From API, to Clinical Trials, to Stability
An Avomeen Case Study
A pharmaceutical company interested in creating a new novel drug product came to Avomeen with only their API and requested that our team develop a time-released, pH dependent tablet, with specific bio availability. The pills required a large amount of API to be present in the final formulation which affected the choice for the pill's shape and size, which added to the unique challenge presented.
To properly create this pharmaceutical tablet and meet the clients exact specifications, Avomeen's team worked directly with the client through the entire product development cycle. Our skilled scientists created multiple unique formulation/processing techniques over several dozen iterations including dry coat, API encapsulation, and entire coated tablet drug designs in order to test the various available options and ensure both proper delivery and dissolution of the API.
Post development our scientists developed a method per ICH guidelines for:
Linearity from limit to LOQ (Range)
These methods were validated under GMP compliance (21 CFR Parts 210 & 211). In total we were able to provide full product development services which included method development and validation in only five months. After the formulation development was complete, the client had their dedicated team of chemists produce 5,000 tablets under cGMP conditions for Phase I Trials and perform their stability testing.
Our CTM team manufactured their clinical supply under the following conditions:
Batch record preparation and raw materials qualification
Bulk packaging and labeling
The stability study in support of Phase I included eight time points with pulls over two years under both real time and accelerated conditions under ICH guidance.