FORMULATION DEVELOPMENT OF CAPTOPRIL ORODISPERSIBLE TABLETS USING SEDEM EXPERT DIAGRAM SYSTEM

Objective: This study aimed to streamline the formulation development process of captopril orodispersible tablets for direct compression by utilizing SeDeM Expert Diagram System as a systematic approach. Material and Method: Captopril and potential excipients for the formulation of orodispersible tablets were individually analysed in terms of powder characteristics including compressibility, flowability, cohesion, hygroscopicity, particle size, and homogeneity. The SeDeM Diagrams were constructed using these micromeritic values of the powders. Subsequently, incidence factors and comprehensive indexes for each powder were calculated to assess the suitability of them for direct compression process. Based on SeDeM analysis, captopril orodispersible tablets were formulated by direct compression using the selected excipients, and characterized in terms of weight variation, diameter, thickness, friability, hardness, disintegration time and dissolution. Result and Discussion: SeDeM analysis indicated that microcrystalline cellulose as a diluent had an index of good compression over 5, with the greatest number of suitable incidence factors, including compressibility which was a critical limitation for captopril. Although sodium starch glycolate (as a disintegrant) and polyvinyl pyrrolidone K30 (as a binder) exhibited some suboptimal incidence factor values, they were incorporated into the formulation with the thought of that microcrystalline cellulose would compensate for their deficiencies, as well as those of captopril. Captopril orodispersible tablets formulated with the aforementioned excipients complied with the pharmacopoeial standards for weight variation, diameter, thickness, friability, hardness, disintegration time and dissolution. In conclusion, the formulation of captopril orodispersible tablets by direct compression was developed to minimize extensive time and experimentation, utilizing SeDeM Expert Diagram System.