Development of a Discriminative Dissolution Method, Using In-Silico Tool for Hydrochlorothiazide and Valsartan Tablets.

ABSTRACT: Hydrochlorothiazide (HTZ) and Valsartan (VAL) are poorly soluble drugs in BCS classes IV and II. This study aimed to develop a method to assess the dissolution profile of tablets containing HTZ (12.5 mg) and VAL (160 mg) as a fixed-dose combination, using in silico tools to evaluate products marketed in Brazil and Peru. Firstly, in vitro dissolution tests were performed using a fractional factorial design 3^3-1. Then, DDDPlus™ was used to carry out experimental design assays of a complete factorial design 3³. Data from the first stage were used to obtain calibration constants for in silico simulations. The factors used in both designs were formulation, sinker use, and rotation speed. Finally, effects and factor interaction assessment was evaluated based on a statistica

SUBMITTER: Leon RM 

PROVIDER: S-EPMC10301187 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature