Epalrestat Case Study

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FORMULATION DEVELOPMENT AND OPTIMIZATION OF EPALRESTAT CONTROLLED RELEASE TABLETS AND THEIR IN-VIVO KINETIC STUDIES 1. Introduction Epalrestat is derivative of carboxylic acid which is aldose reductase inhibitor, which is an enzyme of the sorbitol (polyol) pathway. When there are high levels of glucose in the body it reduces sorbitol accumulation within the cell which is the main cause of the complication of diabetes mellitus(Steele, Faulds et al. 1993). There are no medications available to treat the progression of the diabetic complications such as the diabetic retinopathy, diabetic nephropathy and diabetic neuropathy. Treatment options include pregabalin and gabapentin but these drugs provide symptomatic relief, but neither they affect…show more content…
The usual dose for epalrestat is 50mg t.i.d(Iso, Tada et al. 2000) So there is always a compliance problem in the patients to take this medicine. So to make this drug patient complaint a controlled release tablet was made by taking aid of the modern pharmaceutical technology such as novel drug delivery system. Hydroxypropyl methyl cellulose (HPMC)(Sung, Nixon et al. 1996) is widely used polymer for an extended drug release due to the rapid hydration, good and solid compression characteristics with ease of use, availability and very low toxicity comparatively. It regulates the release of drug by controlling the swelling and cross-linking(Mandal, Gowda et al. 2007) Statistical approaches in the pharmaceutical formulations have the advantages. Central composite design (CCD) was used for this purpose. In the study the computerized software Design expert 9 was used for the implementation of CCD. The target of this research is to develop the controlled release tablets of epalrestat, five formulations were chosen by using central composite design (CCD) in response surface methodology (RSM). The results were not according to the plan for which the experiment was planned, so the amount of HPMC was increased while keeping all other materials weight constant for remaining…show more content…
Direct compression was performed for the formulation and they were rechecked for its accurate weight. The amount of drug was equal in all formulations but amount of material different. The total weight of the tablet was 500mg and the amount of active pharmaceutical ingredient was 150mg. 50 tablets of each formulation were compressed by single punch machine(Asif, Sherwani et al. 2015)The amount of ingredients along with their weight use is shown in the

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