SOLID DISPERSIONS OF FENOFIBRATE BY DROPPING METHOD

The main objective of the study was to enhance the dissolution of fenofibrate (BCS class II), poorly soluble drug. To improve the solubility of the drug, solid dispersions were prepared by dropping method with PEG 4000 and PEG 6000 in the ratios of 1:1 and 1:2. The formulations were filled into capsules and evaluated for solubility, assay, FTIR, X-ray diffractions, DSC, and in-vitro dissolution. The optimized formulation was compared with the marketed formulation. The optimized formulation D4 (containing PEG 6000 (1:2) by dropping method) showed maximum solubility 0.678 ± 0.07 mg/ml when compared to pure drug (0.018 mg/ml), assay, 98.14 ± 12% and practical percentage yield 95.25 ± 0.17%. In-vitro dissolution studies of the prepared solid dispersions showed release in 60 min whereas D4 formulation released 99.10 ± 0.18% in 30 min when compared to pure drug 27.38 ± 0.10% in 60 min, and a marketed capsule containing micronized fenofibrate (Lipicard) 93.91 ± 0.12% in 30 min. FTIR studies confirmed that there is no interaction between the drug and the excipients. The solid-state characterization of solid dispersion formulation by XRD and DSC studies confirmed that the drug present in the formulation was in an amorphous state. The optimized formulations were found to be stable. Hence, with the dropping method using the least ratio of the carrier (1:2), the percentage release of drug was increased similar to micronized fenofibrate (Lipicard).