Industrial Pharmacy - I

 

Course Title: Industrial Pharmacy - I 

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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 Formulation

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 Technology

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