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 further processed into any conventional oral dosage form.