TY - JOUR
T1 - Sterilization of Drug-Loaded Composite Coatings for Implantable Glucose Biosensors
AU - Tipnis, Namita
AU - Kastellorizios, Michail
AU - Legassey, Allen
AU - Papadimitrakopoulos, Fotios
AU - Jain, Faquir
AU - Burgess, Diane J.
N1 - Funding Information:
The research findings indicate that both sterilization techniques are feasible for the sterilization of the dexamethasone-loaded PLGA microspheres/PVA hydrogel composite coatings, while EO was preferred for the sterilization of the glucose-sensing element of the biosensor. sterilization ethylene oxide radiation polymeric implantable medical devices drug device combination US Army Department of Defense W81XWH-15C-0069 edited-state corrected-proof typesetter ts1 The authors thank Sterigenics for assisting with sterilization of samples. Declaration of Conflicting Interests The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: FP and FJ declare a competing financial interest with Biorasis Inc. as they both are cofounders of the company. MK and AL declare a competing financial interest with Biorasis Inc. as they both were partially employed by this company at the time of this work. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The authors thank US Army Department of Defense (Award W81XWH-15C-0069) for funding. ORCID iD Namita Tipnis https://orcid.org/0000-0003-3202-8465
Funding Information:
The authors thank Sterigenics for assisting with sterilization of samples. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The authors thank US Army Department of Defense (Award W81XWH-15C-0069) for funding.
Publisher Copyright:
© 2019 Diabetes Technology Society.
PY - 2019
Y1 - 2019
N2 - Background: An anti-inflammatory drug-loaded composite coating (dexamethasone-loaded poly (lactic-co-glycolic acid) [PLGA] microspheres/polyvinyl alcohol [PVA] hydrogel) was previously developed to counter the foreign body reaction to a fully implantable continuous glucose monitoring biosensor. The long-term sensor functionality was ensured in the presence of the drug-loaded composite coating thus facilitating better diabetes control and management. In order to advance such a drug-device combination product toward clinical testing, addressing sterilization remains a key step due to the heterogeneity of the product components. The main objective of this research was to investigate the effect of two terminal sterilization techniques: gamma radiation and ethylene oxide (EO) on the stability of the anti-inflammatory coatings as well as retention of the glucose sensing ability of the implantable sensor. Method: The composite coatings, their individual components, and the glucose-sensing elements of the biosensor were subjected to low-temperature gamma radiation and EO cycles. Detailed characterization was conducted on all components before and after sterilization. Results: Exposure to gamma radiation affected dexamethasone crystallinity and glucose response linearity of the sensing element, whereas physical aging of microspheres in composite coatings was observed poststerilization with EO. Despite these effects, dexamethasone drug release from coatings was not significantly affected by either technique. Conclusion: The research findings indicate that both sterilization techniques are feasible for the sterilization of the dexamethasone-loaded PLGA microspheres/PVA hydrogel composite coatings, while EO was preferred for the sterilization of the glucose-sensing element of the biosensor.
AB - Background: An anti-inflammatory drug-loaded composite coating (dexamethasone-loaded poly (lactic-co-glycolic acid) [PLGA] microspheres/polyvinyl alcohol [PVA] hydrogel) was previously developed to counter the foreign body reaction to a fully implantable continuous glucose monitoring biosensor. The long-term sensor functionality was ensured in the presence of the drug-loaded composite coating thus facilitating better diabetes control and management. In order to advance such a drug-device combination product toward clinical testing, addressing sterilization remains a key step due to the heterogeneity of the product components. The main objective of this research was to investigate the effect of two terminal sterilization techniques: gamma radiation and ethylene oxide (EO) on the stability of the anti-inflammatory coatings as well as retention of the glucose sensing ability of the implantable sensor. Method: The composite coatings, their individual components, and the glucose-sensing elements of the biosensor were subjected to low-temperature gamma radiation and EO cycles. Detailed characterization was conducted on all components before and after sterilization. Results: Exposure to gamma radiation affected dexamethasone crystallinity and glucose response linearity of the sensing element, whereas physical aging of microspheres in composite coatings was observed poststerilization with EO. Despite these effects, dexamethasone drug release from coatings was not significantly affected by either technique. Conclusion: The research findings indicate that both sterilization techniques are feasible for the sterilization of the dexamethasone-loaded PLGA microspheres/PVA hydrogel composite coatings, while EO was preferred for the sterilization of the glucose-sensing element of the biosensor.
KW - drug device combination
KW - ethylene oxide
KW - polymeric implantable medical devices
KW - radiation
KW - sterilization
UR - http://www.scopus.com/inward/record.url?scp=85076922884&partnerID=8YFLogxK
U2 - 10.1177/1932296819890620
DO - 10.1177/1932296819890620
M3 - Article
C2 - 31786953
AN - SCOPUS:85076922884
VL - 15
SP - 646
EP - 654
JO - Journal of Diabetes Science and Technology
JF - Journal of Diabetes Science and Technology
SN - 1932-2968
IS - 3
ER -