Skip navigation

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., 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)

[img]
Preview
PDF (Author's Review Manuscript)
15561 DOUROUMIS_Ketoconazole_Oral_Strips_2016.pdf - Accepted Version

Download (2MB) | Preview
[img] PDF (Email of Acceptance)
15561 DOUROUMIS_Acceptance_Letter_2016.pdf - Additional Metadata
Restricted to Repository staff only

Download (102kB)

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

Actions (login required)

View Item View Item

Downloads

Downloads per month over past year

View more statistics