Course Title: Industrial Pharmacy - I
Click on module title to Download Note's
Module 1: Preformulation Studies
Introduction to Preformulation
Objectives and Significance of
Preformulation Studies
Physicochemical Characteristics
of Drug Substances
a. Physical Properties: Crystal
vs. Amorphous Forms, Particle Size, Shape, Flow Properties
b. Solubility Profile: pKa, pH,
Partition Coefficient, Polymorphism
c. Chemical Properties:
Hydrolysis, Oxidation, Reduction, Racemization, Polymerization
BCS Classification of Drugs and
Its Relevance
Application of Preformulation
Considerations in Dosage Form Development
Impact of Preformulation on
Stability of Dosage Forms
Module 2: Liquid Oral Dosage Forms
Formulation and Manufacturing
Considerations for:
a. Syrups and Elixirs
b. Suspensions and Emulsions
Filling, Packaging, and
Evaluation of Liquid Oral Dosage Forms
Official Standards for Liquid
Orals in Pharmacopoeia
Module 3: Tablet Dosage Forms
Introduction to Tablets and
Ideal Characteristics
Advantages & Disadvantages Tables over other Dosage forms
Tablet Classification and
Excipients
Formulation of Tablets and
Granulation Methods
Compression, Processing
Challenges, and Tablet Tooling
Tablet Coating:
a. Types, Coating Materials,
Formulation of Coating Composition
b. Coating Methods, Equipment,
and Defects
Quality Control Tests for
Tablets: In-process and Finished Product
Module 4: Capsule Dosage Forms
Hard Gelatin Capsules:
a. Production of Capsule
Shells, Size Specifications
b. Filling Techniques, Special
Formulations, Manufacturing Defects
Soft Gelatin Capsules:
a. Shell Characteristics,
Capsule Content, Size Considerations
b. Production, In-process and
Final Product Quality Control
c. Packaging, Storage,
Stability Testing, and Applications
Module 5: Pelletization
Introduction to Pellets and
Formulation Requirements
Module 6: Parenteral Products
Types, Advantages, and
Limitations of Parenteral Dosage Forms
Preformulation Factors,
Essential Requirements, and Vehicles
Importance of Isotonicity
Production Procedure, Aseptic
Processing, Facilities, and Controls
Formulation of Injections,
Sterile Powders, Large Volume Parenterals, and Lyophilized Products
Containers and Closures
Selection, Filling, and Sealing
Quality Control Tests for
Parenteral Products
Module 7: Ophthalmic Preparations
Introduction and Formulation Considerations
Formulation of Eye Drops, Eye
Ointments, and Eye Lotions
Methods of Preparation,
Labeling, Containers
Evaluation of Ophthalmic
Preparations
Module 8: Cosmetics
Formulation and Preparation of
Cosmetic Preparations:
a. Lipsticks, Shampoos, Cold
Cream, Vanishing Cream
b. Toothpastes, Hair Dyes,
Sunscreens
Module 9: Pharmaceutical Aerosols
Definition of Aerosols and
Types of Aerosol Systems
Formulation and Manufacture of
Aerosols
Propellants, Containers, Valves
Evaluation, Quality Control,
and Stability Studies of Aerosols
Module 10: Packaging Materials Science
Materials Used for
Pharmaceutical Packaging
Factors Influencing Container
Selection
Legal and Official
Considerations in Packaging
0 Comments