DETERMINATION OF OPTIMAL DISSOLUTION TEST CONDITIONS FOR “NAVESTO” CAPSULES

Abstract

The therapeutic efficacy of antihypertensive drugs is closely associated with their biopharmaceutical characteristics, particularly the solubility and dissolution behavior of the active pharmaceutical ingredients (APIs). Therefore, the evaluation of in vitro biopharmaceutical performance, including dissolution testing, represents a critical component of pharmaceutical quality assessment. Since the solubility of valsartan and sacubitril is highly dependent on the pH of the dissolution medium, the scientific justification of optimal dissolution test conditions for “Navesto” capsules containing these active ingredients is of particular importance. Establishing appropriate dissolution conditions and evaluating the in vitro biopharmaceutical characteristics of the formulation are essential for ensuring its quality, performance, and potential therapeutic efficacy.