Hybrigenics develops new oral formulations of inecalcitol

French biopharmaceutical group Hybrigenics has filed a patent application covering new soft gelatin capsules, tablets or drinking solutions optimised for the delivery of high doses of inecalcitol.

French biopharmaceutical group Hybrigenics has filed a patent application covering new soft gelatin capsules, tablets or drinking solutions optimised for the delivery of high doses of inecalcitol. This pharmaceutical optimisation follows the demonstration of safety and the presumption of efficacy of oral doses as high as 4mg of inecalcitol per day in a Phase IIa clinical tolerance study in hormone-refractory prostate cancer patients. Microdosed vitamin D analogues are currently marketed as oily solutions in soft gelatin capsules. The first formulations of inecalcitol were also soft gel capsules of different increasing concentrations and strengths, up to a maximum of 1mg unit dose. Patients treated at the highest tolerated dose had to swallow four such capsules. The new capsules are more concentrated in inecalcitol and contain a fixed 2mg amount. Hybrigenics says treatment will therefore be more convenient with a maximum of two small capsules to swallow, which also favours complian