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Transdermal delivery of vitamin K using dissolving microneedles for the prevention of vitamin K deficiency bleeding
Aaron R J Hutton1, Helen L Quinn1, Paul J McCague1
1School of Pharmacy, Queen's University, Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
Insights
Microneedles offer a potential solution for vitamin K deficiency bleeding in newborns, especially in low-resource areas. This study demonstrates successful in vitro delivery of vitamin K via microneedles, paving the way for safer prophylaxis.
Area of Science:
- Neonatal Medicine
- Biomedical Engineering
- Drug Delivery Systems
Background:
- Vitamin K deficiency bleeding (VKDB) is a serious risk for newborns, particularly in regions with limited healthcare access.
- Current intramuscular vitamin K injections, while effective, pose risks of needle sharing and disease transmission in low-resource settings.
- The World Health Organization recommends routine vitamin K prophylaxis for all newborns.
Purpose of the Study:
- To investigate the feasibility of using microneedles for vitamin K delivery to neonates.
- To assess the mechanical properties and delivery efficiency of vitamin K-loaded microneedles.
- To explore an alternative, potentially safer method for neonatal vitamin K prophylaxis.
Main Methods:
- Microneedles were fabricated for vitamin K delivery.
- Insertion studies were conducted to evaluate microneedle mechanical properties.
- In vitro delivery of vitamin K through neonatal porcine skin was assessed.
Main Results:
- Microneedles were successfully manufactured and demonstrated suitable mechanical properties for skin insertion.
- In vitro studies showed successful delivery of 1.80 ± 0.08 mg of vitamin K over 24 hours through neonatal porcine skin.
- The microneedle array effectively delivered vitamin K across the skin barrier.
Conclusions:
- Microneedle technology shows significant potential as a novel method for neonatal vitamin K prophylaxis.
- This approach could mitigate the risks associated with traditional intramuscular injections in resource-limited settings.
- Further in vivo studies are warranted to confirm the efficacy and safety of microneedle-based vitamin K delivery.
Abstract:
Vitamin K deficiency within neonates can result in vitamin K deficiency bleeding. Ensuring that newborns receive vitamin K is particularly critical in places where access to health care and blood products and transfusions is limited. The World Health Organization recommends that newborns receive a 1 mg intramuscular injection of vitamin K at birth. Evidence from multiple surveillance studies shows that the introduction of vitamin K prophylaxis reduces the incidence of vitamin K deficiency bleeding. Despite these recommendations, coverage of vitamin K prophylactic treatment in low-resource settings is limited. An intramuscular injection is the most common method of vitamin K administration in neonates. In low- and middle-income countries, needle sharing may occur, which may result in the spread of bloodborne diseases. The objective of our study was to investigate the manufacture of microneedles for the delivery of vitamin K. Following microneedle fabrication, we performed insertion studies to assess the microneedle's mechanical properties. Results indicate that vitamin K in a microneedle array was successfully delivered in vitro across neonatal porcine skin with 1.80 ± 0.08 mg delivered over 24 h. Therefore, this initial study shows that microneedles do have the potential to prevent vitamin K deficiency bleeding. Future work will assess delivery of vitamin K in microneedle array in vivo.
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