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Published on: January 7, 2018
Insulin temperature and stability under simulated transit conditions.
Chris Chandler1, Connie M Gryniewicz, Tom Pringle
1Department of Veterans Affairs, Great Lakes Consolidated Mail Outpatient Pharmacy, Hines, IL 60141, USA. chris.chandler@va.gov
Insulin stability is maintained during transit, regardless of packaging or temperature. This study confirms that various insulin types remain potent and stable under simulated summer and winter shipping conditions, ensuring product integrity.
Area of Science:
- Pharmaceutical Science
- Drug Stability
- Logistics and Supply Chain Management
Background:
- Maintaining insulin potency during transit is critical for patient safety and therapeutic efficacy.
- Various insulin formulations (Regular, NPH, 70/30) are susceptible to temperature fluctuations during shipping.
- Current packaging methods for insulin vary, impacting thermal protection.
Purpose of the Study:
- To evaluate the transit temperature profiles, mean kinetic temperatures (MKTs), and stability of insulin samples.
- To compare the performance of insulated versus noninsulated containers under simulated summer and winter transit conditions.
- To assess the impact of packaging on insulin stability during simulated shipping.
Main Methods:
- Insulin samples (Regular, NPH, 70/30) were packaged in insulated and noninsulated containers.
- Samples were exposed to simulated summer and winter transit conditions (24-120 hours) in an environmental chamber.
- High-performance liquid chromatography and size-exclusion chromatography were used to assess sample stability and detect aggregates.
Main Results:
- All insulin samples met United States Pharmacopeia (USP) stability limits, irrespective of shipping conditions or packaging.
- Visual inspection and microscopic analysis showed no significant changes in insulin appearance or crystal morphology post-exposure.
- Mean kinetic temperatures (MKTs) were calculated for each packaging type and condition.
Conclusions:
- Regular, NPH, and 70/30 insulin formulations maintain potency within USP limits under simulated ground delivery conditions.
- Packaging material (insulated vs. noninsulated) did not significantly affect insulin stability during simulated transit.
- The study confirms insulin's resilience to temperature variations encountered during typical shipping durations.
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