‘Modern Pharmaceutics’ imparts advanced knowledge that deals with the product design and development, including market commercialization, whether the categories are NDA, ANDA, SUPAC, etc.

   The book consists of 8 chapters. Chapters are Preformulation Studies – A Step To Formulation Development; Optimization Techniques in Pharmaceutical Product Development; Pharmaceutical Process Validation CGMP Considerations of Pharmaceutical Manufacturing; Industrial Pharmacy Management; Pharmaceutics of Compression and Consolidation; Drug Product Evaluation – Dissolution and Diffusion; Drug Product Evaluation – Statistical Methods.
Special emphasis is given to include the following:
    1. Conceptualization of principles.
    2. Applications of principles.
    3. A number of illustrations.
    4. Question bank.

   The language has been kept simple to understanding the concepts with ease.

1. PREFORMULATION STUDIES - A STEP TO FORMULATION DEVELOPMENT
     ƒ Drug Excipient Compatibility
     ƒ Chemical Kinetics – Basic Principles
     ƒ Preformulation – Stress and Forced Testing
     ƒ Dosage Form Stability Testing – Prolonging Shelf Life
     ƒ Preformulation Aspects of Suspensions
     ƒ Preformulation Aspects of Emulsions
     ƒ Preformulation Aspects of SMEDDS
     ƒ Parenteral Drug Products
     ƒ Preformulation Aspects of Large Volume Parenterals
     ƒ Preformulation Aspects of Small Volume Parenterals
    
2. OPTIMIZATION TECHNIQUES IN PHARMACEUTICAL PRODUCT DEVELOPMENT
     ƒ Simulation and Search Methods
     ƒ Factorial Design
     ƒ Response Surface Designs – Composite and Central Composite Designs
     ƒ Screening Designs – Plackett Burhman Method and Fractional Factorial Design
     ƒ Mixture and Simplex Designs
    
3. PHARMACEUTICAL PROCESS VALIDATION
     ƒ Validation – Documentation
     ƒ Manufacturing Process Model – Stages of Development
     ƒ Pharmaceutical Validation
     ƒ Pharmaceutical Process Validation – Types
     ƒ Equipment – Calibration, Qualification and Validation
     ƒ Validation of Specific Dosage Forms
    
4. CGMP CONSIDERATIONS OF PHARMACEUTICAL MANUFACTURING
     ƒ Objectives, Policies and Principles of CGMP
     ƒ Manufacturing Plant – Location
     ƒ Pharmaceutical Plant - Layout
     ƒ Building Construction – Architectural Details
     ƒ Utilities and Services
     ƒ Total Quality Management
    
5. INDUSTRIAL PHARMACY MANAGEMENT
     ƒ Principles of Industrial Management
     ƒ Sales, Sales Forecasting, Sales Budget and Control
     ƒ Inventory Management
     ƒ Material Management
     ƒ Production Planning, Production and Control
     ƒ Plant Material Handling
     ƒ Equipment Maintenance Management
     ƒ Human Resource Management
    
6. PHARMACEUTICS OF COMPRESSION & CONSOLIDATION
     ƒ General Principles
     ƒ Compression
     ƒ Properties of Materials for Compression
     ƒ Consolidation
     ƒ Decompression
     ƒ Compaction at High Loads
     ƒ Forces Distribution during Compression
     ƒ Compaction Profiles
     ƒ Forces in Compression – Measurement
     ƒ Energy involved in Compaction
     ƒ Properties of Granules for Compression
     ƒ Properties Related to Machinery for Compression
    
7. DRUG PRODUCT EVALUATION - DISSOLUTION AND DIFFUSION
     ƒ Dissolution Mediated Drug Release
     ƒ Dissolution Methods
     ƒ Dissolution Release Modeling – Hixson-Crowell Model
     ƒ Drug Release Analysis– Modeling of Kinetics and Mechanisms
     ƒ Drug Release Profiles – Comparison
     ƒ Dissolution (In Vitro) and PK Parameters (In Vivo)
     ƒ Diffusion Mediated Drug Release
     ƒ Diffusion Methods
     ƒ Drug Diffusion Release Modeling – Matrix Systems
    
8. DRUG PRODUCT EVALUATION - STATISTICAL METHODS
     ƒ Test of Significance
     ƒ Chi-square test
     ƒ Student’s t test for Significance
     ƒ Analysis of Variance (ANOVA)
    
     APPENDIX I   : Key to Numerical Problems
     APPENDIX II  : Glossary of Symbols
     APPENDIX III : Bibliography