Formulation and evaluation of Terminalia chebula retz soft gelatin capsules

Abstract

The purpose of this research was to develop and test soft gelatin capsules with the ethanolic extract of Terminalia chebula Retz, intended to treat nutritional deficiencies as well as overall dietary well-being. The main goal was to create a capsule that is compliant with pharmacopeial standards of stability, uniformity and quality. Preformulation activities of the active pharmaceutical ingredient (API) involved assessment of physical properties, solubility profile, loss on drying, and sulphated ash content. The capsules were formulated by the ethanolic extract of T. chebula in a gelatin shell made of gelatin, glycerin, purified water, and acceptable coloring agents. The fill formula contained the herbal extract, hydrogenated vegetable oil, soy lecithin, soybean oil, and yellow beeswax. Post-formulation analyses involved permeability and seal tests, potency, uniformity of dosage units and content, disintegration time, moisture level, and microbial limit test. Among all prepared batches, batch F4 of fill and batch F2 of shell had better quality at maintained storage conditions, keeping assay values within the limits. Uniform appearance, constant fill weight, appropriate hardness, and acceptable disintegration were also observed in the final capsules. Finally, stable and high-quality soft gelatin capsules of Terminalia chebula extract were successfully formulated. The formulation offered good protection of the active ingredient from degradation and guaranteed steady API delivery.