Abstract

FORMULATION AND EVALUATION OF DULOXETINE HYDROCHLORIDE BY USING PRESS COATING TECHNOLOGY

R. Naresh Babu*, D. Bindu Madhuri, P. Sambasiva Rao, G. Raveendra Babu, B. Sivasai Kiran

ABSTRACT

Enteric coated tablets of duloxetine hydrochloride was developed to get resistance from gastric juice when it is present in stomach, because duloxetine is incompatible with gastric juice. The tablets are prepared by using direct compression technique using polymer hydroxyl propyl methylcellulose phthalate, sodium starch glycolate and other excipients talc, calcium phosphate, magnesium stearate. Hydroxyl propyl methylcellulose phthalate used for preventing drug release in stomach. Sodium starch glycolate used to reduce the disintegration time of tablet in intestine. Core tablet was optimized with 6% concentrations of super disintegrates like sodium starch glycolate press coated tablets were prepared with different concentrations of enteric coated material like hydroxyl propyl methylcellulose phthalate. Press coated tablets were evaluated in terms of their precompression parameters, physical characteristics, weight variation, hardness, drug content and further tablets were evaluated for in-vitro drug release, for 3hrs that is first 2 hrs no drug release was observed and gradually drug release was increased up to 45 min. The present formulation no drug release was observed in F30, F31 in acidic medium at first 2hrs. Gradually drug release was increased in alkaline medium. This study concluded that enteric coated tablets by press coating technology can be prepared by using different concentrations of polymer studied and we can reduce the gastrointestinal tract side effects.

Keywords: Duloxetine, Tablets, Preparation, Evaluation.