Formulation and Evaluation of Oral Disintegrating Tablets of Fenofibrate by Wowtab Technology using Solid Dispersion Technique.

Venkatesh, Pendyala (2012) Formulation and Evaluation of Oral Disintegrating Tablets of Fenofibrate by Wowtab Technology using Solid Dispersion Technique. Masters thesis, RVS College of Pharmaceutical Sciences, Coimbatore.

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Abstract

Fenofibrate is a poorly water-soluble oral antihyperlipidemic agent belonging to fibrate class, with problems of variable bioavailability and bio-inequivalence related to its poor water-solubility. This work investigated the possibility of developing Fenofibrate tablets by WOWTAB technology (with out water) allowing fast, reproducible, and complete drug dissolution, by using solid dispersion of drug. Among various carriers used HPMC 3cps is forming a stable solid dispersion. Solubility studies were performed to investigate the drug-carrier interactions by both solvent evaporation and melt fusion method. DSC, X-ray powder diffraction, and FTIR studies were used to characterize the solid state of solid dispersions. The tablets were prepared by WOW technology by conventional granulation and tableting methods employing low and high-moldability saccharides (Mannitol, sorbitol respectively) to have desired properties of rapid disintegration and hardness. The prepared tablets were evaluated thickness, uniformity of weight, content uniformity, hardness, friability, In vitro disintegration time. The tablets were subjected to moisture treatment to lower the DT. After moisture exposure tablets are evaluated for uniformity of weight, hardness, friability, In vitro disintegration time and In vitro drug release. The tablets apart from fulfilling all official and other specifications, the Fenofibrate dissolution profile from the newly developed tablets was clearly better than those from various conventional tablets of the same drug dosage. The stability studies conducted as per ICH guidelines at 40° and 75% RH showed insignificant loss in drug content and on physical evaluations at the end of six months.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Formulation; Evaluation; Oral Disintegrating Tablets; Fenofibrate; Wowtab Technology; Solid Dispersion Technique.
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 06 Jul 2017 03:14
Last Modified: 22 Mar 2022 07:50
URI: http://repository-tnmgrmu.ac.in/id/eprint/1072

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