Formulation and Evaluation of a Combination Tablet Containing Prucalopride Succinate and Elobixibat for the Treatment of Chronic Constipation

Abstract This research centers on creating and assessing a combination tablet that includes Prucalopride Succinate and Elobixibat aimed at treating chronic constipation. Prucalopride is a prokinetic medication that improves colonic movement, whereas Elobixibat, an IBAT blocker, helps treat constipation by affecting bile acid metabolism. The tablet composition features key excipients like microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate, and hydroxypropyl methylcellulose to guarantee optimal tablet efficiency and stability. Wet granulation was employed for tablet production, followed by compression and optional coating to improve the product's shelf life and patient acceptance. Pre-formulation investigations, which involved compatibility assessments utilizing methods like FTIR and DSC, were conducted to analyze the relationship between the APIs and excipients. The tablets were subjected to multiple quality control assessments, such as tests for weight variation, hardness, friability, and disintegration time, all of which were deemed acceptable. Dissolution studies revealed that both APIs demonstrated quick release profiles, with more than 98% drug release occurring within 30 minutes in the dissolution medium, adhering to pharmacopoeial standards for immediate-release formulations. The findings validate the successful creation of the combination tablet, exhibiting a clear dissolution profile and the necessary physical attributes for effectively treating chronic constipation. This combined treatment holds the promise of enhancing therapeutic results by addressing various pathways linked to constipation, resulting in quicker relief and greater patient adherence.