when next offered.
5.8 Laboratory examination for M.Pharm courses must be conducted with two
Examiners, one of them being Laboratory Class Teacher and second examiner
shall be other Laboratory Teacher.
6.0 EVALUATION OF PROJECT /DISSERTATION WORK:
Every candidate shall be required to submit thesis or dissertation after taking
up a topic approved by the project review committee.
6.1 A Project Review Committee (PRC) shall be constituted with Principal as
chair person, Heads of all the departments which are offering the M.Pharm
programs and two other senior faculty members.
6.2 Registration of Project work: A candidate is permitted to register for the
project work after satisfying the attendance requirement of all the subjects
(theory and practical subjects).
6.3 After satisfying 6.2, a candidate has to submit, in consultation with his project
supervisor, the title, objective and plan of action of his project work to the
Departmental Committee for its approval. Only after obtaining the approval
of Departmental Committee the student can initiate the Project work.
6.4 If a candidate wishes to change his supervisor or topic of the project he can
do so with the approval of Departmental Committee. However, the
Departmental Committee shall examine whether the change of
topic/supervisor leads to a major change of his initial plans of project
proposal. If so, his date of registration for the project work starts from the
date of change of Supervisor or topic as the case may be.
6.5 A candidate shall submit status report (in a bound-form) in two stages at least
with a gap of 3 months between them.
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6.6 The work on the project shall be initiated in the beginning of the second year
and the duration of the project is for two semesters. A candidate is permitted
to submit project thesis only after successful completion of theory and
practical course with the approval of PRC not earlier than 40 weeks from the
date of registration of the project work. For the approval of PRC the
candidate shall submit the draft copy of thesis to the Principal (through Head
of the Department) and shall make an oral presentation before the PRC.
6.7 Three copies of the Project Thesis certified by the supervisor shall be
submitted to the College/School/Institute.
6.8 The thesis shall be adjudicated by one examiner selected by the Institution.
For this, Chairmen, BOS of the respective departments shall submit a panel
of 5 examiners, who are eminent in that field with the help of the concerned
guide and senior faculty of the department.
6.9 If the report of the examiner is not favourable, the candidate shall revise and
resubmit the thesis, in the time frame as prescribed by PRC. If the report of
the examiner is unfavourable again the thesis shall be summarily rejected.
6.10 If the report of the examiner is favourable, viva-voce examination shall be
conducted by a board consisting of the supervisor, Head of the Department
and the examiner who adjudicated the Thesis.
The Board shall jointly report candidates work as:
A. EXCELLENT’
B. GOOD
C. SATISFACTORY
D. UNSATISFACTORY
Head of the Department shall coordinate and make arrangements for the conduct
of viva-voce examination. If the report of the viva-voce is unsatisfactory, the
candidate will retake the viva-voce examination after three months. If he fails to
get a satisfactory report at the second viva-voce examination, he will not be
eligible for the award of the degree.
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7.0 AWARD OF DEGREE AND CLASS
After a student has satisfied the requirement prescribed for the completion of the
program and is eligible for the award of M.Pharm Degree he shall be placed in
one of the following three classes.
Class Awarded % of marks to be secured
First Class with Distinction 70% and above
First Class Below 70% but not less than 60%
Second Class Below 60% but not less than 50%
8.0 WITH – HOLDING OF RESULTS:
If the candidate has not paid any dues to the university or if any case of in
– discipline is pending against him, the result of the candidate will be
withheld and he will not be allowed into the next higher semester. The
issue of the degree is liable to be withheld in such cases.
9.0 TRANSITORY REGULATIONS:
Candidate who have discontinued or have been detained for want of
attendance or who have failed after having undergoing the course are
eligible for admission to the same or equivalent subjects as and when
subjects are offered, subject to 5.5 and 2.0.
10.0 GENERAL:
10.1 The academic regulations should be read as a whole for purpose of any
interpretation.
10.2 In case of any doubt or ambiguity in the interpretation of the above rules,
the decision of the Vice – Chancellor is final.
10.3 The University may change or amend the academic regulations and
syllabus at any time and the changes and amendments made shall be
applicable to all the students with effects from the date notified by the
University.
10.4 Whenever the word he, him or his occur, it will also include she, her and
hers.
There shall be no transfer within the constituent colleges of Jawaharlal
Nehru Technological University.
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MALPRACTICES RULES
DISCIPLINARY ACTION FOR IMPROPER CONDUCT IN EXAMINATIONS
Nature of Malpractices/Improper
conduct
Punishment
If the candidate:
1. (a) Possesses or keeps accessible in
examination hall, any paper, note
book, programmable calculators,
cell phones, pager, palm,
computers or any other form of
material concerned with or related
to the subject of the examination
(theory or practical) in which he is
appearing but has not made use of
(material shall include any marks
on the body of the candidate which
can be used as an aid in the subject
of the examination)
Expulsion from the examination hall and
cancellation of the performance in that
subject only
(b) Gives assistance or guidance or
receives it from any other
candidate orally or by any other
body language methods or
communicates through cell phones
with any candidate or persons in or
outside the exam hall in respect of
any matter.
Expulsion from the examination hall and
cancellation of the performance in that
subject only of all the candidates involved.
In case of an outsider, he will be handed
over to the police and a case is registered
against him.
2. Has copied in the examination hall
from any paper, book,
programmable calculators, palm
computers or any other form of
material relevant to the subject of
the examination (theory or
practical) in which the candidate is
appearing.
Expulsion from the examination hall and
cancellation of the performance in that
subject and all other subjects the candidates
has already appeared including practical
examinations and project work and shall
not be permitted to appear for the
remaining examinations of the subjects of
that semester/year. The hall ticket of the
candidate is to be cancelled and sent to the
controller of examinations, AGI.
3. Impersonates any other candidate
in connection with the
examination.
The candidate who has impersonated shall
be expelled from examination hall. The
candidate is also debarred and forfeits the
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seat. The performance of the original
candidate who has been impersonated,
shall be cancelled in all the subjects of the
examination(including practical’s and
project work) already appeared and shall
not be allowed to appear for examinations
of the remaining subjects of that
semester/year. The candidate is also
debarred for two consecutive semesters
from class work and all semester
examinations. The continuation of the
course by the candidate is subject to the
academic regulations in connection with
forfeiture of seat. If the imposter is an
outsider, he will be handed over to the
police and a case is registered against him.
4. Smuggles in the Answer book or
additional sheet or takes out or
arranges to send out the question
paper during the examination or
answer book or additional sheet,
during or after the examination.
Expulsion from the examination hall and
cancellation of the performance in that
subject and all other subjects the candidates
has already appeared including practical
examinations and project work and shall
not be permitted for the remaining
examinations of the subjects of that
semester/year. The candidate is also
debarred for two consecutive semesters
from class work and all semester
examinations. The continuation of the
course by the candidate is subject to the
academic regulations in connection with
forfeiture of seat.
5. Uses objectionable, abusive or
offensive language in the answer
paper or in letters to the examiners
or writes to the examiner
requesting him to award pass
marks.
Cancellation of the performance in that
subject.
6. Refuses to obey the orders of the
Chief Superintendent/Assistant-
Superintendent/ any officer on duty
or misbehaves or creates
In case of students of the college, they shall
be expelled from examination halls and
cancellation of their performance in that
subjects and all other subjects the
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disturbance of any kind in and
around the examination hall or
organizes a walk out or instigates
others to walk out, or threatens the
officer-in-charge or any person on
duty in or outside the examination
hall of any injury to his person or
to any office relations whether by
words, either spoken or written or
by signs or by visible
representation, assaults the officer-
in-charge, or any person on duty in
or outside the examination hall or
any of his relations, or indulges in
any other act of misconduct or
mischief which result in damage to
or destruction of property in the
examination hall or any part of the
college campus or engages in any
other act which in the opinion of
the officer on duty amounts to use
of unfair means or misconduct or
has the tendency to disrupt the
orderly conduct of the examination.
candidate(s) has (have) already appeared
and shall not be permitted to appear for the
remaining examinations of the subjects of
that semester/year. The candidates also are
debarred and forfeit their seats. In case of
outsiders. They will be handed over to the
police and a police case is registered
against them.
7. Leaves the exam hall taking away
answer script or intentionally tears
of the script or any part thereof
inside or outside the examination
hall.
Expulsion from the examination hall and
cancellation of performance in that subject
and all the other subjects the candidates has
already appeared including practical
examinations and project work and shall
not be permitted for the remaining
examinations of the subjects of that
semester/year. The candidate is also
debarred for two consecutive semesters
from class work and all semester
examinations. The continuation of the
course by the candidate is subject to the
academic regulation in connection with
forfeiture of seat.
8. Posses any lethal weapon or
firearm in the examination hall.
Expulsion from the examination hall and
cancellation of performance in that subject
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and all the other subjects the candidates has
already appeared including practical
examinations and project work and shall
not be permitted for the remaining
examinations of the subjects of that
semester/year. The candidate is also
debarred and forfeits the seat.
9. If student of the college, who is
not a candidate for the particular
examination or any person not
connected with college indulges in
any malpractice or improper
conduct mentioned in clause 6 to 8
Student of the college’s expulsion from the
examination hall and cancellation of
performance in that subject and all the
other subjects the candidates has already
appeared including practical examinations
and project work and shall not be permitted
for the remaining examinations of the
subjects of that semester/year. The
candidate is also debarred and forfeiture the
seat.
Person(s) who do not belong to the
College will be handed over to police and,
a police case will be registered against
them.
10. Comes in a drunken condition to
the examination hall.
Expulsion from the examination hall and
cancellation of performance in that subject
and all the other subjects the candidates has
already appeared including practical
examinations and project work and shall
not be permitted for the remaining
examinations of the subjects of that
semester/year.
11. Copying detected on the basis of
internal evidence, such as, during
valuation or during special
scrutiny.
Cancellation of the performance in that
subject and all other subjects the candidate
has appeared including practical
examinations and project work of the
semester/year examinations.
12. If any malpractice is detected
which is not covered in the above
clauses 1 to 11 shall be reported to
the Malpractices committee, AGI
for further action to award suitable
punishment.
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M. Pharm. (Pharmaceutics)
Course Structure and Syllabus
I YEAR I SEMESTER
Subject
Code
Group Subject L P Credits
A41001 PCET Modern Pharmaceutical Analytical
Techniques
3 0 3
A41002 PCET Advanced biostatistics and research
methods
3 0 3
A41006 PCET Biopharmaceutics and
Pharmacokinetics
3 0 3
A41007 PCET Advanced Physical Pharmaceutics 3 0 3
A41008 PCET Advanced pharmaceutical technology-I 3 0 3
A41204 Lab Modern Pharmaceutical Analytical
Techniques Lab
0 3 2
A41205 Lab Advanced Physical pharmaceutics Lab 0 3 2
A41206 Seminar - - 2
Total Credits (5 Theory + 2 Labs + Seminar) 21
II SEMESTER
Code Group Subject L P Credits
A42001 PCET Intellectual Property Rights and Drug
Regulatory Affairs
3 0 3
A42002 PCET Screening methods and clinical research 3 0 3
A42006 PCET Advances in Drug Delivery Systems 3 0 3
A42007 PCET Industrial Pharmacy 3 0 3
A42008 PCET Advanced Pharmaceutical Technology- II 3 0 3
A42204 Lab Modern Pharmaceutical Analytical
Techniques Lab
0 3 2
A42205 Lab Advanced Physical pharmaceutics Lab 0 3 2
A42206 Seminar - - 2
Total Credits (5 Theory + 2 Labs + Seminar) 21
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II YEAR I SEMESTER
Subject
Code
Group Subject Name L P Credits
A43204 Comprehensive Viva - - 2
A43205 Project Seminar - I - - 2
A43206 Project Work - - 18
Total Credits 22
II YEAR II SEMESTER
Subject
Code
Group Subject Name L P Credits
A44203 Project Work 0 0 20
A44204 Project Seminar - II 0 0 2
Total Credits 22
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I Year – I Sem. M.Pharmacy (PHARMACEUTICS)
(A41001) MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
Unit I
a. Column Chromatography: Adsorption and partition, theory, preparation,
procedure and methods of detection
b. Thin Layer Chromatography: Theory, preparation, procedures, detection of
compounds
c. Paper Chromatography: Theory, different techniques employed, filter
papers used, qualitative and quantitative detection
d. Counter – current extraction, solid phase extraction techniques, gel
filtration
Unit II
a. Gas chromatography: Introduction, fundamentals, instrumentation,
columns: preparation and operation, detection, dramatization.
b. HPLC: Principles and instrumentation, solvents and columns used,
detection and applications
Unit III
a. UV-Visible spectroscopy: Introduction, electromagnetic spectrum,
absorbance laws and limitations, instrumentation-design and working
principle, chromophore concept, auxochromes, Wood-Fisher rules for
calculating absorption maximum, applications of UV-Visible spectroscopy
b. IR spectroscopy: Basic principles-Molecular vibrations, vibrational
frequency, factors influencing vibrational frequencies, sampling
techniques, instrumentation, interpretation of spectra, FT-IR, theory and
applications
Unit IV
Mass spectroscopy: Theory, ionization techniques: electron impact
ionization, chemical ionization, field ionization, fast atom bombardment,
plasma desorption, fragmentation process: types of fission, resolution,
GC/MS, interpretation of spectra and applications for identification and
structure determination
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Unit V
NMR: Theory, instrumentation, chemical shift, shielding and deshielding
effects, splitting of signals, spin-spin coupling, proton exchange reactions,
coupling constant(J), nuclear overhauser effect(NOE), 13
C NMR spectra
and its applications, 2D-NMR, COSY and applications in pharmacy
Text Books:
1.Sharma.B.K, (2007). Instrumental Methods of Chemical Analysis. 26th ed.
Goel Publishing House.
2. Sharma .Y.R,S.Chand (2011). Organic spectroscopy. New Delhi.
3. Connors K.A (2010). A Text book of Pharmaceutical Analysis. 3rd ed.
Wiley India.
4. Vogel A.I (2009). Text book of Quantitative Chemical Analysis. 6th ed.
London: Pearson.
5. Beckeet A.H, Stenlake J.B (2002). Practical Pharmaceutical Chemistry.
4th ed. New Delhi: C.B.S. Publication.
6. Finar I.L (2009). Organic Chemistry. 6th ed. London: Pearson.
7. Kemp W (2005). Organic spectroscopy, 3rd ed. Plagrave.
8. Grrett D.C (2007). Quantitative Analysis of Drugs. . New Delhi: C.B.S
Publishers:
9. Sethi P.D (2010). Quantitative Analysis of Drugs in Pharmaceutical
Formulations. 3rd ed. New Delhi: C.B.S. Publication.
10. Silverstein (2010). Spectrophotometric identification of Organic
Compounds. 6th ed. John Wiley.
11. Seth P.D. HPTLC, (1972). Quantitative Analysis of Pharmaceutical
formulations,CBS Publishers, Delhi:
12. (2007). Indian Pharmacopoeia.
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I Year – I Sem. M.Pharmacy (PHARMACEUTICS)
(A41002) ADVANCED BIOSTATISTICS AND RESEARCH METHODS
Unit-I :
Developing a research question, Resources for research question,
Literature Review: Traditional Qualitative Review
Meta-Analysis—A Quantitative Review
Preparation of Research Proposal
Variables—Definition of Variable, Types of variables—Dependent and
Independent variables, Confounded variables, Measurement of variables, Types
of measurement scales and their comparison. Reliability and Validity of
Measurements.
Unit-II : Validity, Types of validity—Internal validity, Construct validity, External
validity, Threats to validity.
Control: Subject as own control (Within Subject control), Statistical control.
Unit-III:
Non-experimental Research:
Part 1—Observational, Archival and Case-Study Research: The Hermeneutic
Approach.
Observational Research: Naturalistic Observation, Participant-Observer
Research.
Archival Research: Archival Data Collection and Compilation.
Case Studies: Characteristic of Case Studies.
Non-experimental Research: Survey Research—Designing of Questionnaire,
Methods of Administration, Response Rates. Types of Samples—Haphazard
Samples, Purposive Samples, Convenience Samples and Probability Samples.
Unit-IV :
True Experiments: Single-Factor Designs, Factors, Levels, Conditions, and
Treatments. Within-Subject Designs.
True Experiments Part-2—Factorial Designs—Main Effects, Interactions, A
Mixed Factorial Design.
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Unit V :
Single-Subject Experiments: Advantages and Disadvantages.
Quasi Experiments: The differences between Quasi and True Experiments.
Design without Control Groups—Interrupted Time Series Designs and Repeated
Treatment Designs.
Text Books
1.Donald H,McBurney -Theresa ,L. White (2009). “Research Methods”. 3rd ed.
.Cengage learning India Pvt. Ltd.
2.Hooda-R.P- MC (2000). Statistics for business and economics . Millan
Businessbook
3.Tiwar N.K.,Rao G.N (2008).1st ed .Biostatistics & Computer applications.
4. A Gennara ((2009) ). Remingtons pharmaceutical Sciences. 21ed.
Philadelphia, USA,Lippincott: Williams and Wilkins.
5.Lachman (1991) . Theory & Practice of Industrial Pharmacy . New Delhi.
Verghese Publishing House.
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I Year – I Sem. M.Pharmacy (PHARMACEUTICS)
(A41006) BIOPHARMACEUTICS AND PHARMACOKINETICS
Unit-I
1. Bioavailability and bioequivalence studies: Designing of bioavailability
and bioequivalence studies and interpretation of results.
2. Physicochemical properties affecting bioavailability, pH-partition theory,
dissolution, surface area adsorption, complexation, polymorphism and
techniques of enhancing dissolution rate.
3. Formulation factors affecting bioavailability of drugs in dosage forms of
tablets, capsules, parenterals, liquid orals and topical dosage forms.
Unit-II
4. Drug Distribution: Distribution in blood and other fluids, BBB barriers,
placental transfer of drugs and blood flow, volume of distribution, Drug
distribution and drug effects, Drug binding in tissue, Plasma Protein
binding and its role in clinical.
5. Drug metabolism: Site of metabolism, factors affecting drug metabolism
(genetic, species and environmental).
Unit-III
6. Basic concepts of pharmacokinetics: compartment models: One, two and
non-compartmental approaches to pharmacokinetics. Recent trends, merits
and limitations of these approaches. Application of these models to
determine the various pharmacokinetic parameters pertaining to oral and
parenteral.
a. Absorption: (wherever applicable) absorption rate constant,
absorption half-life, lag time and extent of absorption, AUC.
b. Distribution: Apparent volume of distribution and its determination.
c. Metabolism: Metabolic rate constant
d. Elimination: Over all apparent elimination rate constant, and half
life.
e. Noninvasive methods of estimating pharmacokinetics parameters
with emphasis on salivary and urinary compartments
f. Concept of clearance: organ, total clearance, hepatic clearance, lung
clearance and renal clearance.
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Unit-IV
7. Non-linear pharmacokinetics: Concepts of linear and non-liner
pharmacokinetics, Michaelis-Menton Kinetics characteristics. Basic
Kinetic parameters, possible causes of non-induction, non-linear binding,
and non-linearity of pharmacological responses.
8. Clinical Pharmacokinetics: Altered kinetics in pregnancy, infants and
geriatrics. Kinetics in liver and renal disease states.
Unit-V
9. Drug Interactions: Kinetics of drug interaction, study of drug-drug
interaction mediated through absorption, distribution, metabolism and
elimination, mechanisms of interaction and consequence. Influence of
alcohol, smoking, food and beverages on drug action.
10. Time dependent pharmacokinetics: Introduction, classification,
physiologically induced time dependency: Chronopharmacokinetics,
chemically induced dependency.
Text Books
1. Milo Gibaldi (1991) Biopharmaceutics and Clinical Pharmacokinetics. 4th ed.
The University of Michigan: Lea & Febiger.
2. Robert E. Notari ,M.Dekker(1975).. Biopharmaceutics and Clinical pharmacy.
2nd ed. The University of Michigan.
3. Robert E. Notari (1980)Biopharmaceutics and Clinical Pharmacokinetics - An
Introduction. . 3rd ed. The University of Michigan.
4. Leon Shargel .et. al (2010), Applied Biopharmacokinetics and
Pharmacokinetics. 5th ed. The McGraw-Hill Companies, Columbus.
5. Brahmankar D.M, Vallabh Prakashan.et.al (2009).Bio-Pharmaceutics and
Pharmacokinetics. Delhi
6. Venkateshwarlu .V(2008).Bio-Pharmaceutics and Pharmacokinetics . 2nd ed.
Hyderabad.: PharmaMed Press.
7. Shobharani R. H. (2002).Text Book of Biopharmaceutics,Bangalore: Prism
Publication.
2012-2013
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I Year – I Sem. M.Pharmacy (PHARMACEUTICS)
(A41007) ADVANCED PHYSICAL PHARMACEUTICS
Unit-I
1. Particle science and powder technology: Crystal structure, amorphous
state polymorphism, particle size distribution, particle size analysis
methods, solid dispersions/ solid solutions.
2. Physics of tablet compression: Compression and consolidation, strength of
granules, compression and consolidation under high loads, effect of friction,
distribution of forces in compaction, force volume relationships, Heckel
plots, compaction profiles, energy involved in compaction, strength of
tablet, crushing strength, friability, lamination, instrumentation of tablet
machines.
Unit-II
3. Kinetics and drug stability: Stability calculations, rate equation, complex
order kinetics, kinetics of some decompositions, strategy of stability testing,
method of stabilization, method of accelerated stability testing in dosage
forms, Freeze Thaw methods, centrifugal methods, temperature and
humidity control, physical stability testing of pharmaceutical products.
Determination of shelf life by accelerated stability testing, overages and
ICH guidelines
Unit-III
4. Theories on stability of disperse systems: Adsorption, wetting, crystal
growth mechanisms, physical stability of suspensions and emulsions,
stability testing of emulsions and suspensions and release of drugs from
suspension and emulsion formulations. Biopharmaceutical aspects of
disperse systems.
5. Rheology: Theoretical consideration, instrumentation, rheological
properties of disperse systems and semisolids.
Unit-IV
6. Dissolution and solubility: BCAS classification, Dissolution theories and
their mechanisms, Solubility and solubilization by the use of surfactants,
cosolvents, complexation, drug derivatisation and solid state manipulation,
dissolution rates of solids in liquids, measurement of dissolution rates.
2012-2013
21
Unit-V
7. Polymer science: Properties of polymers, Biodegradable and Non
degradable polymers and their mechanisms, phase separation, polymers in
solid state and application of polymers in pharmaceutical formulations.
Text Books
1.Alfred Martin ( 2011). Physical Pharmacy . 6th ed. USA, Philadelphia:
Lippincott Williams&Wilkin.
2.Howard C. Ansel ( 2005). Pharmaceutical Dosage forms . 9th ed. USA,
Philadelphia:
3.Gaud and Gupta ( 2009). Practical Physical Pharmacy , New Delhi, CBS
Publishers.
4.S.J Carter ( 2005). Cooper and Gunn`s Tutorial Pharmacy . 6th ed. New Delhi:
CBS Publishers.
5. S.J. Carter (2008). Cooper and Gunn`s Dispensing for Pharmaceutical
Students. 12th ed. , New Delhi: CBS Publishers.
2012-2013
22
I Year – I Sem. M.Pharmacy (PHARMACEUTICS)
(A41008) ADVANCED PHARMACEUTICAL TECHNOLOGY-I
Unit-1
1. Preformulation studies
Goals of preformulation, preformulation parameters, methodology, solid state
properties, solubility and partition coefficient, drug-excipient compatibility.
Unit-II
Formulation development of solid and powder dosage forms
Improved production techniques for tablets, new materials, processes,
equipment improvements, high shear mixers, compression machines, coating
machines, coating techniques in tablet technology for product development
and computerization for in process quality control of tablets. Formulation
development and manufacture of powder dosage form for internal and
external use including inhalation dosage forms.
Unit-III
Formulation development of soft and hard gelatin capsules
Introduction, production and methods of manufacture, filling equipment and
filling operations, formulations, finishing, special techniques, the nature of the
capsule shell and capsule, advances in capsule manufacture, processing and
control including pharmaceutical aspects, physical stability and packaging.
Unit-IV
Formulation development of liquid dosage forms
Recent advances in formulation aspects and manufacturing of monophasic
dosage forms as well as suspensions.
Unit-V
Optimization techniques in pharmaceutical formulation and processing
Introduction, concept of optimization, optimization parameters, classical
optimization, statistical design, applied optimization methods and their
applications in pharmaceutical industry.
2012-2013
23
Text Books
1. Aulton, ME (2011), Pharmaceutics - The Science of Dosage form design. 3rd
ed. Hungarys: Churchill Livingstone.
2. Lieberman, Lachman and Schwartz (2005). Pharmaceutical Dosage forms – Tablets, Vol I, II and III. New York: Marcel Dekker.
3. Avis, Lieberman and Lachman (1998). Pharmaceutical Dosage forms –
Disperse systems , Vol I, II and III . 2nd ed. New York: Marcel Dekker.
4. Gilbert S. Banker and Christopher T. Rhodes (2005). Modern Pharmaceutics.
4th ed. New York.: Marcel Dekker.
5. Leon Lachman, Herbert A. Lieberman (2009). The Theory and Practice of
industrial Pharmacy ,Special Indian edition. New Delhi: CBS Publishers and
Distributors.
6. A. Gennaro (2009). Remington’s Science and Practice of Pharmacy . 21st ed.
USA: Wolters Kluwer: Lippincott Williams & Wilkins.
7. Loyd V. Allen, Jr. Nicholas G. Popovich, Howard C. Ansel (2005). Ansel’s
Pharmaceutical Dosage form and Drug delivery system. 9th ed. USA: Wolters
Kluwer: Lippincott Williams & Wilkins.
8. Leon Shargel and Isadore Kanfer (2008). Generic Drug Product Development. New York.: Informa Health Care.
9. SJ Carter (2008). Dispensing for Pharmaceutical Students. 12th ed Delhi: CBS
Publishers. 88-90.
2012-2013
24
I Year – I Sem. M.Pharmacy (PHARMACEUTICS)
(A41204) MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
LAB
1. Use of spectrophotometer for analysis of Pharmacopoeial compounds and
their formulations
2. Simultaneous determination of combination formulations (Minimum of 04
experiments)
3. Effect of pH and solvent on UV spectrum of certain drugs
4. Experiments of Chromatography
a. Thin layer chromatography
b. Paper chromatography: Ascending, Descending, circular and two-
dimensional techniques
5. Experiments based on HPLC and GC
6. IR, NMR and mass spectra: Interpretation for the structural elucidation of
organic compounds
7. Any other relevant experiments.
2012-2013
25
I Year – I Sem. M.Pharmacy (PHARMACEUTICS)
(A41205) ADVANCED PHYSICAL PHARMACEUTICS LAB
1. Determination of derived and flow properties of given API
2. Determination of partition coefficient of given API
3. Determination pH and pKa of given API
4. Determination of saturation solubility of given API
5. Verification of stroke’s law
6. Determination of effect of concentration on viscosity
7. Determination of first order constant
8. Determination of second order constant
9. Experiment on Adsorption studies
10. Determination of Loss on drying of a given API
11. Study of compression property by Heckles analysis
2012-2013
26
I Year – II Sem. M.Pharmacy (PHARMACEUTICS)
(A42001) INTELLECTUAL PROPERTY RIGHTS AND DRUG
REGULATORY AFFAIRS
Intellectual Property Management:
Unit I : Types of IP, definition, scope, objectives Patents, types, contents of
patent, claims and types of claims, key terminology used in patents
(Application, examiner, prior art, priority, specifications, provisional and
non-provisional applications, claims, applicant, assignee, inventor,
anticipation, obviousness, infringement and invalidation).
Unit II : Filing process, provisional and non-provisional applications, PCT filing
process, Advantages, Patentability requirement: (Novelty, Utility, non-
obviousness, enablement and best mode), Understanding on
infringement, invalidation and litigations
Unit III : Indian patent act and post 1995 amendments US and European patent
act Trademarks, copyrights, designs International conventions, GATT,
TRIPS, Paris convention, Patent cooperation treaty.
Regulatory Affairs:
Unit IV: National drug regulatory requirements, national drug policy, Drugs and
Cosmetics Act and its amendments, over view of schedules, details of
schedule M, Schedule Y. US FDA, orange book, FDA guidelines on
IND, new drug approvals (NDA), ANDA approvals, SUPAC changes
and understanding on 505 (b) (2) applications.
Unit V : Office of generic drugs, recommendations on dissolution and bio-
equivalence requirements, types of ANDA filing (P I, II, III and IV)
PIV ANDA filing and process involved till the approval Exclusivities
(NCE, NS, NP, NDF, PED, ODE, PC exclusivity) European
regulatory agency, types of filing process (Centralized, de-centralized,
RMS countries), SPCs, SPC exclusivities, data exclusivities, WHO,
WIPO, ICH objectives and guidelines.
2012-2013
27
Text Books:
1. Guarino (2002). New drug approval process. 3rd ed. , New York, Basel:
2. (2004). Commercial Manual on Drugs and Cosmetics . 2nd ed. Delhi.:
Commercial Law Publishers (India) Pvt. Ltd.
3. Vijay Malik. Drugs and Cosmetics act. Publications Eastern Book..
4. S.H. Wiling (2003). Vol. 78, Good Manufacturing Practices for
Pharmaceuticals. 2nd ed. USA.: Marcel Decker.
5. P.Das and Gokul Das. Protection of Industrial Property rights.
6. S.N. Katju (2009). Law and Drugs. Law Publications.
7. Original Laws. Published by Govt. of India.
8. Hussain Laws of drugs. in India.
9. R.A.Guarino, (2009). Vol 100 New Drug Approval Process. New York,
Basel: Marcel Decker.
.
2012-2013
28
I Year – II Sem. M.Pharmacy (PHARMACEUTICS)
(A42002)PHARMACOLOGICAL SCREENING METHODS AND
CLINICAL RESEARCH
Unit I
Care Handling and breeding techniques of laboratory animals, Regulations for
laboratory animals, CPCSEA guidelines, alternatives to animal studies, Good
laboratory Practices.
Unit II
Bioassays: Basic principles of Biological standardization: Methods used in the
bio-assay of Rabbis Vaccine , Oxytocin , Tetanus Antitoxin and Diphtheria
Vaccine . Test for pyrogens.
Unit III
Toxicity tests: OECD guidelines, determination of LD50, acute, subacute and
chronic toxicity studies.
Unit IV
Organization of screening for the Pharmacological activity of new substances
with emphasis on the evaluation cardiac, psychopharmacological, anti-
inflammatory, analgesic and anti diabetic.
Unit V
Clinical evaluation of new drugs, Phases of clinical trial, protocol design, Ethics
in human research.
Pharmacovigilance: Definition, collection of data, reporting, assessment of Post
marketing surveillance, periodic safety update reports, Risk-benefit
assessment
Text Books:
1.Robert .A. Turner and Peter Hebborn (1979). Screening methods in Pharmacology, Vol-
1&2
2.H.G.Vogel and W.H.Vogel (2010). Drug discovery and evaluation. 3rd ed. Heideleberg:
Springerverlag,Berlin.
3.S.K. Kulkarni (2012). Handbook of experimental pharmacology. 4th ed, Vallabh
Prakashan, Delhi.
4. David Machin, Simon Day and Sylvan green (2007). Textbook of clinical trials. 2nd ed.
5. Giovanna di ignazio, Di Giovanna and Haynes (2011). Principles of clinical research,.
6. ICH of technical requirements for registration of pharmaceuticals for human use, ICH
harmonized Tripartite guidelines . Guidelines for good clinical practice. E6,May 1996.
7. Good clinical practice . (2001). Guidelines for Clinical trails on pharmaceutical
products in India, Central drug standard control organization, New Delhi, Minister of
Health..
2012-2013
29
I Year – II Sem. M.Pharmacy (PHARMACEUTICS)
(A42006) ADVANCES IN DRUG DELIVERY SYSTEMS
Unit-1
1. Fundamentals of controlled drug delivery systems, use of polymers in
controlled drug delivery, pharmacokinetic and pharmacodynamic basis of
controlled drug delivery. Design, fabrication, evaluation and applications
of the following controlled releasing systems
(a) Controlled release oral drug delivery systems
(b) Parenteral controlled release drug delivery systems
(c) Implantable therapeutic systems
Unit-2
(a) Transdermal delivery systems: Physical and chemical methods
of enhancing penetration, microneedle penetration iontophoresis,
sonophoresis.
(b) Intrauterine delivery systems
(c) Bioadhesive drug delivery systems
(d) Proteins and peptide drug delivery
Unit-3
Biochemical and molecular biology approaches to controlled drug delivery
of
1. Micro particulate drug carriers: Liposomes, Niosomes,
Microspheres, Nanoparticle and magnetic microspheres.
2. Monoclonal antibodies
Unit-4
Drug targeting to particular organs:
(a) Drug delivery to respiratory systems
(b) Problems of drug delivery to the brain and targeting to brain
(c) Drug delivery to eye
(d) Drug targeting in neoplastic diseases
(e) Drug delivery to colon
Unit-5
Drug carrier systems targeted to widely dispersed cells
a) Delivery to Macrophages
b) Delivery to lymphoid cells of immune network
c) Delivery to lysosomal storage diseases
2012-2013
30
Text Books
1.Yie W. Chien (2009). Novel Drug Delivery System. 2nd ed. New York. Published by
Informa Health care.
2. Joseph R. Robinson and Vincent H. L. Lee (2009). Controlled Drug Delivery. 2nd ed.
New York.: Marcel Dekker, Inc.
3. N. K. Jain (2011). Controlled and Novel drug delivery systems. 4th ed. New Delhi: CBS
Publishers and distributers.
4. S. P. Vyas and Khar (2002). Targeted and Controlled Drug Delivery (Novel carrier
systems). First edition ,New Delhi: CBS Publishers and distributors.
5. Gilbert S. Banker and Christopher T. Rhodes (2005). Modern Pharmaceutics,. 4th ed.
New York.: Marcel Dekker, Inc.
2012-2013
31
I Year – II Sem. M.Pharmacy (PHARMACEUTICS)
(A42007) INDUSTRIAL PHARMACY
Unit-I
Pharmaceutical unit operations: A detailed study involving machinery
and theory of pharmaceutical unit operations like milling, mixing,
filtration, drying and sterilization.
Unit-II
Materials of construction of pharmaceutical equipment and packaging
materials: Study of the principles, production techniques and scale up
techniques in the large scale production of tablets, capsules, emulsions,
suspensions, sterile products, semisolids and liquid pharmaceuticals,
ophthalmic products.
Unit-III
Production management: Production organization, objectives and
policies of good manufacturing practices, layout of buildings, services,
equipments and their maintenance, materials management, handling and
transportation, inventory management and control, production and
planning control, Sales forecasting, budget and cost control, industrial and
personal relationship.
Unit-IV
Quality control, process and dosage form: Process control, control of
manufacturing processes, statistical quality control, control charts and
automated process control, dosage form control, testing programs and
methods, product identification systems, adulteration and misbranding,
drug information profile.
Unit-V
Process validation: Regulatory basis, validation of solid dosage forms,
sterile products, liquid dosage forms, raw materials, validation of analytical
methods, equipment qualification, validation and process.
2012-2013
32
Text Books
1.Warren L. McCabe, Julian C. Smith, Peter Harriott (2001). Unit operations
of Chemical Engineering. 6th
ed. New Delhi: McGraw-Hill, Inc,
2.Leon Lachman, Herbert A. Lieberman, special edition (2011). The Theory
and Practice of industrial Pharmacy. 3rd
ed. Bombay: Varghese publishing
house.
3. Sidney H. Willig (2007). Good Manufacturing Practice for
Pharmaceuticals. 4th
ed. New York.: Informa Healthcare.
4.Robert A. Nash, Alfred H. Wachter (2003). Pharmaceutical Process
validation. 3rd
ed. Marcel Dekker.
5. Gilbert S. Banker and Christopher T. Rhodes (2005). Modern
Pharmaceutics,. 4th ed. New York: Marcel Dekker.
6. H.P.P. Sharma ,CGMP. Delhi.
7. C.V.S. Subrahmanyam (2011). Pharmaceutical production management,.
Delhi: Vallabh Prakash.
8. A. Gennaro (2009). Remington’s Science and Practice of Pharmacy. 21sted.
Philadelphia, USA.: Lippincott: Williams & Wilkins.
9.WL Badger and Julius T. Banchero (2010). Introduction to Chemical
Engineering. 25th reprint. New York.McGraw-Hill.
10. EA Rawlins (2010). Bentley’s Text book of Pharmaceutics by. 8thed.
Oxford.University Printing House.
2012-2013
33
I Year – II Sem. M.Pharmacy (PHARMACEUTICS)
(A42008) ADVANCED PHARMACEUTICAL TECHNOLOGY-II
Unit-I
Pilot plant scale-up techniques used in pharmaceutical manufacturing
General considerations, preparation of master manufacturing procedures, product
considerations of solid dosage forms, liquid dosage forms, semisolid products,
suppositories, contract manufacture.
Unit-II
Formulation development of parenteral dosage forms
Advances in materials and production techniques, manufacturing of small
volume and large volume parenterals, large filling machines, sterilizers,
aseptic processing.
Unit-III
Pharmaceutical Aerosols
Advances in propellants, metered dose inhaler designs, dry powder inhalers,
selection of containers and formulation aspects in aerosols formulation,
manufacture and quality control.
Unit-IV
Formulation development of semi-solid dosage forms
Industrial processing, preparation of oil and aqueous phases, low energy
emulsification, and storage of semisolids.
Unit-V
Aseptic processing operation
Introduction, contamination control, microbial environmental monitoring,
microbiological testing of water, microbiological air testing, characterization
of aseptic process, media and incubation condition, theoretical evaluation of
aseptic operations.
2012-2013
34
Text Books
1. Aulton, ME (2010), Pharmaceutics - The Science of Dosage form design. 3rd ed. London:
Churchill Livingstone.
2. Leon Lachman, Herbert A. Lieberman (2011). The Theory and Practice of industrial
Pharmacy. New York.: Informa Health Care.
3. A. Gennaro (2009). Remington’s Science and Practice of Pharmacy. 21st ed.
New York.: Lippincott: Williams & Wilkins. 88-90.
4. Loyd V. Allen, Jr. Nicholas G. Popovich, Howard C. Ansel (2005). Ansel’s
Pharmaceutical Dosage form and Drug delivery system. 9th ed. Philadelphia,
USA: Lippincott Williams & Wilkins.
5. Avis, Lieberman and Lachman (1986). Pharmaceutical Dosage forms -
Parenterals (Vol I, II and III). 2nd ed. New York.: Marcel Dekker.
6. EA Rawlins (2010). Bentley`s Text Book of Pharmaceutics . 8th ed. Oxford:
University Printing House.
7. Leon Shargel (2008). Generic Drug Product Development. Informa
Healthcare.
8. SJ Carter (2008). Dispensing for Pharmaceutical Students. 12th ed. Delhi:
CBS Publishers and Distributors.
9. Gilbert S. Banker and Christopher T. Rhodes (2005). Modern Pharmaceutics. 4th ed. New
York.: Wiley-Liss, Inc.
2012-2013
35
I Year – II Sem. M.Pharmacy (PHARMACEUTICS)
(A42204) ADVANCES IN DRUG DELIVERY SYSTEMS LAB
1. Formulation and evaluation of novel tablets (3 Expts)
2. Topical novel formulation (2 Expts)
3. Experiments on solubility enhancement techniques (2 Expts)
4. Semi solid dosage forms (2 Expts)
5. Formulation and evaluation of Oral delivery systems (2 Expts)
6. Formulation and evaluation of Dispersion system. (2 Expts)
2012-2013
36
I Year – II Sem. M.Pharmacy (PHARMACEUTICS)
(A42205) ADVANCED PHARMACEUTICAL TECHNOLOGY LAB
1. Formulation and evaluation of oral disintegrating tablets (1 Expts)
2. Formulation and evaluation of topical gels (2 Expts)
3. Formulation and evaluation of injections (2 Expts)
4. Formulation and evaluation of emulsion (2 Expts)
5. Formulation and evaluation of suspension. (2 Expts)
6. Formulation and evaluation of rectal suppositories. (1 Expts)
7. Formulation and evaluation of enteric coating tablets. (1 Expts)
8. Comparision of dissolution release profile of two marketed products (2 Expts)