Lubrizol Life Science Health, a leading pharmaceutical company, has won the Finished Formulation Award at CPhI Barcelona for its innovative technology – Apisolex (trademarked) Polymer solubilising excipient.
With over 180 entries covering 12 innovation categories featuring many of pharma’s biggest names, Apisolex Polymer was again recognised as a breakthrough innovation adding to the prestigious award recognised by The Medicine Maker earlier this year.
The winners were announced at a networking reception held at CPhI Barcelona with over 500 guests in attendance.
Apisolex Polymer is the first solubility-enhancing excipient to be launched specifically for parenteral use in over 20 years. Comprised of building blocks naturally occurring in the body, Apisolex is a poly(amino acid)--based excipient that provides drug formulators with the necessary tools and methods to enhance the solubility of hydrophobic APIs by up to 50,000-fold.
Approximately 60% of new chemical entities (NCEs) under development, and more than 40% of Active Pharmaceutical Ingredients (APIs) in reformulation are poorly water-soluble with each requiring tailored solutions. With several solubilising excipients on the market, it is impossible to find a one-size-fits-all solution. Filling a crucial gap in the market, Apisolex Polymer enables novel brick-dust and grease ball APIs to be formulated, as well as providing existing APIs with the option to be repurposed or reformulated via the FDA’s 505(b)(2) regulatory pathway.
“By drawing on our 40+ year legacy, Lubrizol Life Science Health has developed a non-immunogenic, biocompatible, and biodegradable alternative to PEG-based excipients. Apisolex Polymer offers oncology, CNS, and high-value orphan drug formulators the tools necessary to unlock the potential of previously hard-to-formulate APIs, providing patients with access to life-changing therapeutics that otherwise may not have made it to market,” said Gaurab Sengupta, Senior Global Business Director of Pharmaceuticals & Nutraceuticals, Lubrizol Life Science Health.
