Abstract

DEVELOPMENT AND EVALUATION OF NOVEL FLOATING DRUG DELIVERY SYSTEM OF ITOPRIDE HYDROCHLORIDE

Pooja Pradhan*, Dipanshu Pandey

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Abstract

The objective of this present study was to develop floating capsules (FC) and floating stomach specific in situ gel (FG) of Itopride hydrochloride using natural and/or synthetic polymers and release retardant to optimally release the drug in a sustained manner over a period of 12 hour to relieve dyspepsia nausea and vomiting. Floating capsules of Itopride Hydrochloride were prepared by making a physical mixture of excipients and API with the help of pestle mortor and other mixing devices followed by manual filling of physical mixture into Size “00” hard gelatin capsule shells. Seven consecutive formulations were prepared by the above method of varying Excipients concentrations viz. HPMC K4M, Methyl Cellulose, Carboxymethyl cellulose Na and Ethyl Cellulose. In-situ glassware prepared using varying concentrations of synthetic and natural polymers viz. Guar Gum and Sodium alginate. Five different formulations were prepared by mixing the excipients and Itopride Hydrochloride in the Pre-sterilized de-ionized water, containing preservatives in 9:1 ratio, in specific sequence. Drug content estimation of the formulations shows that drug content lies within 97-99%. Preliminary studies show that HPMC K4M plays the key-role in controlling buoyancy along with Ethyl cellulose and Methyl Cellulose. The floating time of most of the formulations was found to be more than 12 hours in case of floating capsules and more than 8 hours in case of in-situ gel and all formulations show matrix integrity for sufficient duration of time except F7 and FG5. Dissolution studies revealed that Formulation F2 for floating capsules and FG1 in case of insitu gel were found to be optimized with respect to maximum floating time and drug release 98.6 % with respect to time. Both the formulations show promising future potential for manufactured and marketed at Industrial level. Further In this study floating capsule was found to be more suitable than in situ gel of Itopride hydrochloride, over longer period of time with the excellent floating properties.

Keywords: Itopride Hydrochloride, Floating capsules, In-situ gel, floating time, extended release systems.