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.
This study illustrates the feasibility of using a miniature, automated system to manufacture tablets and the benefits of producing tablets on-demand.
Privacy & Cookies Policy
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.