Dual Antibiotic Tablet

By Aptuit, Inc.

The Challenge
The client came to Aptuit with an existing capsule formulation. Due to the dose required, between 100 mg and 800 mg, a tablet formulation was requested. Several problems became apparent in the very early stages of the project. The client was uncertain regarding the ratio of the two actives required for therapeutic dose. The two API's had very different properties and both were poorly soluble, also batch to batch variation was high in each API and the API manufacture process led to high levels of impurities. As these problems presented themselves to the formulation and analytical method development teams, both were required to work closely to find a solution to successfully develop a dual antibiotic tablet.