title: Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing.
abstract: OBJECTIVE
  The aim of this study was to develop mucoadhesive oral strips using hot-melt extrusion as a continuous manufacturing process.
  
  
  METHODS
  Powder blends of ketoconazole, a water-insoluble drug - either hydroxypropyl methylcellulose (HPMC) or soluplus (SOL), sorbitol (SRB) and magnesium aluminometasilicate (MAS) were extruded to manufacture thin strips with 0.5-mm thickness. The presence of the inorganic metasilicate facilitated smooth processing of the extruded strips as it worked as an absorbent directly impacting on the extensive mixing of the drug/excipients inside the extruder barrel.
  
  
  RESULTS
  The use of MAS also favoured the rapid hydration, swelling and eventual disintegration of the strips. Differential scanning calorimetry and transmission X-ray diffraction analysis revealed the existence of the amorphous drug within the extruded strips. Scanning electron microscopy and energy dispersive X-ray undertaken on the formulations showed a homogeneous drug distribution within the extruded strips.
  
  
  CONCLUSIONS
  The strips produced via continuous hot-melt extrusion processing showed significantly faster release of ketoconazole compared to the bulk drug substance.
authors.affiliation: Department of Pharmacy (Chemistry), School of Life Sciences, University of Sussex, Brighton, UK.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Maniruzzaman
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent, UK.
authors.forename: Smirna
authors.initials: S
authors.lastname: Farias
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent, UK.
authors.forename: Ian J
authors.initials: IJ
authors.lastname: Slipper
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent, UK.
authors.forename: Joshua S
authors.identifier: http://orcid.org/0000-0002-6310-729X
authors.initials: JS
authors.lastname: Boateng
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent, UK.
authors.forename: Babur Z
authors.initials: BZ
authors.lastname: Chowdhry
authors.affiliation: Fuji Chemical Industry Co., Ltd., Minato-ku, Tokyo, Japan.
authors.forename: Arun
authors.initials: A
authors.lastname: Nair
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent, UK.
authors.forename: Dennis
authors.initials: D
authors.lastname: Douroumis
mesh_terms: D000269:Adhesives / Q000737:chemistry; D000284:Administration, Oral; D017607:Aluminum Compounds / Q000737:chemistry; D004337:Drug Carriers / Q000008:administration & dosage* / Q000737:chemistry; D004339:Drug Compounding / Q000379:methods*; D065546:Drug Liberation; D065347:Hypromellose Derivatives / Q000737:chemistry; D007654:Ketoconazole / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D017616:Magnesium Compounds / Q000737:chemistry; D011092:Polyethylene Glycols / Q000737:chemistry; D011145:Polyvinyls / Q000737:chemistry; D011208:Powders / Q000008:administration & dosage / Q000737:chemistry; D017640:Silicates / Q000737:chemistry; D013012:Sorbitol / Q000737:chemistry
chemical_list: D000269:Adhesives; D017607:Aluminum Compounds; D004337:Drug Carriers; D017616:Magnesium Compounds; D011145:Polyvinyls; D011208:Powders; D017640:Silicates; C572167:polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; D065347:Hypromellose Derivatives; D011092:Polyethylene Glycols; D013012:Sorbitol; C033065:aluminum magnesium silicate; D007654:Ketoconazole
keywords: Continuous manufacturing; amorphous; energy dispersive X-ray; oral strips; surface analysis