When a pharma company encountered problems manufacturing a high-volume product, Instigator stepped in to help optimize production efficiency.
The Opportunity
During the high-volume manufacture of a new product, a pharmaceutical company found that a hydroscopic active ingredient caused the product to pick in the tablet press tooling. Because the tablet was already large, there was little room for flexibility to add additional excipients. The pharmaceutical company needed a new production approach to maximize efficiency of the plant’s throughput.
The Process
Instigator provided product development expertise to optimize efficiency in the manufacturing process.
First, our team conducted a study of the current ingredient combination. We used DOE (design of experiments) to test a variety of excipient levels in order to maximize compactability and optimize tablet size.
We looked at the production practices in use and tested others – including roller compaction, fluid bed granulation, and high shear granulation – to see which worked best with the product.
As a result of this research and testing, our team discovered several areas where this product could be improved:
We found that the active ingredient was self-binding, so the company was able to cut down on the tablet’s size by eliminating its binder. We also found that high shear granulation was the most efficient manufacturing method.
Finally, we discovered how to optimize the tablet’s moisture content. Leaving more residual water in the tablet’s formulation than in the active raw material allowed us to reduce the picking, create a smaller tablet, and ultimately establish a more efficient manufacturing process.
Result
Our team’s attention to detail helped optimize the manufacture of this product and set it up for long-term success. The product is still on the market, and its annual sales of $54 million have pushed it to the top of its market segment.
