Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem of major significance, the pharmaceutical industry has been slow to apply and further develop this technology. This title provides a comprehensive summary of 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.
Table of Contents
Currently Marketed Oral Lipid-Based Dosage Forms: Drug Products and Excipients. Lipid-Based Excipients for Oral Drug Delivery. Feasibility Assessment for Scaling Initial Prototype Lipid-Based Formulations to Initial Phase I/II Clinical Trial Batches. Materials, Process and Manufacturing Considerations for Lipid-Based Hard Capsule Formats. Liquid Self-Micro-Emulsifying Drug Delivery Systems (SMEDDS). Lipid-Based Isotropic Solutions: Design Considerations. Lipid-Based Self-emulsifying Solid Dispersions. Using Preclinical Data to Dictate Formulation Strategies for Poorly Water-Soluble Drugs. Physiological Processes Governing the Gastrointestinal Absorption of Lipids and Lipophilic Xenobiotics. Characterizing Release from Lipid-Based Formulations. Using In Vitro Dynamic Lipolysis Modeling as a Tool for Exploring IVIVC Relationships for Oral Lipid-Based Formulations. Case Study: Rational Development of Self-Emulsifying Formulations for Improving the Oral Bioavailability of Poorly Soluble, Lipophilic Drugs. Design and Development of Supersaturatable SEDDS (S-SEDDS) Formulations for Enhancing the Gastrointestinal Absorption of Poorly Soluble Drugs