The Comparison of Two Challenging Low Dose APIs in a Continuous Direct Compression Process

Segregation is a common problem in batch-based direct compression (BDC) processes, especially with low-dose tablet products, as is the preparation of a homogenous mixture. The scope of the current work was to explore if a continuous direct compression (CDC) process could serve as a solution for thes...

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Bibliographic Details
Published in:	Pharmaceutics Vol. 12; no. 3; p. 279
Main Authors:	Ervasti, Tuomas, Niinikoski, Hannes, Mäki-Lohiluoma, Eero, Leppinen, Heidi, Ketolainen, Jarkko, Korhonen, Ossi, Lakio, Satu
Format:	Journal Article
Language:	English
Published:	Switzerland MDPI AG 20-03-2020 MDPI
Subjects:	Batch processes continuous direct compression Drug dosages low-dose api Manufacturing material properties Morphology Particle size Pharmaceuticals Physical properties Raw materials tablet China tablet material properties low-dose API Continuous direct compression
Online Access:	Get full text
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Summary:	Segregation is a common problem in batch-based direct compression (BDC) processes, especially with low-dose tablet products, as is the preparation of a homogenous mixture. The scope of the current work was to explore if a continuous direct compression (CDC) process could serve as a solution for these challenges. Furthermore, the principle of a platform formulation was demonstrated for low dose tablets. The combination of filler excipients and the API in the formulation used was suitable for direct compression, but also prone to induce segregation in BDC process. The CDC process was found to be very promising; it was shown that tablets with the desired quality parameters could be manufactured successfully with both of the APIs studied. Powder analysis indicated that the APIs display some fundamental differences in their physical properties, which was also reflected in powder mixture properties and, hence, eventually in processing. However, process parameters, especially mixer impeller speed, were not found to have any significant influence on end product quality. The study suggests that a CDC process can be a viable solution to resolve the challenges described. Moreover, manufacturing by using a universal platform formulation seems to be a feasible way for producing low-dose tablets.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1999-4923 1999-4923
DOI:	10.3390/pharmaceutics12030279