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About The Book
The book ‘Industrial Pharmacy; is concerned with several topics related to post-graduate programs. It covers both the B. Pharmacy and M. Pharmacy topics. Aspects relevant to the research work (dissertation) are incorporated. A few topics related to industrial pharmacy, namely, compaction, optimization and pilot plant included.
The book consists of 16 chapters, Preformulation Selection of Drugs; Preformulation Formulation Development; Drug Stability Kinetics Principles and Applications; Stability Testing Drugs and Dosage Forms; Scale-up Techniques; 3D Printing of Pharmaceutical Manufacturing; Bioelectronic Medicine; Biologics and Biosimilars; Telepharmacy: Personalized Prescription and Medicine; Quality by Design; Risk Management System; Process Analytical Technology Principles; PAT-API Manufacture; PAT Tablets Manufacture; and Programmable Logic Controllers.
Special attention is given to include the following:
1. Conceptualization of principles with illustrations.
2. Applications of principles of product development.
3. Comment type questions and answers,
4. Question bank.
Content
01. Preformulation – Selection of the Drugs
General Principles
Organoleptic Properties
Molecular Size and Molecular Weight
Melting Point
Aqueous Solubility of the Drugs
Lipid Solubility – Partition Coefficient
Dissociation Constant (pKa)
Hygroscopicity
Physical Forms of Drugs
Stability Testing
02. 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
03. Drug Stability Kinetics – Advances and Factor Influencing
Degradation Pathways of Drugs
Complex Chemical Reactions – Kinetics
Factors Affecting Chemical Stability – Solutions
Influence of Temperature and pH of the Vehicle on Drug Degradation
04. 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
05. 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
06. 3D Printing of Pharmaceutical Manufacturing
3D Printers – Methods of Printing
Material Characteristics – 3D printing
Evaluation of 3D Printing Products
07. Bioelectronic Medicine
Bioelectronic Medicine – Functional Modalities
Bioelectronic Medicine – Approved Products
Bioelectronic Medicine Research
Bioelectronic Medicine for Inflammatory Diseases
08. Biologics and Biosimilars
Biologics – Unique Products
Biosimilars
Development of Biosimilars
Biosimilarity and Levels of Evidence
Delivery and Targeting of Biopharmaceuticals
Regulatory Considerations – Biosimilars
09. Telepharmacy
Types of Telepharmacies
Retail Telepharmacy-infrastructure
10. Personalized Prescription and Medicine
Categories of Patients for Personalized Medicine
Development of Personalised Medicine – Flow Chart
Drug Delivery for Customised Personalised Medicine
11. QbD in Pharmaceutical Product Development
USFDA’s View of QbD
Elements of QbD
Generic Drug Products – QbD
12. Risk Management System
General Quality Risk Management Process
Risk Management Methods and Tools
Risk Management Systems – Applications in Specific Areas
13. Process Analytical Technology – Principles
Process Analytical Chemistry
Process Control Systems
Process Control Analyzers – Techniques in PAT
Real-time Release
14. PAT-API Manufacture
15. PAT-Tablets Manufacture
16. Program Logic Controller
Ladder Logic Relay Program
Structure of PLC
Input/Output Configurations
Functions and Function Blocks
Appendix I : Definitions and Meanings
Appendix II : Glossary of Symbols
Appendix III : Bibliography
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