Formulation development and optimization of fast orodispersible tablets of naratriptan hydrochloride by using factorial design

BACKGROUND: The present research was to develop oral fast disintegrating tablets of naratriptan hydrochloride. MATERIALS AND METHODS: Tablets containing naratriptan hydrochloride, sodium starch glycolate (SSG), croscarmellose sodium (CCS) and kyron-T314 were prepared by direct compression technique. Among three super disintegrating agents, croscarmellose sodium was found to have better fast disintegrating properties and higher dissolution efficiency. A 3 2 full factorial design was employed to investigate the influence of two formulation variables: amount of croscarmellose sodium and kyron-T314. The tablets were evaluated for friability and disintegration time. RESULTS: The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an optimum ratio of croscarmellose sodium and kyron-T314. Contour plots were also presented to graphically represent the effect of the independent variables on the disintegration time and percent friability. CONCLUSION: A checkpoint batch was prepared to prove that validity of the evolved mathematical model. There was no difference observed in release profile and drug content after accelerated stability study for 1 month.