Abstract

FORMULATION DEVELOPMENT OPTIMIZATION AND EVALUATION OF ION EXCHANGE RESIN BASED SUSTAINED RELEASE ORAL DRUG DELIVERY SYSTEM

Mufeeda P.*, Dr. Vinaya O. G. and Athulia S.

ABSTRACT

Hydroxyzine hydrochloride is a short acting anti histamine prescribed for chronic urticaria in paediatric population. Due to the frequent dosing and bitter taste of the drug, patient compliance is reduced. Hence, need was felt to deliver Hydroxyzine hydrochloride to the patients, as a taste masked twice daily sustained release dosage form. If this formulation is converted to a oral suspension it will be suitable for paediatric patients. The main objective of this work was an attempt to sustain the release and to mask the unpleasant taste of Hydroxyzine HCl using ion exchange resin based approach and microencapsulation. Hydroxyzine hydrochloride-Indion 234 resinates were prepared by batch process as per the formula proposed by Design of experiment. The process parameters were optimized with central composite design (CCD) approach of response surface methodology in Design expert software. The optimized drug resinates were evaluated for % drug content, in vitro evaluation of taste masking, DSC, FTIR and in vitrodrug release studies. The drug resinates were then microencapsulated with various ratios of ethyl cellulose and characterized by percentage yield, encapsulation efficiency, particle size, SEM and in vitro drug release study. The microencapsulated drug resinates were then formulated into a sustained release suspension. The in vitro evaluation of taste of resinate showed that none of the formulations attained the concentration of pure medication in salivary pH at 120s showing that all the preparations have taste masking property. The results of in vitro drug release study of ethyl cellulose microspheres of drug resinates demonstrated that the formulation MDRC 2 showed 93.47% drug release in 12 hours. Therefore this formulation was selected for preparation of sustained release suspension. In vitro drug release kinetic study was conducted and the release pattern showed first order kinetics. The formulated suspension showed good results when evaluated for sedimentation volume, drug leaching, redispersibility, viscosity, drug content and the results were satisfactory.

Keywords: Sustained, Ion exchange resin, Microencapsulation.