Powder-filled capsules are arguably the most widely utilised dosage form in early-phase clinical studies. They can flexibly be manufactured in different dose strengths through
variations of capsule fill volume, are easily administered and offer a straightforward way to blind the formulation and impart taste-masking properties. To enhance manufacturability of
powder-filled capsules, either by hand or via high-speed capsule-filling machines, the active pharmaceutical ingredient (API) is usually formulated with excipients into a powder blend.
Formulation as a blend is generally also envisaged to enhance quality and performance of the final capsule, e.g. in terms of content uniformity, chemical stability and disintegration.
This document provides an overview of Ardena’s approach to early-phase powder blend development.
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