On-Demand Manufacturing of Direct Compressible Tablets: Can Formulation Be Simplified?

Here at Gamlen we are highlighting some of the fascinating and ground-breaking research that has been carried out by our customers in our Paper of the Month posts.

In this paper the authors use a miniature system to manufacture tablets that incorporates a Gamlen D500. They show how tablet formulations can be simplified when tablets are manufactured on-demand such that long term stability is not a requirement.

  • This paper describes how simplified formulations were developed for five different APIs. The number of excipients in each formulation was kept to a minimum while ensuring that the formulations were suitable for direct compression.
  • A custom made, automated and portable system was used to manufacture tablets of each formulation. The system includes units for feeding, blending, dispensing, and compacting powders to produce tablets.
  • After manufacture and after 2 weeks enhanced stability, the tablets were subjected standardised USP tests to assess their critical quality attributes. For one API a low drug release value was recorded but in all other cases the acceptance criteria for the USP tests were met.

CONCLUSION

This study illustrates the feasibility of using a miniature, automated system to manufacture tablets and the benefits of producing tablets on-demand.

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