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Maniruzzaman M, Farias S, Slipper IJ, et al. Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing. J Pharm Pharmacol. 2016;68(7):890-900doi: 10.1111/jphp.12569.
Maniruzzaman, M., Farias, S., Slipper, I. J., Boateng, J. S., Chowdhry, B. Z., Nair, A., & Douroumis, D. (2016). Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing. The Journal of pharmacy and pharmacology, 68(7), 890-900. https://doi.org/10.1111/jphp.12569
Maniruzzaman, Mohammed, et al. "Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing." The Journal of pharmacy and pharmacology vol. 68,7 (2016): 890-900. doi: https://doi.org/10.1111/jphp.12569
Maniruzzaman M, Farias S, Slipper IJ, Boateng JS, Chowdhry BZ, Nair A, Douroumis D. Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing. J Pharm Pharmacol. 2016 Jul;68(7):890-900. doi: 10.1111/jphp.12569. Epub 2016 May 11. PMID: 27164996.
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J Pharm Pharmacol. 2016 Jul;68(7):890-900. doi: 10.1111/jphp.12569. Epub 2016 May 11.

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

The Journal of pharmacy and pharmacology

Mohammed Maniruzzaman, Smirna Farias, Ian J Slipper, Joshua S Boateng, Babur Z Chowdhry, Arun Nair, Dennis Douroumis

Affiliations

  1. Department of Pharmacy (Chemistry), School of Life Sciences, University of Sussex, Brighton, UK.
  2. Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent, UK.
  3. Fuji Chemical Industry Co., Ltd., Minato-ku, Tokyo, Japan.

PMID: 27164996 DOI: 10.1111/jphp.12569

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.

© 2016 Royal Pharmaceutical Society.

Keywords: Continuous manufacturing; amorphous; energy dispersive X-ray; oral strips; surface analysis

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