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, 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. ISSN 0022-3573

[img] PDF - Accepted Version
Download (2MB)

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
Schools and Departments: School of Life Sciences > Chemistry
Depositing User: Mohammed Maniruzzaman
Date Deposited: 12 May 2016 07:46
Last Modified: 21 May 2017 21:09
URI: http://sro.sussex.ac.uk/id/eprint/60871

View download statistics for this item

📧 Request an update