In Vitro Dissolution Testing for Solid Oral Dosage Forms
APPARATUS 2Figure 1Particle Sciences 2010 Particle Sciences, Inc. All rights drug substance and involves two steps: Dissolution and absorp-tion (or permeability). Understand-ing the multi-step Dissolution pro-cess is essential to proper in Vitro method development. Dissolution is the process of extracting the API out of the Dosage form Solid -state matrix into solution within the gastrointestinal tract. Absorption is the process of transporting the drug substance from the gastroin-testinal lumen into the systemic circulation. Dissolution Testing is an in vi-tro method that characterizes how an API is extracted out of a Solid Dosage form. It can indicate the efficiency of in vivo Dissolution but does not provide any informa-tion on drug substance absorption.
the USP recommended ionic strength.5 For APIs that exhibit low solubilities in aqueous me-dia throughout the pH range, the addition of surfactants is recom-mended.
Download In Vitro Dissolution Testing for Solid Oral Dosage Forms
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Related search queries
FDA Guidance for Industry Dissolution Testing of Immediate, Immediate Release, Dissolution Method Development for Immediate Release, Dissolution, Dissolution Method Development for Immediate Release Solid, European Medicines Agency, RELEASE, RELEASE TESTING OF RECTAL SUPPOSITORIES CONTAINING NIMESULIDE, MULTISOURCE (GENERIC) PHARMACEUTICAL