title: Influence of processing parameters and formulation factors on the bioadhesive, temperature stability and drug release properties of hot-melt extruded films containing miconazole.
abstract: This study investigated the processing parameters and formulation factors on the bioadhesive properties, temperature stability properties, and drug release properties of miconazole in PolyOx® and Klucel® matrix systems produced by Hot-melt Extrusion (HME) technology. Miconazole incorporated into these matrix systems were found to be stable for 8 months by X-ray diffraction (XRD). The addition of miconazole increased area under the curve (AUC) at contact time intervals of 30 and 60 sec, while the bioadhesion decreased with an increase in processing temperatures. The release profiles suggest that a sustained release of miconazole was observed from all of the tested HME film formulations for approximately 10 h. The release from the optimal HME film extruded at 205°C was found to be significantly different than that extruded at 190°C. Therefore, this matrix system may address the present shortcomings of currently available therapy for oral and pharyngeal candidiasis.
authors.affiliation: GuangDong Research Center for Drug Delivery Systems, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong, 510006, China.
authors.forename: Meiwan
authors.initials: M
authors.lastname: Chen
authors.forename: Jiannan
authors.initials: J
authors.lastname: Lu
authors.forename: Weibin
authors.initials: W
authors.lastname: Deng
authors.forename: Abhilasha
authors.initials: A
authors.lastname: Singh
authors.forename: Noorullah Naqvi
authors.initials: NN
authors.lastname: Mohammed
authors.forename: Michael A
authors.initials: MA
authors.lastname: Repka
authors.forename: Chuanbin
authors.initials: C
authors.lastname: Wu
mesh_terms: D000268:Adhesiveness; D000935:Antifungal Agents / Q000737:chemistry*; D019540:Area Under Curve; D002482:Cellulose / Q000031:analogs & derivatives / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D018360:Crystallography, X-Ray; D003692:Delayed-Action Preparations; D004355:Drug Stability; D005240:Feasibility Studies; D006358:Hot Temperature; D007700:Kinetics; D008825:Miconazole / Q000737:chemistry*; D011092:Polyethylene Glycols / Q000737:chemistry; D011108:Polymers / Q000737:chemistry*; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000379:methods*; D013818:Thermogravimetry
chemical_list: D000935:Antifungal Agents; D003692:Delayed-Action Preparations; D011108:Polymers; D011092:Polyethylene Glycols; D008825:Miconazole; D002482:Cellulose; C008079:hydroxypropylcellulose