Soluplus®

Description

Soluplus® is an innovative excipient that enables new levels of solubility and bioavailability for poorly soluble active ingredients. Developed specifically for solid solutions, Soluplus® is unique in many ways. Thanks to its high flowability and excellent extrudability, Soluplus® shows superior performance in forming solid solutions, especially in hot melt extrusion processes. This solid solution makes the active pharmaceutical ingredient (API) available in a dissolved state, resulting in improved bioavailability, once in the body. The safety of Soluplus® is documented by a comprehensive range of toxicological data. Soluplus® has already been approved in Europe.

Soluplus® at a glance

• Outstanding solubilization properties, especially for poorly soluble APIs
• Enables bioavailability enhancement
• Ideal for hot melt extrusion and all standard granulation techniques
• Market proven solution for unique formulation challenges
• Amphiphilic structure: polymer and solubilizer perfectly combined in one product
• Molecular weight optimized for superior ASD stability
• Glass transition temperature optimized for easy processing

Regulatory Documentation US-DMF #23504 (Type IV DMF, containing CMC information). Regulatory Information File (RIF) with equivalent content to an Open Part/Applicants Part of a DMF – US-DMF #23626 (Type V DMF, containing pre-clinical safety data)