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Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing

Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing

Maniruzzaman, Mohammed, Farias, Smirna, Slipper, Ian J., Boateng, Joshua S. ORCID: 0000-0002-6310-729X, Chowdhry, Babur Z., Nair, Arun and Douroumis, Dennis (2016) Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing. Journal of Pharmacy and Pharmacology, 68 (7). pp. 890-900. ISSN 0022-3573 (Print), 2042-7158 (Online) (doi:10.1111/jphp.12569)

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Abstract

Objectives

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.

Key findings

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.

Conclusion

The strips produced via continuous hot-melt extrusion processing showed significantly faster release of ketoconazole compared to the bulk drug substance.

Item Type: Article
Uncontrolled Keywords: Amorphous; Continuous manufacturing; Energy dispersive X-ray; Oral strips; Surface analysis
Subjects: Q Science > QD Chemistry
Faculty / Department / Research Group: Faculty of Engineering & Science
Faculty of Engineering & Science > Department of Pharmaceutical, Chemical & Environmental Sciences
Faculty of Engineering & Science > Medway Centre for Pharmaceutical Science > Pharmaceutical and Medicinal Science Research Group
Last Modified: 20 Nov 2017 12:05
Selected for GREAT 2016: None
Selected for GREAT 2017: None
Selected for GREAT 2018: None
URI: http://gala.gre.ac.uk/id/eprint/15561

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