QbD method to the formulation and development of a spironolactone immediate-release tablet with enhanced dissolving research

Abstract

This work aimed to improve the solubility of medication D (Spironolactone) by encapsulating it in HPCD and constructing an inclusion complexation using the kneading process. All of the formulations were put through a series of tests based on Indian pharmacopeia. All of the generated formulations were tested in vitro for drug release, and the optimal formulation was also subjected to stability tests. In terms of superior solubility profile and increase in dissolving rate, the inclusion complex created with HPCD and drug concentration of 1:1 M ratio was the best formulation among the eight batches of inclusion complex prepared. Direct compression technology produces immediate-release tablets of medication D with a quality-by-design approach. The prepared tablet in the optimal formulation has good mechanical strength, appropriate Hardness, and less than 1% friability. All batches passed the weight variation test, and the limit was kept within the Pharmacopeial standard of 5% of the total weight. The improved formulation's drug content was determined to be between 97 and 100 percent, with a disintegration time of 1 to 12 min for Spironolactone. The formulation containing Crospovidone disintegrated quickly, with medication release reaching more than 97 percent after 10 min.