Customer Credentials – Direct Compression not always possible for every API
Situation at first contact
We were consulted by an international pharmaceutical company that wanted to transfer one of its major products to direct tableting. Until then, the product was produced by wet granulation and the company hoped to save production costs.
Our Approach
Step 1 – Initial Consulting
After exchanging formulation and process details, it turned out that the product had a high drug load and some functional excipients that could not be changed. Additionally, other necessary excipients like super-disintegrant and lubricant were required, so that the remaining quantity of exchangeable excipients was below 15%. Given these conditions, it became clear that the API itself had to play its part for direct tableting to be possible. Nevertheless, we agreed with the customer to characterize the formulation and, above all, the API for its tabletability.
Step 2 – Characterization of API & Formulation
During the trial preparations, it turned out that the API was available from different suppliers in different qualities, sometimes with very different particle size distributions. We tested some of them and the tabletability changed from almost not tabletable to quite good tabletable. Unfortunately, the tabletability was inversely proportional to flowability, which allowed a poorly flowing but good tabletable grade for the granulation but did not work out for the direct compression.
Results
Several options were discussed, e.g., increasing the tablet weight to get more proportion of highly binding excipients, trying to find an optimal API grade or even develop one for direct compression with one of the suppliers. All had its pros and cons. In the end the customer decided to stay to the actual manufacturing process. The decision was based not only on costs, but also on factors such as delivery capability and continuity.
Not every formulation is made for direct compression – but every challenge deserves the right development approach.
Let’s talk about your formulation goals and how we can help you get there.
Contact us (www.solids-development.com) or email us at contact@solids-development.com.