Oral Lipid-Based Formulations covers the theoretical and practical aspects of oral lipid-based formulations for use in industry, and provides further insights into a developing technology expected to assume increasing prominence in years to come.

Features:

• provides a detailed review of currently marketed drug products formulated with lipids and an in-depth review of the excipients used to prepare these formulations
• details the sequential stages of lipid-based formulation development, beginning with feasibility assessment and prototype formulation development and concluding with product scale-up and manufacturing considerations
• describes the development and characterization of liquid, semi-solid, and self-emulsifying formulations
• reviews the physiology of gastrointestinal lipid absorption-an important point for understanding the mechanisms by which lipid-based formulations enhance drug bioavailability
• includes case studies detailing the development of oral lipid-based formulations within a major pharmaceutical company

Contents

1. Currently Marketed Oral Lipid-Based Dosage Forms: Drug Products and Excipients
2. Lipid-Based Excipients for Oral Drug Delivery
3. Feasibility Assessment for Scaling Initial Prototype Lipid-Based Formulations to Initial Phase I/II Clinical Trial Batches
4. Materials, Process and Manufacturing Considerations for Lipid-Based Hard Capsule Formats
5. Liquid Self-Micro-Emulsifying Drug Delivery Systems (SMEDDS)
6. Lipid-Based Isotropic Solutions: Design Considerations
7. Lipid-Based Self-emulsifying Solid Dispersions
8. Using Preclinical Data to Dictate Formulation Strategies for Poorly Water-Soluble Drugs
9. Physiological Processes Governing the Gastrointestinal Absorption of Lipids and Lipophilic Xenobiotics
10. Characterizing Release from Lipid-Based Formulations
11. Using In Vitro Dynamic Lipolysis Modeling as a Tool for Exploring IVIVC Relationships for Oral Lipid-Based Formulations
12. Case Study: Rational Development of Self-Emulsifying Formulations for Improving the Oral Bioavailability of Poorly Soluble, Lipophilic Drugs
13. Design and Development of Supersaturatable SEDDS (S-SEDDS)
14. Formulations for Enhancing the Gastrointestinal Absorption of Poorly Soluble Drugs

Index

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