A reliable quantitative method for determining CBD content and release from transdermal patches in Franz cells

Liyun Yu; Frederikke Bahrt Madsen; Sofie Helvig Eriksen; Aaron J. C. Andersen; Anne Ladegaard Skov

doi:10.1002/pca.3188

A reliable quantitative method for determining CBD content and release from transdermal patches in Franz cells

Liyun Yu, Frederikke Bahrt Madsen, Sofie Helvig Eriksen, Aaron J. C. Andersen, Anne Ladegaard Skov^*

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

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Abstract

Introduction: There are several cannabidiol (CBD) transdermal patches available on the market. However, none are FDA-approved. Furthermore, not much evidence has been published about CBD release and skin permeation from such patches, so the effectiveness and reliability remain unclear. Objectives: We aimed to develop a method to determine the in vitro release and skin permeation of CBD from transdermal patches using Franz cell diffusion in combination with quantitative ¹H-NMR (qNMR). Materials and Methods: The study was conducted on CBD patches with known CBD content and six different commercially available or market-ready CBD patches using a Franz cell with a Strat-M™ membrane and with samples taken directly from the transdermal patch for qNMR analysis. Results: The use of qNMR yielded an average recovery of 100% ± 7% when samples with known CBD content were tested. Results from the testing of six commercially
available patches indicated that five out of six patches did not contain the CBD amount stated by the manufacturer according to a ± 10% variance margin, of which four patches were under-labeled and one was over-labeled. The release rate of patches was determined, and significant differences between the patches were shown. Maximum release of CBD was calculated to occur after 39 to 70 h. Conclusion: The established method was proven to be a reliable means of determining
the quantity and release of CBD from transdermal patches and can be used to verify CBD content and release rate in transdermal patches.

Original language	English
Journal	Phytochemical Analysis
Volume	33
Issue number	8
Pages (from-to)	1257-1265
ISSN	0958-0344
DOIs	https://doi.org/10.1002/pca.3188
Publication status	Published - 2022

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@article{c9895deca90b4e1b9e3c85e9f4649c71,

title = "A reliable quantitative method for determining CBD content and release from transdermal patches in Franz cells",

abstract = "Introduction: There are several cannabidiol (CBD) transdermal patches available on the market. However, none are FDA-approved. Furthermore, not much evidence has been published about CBD release and skin permeation from such patches, so the effectiveness and reliability remain unclear. Objectives: We aimed to develop a method to determine the in vitro release and skin permeation of CBD from transdermal patches using Franz cell diffusion in combination with quantitative 1H-NMR (qNMR). Materials and Methods: The study was conducted on CBD patches with known CBD content and six different commercially available or market-ready CBD patches using a Franz cell with a Strat-M{\texttrademark} membrane and with samples taken directly from the transdermal patch for qNMR analysis. Results: The use of qNMR yielded an average recovery of 100% ± 7% when samples with known CBD content were tested. Results from the testing of six commerciallyavailable patches indicated that five out of six patches did not contain the CBD amount stated by the manufacturer according to a ± 10% variance margin, of which four patches were under-labeled and one was over-labeled. The release rate of patches was determined, and significant differences between the patches were shown. Maximum release of CBD was calculated to occur after 39 to 70 h. Conclusion: The established method was proven to be a reliable means of determiningthe quantity and release of CBD from transdermal patches and can be used to verify CBD content and release rate in transdermal patches.",

author = "Liyun Yu and Madsen, {Frederikke Bahrt} and Eriksen, {Sofie Helvig} and Andersen, {Aaron J. C.} and Skov, {Anne Ladegaard}",

year = "2022",

doi = "10.1002/pca.3188",

language = "English",

volume = "33",

pages = "1257--1265",

journal = "Phytochemical Analysis",

issn = "0958-0344",

publisher = "John Wiley and Sons Ltd",

number = "8",

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TY - JOUR

T1 - A reliable quantitative method for determining CBD content and release from transdermal patches in Franz cells

AU - Yu, Liyun

AU - Madsen, Frederikke Bahrt

AU - Eriksen, Sofie Helvig

AU - Andersen, Aaron J. C.

AU - Skov, Anne Ladegaard

PY - 2022

Y1 - 2022

N2 - Introduction: There are several cannabidiol (CBD) transdermal patches available on the market. However, none are FDA-approved. Furthermore, not much evidence has been published about CBD release and skin permeation from such patches, so the effectiveness and reliability remain unclear. Objectives: We aimed to develop a method to determine the in vitro release and skin permeation of CBD from transdermal patches using Franz cell diffusion in combination with quantitative 1H-NMR (qNMR). Materials and Methods: The study was conducted on CBD patches with known CBD content and six different commercially available or market-ready CBD patches using a Franz cell with a Strat-M™ membrane and with samples taken directly from the transdermal patch for qNMR analysis. Results: The use of qNMR yielded an average recovery of 100% ± 7% when samples with known CBD content were tested. Results from the testing of six commerciallyavailable patches indicated that five out of six patches did not contain the CBD amount stated by the manufacturer according to a ± 10% variance margin, of which four patches were under-labeled and one was over-labeled. The release rate of patches was determined, and significant differences between the patches were shown. Maximum release of CBD was calculated to occur after 39 to 70 h. Conclusion: The established method was proven to be a reliable means of determiningthe quantity and release of CBD from transdermal patches and can be used to verify CBD content and release rate in transdermal patches.

AB - Introduction: There are several cannabidiol (CBD) transdermal patches available on the market. However, none are FDA-approved. Furthermore, not much evidence has been published about CBD release and skin permeation from such patches, so the effectiveness and reliability remain unclear. Objectives: We aimed to develop a method to determine the in vitro release and skin permeation of CBD from transdermal patches using Franz cell diffusion in combination with quantitative 1H-NMR (qNMR). Materials and Methods: The study was conducted on CBD patches with known CBD content and six different commercially available or market-ready CBD patches using a Franz cell with a Strat-M™ membrane and with samples taken directly from the transdermal patch for qNMR analysis. Results: The use of qNMR yielded an average recovery of 100% ± 7% when samples with known CBD content were tested. Results from the testing of six commerciallyavailable patches indicated that five out of six patches did not contain the CBD amount stated by the manufacturer according to a ± 10% variance margin, of which four patches were under-labeled and one was over-labeled. The release rate of patches was determined, and significant differences between the patches were shown. Maximum release of CBD was calculated to occur after 39 to 70 h. Conclusion: The established method was proven to be a reliable means of determiningthe quantity and release of CBD from transdermal patches and can be used to verify CBD content and release rate in transdermal patches.

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SN - 0958-0344

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SP - 1257

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JO - Phytochemical Analysis

JF - Phytochemical Analysis

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A reliable quantitative method for determining CBD content and release from transdermal patches in Franz cells

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