European Journal of Biomedical and Pharmaceutical Sciences

DESIGN AND EVALUTION OF SUSTAINED RELEASE ENTERIC COATED DOSAGE FORM OF FLUOXETINE HYDROCHLORIDE

*V. Mounika and A. Kiran Kumar

ABSTRACT

An enteric coating is a barrier that controls the location of oral medication in the digestive system where it is absorbed. The word “enteric” indicates small intestine. Therefore enteric coatings will prevent the release of medication before it reaches the small intestine. Preformulation studies have been performed to study the nature of API and compatibility of API with excipients by physical observation and FT-IR studies. The results showed that there was no interaction between API and all the excipients selected. The results of micromeritic properties indicates that the flow property of all formulation were good. All formulations possessed uniform thickness. The prepared tablets also possessed good mechanical strength and uniform hardness. All formulations of Fluoxetine Hydrochloridetablets passed the weight variation, friability test and disintegration test. The percentage drug content was found in the range of 98.55% to 102.16% for all the formulations, which was within the I.P acceptable limits.In the in vitro dissolution study, formulation F-IV and F-V showed maximum drug release of 95.78% and 100.67% at the end of 45 min. Hence formulation F-IV and F-V were selected for enteric coating and coated with protectab enteric M1 as coating polymer in different concentration. 4% coating thickness was applied in formulation F-IV and 8% in formulation F-V. Both the formulations were evaluated for various parameters. Formulation F-IV failed in disintegration test of enteric coated tablets. So formulation F-V was taken as best formulation and the drug release of formulation F-V was compared with marketed enteric coated tablet of Duloxetine hydrochloride. In the comparative in vitro dissolution study, formulation F-V showed better drug release than the marketed product. Formulation (F-V) was selected for the stability study and stored at 25±2°C/60%±5% RH and 40±2ºC/75%±5%RH for 3 months. The results indicated that there was no significant change found in appearance, thickness, weight variation, disintegration time, drug content and in vitro dissolution study. The study results showed that the formulation F-V was stable even after stored at 25±2°C/60%±5% RH and 40±2ºC/75%±5% RH for 3 months.

Keywords: Delayed release, Fluoxetine HCl, Microcrystalline cellulose-PH, Povidone-K30.