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In vitro stability of insulin aspart in simulated continuous subcutaneous insulin infusion using a MiniMed 508 insulin pump

spring119 添加于 2015-6-1 11:11 | 1421 次阅读 | 0 个评论

作者
Senstius J, Harboe E, Westermann H
摘要
BACKGROUND: This study was designed to assess the stability and potency of insulin aspart under experimental circumstances simulating worst-case conditions during clinical use for continuous subcutaneous insulin infusion (CSII). METHODS: The potency and stability of two batches of U100 insulin aspart, one recently manufactured and one nearing the end of shelf life, were evaluated after storage in a Medtronic (Northridge, CA) MiniMed 508 pump for up to 7 days at 37 +/- 2 degrees C. The pumps were placed on a vibrating platform (30 +/- 3 oscillations/min, 2 +/- 0.5 cm amplitude displacement) for 24 h/day to simulate movement by the pump user. The product remaining in the pump reservoir was tested at days 3, 4, and 7 and compared with control samples. RESULTS: After 7 days of in-pump use, there was no significant reduction in potency of insulin aspart or difference from reference values with regards to pH, isoAsp(B28), desamido insulin aspart, insulin aspart-related impurities, or high-molecular-weight proteins. The concentration of phenol and m-cresol remained at levels sufficient to ensure preservative efficacy for both control and test samples. There was no evidence of fibrillation or precipitation. CONCLUSIONS: The data indicate that storage in the plastic pump reservoir under temperature and vibration conditions simulating worst-case conditions during clinical use for CSII did not affect the stability or potency of insulin aspart significantly, and support an in-pump-use time of 7 days in the MiniMed 508 pump.
详细资料
- 关键词: Drug Stability; Hydrogen-Ion Concentration; Insulin/*analogs & derivatives/chemistry; Insulin Aspart; *Insulin Infusion Systems; Motion; Preservatives, Pharmaceutical; Temperature
- 文献种类:期刊
- 期刊名称: Diabetes Technology & Therapeutics
- 期刊缩写: Diabetes Technol Ther
- 期卷页: 2007年第9卷第1期 75-79页
- 地址: Novo Nordisk A/S, Bagsvaerd, Denmark. Jbse@novonordisk.com
- ISBN: 1520-9156
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