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Open AccessArticle

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

1
School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, 70210 Kuopio, Finland
2
Orion Pharma Oyj, 02200 Espoo, Finland
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(3), 279; https://doi.org/10.3390/pharmaceutics12030279
Received: 19 February 2020 / Revised: 13 March 2020 / Accepted: 18 March 2020 / Published: 20 March 2020
(This article belongs to the Special Issue Continuous Pharmaceutical Manufacturing)
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. View Full-Text
Keywords: Continuous direct compression; low-dose API; tablet; material properties Continuous direct compression; low-dose API; tablet; material properties
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MDPI and ACS Style

Ervasti, T.; Niinikoski, H.; Mäki-Lohiluoma, E.; Leppinen, H.; Ketolainen, J.; Korhonen, O.; Lakio, S. The Comparison of Two Challenging Low Dose APIs in a Continuous Direct Compression Process. Pharmaceutics 2020, 12, 279.

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