KinetiSol® has been the subject of numerous research articles published in top peer-reviewed journals in recent years. These papers demonstrate unique capabilities of the KinetiSol® process and its benefits for amorphous solid dispersion processing. Key advantages of the KinetiSol® process are illustrated in these case studies.

Itraconazole-A Very Low Bioavailability BCS Class II Drug

KinetiSol® was able to formulate itraconazole, a very difficult drug, and achieve 6-fold enhanced bioavailability over the marketed Sporanox® product.

KinetiSol Processing for Amorphous Vemurafenib Compositions

KinetiSol® is the only other manufacturing technology besides Roche’s in-house micro-precipitated bulk powder (MBP) process that has ever been able to create a viable solid dispersion of vemurafenib, the active ingredient in Zelboraf®.

KinetiSol Enabled Reformulation of Marketed IR Product

After years of trying all available dispersion and modified-release technology options with no success, a partner brought their immediate-release product to DisperSol. We were the first and only technology successful in creating a modified release dosage form of its drug.

KinetiSol® Enhanced Amorphous Compositions of Ritonavir

It is a common problem in dispersions that when drug load is pushed past a certain point, formulation performance as measured in solubility and bioavailability drops off. Ritonavir (Norvir®) is a prime example where drug load in the marketed tablet has been limited to 15%. KinetiSol® was able to double the drug load to 30% with no loss of performance in the formulation.

WHY USE KINETISOL?

KinetiSol® Fits In-Line with Existing Manufacturing Operations

KinetiSol® is a new unit operation for pharmaceutical manufacturing; however, the operations upstream and downstream of the KinetiSol® compounder are conventional. The amorphous powder intermediate resulting from the KinetiSol® process train can be utilized as a powder for constitution, or can be furtherprocessed into any conventional oral dosage form.