A therapeutic candidate incorporating excipient specialist Lubrizol's Apisolex has progressed into Phase I clinical trials.
The polyamino acid-based polymer excipient is designed to enhance the solubility of BCS Class II and IV active pharmaceutical ingredients (APIs), enhancing their efficacy and absorption in the body.
During the study, the parenteral formulation's safety, pharmacokinetic profile and associated side effects will be tested.
Notably, Apisolex has been proven to increase the solubility of certain APIs by up to 50,000x in previous studies.
To ensure the therapeutic is safe and effective, the undisclosed company responsible for the development of the unnamed drug is running multiple programmes across the globe.
Apisolex is primarily designed to enable the delivery of hard-to-formulate APIs from a range of therapeutic classes, and is suitable for multiple types of dosage forms — including parenteral.
The excipient is also GMP compliant.
“A medicinal product formulated with Apisolex polymer excipient has reached the clinical trial stage, demonstrating its ability to provide differentiated solutions to solubility and bioavailability challenges in parenteral formulations," noted Kevin Song, Senior Director, Global Pharmaceutical and Nutraceutical Business.
"Lubrizol will continue to expand the reach of the Apisolex polymer excipient across global markets, while nurturing relationships with drug product manufacturers that are facing insoluble API challenges," he concluded.