Pharmaceutical Dosage Forms: Capsules

Features

·         Updates the current status of gelatin and gelatin alternatives in capsule shell production

·         Addresses capsules as a carrier platform both for oral modified release and technologies for solving difficult drug solubility problems

·         Discusses modeling in support of Quality-by-Design (QbD) and capsule formulation development and manufacture

·         Updates the role of capsules in clinical trials based on new technologies such as miniaturization for direct "Powder in a Capsule" filling and capsule engineering

·         Provides practical formulation, manufacturing, and regulatory considerations in development and scale-up

·         Updates the latest technologies in capsule shell filling and reviews historic developments in capsule filling

·         Presents many topics authored by experts in the field

Summary

Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Table of Contents

1. Advances in Capsule Formulation Development and Technology

[Larry L. Augsburger and Stephen W. Hoag]

2. An Introduction to Two-Piece Hard Capsules and Their Marketing Benefits

[Dennis Murachanian]

3. Hard Shell Capsules in Clinical Trials

[Moji Christianah Adeyeye and Amusa Adebayo]

4. Capsule Shell Manufacture

[Brian E. Jones, Fridrun Podczeck, and Paul Lukas]

5. Non-Gelatin-Based Capsules

[Sven Stegemann]

6. Hard Shell Capsule Filling Machines

[Donald K. Lightfoot]

7. Instrumented Automatic Capsule Filling Machines and Filling Machine Simulation

[Larry L. Augsburger and Vikas Moolchandani]

8. Dry-Fill Formulation and Filling Technology

[Pavan Heda, Vikas Agarwal, and Shailesh K. Singh]

9. Plug Formation

[Fridrun Podczeck]

10. Modeling Powder Filling during Encapsulation

[Ammar Khawam]

11. Scale-Up and Transfer of Hard Shell Formulations across Machine Types

[Larry L. Augsburger and Michael Levin]

12. Modified-Release Delivery Systems: Extended-Release Capsule Platform

[Reza Fassihi]

13. Analytical Testing and Evaluation of Capsules

[Stuart L. Cantor and Asish K. Dutta]

14. Rheological Aspects of Capsule Shell Excipients and the Manufacture of Encapsulated Formulations

[Lawrence H. Block]

15. Quality-by-Design (QbD) for Capsule Formulation and Process Development: Regulatory Science Relevance, Scientific Case Studies, and Future Challenges

[Huiquan Wu, Lin Xie, Stephen W. Hoag, Larry L. Augsburger, and Mansoor Khan]