European Journal of Biomedical and Pharmaceutical Sciences

FORMULATION AND EVALUATION OF DULOXETINE HYDROCHLORIDE ENTERIC COATED TABLETS

Yahya Quadri*, Dr. Ravi Prakash Yadav, Dr. Brajesh Kumar Arjariya, Rahim Khan and Rahul Dubey

ABSTRACT

The present study was undertaken to formulate and evaluate enteric coated tablets of Duloxetine hydrochloride using calcium carbonate as an alkalizing agent to improve the solubility of drug and to convert micro pH environment to alkaline nature. Five formulations (F-I to F-V) of Duloxetine hydrochloride tablets were prepared by direct compression method. The prepared blend was evaluated for precompression parameters like angle of repose, bulk density, tapped density, compressibility index and hausner’s ratio. The prepared tablets were evaluated for post compression parameters such as hardness, thickness, weight variation, friability, assay, disintegration test and dissolution study. A total of five formulations (F-I to F-V) of Duloxetine hydrochloride tablets were developed by direct compression method. The work was carried out to delay the release of Duloxetine hydrochloride by using enteric polymer. From all the above observation it was concluded that the formulation F-V containing calcium carbonate as an alkalizing agent along with mannitol and microcrystalline cellulose as diluent was selected as the best formulation among the five formulations and 8% coating solution of Protectab enteric M1 polymer was applied as enteric coating. Formulation F-V showed better drug resistance in acidic medium and release the drug in alkaline medium as per I.P specification and showed rapid drug release in intestine than marketed Duloxetine hydrochloride enteric coated tablet. Hence the study concluded that formulation F-V satisfied all the criteria for enteric coating tablets.

Keywords: Duloxetine hydrochloride, enteric coated tablet, Protectab, polymers.