Case-Study-Physical-Form-Selection-for-a-New-Chemical-Entity

Case Study - Physical Form Selection for a New Chemical Entity

About Our Client:

Our client, a US-based biotech company involved in the discovery and development of small molecule therapeutics for the treatment of infectious diseases.

The Challenges:

A highly soluble molecule with poor solid-state properties, i.e., very low melting point and high hygroscopicity
The molecule's poor solid-state properties posed significant challenges for late-phase, oral solid dosage (OSD) formulation development
The molecule's low melting point and high hygroscopicity properties would make it diicult to develop an OSD that does NOT require special handling and storage conditions
The molecule has ionizable functional groups that can form salts

Download this case study to learn how the solution provided by Aragen removed uncertainty regarding stability during clinical development and de-risked all issues while maintaining the same solubility profile.

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