Apisolex™ Polymer

Description

Apisolex™, the injectable-grade excipient is a safe, GMP-validated, polyamino acid-based polymer that enhances the solubility of BCS Class II and IV APIs by 50,000-fold.

Solubility-enhancing Excipient for Injectable Drug Formulations.

Approximately 60% of potential active pharmaceutical ingredients (APIs) under development, and more than 40% of those in reformulation, are poorly water soluble. Excipients offer the most versatile approach to solving these solubility challenges and have long played a key role in allowing poorly soluble APIs to be formulated into products with improved bioavailability and therapeutic effects. However, as the number of poorly soluble APIs grows, existing excipients are still not able to solve all of the complex formulation challenges.

Rescue Your Parenteral Drug Formulation with Apisolex™ Polymer

• Safe, poly-amino acid based amphiphilic polymer which is a non-toxic, non-immunogenic, biocompatible, and biodegradable alternative to PEG.
• Increases solubility of hydrophobic APIs by up to 50,000-fold.
• High drug loading (up to 40:100 API:solubilizer ratio).
• Forms stable, lyophilized drug product that reconstitutes in less than 30 seconds in saline.
• Enables IP protection and 505(b)(2) formulations/lifecycle management.