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About The Book
The book ‘Industrial Pharmacy – Selected Topics’, is concerned with several topics related to the post-graduate programs. It is difficult to draw a line that clearly separates the B. Pharmacy and M. Pharmacy topics in terms of content area. Several topics, which hitherto vogue, are dealt with in detail considering the recent advances. In addition, aspects relevant to the research work dissertation are incorporated.
The demands of the pharmaceutical industry are wide and varied. It is very difficult to include all of them comprehensively. Therefore, a few selected topics, which a student may find difficult, are included in this edition.
The book consists of 8 chapters, Preformulation – Selection of Drug, Preformulation – Formulation Development, Compaction – Compression and Consolidation, Optimization Techniques – Product Development, Drug Stability Kinetics – Principles and Applications, Stability Testing – Drugs and Dosage Forms, Pharmaceutical Pilot Plant and Scale up Techniques.
Special attention is given to include the following:
1. Conceptualization of principles with illustrations.
2. Application of principles of product development.
3. Question bank.
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Chapter 1. Preformulation – Selection of the Drugs
General Principles
Organoleptic Properties
Molecular Size and Molecular Weight
Melting Point
Aqueous Solubility of the Drug
Lipid Solubility - Partition Coefficient
Dissociation Constant (pKa)
Hygroscopicity
Physical Forms of Drugs
Stability Testing
Question Bank
Chapter 2. Preformulation – Formulation Development
Dose and Dosing Interval
Excipient Science – Tablets
Tablets – Formulation Development
Hard Gelatin Capsules – Formulation Development
Solution Dosage Forms – Formulation Development
Suspensions – Formulation Development
Question Bank
Chapter 3. Compaction – Compression and Consolidation
General Principles
Compression
Consolidation
Decompression
Compaction at High Loads
Forces Distribution during Compression
Compaction Profiles
Forces in Compression - Measurement
Energy involved in Compaction
Properties of Granules for Compression
Properties Related to Machinery for Compression
Influence of Compression Force on the Properties of Tablets
Question Bank
Chapter 4. Optimization Techniques in Pharmaceutical Product Development
General Principles
Mathematical Models and Statistical Tests
Simulation and Search Methods
Parametric Methods of Optimization
Factorial Designs
Central Composite Designs
Mixture and Simplex Designs
Lagrangian Method
Nonparametric Methods
Screening Designs – Plackett Burqman Method
Question Bank
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Chapter 5. Drug Stability Kinetics – Principles and Applications
Chemical Kinetics
Complex Chemical Reactions – Kinetics
Degradation Pathways of Drugs
Factors Affecting Chemical Stability - Solutions
Influence of Temperature on Drug Degradation
Influence of pH of the Vehicle on Drug Degradation
Question Bank
Chapter 6. Stability Testing – Drugs and Dosage Forms
Solid State Drug Stability
Accelerated Stability Studies – Solution Dosage Forms
Physical Degradation of Pharmaceutical Products
Prolonging the Shelf Life - Strategies
Dosage Form Stability – Packaging Materials
Question Bank
Chapter 7. Pharmaceutical Pilot Plant
Scale of Batches - Product Development
Layout of Pharmaceutical Pilot Plant
Organizational Structure and Personnel – Pilot Plant
Activities - Pilot Plant
Tablets– Pilot Plant
Hard Gelatin Capsules – Pilot Plant
Solution Dosage Forms – Pilot Plant
Disperse Systems – Pilot Plant
Parenteral Products – Pilot Plant
Question Bank
Chapter 8. Scale Up Techniques
Principles of Similarity
Dimensional Analysis
Mixing Scale up Techniques
Granulation Scale up Techniques
Size Reduction Scale up Techniques
Compression Scale up Techniques
Film Coating Scale up Techniques
Hard Gelatin Capsules – Filling Scale up Techniques
Microspheres (Emulsification Method) – Scale up Analysis
Question Bank
APPENDIX-I : Answers to Numericals
APPENDIX-II : Definitions and Meanings
APPENDIX-III : Bibliography
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