Rajiv
Gandhi Proudyogiki Vishwavidalaya, Bhopal (M.P.)
B.
PHARMA-VIII SEMESTER
PY801: PHARMACEUTICS
– X
PHARMACEUTICAL
TECHNOLOGY-II
Granulation technology:
production of granules on large scale by various techniques, evaluation
of granules. Compression and
consolidation of powdered solids. Heckel plots. Force
displacement (F-D) Curves.
Microencapsulation techniques:
Coating of particles. Fluidized bed and air suspension coating.
Phase separation co-acervation,
multiorifice centrifugal, spray drying, spray congealing,
polymerization complex emulsion
techniques. Top bottom and tangential spray coating
machines. Evaluation of
microcapsules.
Sustained and controlled drug
delivery systems: concept of sustained release, designing of
sustained release products, zero
order and first order approximation concept. Matrix and
reservoir based techniques. Product
evaluation and testing.
Novel drug delivery systems:
Transdermal drug delivery systems. Osmotic drug delivery
systems. Liposomes and implants.
Packaging of Pharmaceutical
Products: Objective of packaging, packaging components, types,
functions, containers and
closures, foil and blister packaging. Packaging equipment, legal and
official requirements for
containers and closures. Package testing.
Pilot plant scale-up techniques:
General considerations, personnel requirements, space
requirements, review of formula
and raw materials. Processing equipments. Process evaluation.
GMP considerations.
Books &
References Recommended:
1. Leon Lachman, Herbert A.
Liebermann and Joseph L.Kanig., The Theory and Practice of
Industrial Pharmacy.
2. Banker G.S. and Rhodes C.D.,
Modern Pharmaceutics.
3. Remington’s Pharmaceutical
Sciences.
4. Aulton M. E., The Science of
Dosage Form Design.
PY802 :
PHARMACEUTICS-XI (Pharmaceutical Jurisprudence)
Review of Indian regulatory
legislations for drug and pharmaceutical industries, and
pharmaceutical education.
An elaborated
study of the following:
a. Pharmacy Act 1948
b. Drugs and Cosmetics Acts 1940
and Rules 1945
c. Medicinal and Toilet
Preparations (Excise Duties) Act 1955
d. Narcotic Drugs and
Psychotropic Substances Act 1985 and Rules
e. Patent Act 1970
f. Essential Commodities and Drug
Price Control Order
g. Drugs and Magic Remedies Act
(Objectionable Advertisement Act 1954)
A brief study of
the following:
a. Medical Termination of
Pregnancy Act 1970 and Rules 1975
b. AICTE Act 1987
c. Prevention of Cruelty to
Animal Act 1960
d. Poison Act and rules
e. MRTP Act
f. Minimum Wages Act 1948
g. State Shops and Establishment
Act and Rules
h. Factories Act 1948
i. Insecticides Act 1968.
Brief Study of various
prescription and non-prescription products, medical and surgical
accessories, diagnostic aids and
appliances marketed in India.
Books
Recommended:
1. Jain N. K., A Textbook of
Forensic Pharmacy.
2. Mittal, B.M., A Textbook of
Forensic Pharmacy.
3. Malik V., Drug & Cosmetic
Act.
4. The Gazette of India. The
Drugs and Cosmetics act and rules.
5. The Gazette of India. The
Patent act 1970 and its latest amendments.
PY803
: PHARMACEUTICAL ANALYSIS-III
Analytical method
development: Development of new analytical methods for bulk drugs
and dosage forms
using titrimetry, UV/visible spectrophotometry and HPLC.
Development of
analytical methods for combination drug products, derivative
spectrophotometric
methods. Development of stability indicating assay procedures. Drug
analysis in
biological fluids like blood plasma and urine.
Validation of
analytical methods: Parameters of validation, pharmacopoeial requirements
of analytical method
validation.
Validation of
analytical instruments: UV/visible spectrophotometer and HPLC as per
Indian Pharmacopoeia.
ICH guidelines for
impurities in drug substances and drug products, Residual solvents.
Water analysis:
Validation and qualification of water purification systems. Total organic
carbon, pH, and
conductivity test. Moisture content analysis in drug and dosage forms.
Quality control
testing: Dosage form evaluation as per monograph with special reference
to Indian
Pharmacopoeia. Drug identification test, drug content and assay, content
uniformity. Sampling
considerations.
Good laboratory practices.
Books
and References recommended:
1. Indian
Pharmacopoeia, 2007.
2. Current ICH
guidelines.
3. Vogel’s,
Quantitative Inorganic Analysis.
4. Beckett,
Pharmaceutical Analysis.
PY804A :
PACKAGING TECHNOLOGY
Packaging material science: Basic
materials used in packaging, their properties, method of
manufacturing and
applications-Paper, Plastics, Glass, Metal, and Elastomers.
Containers and closures:
Introduction and applications of Glass containers, Plastic containers,
Collapsible tubes, Plastic tubes,
Aerosol containers, Closures, Liners, and Rubber stoppers.
Introduction and applications of
Form-Fill-Seal (FFS) technology.
Tamper resistant and child
resistant packages: Introduction, method of preparation, and
applications of Blister and Strip
packs, Film Wrappers, Bubble packs, Shrink seals, Sachet and
Pouches, Tape seals, Breakable
caps, Sealed tubes, Aerosol containers, etc.
Quality control and quality
assurance of packaging materials: Detection of defects in packaging
materials, Quality testing of
formed packs, Quality testing of containers and closures, Testing of
child resistance and temper
evidence property of packaging materials. Quality control tests for
containers and closures as per
Indian Pharmacopoeia.
Legal and regulatory
requirements: Requirements of labels and labeling as per Drug &
Cosmetics act and rules. Product
/ patient information literatures. Regulatory aspects of storage,
handling and distribution of
packaging materials with special emphasis on cGMP and cGLP
requirements.
Suggested Books:
1. Dean, D.A.; Evans, E.R.; and
Hall I.H., Pharmaceutical Packaging Technology.
2. Leon Lachman, Herbert A.
Lieberman, Joseph L. Kanig, The Theory and Practice of
Industrial
Pharmacy.
3. Drug and cosmetic Act and
Rules.
PY804C : FOOD
AND NUTRACEUTICAL TECHNOLOGY
Functional
foods and nutraceuticals:
(a) Sources and role of
Tocotrienols, polyunsaturated fatty acids, sphingolipids, lecithin,
choline, terpenoids. Vegetables,
Cereals, milk and dairy products as Functional foods.
(b) Nutritive and Non-nutritive
food components with potential health effects. Effect of
processing on Nutrients. Soy
proteins and soy isoflavones in human health; Functional
foods from wheat and rice and
their health effects. Role of Dietary fibers and nuts in
disease prevention. General ideas
about role of Probiotics and Prebiotics as
nutraceuticals.
(c) Properties, structure and
functions of various Nutraceuticals: Glucosamine, Octacosanol,
Lycopene, Carnitine, Melatonin
and Ornithine alpha ketoglutarate. Use of
proanthocyanidins, grape
products, flaxseed oil as Nutraceuticals.
Food
processing and preservation:
(a) General principles and
techniques of food processing and food preservation, shelf life of
food and nutraceutical products.
Food stability: methods to enhance stability- freezing,
lyophilization, and air drying
techniques.
(b) Contamination and microbial
spoilage of food products: Milk and milk products, eggs
and poultry, fish, breads and
cereals, meat, canned foods, vegetables and fruits. Food
borne infections and
intoxications.
(c) Methods of food preservation,
approved preservatives, Radiation and food preservation:
Role of radiation in food
preservation. Principles underlying destruction of microorganisms
by irradiation. Effect of
irradiation on food constituents. Legal status of food
irradiation.
Regulatory affairs:
(a) Regulatory aspects of food
and nutraceutical products. The prevention of Food
Adulteration Act 1954, The Food
Safety & Standards Act, 2006.
(b) Regulatory certifications:
FPO regulations, Manufacturing guidelines, Manufacturing and
marketing licenses, AGMARK, Green
Label certification, Organic food certifications.
Books
recommended:
1. Essentials of Food and
Nutrition by Swaminathan M., Ganesh and Co, 1985
2. Handbook of Nutraceuticals and
Functional Foods Edited by Robert E.C. Wildman,
Routledge Publishers.
3. Nutraceuticals by L. Rapport
and B. Lockwood, Pharmaceutical Press.
4. Dietary Supplements of Plant
Origin, M. Maffei (Ed.), Taylor & Francis, 2003.
5. Food packaging principals and
practice, Gordon L. Robertson, Marcel and Dekker Inc.
New York. 1993.
PY805A
: PERFUMES AND COLOURS
Perfumes:
Historical
background & present scenario of perfumery industry.
Definition of
odour, its classification. Definition of perfumes, attars, cologne, deodorants,
aromatic waters.
Chemical classification of perfumes obtained from plant and animal sources.
Essential oils:
Introduction, study of various physical and chemical properties of essential
oils.
Study of various
isolation methods of essential oils.
Formulation of
perfumes, formulation excipients, manufacturing methods of perfumes,
deodorants,
colognes, and aromatic waters.
Regulatory considerations:
Analysis & standardization of perfumes. Toxicological aspects of use
of perfumes, safety
study of perfumes on naked skin including various dermatological tests.
Application of
perfumes in various cosmetic products like skin cosmetics, hair cosmetics, men’s
toiletries etc.
Colours:
Definition of
colour, lake, dye, pigment. Theory of color formation at molecules level
including
Hund’s Rule of
multiplicity volume band approach & molecular orbital approach to colour.
Detailed
classification of colour obtained from natural sources like plant & animal
sources,
colours obtained
from mineral sources, synthesis colours, dyes & pigments. FDA
classification
of colours. Various
physiochemical properties of dyes & colours.
Manufacturing of
colors: manufacturing methods of colours, dyes, lakes, and pigments.
Regulatory aspects
of use of colours in drug and cosmetics as per schedule Q of Drug and
Cosmetic Act.
Analysis of colours using instrumental methods & chromatographic methods.
Applications of
colours in various cosmetics like skin, nail, and hair cosmetics, etc.
Suggested
Books:
1. Sagarine,
Cosmetic Science and Technology, Vol. 1-4.
2. Harry’s
Cosmetology.
3. The Chemistry
and Manufacture & Cosmetics, Vol. IV - Mainson G. De. Nawarre.
4. Colour and
Cosmetic colour material - New Cosmetic Science - Mitsui.
5. The Cosmetic
Industry - edited by Norman Scientific & Regulatory foundation - F. Estrin.
PY805B :
CLINICAL RESEARCH
Introduction: Clinical pharmacy,
duties and activities of a clinical pharmacist in hospital,
monitoring of pharmacotherapy
(patient chart review, medication counseling, clinical out put
review), ward round
participation, patient relevant history (dieses and medication), prescriptions,
drug prescribing guidelines,
therapeutic drug monitoring.
Patient data analysis:
Introduction to common medical terminologies and abbreviation used in
clinical pharmacy. Patient case
history & case history formats, use of case history in evaluation
of drug therapy.
Clinical laboratory tests:
Interpretation of laboratory tests used in evaluation of disease state:
Tests for hormones, body organ
function, blood, urine, microbial culture, etc.
Drug and poison information:
Introduction to information resources and institutes, systemic
approach in answering drug
information queries, preparation of reports. Detection and
assessment of adverse drug
reactions and their documentation.
Clinical pharmacokinetic:
Individualization of drug therapy, introduction to clinical
pharmacokinetics models,
determination of drug clearance and volume of distribution, renal and
non-renal clearance, hepatic
clearance.
Clinical trial: Designs of
clinical trials, Good clinical practices (ICH & GCP guideline for safety
and efficacy), Institutional
Ethical Committee and its function.
Various phases of clinical
trials, introduction to monitoring and auditing of clinical trials. Basic
concepts of biostatistics.
Clinical research organization
(CRO): Organizational structure, present status and future
prospects of clinical research
organizations in India.
Books
Recommended
1 Hefindal, E. T., Clinical
Pharmacy & Therapeutics-. Williams & Wilkins.
2 Katzung, B., Basic and Clinical
Pharmacology, Lange Medical Publication, California
3 Laurence D.R. and Bennet, P.N.,
Clinical Pharmacology, Churchill Livingstone
4 Walker, R. & Edwards, C.,
Clinical Pharmacy & Therapeutics, Churchill Livingston
5 DiPiro, J.T. et.al.,
Pharmacotherapy a pathophysiological approach, McGraw-Hill
companies, Inc.
6 Green and Harris, Pathology and
Therapeutics for Pharmacists: A Basis for Clinical
Pharmacy Practice, Chapman and
Hall Publications.
PY805C : HERBAL
DRUG TECHNOLOGY
Introduction: Definition, source
of herbal raw materials, identification, authentication, Collection
and processing of herbal drugs.
Seasonal & geographical variations, natural & artificial drying
methods. Packaging & labeling
of herbal drugs prior to extraction.
Standardization techniques: WHO
guidelines for assessing quality of herbal medicine. Analysis
of raw herbal extracts and their
formulation using TLC, HPTLC, GC, HPLC, UV& IR
techniques.
Herbal Formulations: Principles
of Ayurveda, Ayurvedic dosage forms and their evaluation as
per Ayurvedic pharmacopoeia.
Formulation considerations of herbal infusion, decoction, lotion,
washers, insect repellents,
tincture, syrups, compresses, poultice, plasters, ointments, oils and
salves, tablets and capsules.
Plant Tissue Culture Techniques
& its Application in Pharmacy: Introduction, techniques of
initiation and maintenance of
various types of cultures for industrial level production of phytoconstituents.
Immobilized cell techniques &
biotransformation studies including recent
developments in production of
biological active constituents in static, suspension and hairy root
cultures.
Brief account of plant based
industries of India and world involved in R & D work on medicinal
and aromatic plants and
manufacturing herbal medicine. Regulatory requirements for herbal
medicine industries:
Infrastructure, Quality control, safety and stability, import and export of
herbal products. Analytical
Pharmacognosy – drug adulteration and detection.
Books
Recommended:
1. Herbal Drug Technology by S.S.
Agrawal & M. Paridhavi.
2. Modern Methods of Plant
Analysis by Peach & Tracey
3. Biotechnology by S.S. Purohit.
4. Quality control of herbal
drugs: an approach to evaluation of botanicals by Pulok K.
Mukherjee.
5. Pharmacognosy by C.K. Kokate,
A.P. Purohit and S.B. Gokhale
6. Ayurvedic Pharmacopoeia of
India
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