Transdermal delivery of vitamin K using dissolving microneedles for the prevention of vitamin K deficiency bleeding

https://doi.org/10.1016/j.ijpharm.2018.02.031Get rights and content
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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.

Abbreviations

FTIR
Fourier Transform Infrared Spectroscopy
ICH
International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
IM
intramuscular
LEDC
less economically developed country
LoD
limit of detection
LoQ
limit of quantification
MN
microneedle
OCT
optical coherence tomography
PVP
polyvinylpyrrolidone
RH
relative humidity
UK
United Kingdom
UV
ultraviolet
VKDB
vitamin K deficiency bleeding

Keywords

Dissolving microneedles (MN)
Less economically developed countries (LEDCs)
Transdermal drug delivery
Vitamin K
Vitamin K deficiency bleeding (VKDB)

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