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The stability of insulin in solid formulations containing melezitose and starch. Effects of processing and excipients
YKI – Ytkemiska institutet.
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2006 (English)In: Drug Development and Industrial Pharmacy, ISSN 0363-9045, E-ISSN 1520-5762, Vol. 32, no 6, p. 765-778Article in journal (Refereed)
Abstract [en]

Solid insulin formulations obtained by different methods of preparation were compared with respect to chemical stability and morphology. Spray- and freeze-drying, solution enhanced dispersion by supercritical fluids (SEDS) and precipitation into starch microspheres were the methods used for preparation of solid powders. The excipients applied were melezitose, starch and sodium taurocholate. The stability of the samples was evaluated after storage in open containers at 25°C and 30% RH for 6 months. All samples were amorphous after processing and storage as detected by XRD, except for the starch microspheres which were semi-crystalline. The spray- and freeze-dried samples containing melezitose and sodium taurocholate experienced a significant water uptake during storage, resulting in changes in morphology and disappearance of Tg. However, the chemical stability of these samples did not seem to be affected by the water uptake. Changes in morphology were not observed for the SEDS powders and the starch microspheres. The chemical stability of the samples was assessed by HPLC. In general, conventional spray and freeze drying resulted in samples with higher chemical stability compared to SEDS powders and starch microspheres. Nevertheless, the excipients applied were observed to be of major importance, and further optimization of the formulation as well as processing conditions may lead to slightly different conclusions.

Place, publisher, year, edition, pages
2006. Vol. 32, no 6, p. 765-778
Keywords [en]
Insulin, spray-drying, lyophilization, freeze-drying, chemical stability, SEDS, starch microspheres
National Category
Natural Sciences
Identifiers
URN: urn:nbn:se:ri:diva-26515OAI: oai:DiVA.org:ri-26515DiVA, id: diva2:1053518
Note
A1767Available from: 2016-12-08 Created: 2016-12-08 Last updated: 2017-11-29Bibliographically approved

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