Advances In Formulation & Technology Of Sterile Products

Advances In Formulation & Technology Of Sterile Products by Dr. Suresh Ramnath Naik, Prof. Afaque Raza Mehboob Ansari

Book Summary:

The desire to write this book, 'Advances in Formulation and Technology of Sterile Products' arose while teaching the course at post graduate level, we became aware of the difficulties encountered by students through the lack of easily accessible critical aspects of pharmaceutical sterile products, and specially of the need for a handy single volume, which would provide basic information of such products. Hence, while writing this book a special effort was made to stress and focus on various facets of sterile dosage forms (small and large volume parenterals) and the concept that are relevant for successful development of such sterile products have also been explained with illustrations.

The process outline, containers closures and delivery aspects including bottleneck faced and finally basic aspects of Current Good Manufacturing Practices which may facilitate commercial product development, innovations and advancement of aseptic filling processes including unit operations of lyophilized parenteral preparations. In addition, regulatory and quality control aspects with respect to particulate matter, physicochemical testing, sterile filtration and sterilization process, microbial contamination testing and validation of the sterile methods have also been explained lucidly. A special attention has been paid for interospection of the currently practiced procedures and to evolve a better and improved regulatory aspects for sterile products and their further scope for improvement. In many sterilized products, the importance of certain critical in-process checks has also been emphasized from Quality Assurance point of view.

Audience of the Book :

This book Useful for B.Pharma & M.Pharma students.

Table of Contents:

1. Introduction

2. Characteristics of Parenterals

3. Formulation Aspects of Parenterals

4. Dosage Forms

5. Quality Assurance of Sterile Preparations

6. cGMPs Used in Parenteral Manufacture: Revised Schedule-M

7. Sterilization Techniques

8. Steps Involved in Processing

9. Personnel: The Key Factor in Clean Room Operations

10. Blow-Fill-Seal (BFS/FFS) Technology

11. Total Parenteral Nutrition

12. Design of Devices for Parenteral Administration

13. Packaging of Parenteral Dosage Forms

14. Quality control of Parenterals

15. Labelling of Parenterals

16. Ophthalmic Formulations

17. Otic Formulation

Glossary of Terms

Index

Bibliography