Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation

Rebecca E M Lutton, Jessica Moore, Eneko Larrañeta, Stephen Ligett, A David Woolfson, Ryan F Donnelly

Research output: Contribution to journalReview article

27 Citations (Scopus)
1420 Downloads (Pure)

Abstract

With interest in microneedles as a novel drug transdermal delivery system increasing rapidly since the late 1990s (Margetts and Sawyer Contin Educ Anaesthesia Crit Care Pain. 7(5):171-76, 2007), a diverse range of microneedle systems have been fabricated with varying designs and dimensions. However, there are still very few commercially available microneedle products. One major issue regarding microneedle manufacture on an industrial scale is the lack of specific quality standards for this novel dosage form in the context of Good Manufacturing Practice (GMP). A range of mechanical characterisation tests and microneedle insertion analysis techniques are used by researchers working on microneedle systems to assess the safety and performance profiles of their various designs. The lack of standardised tests and equipment used to demonstrate microneedle mechanical properties and insertion capability makes it difficult to directly compare the in use performance of candidate systems. This review highlights the mechanical tests and insertion analytical techniques used by various groups to characterise microneedles. This in turn exposes the urgent need for consistency across the range of microneedle systems in order to promote innovation and the successful commercialisation of microneedle products.

Original languageEnglish
Pages (from-to)313-331
Number of pages19
JournalDrug Delivery and Translational Research
Volume5
Issue number4
Early online date29 May 2015
DOIs
Publication statusPublished - Aug 2015

Fingerprint

Dosage Forms
Drug Delivery Systems
Anesthesia
Research Personnel
Safety
Pain
Equipment and Supplies

Cite this

@article{3e26edc09d364c3fb56247e40b95a7c3,
title = "Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation",
abstract = "With interest in microneedles as a novel drug transdermal delivery system increasing rapidly since the late 1990s (Margetts and Sawyer Contin Educ Anaesthesia Crit Care Pain. 7(5):171-76, 2007), a diverse range of microneedle systems have been fabricated with varying designs and dimensions. However, there are still very few commercially available microneedle products. One major issue regarding microneedle manufacture on an industrial scale is the lack of specific quality standards for this novel dosage form in the context of Good Manufacturing Practice (GMP). A range of mechanical characterisation tests and microneedle insertion analysis techniques are used by researchers working on microneedle systems to assess the safety and performance profiles of their various designs. The lack of standardised tests and equipment used to demonstrate microneedle mechanical properties and insertion capability makes it difficult to directly compare the in use performance of candidate systems. This review highlights the mechanical tests and insertion analytical techniques used by various groups to characterise microneedles. This in turn exposes the urgent need for consistency across the range of microneedle systems in order to promote innovation and the successful commercialisation of microneedle products.",
author = "Lutton, {Rebecca E M} and Jessica Moore and Eneko Larra{\~n}eta and Stephen Ligett and Woolfson, {A David} and Donnelly, {Ryan F}",
year = "2015",
month = "8",
doi = "10.1007/s13346-015-0237-z",
language = "English",
volume = "5",
pages = "313--331",
journal = "Drug Delivery and Translational Research",
issn = "2190-393X",
publisher = "Springer Publishing Company",
number = "4",

}

TY - JOUR

T1 - Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation

AU - Lutton, Rebecca E M

AU - Moore, Jessica

AU - Larrañeta, Eneko

AU - Ligett, Stephen

AU - Woolfson, A David

AU - Donnelly, Ryan F

PY - 2015/8

Y1 - 2015/8

N2 - With interest in microneedles as a novel drug transdermal delivery system increasing rapidly since the late 1990s (Margetts and Sawyer Contin Educ Anaesthesia Crit Care Pain. 7(5):171-76, 2007), a diverse range of microneedle systems have been fabricated with varying designs and dimensions. However, there are still very few commercially available microneedle products. One major issue regarding microneedle manufacture on an industrial scale is the lack of specific quality standards for this novel dosage form in the context of Good Manufacturing Practice (GMP). A range of mechanical characterisation tests and microneedle insertion analysis techniques are used by researchers working on microneedle systems to assess the safety and performance profiles of their various designs. The lack of standardised tests and equipment used to demonstrate microneedle mechanical properties and insertion capability makes it difficult to directly compare the in use performance of candidate systems. This review highlights the mechanical tests and insertion analytical techniques used by various groups to characterise microneedles. This in turn exposes the urgent need for consistency across the range of microneedle systems in order to promote innovation and the successful commercialisation of microneedle products.

AB - With interest in microneedles as a novel drug transdermal delivery system increasing rapidly since the late 1990s (Margetts and Sawyer Contin Educ Anaesthesia Crit Care Pain. 7(5):171-76, 2007), a diverse range of microneedle systems have been fabricated with varying designs and dimensions. However, there are still very few commercially available microneedle products. One major issue regarding microneedle manufacture on an industrial scale is the lack of specific quality standards for this novel dosage form in the context of Good Manufacturing Practice (GMP). A range of mechanical characterisation tests and microneedle insertion analysis techniques are used by researchers working on microneedle systems to assess the safety and performance profiles of their various designs. The lack of standardised tests and equipment used to demonstrate microneedle mechanical properties and insertion capability makes it difficult to directly compare the in use performance of candidate systems. This review highlights the mechanical tests and insertion analytical techniques used by various groups to characterise microneedles. This in turn exposes the urgent need for consistency across the range of microneedle systems in order to promote innovation and the successful commercialisation of microneedle products.

U2 - 10.1007/s13346-015-0237-z

DO - 10.1007/s13346-015-0237-z

M3 - Review article

C2 - 26022578

VL - 5

SP - 313

EP - 331

JO - Drug Delivery and Translational Research

JF - Drug Delivery and Translational Research

SN - 2190-393X

IS - 4

ER -