Title : New excipient to formulate poorly soluble APIs
One of the toughest challenges facing the drug development today is poor solubility of the API. It is estimated that 70%+ of the APIs in drug development pipeline are poorly soluble in water. There are several approaches to this problem with many requiring processes such as spray drying and hot melt extrusion, complex manufacturing processes. Through our presentation we would like to introduce a new tool to formulate poor water- soluble APIs without the need for spray drying or hot melt extrusion. Through this talk we would like to present our formulation studies with several poorly soluble API. Our dataset for the presentation will include mechanism of action, dissolution, stability, and bioavailability. The presentation will also highlight the formulations of two examples APIs (Aprepitant and Tacrolimus) for the case study. We will also demonstrate the safety of the new excipient and share recently approved reference drug. While not the main topic, we will also demonstrate how this new tool enables the formulation of long acting injectable without the need for any implants.
Audience Take Away Notes:
- A new tool to solve a persistent problem: poorly soluble APIs.
- Sample formulations from case study API