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Abstract

DESIGN AND OPTIMIZATION OF CONTROLLED RELEASE MATRIX AND RESERVOIR BASED VENLAFAXINE HCL TABLETS USING DESIGN OF EXPERIMENTS

*Y. Shirisha, Ch. Srinivas Reddy, G. Babu, T. Lalitha, K. Sravanthi

ABSTRACT

Venlafaxine Hcl is one of the most widely used antidepressant drug. The exact mechanism of action of Venlafaxine hydrochloride is unknown, but appears to be associated with its potentiating of neurotransmitter activity in the CNS. Venlafaxine HCl inhibits the reuptake of both serotonin and nor epinephrine with a potency greater for the 5-HT than for the NE reuptake process. Due to its short half life it is formulated as a controlled release dosage form which allows for once a day drug administration. The innovator product available in the market is a reservoir system based on the MUPS platform. This system typically involves a complex process of loading of the drug onto non peril pellets followed by solvent based coating of the pellets with ethyl cellulose and pore former. The processing times may be as high as 36 to 60 hours and involve multiple stage sampling and analysis. The current work focuses on developing a simple tablets system based on swellable hydrophilic matrix and reservoir based coating systems in order to give a release profile similar to the innovator product. Our Aim is to design and optimize the controlled release matrix and reservoir based tablets of Venlafaxin hydrochloride (antidepressant drug) by using design of experiments. Our objective is to study the effect of concentration of polymers on the rate of drug release. In order to establish the controlled release we planned to use the polymers of 3 different grades (HPMC-K4M,K15M,K100M) at 3 different levels. Another 3³ factorial design will be introduced to optimize the formulation of Venlafaxin hydrochloride loaded with PVP, Aerosil and with 3 different grades (k4M,k15M,k100M) of HPMC in 3 different levels(10%,15%,20%.). For the reservoir based system, core tablets of Venlafaxin HCl shall be formulate and then coated with Ethyl cellulose and pore former. The coating weight gain, and the level of Ethyl cellulose and pore former shall be optimized using design of experiments (DOE).

Keywords: Venlafaxine Hcl, antidepressant, 3 different grade polymers (HPMCK4M, K15M,K100M), 3³ factorial design method, PVP,Aerosil, 3 different grades of HPMC (k4M,k15M,k100M), Ethyl cellulose, DOE.


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