Design Formulation and Evaluation of Anti Migraine Mouth Dissolving Tablets Using Different Super Disintegrants

Abstract

The main objective of this research was to create and evaluate the efficacy of orally disintegrating tablets containing sumatriptan succinate at a dosage of 25 milligrammes, a medicine commonly prescribed for the treatment of migraines. The tablets are made using the direct compression method. In order to achieve best results, the formulations were enriched with microcrystalline cellulose of varying composition (Avicel PH 102), mannitol as a diluent, crospovidone, croscaramellose, and sodium starch glycollate as superdisintegrants. Carbomer (carbopol 940), Sodium CMC, and Sodium Alginate were among the other excipients that were used. When used at varying doses, these excipients act as disintegrants. In addition, magnesium stearate was used as a substance to reduce friction, while talc was used as a substance to improve flow. We assessed each of the excipients to ascertain their compatibility with the model drug. The findings revealed no occurrence of any physical or chemical interaction. Before compression, the preformulation features of the tablet blend were examined. The criteria considered were bulk density, tapped density, compressibility index, and hausner ratio. An assessment was carried out on central tablets to ascertain their dimensions, firmness, tendency to crumble, variability in weight, rate of disintegration, and uniformity of drug content properties. Furthermore, an investigation was conducted to examine the impact of these variables on the release of the drug. The drug release studies were performed in vitro using the USP dissolving apparatus-II (paddle type) with a phosphate buffer solution at a pH of 6.8. The experiments were conducted at a speed of 50 revolutions per minute at a temperature of 37 degrees Celsius, with a standard deviation of 5 degrees Celsius. The sampling was conducted at consistent intervals of 2, 4, 6, 8, and 10 minutes. After each withdrawal, an equivalent volume of dissolving medium was replaced with the sample. The ultraviolet (UV) method is employed to evaluate the cumulative quantity of medications that have been discharged at different time intervals. Based on the evaluation results, the F-3 trial formulation, which included 6% crospovidone, was selected as the superior formulation among the superdisintegrants. Conversely, the F-10 trial formulation, which included 2% carbopol 940p, was selected as the superior formulation compared to other basic disintegrants.