FORMULATION AND EVALUATION OFDIMENHYDRINATE MOUTH DISSOLVING TABLETS (original) (raw)

ABSTRACT Dimenhydrinate is a salt of Diphenhydramine and 8- chlorotheophylline. Diphenhydramine is an Antihistaminic drug that is antagonistic at the H1receptor in order to prevent and treat nausea and motion sickness. 8-chlorotheophylline is added to counteract drowsiness triggered by diphenhydramine. Dimenhydrinate mouth dissolving tablets were prepared by direct compression technique by using mannitol as a diluent, crospovidoneand sodium starch glycolate as a superdisintegrants, Aspartame as a sweetening agent which is suitable for diabetic patients. Drug compatibility with excipients was checked by FTIR studies. After examining the flow properties of the powder blends, the results are found to bewithin prescribed limits and indicated good flow property, it was subjected to tablet compression. All the formulations were subjected to post compression parameters such ashardness and friability (≤1%), indicated that tablets had a good mechanical strength and resistance.Percentage cumulative drug release was found to be in the range of 87.08 to 94.35 %. The wetting time was found to be in the range of 15.9±0.62 to 32.4±0.47 seconds. Among all the designed formulations, formulation MDF2 was found to be promising and displayed an in-vitro disintegration time, in-vitro dispersion time of 10.57±0.93 and 25.87±1.29 seconds respectively, which facilitates its faster disintegration and dispersion in the mouth.Depend upon percentage cumulative drug release, in-vitro disintegration time, in-vitro dispersion time, wetting time results, oneformulationMDF2 were selected for stability studies and subjected at 400C/75%RH for 2 months. Formulations MDF2 found tobe stable after performing physical and chemical parameters at suitable intervals.

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