For Better Solubility
For Better Solubility and Bioavailability
With its excellent capability to form solid solutions, Soluplus® is suitable for innovative processing technologies, such as hot melt extrusion. Soluplus® was awarded with the CPhI Silver Innovation Award in 2010.
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.
Hot melt extrusion technology has become increasingly popular in recent years. Although this technique has been used in the plastics and food industries for decades, it is relatively new in the pharmaceutical industry and only a few drug products manufactured this way are currently available on the market. Hot melt extrusion technology shows numerous benefits over traditional methods, including shorter processing times, environmental advantages due to the elimination of solvents and the more efficient delivery of drugs to patients.
The high flowability and excellent extrudability of Soluplus® make for first-class results in hot melt extrusion. Soluplus® was specifically designed to solubilize poorly soluble APIs in this innovative production process. Its outstanding ability to form solid solutions and excellent solubilization capabilities, combined in one molecule, distinguish Soluplus® from other molecules that are used to form solid solutions or deployed in hot melt extrusion. However, Soluplus® is not limited to solid solutions formed via hot melt-extrusion, but can also be used as a matrix former in spray drying processes. Furthermore, it can be deployed as a binder in wet granulation or dry granulation and in drug layering. These possibilities, and many others, extend the potential scope of Soluplus®. Formulators can use the new polymer in many different ways to significantly improve solubility and bioavailability.
A wide range of toxicological studies have been performed on Soluplus®, and the safety of the product has been documented in comprehensive studies. Toxicological data can be provided upon request.
Even though Soluplus® was developed for solid solutions, it can be used for other applications too. Besides hot melt extrusion, drug layering and spray drying, it can be also applied as a binder in wet granulation or dry binder in direct compression. With multiple applications like these, you stand to benefit from the solubilization capabilities of Soluplus® while using it in standard processes.
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