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Soluplus®

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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)

Additional information

Manufacturer

BASF

Composition

Polyvinyl caprolactampolyvinyl acetate-polyethylene glycol graft co-polymer

Dosage Form

solid oral dosage forms, Tablets

Function

bioavailability enhancer, solubility enhancer

Synonym

Polyvinyl caprolactampolyvinyl acetate-polyethylene glycol graft co-polymer

Quality

IPEC GMP

Documents and Links

Soluplus® Brochure

Download