co-extrusion as a processing technique to manufacture a dual sustained release fixed-dose combination product.共挤压加工技术来制造一个双重持续释放固定剂量组合产品.pdfVIP

Research Paper Co-extrusion as a processing technique to manufacture a dual sustained release fixed-dose combination product a b a a An-Katrien Vynckier , Jody Voorspoels , Jean Paul Remon and Chris Vervaet aLaboratory of Pharmaceutical Technology, Ghent University, and bCONEXUS Pharma, Ghent, Belgium Keywords Abstract continuous production; fixed-dose combination product; hot-melt co-extrusion; Objectives This study aimed to design a fixed-dose combination dosage form sustained release which provides a sustained release profile for both the freely water-soluble met- formin HCl and the poorly soluble gliclazide, two antidiabetic compounds used Correspondence to treat diabetes mellitus. Prof. Dr. Chris Vervaet, Laboratory of Methods Hot-melt co-extrusion was used as an innovative manufacturing tech- Pharmaceutical Technology, Ghent University, Ottergemsesteenweg 460, 9000 nique for a pharmaceutical fixed-dose combination product. In this way, a Ghent, Belgium. matrix formulation that sustained metformin release could be developed, despite E-mail: Chris.Vervaet@UGent.be the high drug load in the formulation and the freely soluble nature of the drug. Key findings It was clear that co-extrusion was perfectly suited to produce a Received April 23, 2015 fixed-dose combination product with adequate properties for each of the incor- Accepted December 13, 2015