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- W2783265173 abstract "the present study is to develop and evaluate a delayed release oral capsule comprising Duloxetine Hydrochloride mini tablets 60mg strength with various enteric coating polymers with the following objectives : To study the Drug-Excipient compatibility. To minimize the drug release in stomach (acidic environment) thereby reduce the formation of metabolite and increase the bioavailability.To develop a formulation which is similar in dissolution profile and there by establishing similarity to that of the reference product CYMBALTA. To develop a cost effective medicine when compare to marketed product. To improve patient compliance. Duloxetine hydrochloride is an acid labile drug which degrades at the acidic pH of the stomach so duloxetine hydrochloride multi particulate has been designed as gastroresistant mini tablets. The preformulation studies of Duloxetine hydrochloride including the drug excipient compatibility has been conducted and the formulation is developed in such a way to release the drug in small intestine and keep the formulation stable for a long time.Multiparticulate formulation has enormous advantages over all other oral dosage forms, especially in modified release formulation thus Duloxetine is made as multiparticulate drug delivery system. And the formulation is made in fluidised bed processor (wurster process), using bottom spray.The enteric system of duloxetine was evaluated with 3 polymers with various percentage build ups and evaluated for acid resistance and dissolution profile The initial result indicates, the product is having good acid resistant, when it exposed to acidic environment, and having good dissolution profile in pH 6.8 phosphate buffer, and comparable to the marketed formulation.Stability study is initiated." @default.
- W2783265173 created "2018-01-26" @default.
- W2783265173 creator A5074934703 @default.
- W2783265173 date "2013-04-01" @default.
- W2783265173 modified "2023-09-26" @default.
- W2783265173 title "Formulation and Evaluation of Duloxetine Hydrochloride Delayed Release Capsules" @default.
- W2783265173 hasPublicationYear "2013" @default.
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