Lubrizol announces an important milestone for its novelpatented excipient, Apisolex™ polymer
pharmafile | June 10, 2025 | News story | Research and Development | Apisolex polymer, Good Manufacturing Practices (GMP) guidelines, Lubrizol, Pharmacy, clinical trial
June 10, 2025 – 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.”
About Lubrizol
Lubrizol, a Berkshire Hathaway company, is a science-based company whose specialty
chemistry delivers sustainable solutions to advance mobility, improve well-being and
enhance modern life. Every day, the innovators of Lubrizol strive to create extraordinary
value for customers at the intersection of science, market needs and business success,
driving discovery and creating breakthrough solutions that enhance life and make the
world work better. Founded in 1928, Lubrizol has global reach and local presence, with
over 100 manufacturing facilities, sales and technical offices and over 7,000 employees
worldwide.
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