Abstract

OPTIMIZATION, FORMULATION AND IN VITRO EVALUATION OF ORO-DISPERSIBLE TABLETS OF DEXAMETHASONE

Radhakrishnan Sarveswaran*, Natarajan Rangasamy

ABSTRACT

Oro dispersible tablets (ODTs) is one such novel approach to increase consumer acceptance by virtue of rapid disintegration, self-administration without water or chewing. This novel type of delivery system offers convenience for treatment-resistant population who have difficulty in swallowing unit oral dosage form, namely tablets and capsules. Dexamethasone is a glucocorticoid available in various modes of administration that is used for the treatment of various inflammatory conditions, including bronchial asthma, as well as endocrine and rheumatic disorders. The formulations were optimized by using design expert software all the Five formulations (F1 to F5) of Oro dispersible tablets of Dexamethasone were successfully prepared using Sodium Starch Glycollate as a super disintegrants and Micro Crystalline Cellulose by direct compression method. The Formulations were evaluated for parameters like thickness, hardness, friability, in-vitro disintegration time, wetting time, water absorption ratio, and in- vitro dissolution studies. Based on the % of drug release at 15 minutes shows F1 maximum of 86.6 % and 60 minutes the maximum release of 95.66 %. And also, the Formulation (F1) shows as per the Optimized study for disintegration time. (14.5) seconds and dissolution study (19.5) minutes. The optimized formulation was subject to stability studies for 6 months by storing them at 30°C/65%RH, 35°C/70%RH and 40°C/75%RH. The Obtained Results of physical appearance, hardness, friability, disintegration test, and % drug release has shown that there was no significant change at different storage conditions.

Keywords: Dexamethasone, Optimization, Factors, Factorial design, Central Composite design, Super Disintegrants, SSG, MCC, Stability Studies, Direct Compression, Invitro dissolution studies, Disintegration time.