Lubrizol announces that an Apisolex polymer excipient-enabled drug formulation is in Phase 1 clinical trials.

Introduced to the market in 2022, Apisolex polymer excipient is a polyamino acid-based polymer that enhances the solubility of BCS Class II and IV active pharmaceutical ingredients (API). Apisolex polymer excipient is manufactured following Good Manufacturing Practices (GMP) guidelines and can be used in dosage forms for various routes of administration, including parenteral.

The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold. Apisolex polymer excipient is currently being evaluated in multiple programs across the globe, enabling delivery of hard-to-formulate APIs from various therapeutic classes and by multiple routes.

Kevin Song, Senior Director, Global Pharmaceutical and Nutraceutical Business, notes “the progression to clinical trials of a medicinal product formulated with Apisolex polymer excipient demonstrates its ability to provide differentiated solutions to solubility and bioavailability challenges in parenteral formulations.” Song adds, “Lubrizol continues to invest in expanding the reach of the Apisolex polymer excipient across global markets and nurturing relationships with drug product manufacturers that are facing insoluble API challenges.”