Lubrizol Life Science (LLS) Health has launched Apisolex, a solubility-enhancing excipient for use in parenteral drug products. This technology overcomes solubility hurdles that challenge existing excipients or manufacturing techniques.
At present, 60-90% of potential new active pharmaceutical ingredients (APIs) in development pipelines, and more than 40% of those in reformulation, are poorly water soluble. As solubility impacts bioavailability and efficacy, tackling the growing number of poorly soluble APIs is critical to secure the route to market for therapeutics.
With the ability to improve solubility by up to 50,000-fold and support high drug loading, Apisolex technology provides access to new and improved parenteral drug products. This is especially relevant in the oncology field, as direct injection of drugs into the bloodstream ensures higher bioavailability and lower patient variability, compared to oral delivery.
Understanding the need of the industry, Apisolex polymer is designed to work with the simplest formulation techniques to streamline manufacturing and minimise API loss with high encapsulation rate. Comprised of biocompatible, biodegradable building blocks, Apisolex is a non-toxic, non-immunogenic alternative to PEG or surfactants.
“Apisolex is the first solubility-enhancing excipient for parenteral use introduced in more than 20 years,” says Rob Lee, president of the CDMO Division of LLS Health. “With its toxicity profile and simple processing techniques, Apisolex polymer can both improve existing drugs and enable some important new molecules.”
Apisolex excipient’s patent protection enables both the formulation of new chemical entities and the reformulation of existing APIs to enhance their therapeutic effect and deliver improved patient outcomes via the FDA’s 505(b)(2) regulatory pathway.
LLS Health already has a portfolio of differentiated excipients to help drug developers transform drug products which include the original Carbopol, Pemulen TR-2 NF, and Noveon AA-1 excipients. Solubility enhancing Apinovex polymer, used to maximise API concentration and stability in oral amorphous solid dispersion drug formulations, was introduced last year.