Revised 2
year P.G. Programme
1.
DURATION OF COURSE:
a. The
duration of course will be of 3 semester, first and second semester each of six
months duration having 15 to 16 weeks approximately and the third semester will
have one year’s duration.
Work,
practical (lab) work, design project and seminars.
Voce.
2.
COURSE STRUCTURE:
(Product
Development) 3
- 100 -
One
paper from interdisciplinary core subjects of
other
departments /Departmental
core subjects(Quality Assurance) 3 - 100
-
Three
papers from field of study &
Specialization 1 major + 2 minor 3*3 - 3*100
-
Sessional:
Laboratory - I (Quality Assurance) - 4 - 100
Assignment
– I (To be assigned by the supervisor)
- 4 - 100
Seminar -do- - 4 -
-
18 12 600 200
Total
periods/week : 30
Total
Marks : 800
Engg. Dept.
Engg, Dept.
Second Semester:
Four
papers from field of study/
Specialization (Two minors and two majors) 4*3 -
4*100 -
Sessional:
Assignment
–II (To be assigned by the - 4 - 100
Research Supervisor)
Term
Paper Leading to Thesis - 6 - 100
Seminar:
- 4
Report - 100
Viva
- 100
______________________________
12 14 400 400
Total
periods/week : 26
Total
marks : 800
Thesis/Project/Dissertation
44(Full Time)
300
Viva
Voce on Thesis --- 100
--------
-------
48
400
Total
periods/weeks : 44
Total
marks : 400
Preformulation testing, preformulation trials, in-vitro and in-vivo evaluations. Stages in product development and evaluation, pharmaceutical preparations; product development functions; data required for product development; formulation factors; stability and stabilization; preservatives; organoleptic properties and product appeal, packaging, evaluation of raw materials. Pilot Plant Scale Up: Importance and techniques involved.
PG/T/DC-Int/Pharm/12:
Pharmaceutical Quality Assurance: (for students of other dept. also)
Analytical
method development and monitoring of drug release from formulation ,
instrumental methods and techniques involved in drug and formulation testing,
in process quality assurance method , selection and testing of major raw
material input, methods of drug sampling, statistical quality control of major
categories of dosage forms. High throughput screening of drug development,
evaluation and assessment of drugs with the modern techniques like HTS ,
HRS,Bioassay guided fractionation etc.Development of chromatographic techniques
for drug development like HPLC,HPTLC, CPC, LC-MS etc.
PG/T/Pharm/102: Pharm. Chem.
– I:
1.
Theory
and application of modern analytical instruments.
2.
Kinetics
in homogeneous system.
3.
Physicochemical
factors regulating bioavailability, bioequivalance and ADMET parameters.
4.
Drugs
from their natural origin with therapeutic importance, their toxicity and
regulation:
Secondary metabolites with therapeutic importance; Safety, toxicity,
pharmacokinetic
pharmacodynamic issues; Regulatory perspectives on drug development from
Natural sources.
5.
Systemetic
study of some newer synthetic drugs.
6.
Steriochemical
studies and conformation analysis -- Cyclic and acyclic systems.
7.
Physicochemical
incompatibilities.
8.
Combinatorial
chemistry, HTS, and deconvolution analysis.
9.
Introduction
to topological structure representation.
10.
Protein
and peptide drugs.
PG/T/Pharm/101:
Pharmaceutics –I:
General
considerations for newer delivery systems of some classes of drugs ---
proteins, polypeptides and peptides, nucleic acids etc.
Outline
of some alternate routes of drug delivery, ocular delivery, transdermal
delivery, pulmonary delivery, rectal and vaginal delivery, liposomes, fusogenic
liposomes, niosomes, multiple emulsion system,
Control
and Sustained Release systems—Non degradable and non absorbable &
absorbable and degradable polymers.
Pharmacy
Practice—Concept of clinical pharmacy, GMP, vendor selection, inventory control
of ware housing. Biopharmaceutical considerations in dosage form design. Some
conventional deliveries.
1.
Pharmacokinetics:
The dynamics of drug absorption, distribution and elimination
2.
Pharmacodynamics:
Mechanism of drug action, drug receptor interaction.
3.
Drug
development, evaluation and safety studies.
4.
General
understanding of peptides and protein mediators, biosynthesis, regulation of
peptides, peptide antagonists and peptides as drugs.
5.
Individual
variations and drug interactions.
6.
Adverse
drug reaction, drug toxicity.
7.
Molecular
basis of chemotherapy.
8.
Drug
addiction and abuse.
9.
Methods
measurement in pharmacology
PG/T/Pharm/104:
Pharmacognosy I :
1.
Quality control of herbal drugs.
2.
General consideration of drug constituents from natural
origin.
3.
Antitumor and antidiabetic drugs of natural origin.
4.
Natural drugs of steroid group.
5.
Preservation and storage of crude drugs.
6.
Natural drug of protein group.
7.
Pharmacological activity of crude drugs.
8.
Hallucinogenic, allergenic, teratogenic drugs.
9.
Chemotoxonomy of natural drugs.
10. Modern
methods of extraction, application of latest techniques like chromatography and
electrophoresis in the isolation, purification and identification of
phytochemical of crude drugs.
Metabolic pathways lag cholostorol synthesis,
tryptophan metabolism etc) and their relation to general drug development.
Modern elementary concepts of protein and nucleic acid structures. Elementary
cytochemistry of mamalian, bactorial and viral cells.Importance of
cytochemistry drug development.Study of enzymes emphasizing their general
properties,active sites,Kinetics of enzyme reaction ,activation and inhibition
of enzyme.Basis of metabolic antagonism.Medical enzymes,their production, uses
and assay methods.Vitamins as cofactors,their preparation, assay methods and
role as drugs.
PG/T/Pharm/106:
Microbiology – I:
Classification and taxonomy; structure and cytology, Nutritional requirements; Enzymes
and metabolism by micro –organisms Methods of cultivation of bacteria fungi and
viruses.Isolation and identification of contaminants in spoiled pharmaceutical
products.Fermenta-tive products of carbohydrates and their uses for
identification of some genera of true bacteria.
Methods of sterilization used in
pharmaceutical products. Methods of sterility testing for pharmaceutical
products. Industrial production of malts, Beverages, antibiotics, and other
common products. Methods of preservation against microbial attacks. Different
germicidal tests. Mode of action of chemotherapautic agents in relation to
their inhibition of cell wall, protein, cell membrane, RNA, DNA.etc.
Studies of microbial agents of disease by bacteria, and fungi, clinical
features, laboratory diagnosis and epideniology of bacterial diseases. Anti
biotics and chemotheraputic agents. Drug parasite relationships and drug
dependence.
Host-parasite relationships, structure and formation of antigens and
antibodies; Antigen antibody reaction. Immunofluorescence and electrophoresis,
Complement system, etc.
1. (a) Flow of fluids
i) Newtonian fluid flow: Revision of undergraduate curriculum;
boundary layer concept and applications ; Displacement thickness; Problems.
ii) Nonnewtonian fluid flow: Classification; streamline and
turbulent flows, modified Reynolds number; applications and problems.
(b) Motion
of particles in a fluid
Drag force on spherical and nonspherical particles; Motion of particles
in different fields; application and problems; Fluidization – theory and
particle.
(a)
Filtration and Centrifugation:
Theory; Different equipment’s
and applications; Filter aids ;Super centrifuge; Problems.
(b)
Gravitational separation:
Total and frictional drags;
sedimentation; Thickeners and clarifiers; Pharmaceutical applications.
(c)
Chromatographic separation:
Different types; Theories and
equipments; selective adsorption of biological macromolecules.
(d)
Membrane separation:
Classification; different
membranes and types of operation; Reverse osmosis; Electrodialysis;
perevaporation; different applications.
(e)
Separation of drugs by adsorptive bubble separation method.
3
(a)
Packaging of solids and liquids
Solid packaging; liquid
packaging, fillers; marking and labeling, handling and storage.
(b)
Conveying of solids.
Syllabus
for subjects of
M. Pharm,
1st Year, 2nd Sem
9. Stereochemistry of fused ring and bridged systems.
10. Insight to drug
discovery from natural sources:
Ethnobotany,
Ethnopharmacology and aspects of biodiversity for development of natural
products; Screening and evaluation of natural products; Standardization and
Quality Control of natural products in Global and Indian Perspectives.
9. Synthetic hormones.
10. Phytopharmaceuticals --
development and evaluation:
Extraction, isolation and
characterization of different classes of phytoceuticals of therapeutic
importance; Evaluation of assessment parameters based on WHO guidelines; Modern
techniques used for evaluation of natural products: HPTLC, HPLC, GC, etc.
DNA
Structure, Replication, Transcriptional (Gene Expression) and Translocation
Processes, protein folding and design, protein design tests and their
significances to create new molecules, DNA recombination and cloning, basics of
Immuno-pharmacology and its relevance to drug and pharmaceutical research.
Various
drugs and vaccines ( whole organism vaccines, recombinant vector vaccines,
synthetic peptide vaccines, multivalent sub-unit vaccines and anti-idiotype
vaccines ) of biotechnological origin.
Anti-sense
therapy and technology.
Gene
as drug delivery system and gene therapy using polymeric carrier systems.
Biotransformation:- Induction, type of reaction involved, design
of biotransformation process and their improvement. Technology and
immobilization of enzymes and its significance in Drug Research.
Regulation
of clinical trials and management:- An overview of GMP, cGMP, Patent laws and
ISO certification.
PG/T/Pharm/202:
Pharmaceutics – III (Bio-pharmaceutics and Pharmacokinetics):
Bio-pharmaceutical
considerations in the design of various categories of dosage forms. Advanced
pharmacokinetics- Two compartment and multi-compartment models, bioavailability
estimations, rate and extent of absorption, non-linear kinetics, correlation of
pharmacological responses with blood concentration. Fundamentals of drug absorption, distribution and drug
metabolism.
1.
Drugs
affecting renal and cardiovascular system, homeostasis and thrombosis, anti
platelet and fibrinolytic drugs.
2.
Drugs
in arteriosclerosis, hypolipidemic drugs.
3.
Gene
therapy.
4.
Concept
of angiogenesis and apoptosis – targets for new drug development.
5.
Chemical
transmission in the central nervous system- chemical signaling, types of drug
action, drug acting in the CNS, Psychotropic drugs.
1.
Neurodegenerative
disorders-mechanism of neuronal death, ischeamic brain damage, drugs used in
Alzheimer’s disease, Parkinsonism and prion disease.
2.
Molecular
aspect of drug action- Concept of receptors, expression of receptors, receptors
and disease.
3.
Targeting
and control of gene expression- transgenic animal models.
4.
Obesity-
Mechanism of controlling energy balance, anti obesity drugs.
5.
Amino
Acid Transmitters- role in disease and concept of drug therapy.
PG/T/Pharm/207:
Pharmacognosy II:
1.
Recent advances in Pharmacognosy
2.
Tissue culture and its applications.
3.
Microscopic evaluation of crude drugs.
4.
Pharmaceutical aids of natural origin.
5.
Intrinsic and extrinsic, factors involving the quality of
natural drugs.
6.
Marine natural products.
7.
Pest and their control in the cultivation of medicinal
plants. Pesticides of natural origin.
8.
Medicinal plants growth regulator.
9.
Commercial aspects of natural drug production.
PG/T/Pharm/208:
Pharmacognosy - III:
1.
Concept of biogenesis and application of radio chemical
techniques in the study of the biogenesis of the secondary metabolites.
2.
Study of biogenetic pathway for certain important
phytochemicals.
3.
General consideration of the principles and application of
chromatography as applied to natural products of industrial usage.
4.
General consideration of principle of physical
instrumentation as applied to natural product analysis of industrial usage.
5.
Principle involved in the preparation and standardization
of herbal drugs.
6.
Commercial production of certain important natural drugs.
7.
Genetic aspects of plant drugs.
PG/T/Pharm/213:
Biochemistry - II :
Elementary concept of
molecular biology: i) Biosynthesis of proteins and nucleic acids; ii) cellular
regulation mechanisms at the genetic level and at the enzymes level iii)
Mutation and adaptability. Study of mutation at the DNA level iv) Bacterial
viruses, their replication biochemical basis of viral infectivity process.
Modern cancer chemotherapy
and its biochemical basis, Develop of drugs like fluorouracil, 8- azagnenine
alkylating agents etc. Biochemistry study of cell membranes and cell walls,
permeability problems, Relevance of the problem in drug development.
Polysaccharides and lipids of bacterial cells, their chemical and
immunobiological aspects.
Biochemistry of drug action
and drug resistance, metabolic products, detoxification, delayed action,
binding with blood constituents.
Enzymes: Kinetics of
allosteric inhibition. Potential use of allosterism in drug development.
PG/T/Pharm/214: Biochemistry - III :
Intensive study of a few
metabolic pathways (e.g. Tricarboxylic acid cycle), at the enzymatic level
oxidative phosphorylation and other energy conserving mechanisms. Drugs laying
their sites of action at these points.
Biochemistry and mode of
action on steroid hormones; their use as drugs.
Biochemistry and mode of
action of hormones which are proteins or peptides in nature; their preparation,
assay methods and role as drugs.
Radio –isotopes: Their importance in
biochemistry and medicine.
Synthesis of radioactive
compounds of medicinal importance.
PG/T/Pharm/211: Microbiology - II:
Classification, structure
and size of viruses. Identification and replication of viruses’
chemoprophylaxis of viral infection, interferences and interferon.
Hypersensitivity and immunity.anaphylaxi drug
hypersensitivity, delayed hypersensitivity reaction.autoimurune diseases.
Transplantation immunity and tumor immunity.
Prokaryotic chromosome and the physical basis of
heredity. Mutation, intercellular genetic recombination, transformation,
transduction and conjugation.insertion sequences and transporance.theories of
drug resistances, genetic engineering.
PG/T/Pharm/212: Microbiology –III
Industrial
microbiology
Microbial
contamination of different pharmaceutical products. Microbial spoilage and
preservation. Heat resistance parameter and their uses in designing
heat-sterilizations processes for different pharmaceuticals. Screening of
antagonistic organisms and their antagonistic activity. Classification of
antibiotics, proportion of antibiotics isolation, purification and
identification of new antibiotics from fermentation broth. Analysis of water
and treatment of wastewater. Production of antibiotics enzymes, steroids, amino
acid.etc by immobilization. Methods of chemical, pharmacological, neurological
and immunological behavior in relation to host. Preparation of immunological
products. Industrial application of modern genetics for production of
pharmaceuticals.
PG/T/Pharm/209: Pharmaceutical Engineering –II:
1 (a) Heat transmission
and evaporation
Natural and forced convections; Heat Exchangers;
Heat transfer with phase changes; Radiation; Different applications; Multiple
effect evaporation and evaporator performance; problems.
(b)Diffusion and adsorption
Molecular and eddy diffusion; different
applications.Theory of adsorption; Different adsorbent; Adsorption isotherms;
Absorbers and it’s design as well as performance; problems.
2 (a) Drying and humidification
Important dryers used in pharmaceutical industries;
selection of drying equipment; psychometric chart; application of psychometry
to drying; Humidifiers and dehumidifiers; problems.
(b) Fermentation Technology:
Different fermentations; performance of different
fermenters; sterilization practices; production of pharmaceuticals by
fermentation.
(c) Agitation, mixing & blending
Fundamentals, types of mixers; Fitting the mixer to
the operation; power requirements – theory of mixing; Mixing index;
problems.
PG/T/Pharm/210: Pharmaceutical Engineering –III :
1 (a) Unit process
Introduction to basic pharmaceutical and fine
chemical industries in India; Unit processes like acylation, alkylation,
amination.esterification, halogenation, hydrolysis, nitration, oxidation and
reduction, sulfonation and sulfation, polymerization etc; manufacturing aspects
or important pharmaceuticals.
(b) Hazards in process units and safety practices.
(c) Corrosion and materials of construction: Different types of
corrosion; prevention of corrosion; Materials for pharmaceutical plant
construction, machineries and accessories.
2
(a)Basic
Instrumentation in pharmaceutical Industries:
Instrumentation for measuring pressure,
temperature, humidity, density, flow rate etc; control devices; Transducers.
Instrumentation and
techniques in tablet & capsule manufacturing.
(b) Effect of pollution in Pharmaceutical Industries
Air and water pollution; pollution monitoring and
controlling equipments; wastewater treatments plant (E T P); waste management.
(c) Pilot plant and scale up Techniques
Similarity concept, Rezime concept, concept of
model and pilot plant, scale equations, problems.
Sessionals:
1. Laboratory –I:
Quality Assurance Laboratory: - Experiments on current important
topics.
2.
Assignment –I: To be given by the Research
supervisor of the student.
(Design project/analysis/software
development)
3.
Seminar:
The problem will be given to the student in the
first semester by his Research Supervisor and
the work will be continued into the second semester.
The student will be required to give a
Write up and present a seminar in the first
semester.
4.
Assignment –II :
Each student will be given
an assignment (Design project/laboratory programme/software
development/industrial training) which he/she has to work and submit a report.
5.
Term paper leading to
thesis:
Each student
will be given a thesis problem at the beginning of 2nd semester. He
or she will work on the
Literatures survey, scope of work, equipment
development etc. and submit a report. The main thesis work will, however be
done in the third semester.
6.
Thesis:
Each student will devote full time in the third
semester on a research problem assigned by his research supervisor. A Board of
Examiners, consisting of the supervisor and external will evaluate the thesis
Examiner. The evaluation of the thesis will be followed
by a viva-voce in front of faculty members and other post-graduate students.