Increased dissolution rates of tranilast solid dispersions extruded with inorganic excipients

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Maniruzzaman, M. and Ross, S. A. and Islam, M. T. and Scoutaris, N. and Nair, A. and Douroumis, D. (2017) Increased dissolution rates of tranilast solid dispersions extruded with inorganic excipients. Drug Development and Industrial Pharmacy. ISSN 0363-9045

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Abstract

The purpose of this study was to evaluate the performance of Neusilin® (NEU) a synthetic magnesium aluminometasilicate as inorganic drug carrier co-processed with the hydrophilic surfactants Labrasol and Labrafil to develop Tranilast (TLT) based solid dispersions using continuous melt extrusion (HME) processing. Twin – screw extrusion was optimized to develop various TLT/excipient/surfactant formulations followed by continuous capsule filling in the absence of any downstream equipment. Physicochemical characterisation showed the existence of TLT in partially crystalline state in the porous network of inorganic NEU for all extruded formulations. Furthermore, in-line NIR studies revealed a possible intermolecular H–bonding formation between the drug and the carrier resulting in the increase of TLT dissolution rates. The capsules containing TLT extruded solid dispersions showed enhanced dissolution rates and compared with the marketed Rizaben® product.

ORCID iDs

Maniruzzaman, M., Ross, S. A., Islam, M. T. ORCID logoORCID: https://orcid.org/0000-0002-3530-0519, Scoutaris, N., Nair, A. and Douroumis, D.;
CORE (COnnecting REpositories)