Development and in vitro evaluation of floating multiparticulate system of Repaglinide
 Muddana Eswara Bhanoji RAO*, Suryakanta SWAIN*^,°, Chinam Niranjan PATRA*, Jammula SRUTI*, Subhasmita PATRA*
 * Department of Pharmaceutics, Roland Institute of Pharmaceutical Sciences, Khodasingi, Berhampur-760010 (Ganjam), Odisha, India.

 ° Corresponding Author E-mail: swain_suryakant@yahoo.co.in, suryakantarips@gmail.com

Summary

Floating multi-particulate system for Repaglinide was prepared by melt granulation method using Gelucire 43/01 as the binder. Inclusion in 1:1 complex ratio of β-CD and HP-β-CD enhanced the solubility of Repaglinide by 4 to 5 folds. In vitro release studies, using release modulators such as HPMC K4M, HPMC K15M, HPMC K100M and ethyl cellulose (20cPs) in different ratios with the drug showed extended release of up to 12h following zero order. Even though Gelucire 43/01 based drug-βCD complexes showed good floating property but the release was associated with an initial
brust release followed by a sustained release that is less than 50% within 12h. The hydrophobic to hydrophilic seems to be critical in the controlled release of the drug. FT-IR studies indicated that there was no interaction of drug and excipients. X-ray diffraction study of the optimized formulation showed hollow shaped spectrum with complete absence of peaks, proving that Repaglinide was in amorphous form in the inclusion complex. There was no significant change in the drug content and floating property from the granules stored at conditions as per ICH guidelines confirming that the Repaglinide multiparticulatesystem were stable.

Key Words :
Melt granulation, Gelucire 43/01, Phase solubility study, Powder X-ray Diffraction, In vitro drug release profile.