Pharmaceuticals
Soluplus® now officially monographed in the European Pharmacopoeia
Sept 2025: BASF Pharma Solutions is pleased to share an important regulatory milestone: Soluplus® is now officially listed in the European Pharmacopoeia (Ph. Eur. 12.1) under the monograph title:
MACROGOL POLY(VINYL ACETATE)-POLY(VINYLCAPROLACTAM) GRAFTED COPOLYMER
The new monograph was published by EDQM on July 1st 2025, with the latest version of the European Pharmacopoeia (Ph. Eur. 12.1).
Soluplus® is no longer considered a novel excipient for oral applications in Europe. With this recognition, Soluplus® benefits from official Ph. Eur. status, allowing for simplified product development activities and regulatory submissions.
Soluplus® at a Glance
Soluplus® is a multifunctional pharmaceutical polymer designed to enhance the performance of poorly soluble active pharmaceutical ingredients (APIs). Its unique amphiphilic structure improves solubilization, making it an ideal choice for modern drug delivery systems.
Key Benefits
- Enhanced Solubility: Improves dissolution and absorption of poorly soluble APIs, supporting bioavailability enhancement.
- Hot Melt Extrusion Ready: Offers excellent extrudability and smooth processing, ideal for continuous manufacturing.
- Matrix-Forming Capability: Enables the creation of stable amorphous solid dispersions (ASDs) for improved drug performance.
Access the Monograph
The official monograph is available for download via the European Pharmacopoeia Online (license necessary).
Learn More
Explore the benefits of Soluplus® in our product brochure or request a sample to experience its performance firsthand.
Need formulation help? ZoomLab® has you covered.