Synopsis

During the development and manufacture of commercial drug products, it is challenging to optimise formulations during early-stage formulation development to achieve maximum commercial output (tablets/year). From an operations perspective, the greater the output the better. A second challenge encountered is the ability to use studies generated on pilot scale equipment during scale-up development. As a result, studies that are completed on pilot equipment must be repeated at a commercial scale, which duplicates work and thus creates inefficiencies. With these challenges in mind, to reduce inefficiencies and thus streamline tech transfer and scale-up activities, an industry-academic collaborative project was devised funded through Enterprise Ireland and supported by PMTC and SSPC researchers. A unique DoE approach was applied to study the behaviour of the formulations with a range of flow and compaction behaviour on pilot and production-scale tablet presses. Models to predict commercial scale tableting performance using small-scale blend data were developed which can now be used to maximise production. For example, the models revealed that improving flow properties can more than double commercial production output. If you can double your output, you could potentially double your revenue which obviously has massive implications from a business perspective.