1. Describe the advance knowledge of pharmaceutical technology with developed expertise on technical know how of manufacturing.
2. Explain the comprehensive and integrated approach of NDD (novel drug delivery).
3. Consider the pre-formulation study for developing a formulation and evaluation of pharmaceutical products.
4. Justify the advance technique used in the manufacturing of pharmaceutical products.
Course Outcome:
1. Define different terms related to advanced pharmaceutical manufacturing
2. Explain the concepts of manufacturing of quality pharmaceutical products using advanced technology
3. Differentiate between traditional and advance technology in the manufacturing of pharmaceutical products
4. Generate the idea of formulating and manufacturing drugs with advanced technical know how
5. Justify the manufacturing process of advanced pharmaceutical products
Course Content:
1. Preformulation Technology: Goals of preformulation, preformulation parameters, methodology,
solid state properties, solubility and partition coefficient, solubility,
modern concepts in rheology, drug excipient compatibility. Theory, mathematical
models, types of dissolution equipments, sink condition and its importance.
2. Compaction and Compression of Powders:
The
process of compression, properties of tablets affected by compression,
measurement of compressional force and instrumented tablet machine, energy
expenditure in tablet manufacturing and effect of lubricant in tablet strength.
3. Granulation Technology: Characterization of
granules, principle governing particle size enlargement, granule size
measurement and interpretation of size data, characterization of granule shape,
characterization of granule surface area, granule density and packing characteristics,
electrostatic properties of tablets, rheological properties of granules,
granule strength and friability.
4. Advanced Film Coating Technology: Theories
of film coating, adhesive and cohesive strengths, polymers used in film
coating, physico-mechanical properties of polymer films, diffusion properties
of polymer films, processing conditions for both organic and aqueous systems,
film coating problems and remedies.
5. Advanced Drug Delivery Technologies:
(a)
Sustained Release Drug Delivery
Technologies: Rate-preprogrammed drug delivery systems,
activation-modulated drug delivery systems, feedback-regulated drug delivery
systems, site-targeting drug delivery systems, etc.
(b) Transdermal
drug delivery system, nasal drug delivery system, ocular drug delivery system,
parenteral drug delivery system, vaginal drug delivery system, intrauterine
drug delivery system, liposomes and nanoparticles drug delivery system,
biodegradable drug delivery system, hydrogel-based drug delivery system, drug
delivery to the lungs: Metered dose
inhalers and dry powder inhalers.
6. Aseptic Pharmaceutical Manufacturing:
Clean
rooms for aseptic pharmaceutical manufacturing, HVAC systems for clean room,
validation of clean rooms, container and closure cleaning and sterilization,
pyrogens and depyrogenation, aseptic filling of sterile powders, Blow-Fill-Seal
aseptic packaging technology, clean in place (CIP) and sterilization in place (SIP)
systems.
7. Validation Techniques for
Pharmaceutical Industries: Definitions, scope of validations,
hierarchy of validation, validation
protocol, prospective validation, retrospective validation, concurrent
validation, revalidation, validation in pharmaceutical development, benefits of
validation, Process validation: Validation of solid products & sterile products,
facilities, equipment & services validation, raw materials validation,
cleaning validation, analytical methods validation, packaging components
validation, computer systems validation, etc.
8.
Materials
of Constructions for pharmaceutical manufacturing: General
considerations affecting choice of materials, chemical factors considerations,
physical factors considerations, metals and non-metals used in pharmaceutical
plants, iron, steel & other non-ferrous metals, corrosion testing, mechanism
of metallic corrosion, etc.
9.
Industrial
Management: Organization
structures, managerial role of Pharmacists, Personnel management and industrial relations, Objectives
and functions of personnel department, employment and development of personnel;
industrial relations: problems of labor management relations, causes of
industrial disputes, remedies, industrial dispute act, trade union grievance
and grievance handling procedure, causes of grievances and remedies.
10.
Good manufacturing practices for
pharmaceuticals: Status and applicability of regulation,
current good manufacturing practices in manufacturing, processing, packaging
and holding of drugs, production and process controls, ISO certification
systems etc.
Recommended Books:
1. Cooper and Gunn's Dispensing for pharmaceutical
students - John
William Cooper, Colin
Gunn
2. Pharmaceutical Dosage Forms:
Tablets.
- H A Liberman,
L Lachman and J B Schwartz
3. Bentley's
Textbook of Pharmaceutics - Sanjay
Kumar Jain & Vandana
Soni
4. An
Introduction to Pharmaceutical Formulations – A.G. Fishburn
5. Ansel's
Pharmaceutical Dosage Forms and Drug Delivery Systems - Loyd
V. Allen, Nicholas
G. Popovich & Howard
C. Ansel
6. Pharmaceutics
and pharmacy practice - Gilbert
S. Banker & Robert
K. Chalmers
7. The
Art, Science and Technology of Pharmaceutical Compounding – Loyd V. Allen & Loyd V. Allen Jr.
8. Theory
and practice of Industrial Pharmacy – Leon Lachman,
Herbert A.
Lieberman & Joseph L.
Kanig
9.
Sprowls' American Pharmacy: an introduction to pharmaceutical
techniques and dosage forms - Joseph
Barnett Sprowls
10.
Aulton's Pharmaceutics: The Design and
Manufacture of Medicines - Michael
E. Aulton
11. Encyclopedia
of Pharmaceutical Technology - James
Swarbrick & James
C. Boylan
Assessment Strategy:
- Class Attendance: 5
- Quiz: 10
- Presentation: 5
- Midterm: 30
- Final Exam: 50
- Total: 100
Grading System:
Numerical grade | | Letter Grade | Grade Point |
80% and above | A+ | | A Plus | 4.0 |
75% to less than 80% | A | | A Regular | 3.75 |
70% to less than 75% | A- | | A Minus | 3.5 |
65% to less than 70% | B+ | | B Plus | 3.25 |
60% to less than 65% | B | | B Regular | 3.0 |
55% to less than 60% | B- | | B Minus | 2.75 |
50% to less than 55% | C+ | | C Plus | 2.5 |
45% to less than 50% | C | | C Regular | 2.25 |
40% to less than 45% | D | | D Regular | 2.0 |
Less than 40% | F | | Fail | 0.0 |