per person /
Free
Industrial Pharmacy-I (Theory)
Teacher
Mr Himansu Bhusan Samal
Category
Core Courses
Course Attendees
Still no participant
Course Reviews
Still no reviews
Course Name : Industrial Pharmacy-I
Code(Credit) : BPHT3102 (4-0-0)
Course Objectives
To Understand and appreciate the influence of Pharmaceutical additives and various Pharmaceutical dosage forms on the performance of the drug product.
Course Outcomes
| CO | Statement | Mapping with POs |
| CO-1 | To understand various Pharmaceutical Dosage forms and their manufacturing techniques | PO1, PO2, PO10 |
| CO-2 | To Know various considerations in development of pharmaceutical dosage forms | PO1, PO2, PO10, PO11 |
| CO-3 | To formulate and evaluate solid, liquid and semisolid dosage forms | PO1, PO2, PO10 |
| CO-4 | To correlate the theoretical knowledge with professional and practical need of Pharmaceutical industry. | PO1, PO2, PO6 PO10 |
| CO-5 | Able to Select the appropriate packaging materials for various pharmaceutical dosages form. | PO1, PO2, PO10 |
Course Syllabus:
MODULE-I
Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.
MODULE-II
Tablets:
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipments and tablet tooling.
b. Tablet coating: Types of coating, coating materials, formulation of coating
composition, methods of coating, equipment employed and defects in coating.
c. Quality control tests: In process and finished product tests
Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia
MODULE-III
Capsules:
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, size of
capsules,importance of base adsorption and minim/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.
Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets
MODULE-IV
Parenteral Products:
a. Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity
b. Production procedure, production facilities and controls,
aseptic processing
c. Formulation of injections, sterile powders, large volume parenterals and
lyophilized products.
d. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations
MODULE-V
Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products,factors influencing choice of containers, legal and official requirements for containers, stability aspects of packaging materials, quality control tests.
Reference :
1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman &J.B.Schwartz
2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman
3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman
4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition
5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science (RPS)
6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
7. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill livingstone, Latest edition
8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger, Philadelphia, 5thedition, 2005
9. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel Dekker Series, Vol 107.
Session Plan
Session 1
Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances
Session 2
Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism
Session 3
Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
Session 5
Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.
Session 8
Formulation of tablets, granulation methods, compression
Session 10
Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating
Session 12
Formulation and manufacturing consideration of syrups and elixirs
Session 13
Session 14
Filling and packaging; evaluation of liquid orals official in pharmacopoeia
Session 15
Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules
Session 16
Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.
Session 17
Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance of base adsorption and minim/gram factors
Session 18
Production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.
Session 21
Definition, types, advantages and limitations of Parenterals. Preformulation factors and essential requirements
Session 22
Vehicles & additives in Parenterals, importance of isotonicity
Session 23
Production procedure, production facilities and controls, aseptic processing
Session 24
Formulation of injections, sterile powders, large volume parenterals and lyophilized products.
Session 25
Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids
Session 28
Formulation of eye drops, eye ointments and eye lotions
Session 29
Methods of preparation; labeling, containers; evaluation of ophthalmic preparations
Session 30
Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Session 31
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems
Session 32
Formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.
Session 33
Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influencing choice of containers, legal and official requirements for containers
Session 34
Stability aspects of packaging materials, quality control tests of packaging materials
Case Studies
Case Studies
Our Main Teachers