Transcription of In Vitro Dissolution Testing for Solid Oral Dosage Forms
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In Vitro Dissolution Testing for Solid Oral Dosage Forms
APPARATUS 2 Figure 1 Particle 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. Pharmacokinetic data supplements and provides additional informa-tion regarding API absorption of the appropriate in Vitro conditions (media and hydro-dynamics) that simulate the in vivo conditions can lead to the genera-tion of successful IVIVC or at the very least, in Vitro -in vivo relations (IVIVR).
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.
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