Enforcement Report - Week of November 17, 2021
Innovus Pharmaceuticals, Inc. (Innovus Pharma), an emerging commercial stage pharmaceutical company, has initiated a pre-clinical and clinical programme intended to evaluate the safety and efficacy of the combination of its supplement Vesele for promoting sexual health with sildenafil indicated for treating erectile dysfunction. Sildenafil in the US is sold under the name Viagra by Pfizer, Inc. (Pfizer).
Co-amorphization has recently been shown to be a promising approach for stabilizing amorphous drugs and improving the dissolution rate of poorly water-soluble drugs. In this study, three basic amino acids were chosen as small molecular weight excipients to interact with the drug to form co-amorphous combinations. The co-amorphous combinations of valsartan (VAL) with l-histidine, l-arginine, and l-lysine were prepared by vibrational ball milling. Solid-state characterization with X-ray powder diffraction and differential scanning calorimetry (DSC) revealed that all of the co-amorphous mixtures were homogeneous. The molecular interactions of the co-amorphous mixtures were investigated through the glass transition temperature (Tg) in the DSC measurements and Fourier transform infrared spectroscopy.
Recall: Baxter`s Clinimix (2015-06-19)