Dissolution Theory, Methodology and Testing
Dissolution as a science has matured over the last four decades. This text is the first to include all aspects of dissolution; theory, methodology and testing. Each chapter has been authored by leading experts in the specific area. Authors are from academia, industry and governmental bodies. It presents a balanced approach on all three areas. Extensively referenced it is the most current definitive work on the topic, important to all pharmaceutical formulators and scientists. It is useful both as a reference for experienced scientists and as a primer for those just starting in the science of dissolution.
Chapter Highlights
Chapter 1, Theory of Dissolution by Arthur Kibbe. This chapter includes a discussion of the basic theory of dissolution suitable for the pharmaceutical scientist and non-pharmaceutical scientist. Covered are such topics as kinetics, dissolution from a pure solvent and dissolution from a matrix.
Chapter 2, The USP Dissolution Procedure by William Brown. The definitive reference on USP criteria for dissolution, it covers material as the necessity for compendial criteria, test apparatuses and acceptance criteria.
Chapter 3, Dissolution Equipment by Bryan Crist. This section includes a complete and up-to-date discussion and illustrated chapter on the various testing equipment including the less known methods. There is also a discussion and explanation of the "unofficial" apparatus such as rotating bottles and diffusion cells.
Chapter 4, International dissolution Standards and harmonization of Dissolution standards and Testing by De Villiers, et al. This chapter includes differences in the USP, BP, EP and JP as related to dissolution criteria. The authors discuss the challenges and opportunities facing international drug developers and a provocative discussion on future directions of international harmonization of dissolution criteria.
Chapter 5, Dissolution of Solid Oral Dosage Forms by Peng, et al. This lengthy and thorough chapter includes specific discussions on various effects of storage, processing and physicochemical properties of tablets and capsules.
Chapter 6, Dissolution of Modified-Release Oral Dosage forms by Williams and Brown. Included in this chapter is an extensive mathematical modeling technique for modified release products. Covering the challenge of sustained release dose form dissolution, the authors cover scientific and regulatory issues with over 1200 references for further reading.
Chapter 7, Dissolution of Heterogeneous Dosage Forms by Palmieri and Gray. This chapter covers dissolution of suppositories and suspensions, an area where not much research has been reported. The authors discuss the various dissolution apparatus modifications, and method development topics that are useful to determine the dissolution from these dosage forms.
Chapter 8, Dissolution of Aerosols by Zhang and Wiedmann. This is a complete and thorough discussion on challenges for determining aerosol particle dissolution. This chapter includes discussions on theory, particle size distribution and theoretical considerations. Also included is a review on respiratory tract drug delivery. The authors also include pharmacokinetic implications and the use of liposomes as well as polymeric particles for lung delivery.
Chapter 9, Usefulness of Dissolution to Predict Bioavailability and Bioequivalence by Tim Eley. This final chapter in the text discusses the use of dissolution to determine bioequivalency and a thorough discussion on in vivo/in vitro correlations.