QbD approach to downstream processing of spray-dried amorphous solid dispersions - a case study

In the current study, we demonstrate a structured approach to downstream process development for spray dried amorphous solid dispersions. Direct compression is generally not suitable due to typically poor flow of spray dried powders in tablets. Roller compaction (RC) is therefore the method of choic...

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Bibliographic Details
Published in:Pharmaceutical development and technology 2021-03, Vol.26 (3), p.269-277
Main Authors: Henriques, João, Moreira, Jorge, Doktorovová, Slavomíra
Format: Article
Language:English
Subjects:
amorphous solid dispersions
DoE
loss of compactability
Roller compaction
tablets manufacture
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Summary:In the current study, we demonstrate a structured approach to downstream process development for spray dried amorphous solid dispersions. Direct compression is generally not suitable due to typically poor flow of spray dried powders in tablets. Roller compaction (RC) is therefore the method of choice to enable spray dried dispersion downstream processing. Here, a structured experimental design of RC process parameters was used. The objective was to identify process conditions that lead to improved powder flow without compromising tablet robustness. Ten blends were compacted using different process parameters, and subsequently compressed into tablets. The impact of process parameters on granules and tablet properties was analyzed. We demonstrate that compaction force, gap and mesh aperture have major impact on RC outcomes. A combination of large gap and low force was identified as optimum combination of RC process parameters leading to powder flow improvement that could guarantee low tablet weight variation and at the same prevented loss of blend compressibility.
ISSN:1083-7450
1097-9867
DOI:10.1080/10837450.2020.1863985