June 12, 2018 – Skyepharma is contributing to San Francisco Compaction Simulation Forum from June 11 to June 13, with a scientific poster about compaction simulation as a QbD tool to develop complex oral solid dosage forms.
Indeed, compaction simulation is a powerful tool to accelerate time to market at every stage of drug development, particularly when complex dosage forms are developed.
Skyepharma is presenting and discussing the following case studies, they illustrate key aspects of Quality by Design approach with concrete examples:
- Compression force criticality determination on the dissolution profile of a sustained release matrix tablet, as a tool during early stage prototyping; This is the base of tableting but our experience and data show that the basic cannot be overlooked and need to be audited.
- STYL’One / HATA 55-LSU/3L correlation study on a biphasic IR / SR 3-layer tablet, as a tool for process scale-up; an extension of rotary press simulation extended to multi-layer environment. Finding critical parameters and set-up at early stages.
- STYL’One / Kilian S250 correlation study on a tab-in-tab dosage form, with the aim to optimize production planification. The study focuses on physical core positioning and impact on in vitro dissolution.
Click here to see the Scientific Poster : Compaction simulation as a QbD Tool
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