diario americano de Administración de Medicamentos y Terapéutica Acceso abierto

Abstracto

Formulation Development and Physico- Chemical Study of Epalrestat Tablet with Improved Bioavailability in Terms of Disintegration and Dissolution

Swapon Kumar Biswas, Sujit Biswas, Jamilur Rahman Bhuiyan, Md Abdullah-Al-Mamun, and Sukalyan Kumar Kundu

Experiments were conducted on Epalrestat 50 mg tablet which is antidiabetic drug that is used for the treatment peripheral diabetic neuropathy as well as diabetic neuropathy. Six study which were coded as F- 1, F-2, F-3, F-4, F-5&F-6 were conducted to optimize the formulation to find out the better formulation that exhibits good systemic bioavailability. The active material of this formulation was collected from Cangzou senary Chemical S. & T. Co., Ltd., China. The local agent of this active is ASN Corporation. All of these formulations conducted in accordance with strong cGMP guidelines. The first three formulations were done through direct compression method but last two, formulated through wet granulation method. Then coating operation was performed for the formulation-05 to ensure good aesthetic value and taste and also to protect the drug from moisture. Then certain quality control tests (e.g. Thickness, Individual weight, Hardness, Friability Disintegration and dissolution) were carried out for the formulation-05, the final formulation. The assay content of Epalrestat were calculated by UV-instrumental method which was developed for getting convenient and cost effective result. Test was carried out at 400 nm wavelength .The dissolution test of six tablets of the final formulation were also performed and the result of dissolution test performed through dissolution test apparatus-п (paddle method) with phosphate Buffer (PH=7.2) with 75 Rotation per minute and it exhibited better result that ensure good bioavailability by means of enhanced dissolution property.