14-day in vitro chemical stability of insulin lispro in the MiniMed Paradigm pump

Diabetes Technology and Therapeutics

Volumn 14, Issue 3, 2012, Pages 264-270

  Sharrow, Scott D ^a   Glass, Leonard C ^a   Dobbins, Michael A ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INSULIN LISPRO; META CRESOL;

ARTICLE; DRUG POTENCY; DRUG STABILITY; HUMAN; IN VITRO STUDY; INFUSION PUMP; INSULIN INFUSION; PH; PHYSICAL CHEMISTRY; PRECIPITATION; PRIORITY JOURNAL; TEMPERATURE SENSITIVITY;

DRUG STABILITY; HOT TEMPERATURE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN INFUSION SYSTEMS; INSULIN LISPRO; TIME FACTORS; UNITED STATES; VIBRATION;

EID: 84857893808     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2011.0125     Document Type: Article

References (31)

1. Renner R, Pfützer A, Trautmann M, Harzer O, Sauter K, Landgraf R: Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. German Humalog-CSII Study Group. Diabetes Care 1999;22: 784-788. (Pubitemid 29220780)
2. Bode BW: Use of rapid-acting insulin analogues in the treatment of patients with type 1 and type 2 diabetes mellitus: insulin pump therapy versus multiple daily injections. Clin Ther 2007;29(Suppl D):S135-S144.
3. Hirsch IB: Insulin analogues. N Engl J Med 2005;352:174-183. (Pubitemid 40096614)
4. Mannucci E, Monami M, Marchionni N: Short-acting insulin analogues vs. regular human insulin in type 2 diabetes: a meta-analysis. Diabetes Obes Metab 2009;11:53-59.
5. Lind M, Fahlén M, Happich M, Odén A, Eliasson B: The effect of insulin lispro on glycemic control in a large patient cohort. Diabetes Technol Ther 2009;11:51-56.
6. Retnakaran R, Hochman J, DeVries JH, Hanaire-Broutin H, Heine RJ, Melki V, Zinman B: Continuous subcutaneous insulin infusion versus multiple daily injections: the impact of baseline A1c. Diabetes Care 2004;27:2590-2596. (Pubitemid 39441456)
7. Pickup JC, Sutton AJ: Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med 2008;25:765-774.
8. Bruttomesso D, Costa S, Baritussio A: Continuous subcutaneous insulin infusion (CSII) 30 years later: still the best option for insulin therapy. Diabetes Metab Res Rev 2009;25: 99-111.
9. Bode BW: Insulin pump use in type 2 diabetes. Diabetes Technol Ther 2010;12(Suppl 1):S17-S21.
10. Brange J, Langkjaer L, Havelund S, Vølund A: Chemical stability of insulin. 1. Hydrolytic degradation during storage of pharmaceutical preparations. Pharm Res 1992;9:715-726.
11. Brange J, Havelund S, Hougaard P: Chemical stability of insulin. 2. Formation of higher molecular weight transformation products during storage of pharmaceutical preparations. Pharm Res 1992;9:727-734.
12. Grau U: Chemical stability of insulin in a delivery system environment. Diabetologia 1985;28:458-463. (Pubitemid 15018840)
13. Poulsen C, Langkjaer L, Worsøe C: Precipitation of insulin products used for continuous subcutaneous insulin. Diabetes Technol Ther 2005;7:142-150. (Pubitemid 40354584)
14. Lougheed WD, Woulfe-Flanagan H, Clement JR, Albisser AM: Insulin aggregation in artificial delivery systems. Diabetologia 1980;19:1-9. (Pubitemid 10063091)
15. Lougheed WD, Zinman B, Strack TR, Janis LJ, Weymouth AB, Bernstein EA, Korbas AM, Frank BH: Stability of insulin lispro in insulin infusion systems. Diabetes Care 1997;20: 1061-1065. (Pubitemid 27274263)
16. DeFelippis MR, Bell MA, Heyob JA, Storms SM: In vitro stability of insulin lispro in continuous subcutaneous insulin infusion. Diabetes Technol Ther 2006;8:358-368. (Pubitemid 46100529)
17. U.S. Food and Drug Administration Draft Guidance for Industry and FDA Staff. Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] Submissions. Rockville, MD: U.S. Food and Drug Administration, 2010.
18. U.S. Pharmacopeia Monographs. Insulin Lispro Injection. USP32-NF27. Rockville, MD: U.S. Pharmacopeial Convention, 2011:1128.
19. U.S. Pharmacopeia General Chapters. 791 pH. USP32-NF27. Rockville, MD: U.S. Pharmacopeial Convention, 2011:2037.
20. U.S. Pharmacopeia General Chapters. 51 Antimicrobial Effectiveness Testing. USP29-NF24. Rockville, MD: U.S. Pharmacopeial Convention, 2005:2499-2500.
21. Petty C, Cunningham NL: Insulin adsorption by glass infusion bottles, polyvinylchloride infusion containers, and intravenous tubing. Anesthesiology 1974;40:400-404.
22. Brange J, Langkjaer L: Chemical stability of insulin. 3. Influence of excipients, formulation, and pH. Acta Pharm Nord 1992;4:149-158.
23. Chantelau E, Lange G, Gasthaus M, Boxberger M, Berger M: Interaction between plastic catheter tubings and regular insulin preparations used for continuous subcutaneous insulininfusion therapy. Diabetes Care 1987;10:348-351. (Pubitemid 17083579)
24. Tarr BR, Campbell RK,Workman TM: Stability and sterility of biosynthetic human insulin stored in plastic insulin syringes for 28 days. Am J Hosp Pharm 1991;48:2631-2634.
25. Wolpert HA, Faradji RN, Bonner-Weir S, Lipes MA: Metabolic decompensation in pump users due to lispro insulin precipitation. BMJ 2002;324:1253. (Pubitemid 34553564)
26. Wright AW, Little JA: Cannula occlusion with use of insulin lispro and insulin infusion system. Diabetes Care 1998;21: 874-875. (Pubitemid 28487094)
27. Zinman B, Tildesley H, Chiasson JL, Tsui E, Strack T: Insulin lispro in CSII: results of a double-blind crossover study. Diabetes 1997;46:440-443. (Pubitemid 27090273)
28. Melki V, Renard E, Lassmann-Vague V, Boivin S, Guerci B, Hanaire-Broutin H, Bringer J, Belicar P, Jeandidier N, Meyer L, Blin P, Augendre-Ferrante B, Tauber JP: Improvement of HbA1c and blood glucose stability in IDDM patients treated with lispro insulin analog in external pumps. Diabetes Care 1998;21:977-982. (Pubitemid 28488791)
29. Raskin P, Holcombe JH, Tamborlane WV, Malone JI, Strowig S, Ahern JA, Lavent F: A comparison of insulin lispro and buffered regular human insulin administered via continuous subcutaneous insulin infusion pump. J Diabetes Complications 2001;15:295-300. (Pubitemid 33065671)
30. Bode B, Weinstein R, Bell D, McGill J, Nadeau D, Raskin P, Davidson J, Henry R, Huang WC, Reinhardt RR: Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion: a randomized study in type 1 diabetes. Diabetes Care 2002;25: 439-444. (Pubitemid 41103333)
31. Kerr D, Morton J, Whately-Smith C, Everett J, Begley JP: Laboratory-based non-clinical comparison of occlusion rates using three rapid-acting insulin analogs in continuous subcutaneous insulin infusion catheters using low flow rates. J Diabetes Sci Technol 2008;2:450-455.