Dose Accuracy and Injection Force of Disposable Pens Delivering Pramlintide for the Treatment of Diabetes
Abstract
Background:
The pen injection format, typically used for insulin administration, has been adapted for the injectable, noninsulin diabetes therapy pramlintide. Administered before major meals, pramlintide therapy requires two to four injections/day in addition to the patients' usual insulin injections. The dose accuracy and injection force was determined for the 60 and 120 μg pramlintide pens.
Methods:
Dose accuracy testing was conducted at two sites on multiple 60 μg (15, 30, and 60 μg doses) and 120 μg pens (60 and 120 μg doses) at prespecified temperatures (5–40 °C) and humidities (0–75%) using 29 G half-inch needles. All pens were stabilized under testing conditions for 4 h prior to testing. One site used a compression load cell (Zwick device) to test pens; one site performed tests manually.
Injection-force testing was conducted at one site on multiple 60 and 120 μg pens at multiple temperatures (18–28 °C) and humidities (25–75%) using 29 and 31 G half-inch needles and an injection speed of 150 m/min. Injection-force testing was performed using a Zwick device.
Results:
Dose accuracy for all pens tested, regardless of location, reproducibly met/exceeded acceptance criteria. Mean percentage of dose accuracy was 96.04 to 102.45% [standard deviations (SDs) 0.3 to 1.4 μg] for the 60 μg pen and 98.16 to 101.83% (SDs 0.4 to 2.5 μg) for the 120 μg pen. The average injection force across both pens did not exceed 7 N regardless of needle size.
Conclusions:
High dose accuracy and low injection force were observed for the 60 and 120 μg pens under a variety of conditions.
References
1. Clarke A, Spollett G. Dose accuracy and injection force dynamics of a novel disposable insulin pen. Expert Opin Drug Deliv. 2007; 4 (2): 165–74.
2. Klonoff DC. The pen is mightier than the needle (and syringe). Diabetes Technol Ther. 2001; 3 (4): 631–3.
3. Molife C, Lee LJ, Shi L, Sawhney M, Lenox SM. Assessment of patient-reported outcomes of insulin pen devices versus conventional vial and syringe. Diabetes Technol Ther. 2009; 11 (8): 529–38.
4. Diabetes Health. Product reference guide 2010. http://www.diabeteshealth.com/media/pdfs/PRG2010/2-Insulin_Pens_Chart-Diabetes_Health_2010.pdf. Accessed July 13, 2010.
5. Luijf YM, DeVries JH. Dosing accuracy of insulin pens versus conventional syringes and vials. Diabetes Technol Ther. 2010; 12 Suppl 1: S73–7.
6. SYMLIN (pramlintide acetate) injection. Prescribing Information. Amylin Pharmaceuticals Inc., San Diego, CA. Revised July 2008. https://www.symlin.com/pdf/SYMLIN-pi-combined.pdf. Accessed September 8, 2010.
7. International Organization for Standardization. Pen-injectors for medical use—Part 1: Pen-injectors—requirements and test methods. ISO 11608–1: 2000(E). http://www.iso.org/iso/catalogue_detail.htm?csnumber=19545. Accessed September 8, 2010.
8. Haak T, Edelman S, Walter C, Lecointre B, Spollett G. Comparison of usability and patient preference for the new disposable insulin device SoloStar versus FlexPen, Lilly disposable pen, and a prototype pen: An open-label study. Clin Ther. 2007; 29 (4): 650–60.
9. Gnanalingham MG, Newland P, Smith CP. Accuracy and reproducibility of low dose insulin administration using pen-injectors and syringes. Arch Dis Child. 1998; 79 (1): 59–62.
10. Lteif AN, Schwenk WF. Accuracy of pen injectors versus insulin syringes in children with type 1 diabetes. Diabetes Care. 1999; 22 (1): 137–40.
11. Jehle PM, Micheler C, Jehle DR, Breitig D, Boehm BO. Inadequate suspension of neutral protamine Hagendorn (NPH) insulin in pens. Lancet. 1999(9190); 354: 1604–7.
12. Pearson TL. Practical aspects of insulin pen devices. J Diabetes Sci Technol. 2010; 4 (3): 522–31.
13. Selam JL. Evolution of diabetes insulin delivery devices. J Diabetes Sci Technol. 2010; 4 (3): 505–13.
14. [Fear of the injection must not be an argument. Every second type 2 diabetic patient needs insulin.]. MMW Fortschr Med. 2002; 144 (49): 60.
15. Wagner J, Malchoff C, Abbott G. Invasiveness as a barrier to self-monitoring of blood glucose in diabetes. Diabetes Technol Ther. 2005; 7 (4): 612–9.
16. Keith K, Nicholson D, Rogers D. Accuracy and precision of low-dose insulin administration using syringes, pen injectors, and a pump. Clin Pediatr (Phila). 2004; 43 (1): 69–74.
17. Summers KH, Szeinbach SL, Lenox SM. Preference for insulin delivery systems among current insulin users and nonusers. Clin Ther. 2004; 26 (9): 1498–505.
18. Bell DS, Clements RS Jr, Perentesis G, Roddam R, Wagenknecht L. Dosage accuracy of self-mixed vs premixed insulin. Arch Intern Med. 1991; 151 (11): 2265–9.
19. U. S. Department of Health and Human Services, U.S. Food and Drug Administration. About human factors. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/HumanFactors/ucm119185.htm. Accessed February 4, 2010.
Cite article
Cite article
Cite article
OR
Download to reference manager
If you have citation software installed, you can download article citation data to the citation manager of your choice
Information, rights and permissions
Information
Published In
Article first published online: November 1, 2010
Issue published: November 2010
Keywords
PubMed: 21129339
Authors
Metrics and citations
Metrics
Journals metrics
This article was published in Journal of Diabetes Science and Technology.
VIEW ALL JOURNAL METRICSArticle usage*
Total views and downloads: 274
*Article usage tracking started in December 2016
Altmetric
See the impact this article is making through the number of times it’s been read, and the Altmetric Score.
Learn more about the Altmetric Scores
Articles citing this one
Receive email alerts when this article is cited
Web of Science: 0
Crossref: 0
-
USFDA-approved parenteral peptide formulations and excipients: Industr...
-
FlexTouch: An Insulin Pen-Injector with a Low Activation Force Across ...
-
Hydrogels from amphiphilic star block copolypeptides
-
Pramlintide: profile of an amylin analog
Figures and tables
Figures & Media
Tables
View Options
View options
PDF/ePub
View PDF/ePubGet access
Access options
If you have access to journal content via a personal subscription, university, library, employer or society, select from the options below:
loading institutional access options
Alternatively, view purchase options below:
Purchase 24 hour online access to view and download content.
Access journal content via a DeepDyve subscription or find out more about this option.
