FORMULATION AND EVALUATION OF MUCOADHESIVE BUCCAL PATCHES OF DIMENHYDRINATE

Manthina Jayasri*, Praveen Guijula, D. Raghava, Kavala Nageswara Rao

ABSTRACT

Dimenhydrinate is a H1 Antagonist; it is used in the treatment of vomiting caused by motion sickness.These controlled release Muccoadhesive buccal patches mainly prepared for release of the drug for longer period of time i.e., 10 hours and utilizing the drug to full extent avoiding unnecessary frequency of dosing. For the formulation of Muccoadhesive buccal patches HPMC E15, HEC, PVA and PVP were used as matrix forming agents. Other excipients used are Propylene glycol as a plasticizer. Fourier transform Infrared spectroscopy confirmed the absence of any drug/polymers/excipients interactions. The Muccoadhesive buccal patches were prepared by solvent casting method using magnetic stirrer. The prepared controlled release Muccoadhesive buccal patches were evaluated for thickness, folding endurance, weight variation, water uptake, bioadhesive strength, drug content uniformity, surface pH, Mechanical strength, Scanning electron microscopy (SEM), In-vitro release study, Invitro residence time, Ex-vivo drug release study, Stability study and Kinetic study. Formulation F3 showed good Bioadhesive strength and a controlled drug release and also shown good result for all other parameters when compared with all other formulations. Hence formulation F3 is considered to be the optimized formulation. Stability studies were carried out for F3 formulation they had showed good stability when stored at accelerated stability state as per the ICH guideline and the values were with in a permissible limits. It was observed that Formulations F3 retained the drug release up to 24 hrs. All formulations were subjected for four different models viz. Zero order, First order, Higuchi matrix and Peppas model equations and all the formulations best fit in to the Peppas model by giving the values of diffusional exponent (n) in the range of 0.6-0.9 that indicate the formulation had release the drug by diffusion followed by erosion mechanism. It was revealed that polymer ratios had significant influence on drug release. Thus conclusion can be made that stable dosage form can be developed for Dimenhydrinate for controlled release by buccal patches.

Keywords: Formulation, Evaluation, Mucoadhesive Buccal Patches, Dimenhydrinate.