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Models and methods to characterise levonorgestrel release from intradermally administered contraceptives. | LitMetric

Models and methods to characterise levonorgestrel release from intradermally administered contraceptives.

Drug Deliv Transl Res

School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, CF10 3NB, UK.

Published: February 2022

AI Article Synopsis

  • * The study developed and tested two laboratory models to measure how LNG releases from microneedle formulations, one of which includes human skin homogenate.
  • * Results showed high extraction efficiency and effective detection of LNG, establishing a method for evaluating the drug’s sustained release from intradermal systems over time.

Article Abstract

Microneedle (MN)-based technologies have been proposed as a means to facilitate minimally invasive sustained delivery of long-acting hormonal contraceptives into the skin. Intradermal administration is a new route of delivery for these contraceptives and therefore no established laboratory methods or experimental models are available to predict dermal drug release and pharmacokinetics from candidate MN formulations. This study evaluates an in vitro release (IVR) medium and a medium supplemented with ex vivo human skin homogenate (SH) as potential laboratory models to investigate the dermal release characteristics of one such hormonal contraceptive that is being tested for MN delivery, levonorgestrel (LNG), and provides details of an accompanying novel two-step liquid-liquid drug extraction procedure and sensitive reversed-phase HPLC-UV assay. The extraction efficiency of LNG was 91.7 ± 3.06% from IVR medium and 84.6 ± 1.6% from the medium supplemented with SH. The HPLC-UV methodology had a limit of quantification of 0.005 µg/mL and linearity between 0.005 and 25 µg/mL. Extraction and detection methods for LNG were exemplified in both models using the well-characterised, commercially available sustained-release implant (Jadelle®). Sustained LNG release from the implant was detected in both media over 28 days. This study reports for the first time the use of biologically relevant release models and a rapid, reliable and sensitive methodology to determine release characteristics of LNG from intradermally administered long-acting drug delivery systems.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8724103PMC
http://dx.doi.org/10.1007/s13346-021-01091-5DOI Listing

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