jphp_12569_proofs.pdf (2.14 MB)
Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing
journal contribution
posted on 2023-06-09, 01:12 authored by Mohammed Maniruzzaman, Smirna Farias, Ian J Slipper, Joshua S Boateng, Babur Z Chowdhry, Arun Nair, Dennis DouroumisObjectives 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.
History
Publication status
- Published
File Version
- Accepted version
Journal
Journal of Pharmacy and PharmacologyISSN
0022-3573Publisher
Royal Pharmaceutical Society of Great Britain / WileyExternal DOI
Issue
7Volume
68Page range
890-900Department affiliated with
- Chemistry Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2016-05-12First Open Access (FOA) Date
2017-05-12First Compliant Deposit (FCD) Date
2016-05-12Usage metrics
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