Challenges and Opportunities of Development of Salts of Weak Bases

17:10 - 17:45

Salts present a unique opportunity at fixing solubility/dissolution related exposure and/or solid form related challenges. However the drive to progress molecules with low basic pKa (to address safety concerns) in the discovery setting increases risks associated with the design of a robust solid dosage form (namely disproportionation to the base as drug substance or drug product).  Relationship between pKa, pHmax, and salt disproportionation will be discussed.  How to assess this risk and mitigation strategies will be presented

Anand Sistla, Associate Research Fellow, Pfizer