Downstream processing of spray-dried ASD with hypromellose acetate succinate – Roller compaction and subsequent compression into high ASD load tablets
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.
This month’s paper of the month demonstrates how a Gamlen Powder Compaction Analyser can be used as part of the formulation development process. Here the authors are investigating the roller compaction and tablet compression of a formulation with a high ASD (amorphous solid dispersion) content. ASD methods are used to improve the solubility of BCS class II drugs.
In this instance, the ASD was produced by spray drying the API (Nifedipine) with a carrier polymer, HPMCAS (hypromellose acetate succinate). This process transfers the API into an amorphous state increasing its solubility.
Two formulations were prepared, one using microcrystalline cellulose/croscarmellose as the binder/disintegrant and the other using MCC/low-substituted hydroxypropyl cellulose.
The formulations were subjected to roller compaction and the resultant granules were analysed using the Gamlen and a number of additional material physical property tests.
Tablets were manufactured using a rotary tablet press and the final tablets were evaluated.
A tablet formulation was successfully developed containing a high level of spray dried ASD. This was facilitated by careful selection of the roller compaction compression pressure and the binder/disintegrant system.
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