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Abstract

PREPARATION OF HOT MELT EXTRUDES OF FENOFIBRATE USING PEG 1500 AND KOLLIDONVA64 AND ESTIMATION OF WETTING EFFICIENCY EMPLOYING WASH BURN METHOD

Satyajeet A Narode*, Dr P. Srinivasa Babu, Dr M.V. Basaveswara Rao, Dr G. Kishore Babu

ABSTRACT

Fenofibrate is fibrate class of drug mainly used for primary hypercholesterolemia or mixed dyslipidemia. The drug belongs to BCS class II with low solubility and high permeability. Many methods were investigated to enhance solubility of poorly soluble drugs but the major problem being scale-up of the method for industrial production. In this regard a suitable Hot Melt Extrusion (HME) technique along with extrusion carriers such as PEG 1500 and Kolldon VA 64 is carried out. The prepared HME were tested for wetting efficiency using Washburn method. When compared to pure drug a 17.7 folds increase in wash burn slope was observed in case of HME and about 3.2 folds of increase in wash burn slope is observed when compared to physical mixtures. From the results HME containing F: Kollidon VA 64: PEG 1500 at a ratio of 1:4:0.4 is selected as best formulation and evaluated further for dissolution. Statistical analysis of dissolution data performed using paired t test employing Graphpad® software showed that t the two-tailed P value is less than 0.0001 and by conventional criteria this difference is considered to be extremely statistically significant.

Keywords: Fenofibrate, Hot Melt Extrusion, Wash Burn Method, Paired t test.


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