Apisolex polymer excipient formulation enters Phase 1 trials, supporting delivery of challenging APIs

Lubrizol has reached a key clinical development milestone, announcing that a drug formulation enabled by its novel excipient, Apisolex polymer, is now in Phase 1 clinical trials.

The polyamino acid-based excipient, introduced in 2022, is designed to improve the solubility of poorly water-soluble compounds—particularly BCS Class II and IV active pharmaceutical ingredients (APIs). Developed under Good Manufacturing Practices (GMP), the excipient is suitable for multiple administration routes, including parenteral.

Lubrizol reports that Apisolex polymer has demonstrated the ability to increase solubility by up to 50,000-fold for certain compounds. The excipient is currently being evaluated in several drug development programs globally, spanning multiple therapeutic areas and dosage forms.

“The progression to clinical trials of a formulation using Apisolex polymer marks an important step in addressing solubility and bioavailability challenges in injectable drug development,” said Kevin Song, senior director of Lubrizol’s global pharmaceutical and nutraceutical business. “We’re continuing to invest in broadening access to this platform and supporting manufacturers working with complex APIs.”

Apisolex is currently under investigation as part of a number of programs addressing difficult-to-formulate drug candidates.