title: A proposed model membrane and test method for microneedle insertion studies.
abstract: A commercial polymeric film (Parafilm M(®), a blend of a hydrocarbon wax and a polyolefin) was evaluated as a model membrane for microneedle (MN) insertion studies. Polymeric MN arrays were inserted into Parafilm M(®) (PF) and also into excised neonatal porcine skin. Parafilm M(®) was folded before the insertions to closely approximate thickness of the excised skin. Insertion depths were evaluated using optical coherence tomography (OCT) using either a force applied by a Texture Analyser or by a group of human volunteers. The obtained insertion depths were, in general, slightly lower, especially for higher forces, for PF than for skin. However, this difference was not a large, being less than the 10% of the needle length. Therefore, all these data indicate that this model membrane could be a good alternative to biological tissue for MN insertion studies. As an alternative method to OCT, light microscopy was used to evaluate the insertion depths of MN in the model membrane. This provided a rapid, simple method to compare different MN formulations. The use of Parafilm M(®), in conjunction with a standardised force/time profile applied by a Texture Analyser, could provide the basis for a rapid MN quality control test suitable for in-process use. It could also be used as a comparative test of insertion efficiency between candidate MN formulations.
authors.affiliation: Queens University, Belfast School of Pharmacy, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors.forename: Eneko
authors.initials: E
authors.lastname: Larrañeta
authors.affiliation: Queens University, Belfast School of Pharmacy, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors.forename: Jessica
authors.initials: J
authors.lastname: Moore
authors.affiliation: Queens University, Belfast School of Pharmacy, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors.forename: Eva M
authors.initials: EM
authors.lastname: Vicente-Pérez
authors.affiliation: Queens University, Belfast School of Pharmacy, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors.forename: Patricia
authors.initials: P
authors.lastname: González-Vázquez
authors.affiliation: Queens University, Belfast School of Pharmacy, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Lutton
authors.affiliation: Queens University, Belfast School of Pharmacy, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors.forename: A David
authors.initials: AD
authors.lastname: Woolfson
authors.affiliation: Queens University, Belfast School of Pharmacy, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom. Electronic address: r.donnelly@qub.ac.uk.
authors.forename: Ryan F
authors.initials: RF
authors.lastname: Donnelly
mesh_terms: D000818:Animals; D000831:Animals, Newborn; D008567:Membranes, Artificial; D008845:Microinjections; D009339:Needles; D010232:Paraffin; D012867:Skin / Q000378:metabolism; D013552:Swine
chemical_list: D008567:Membranes, Artificial; D010232:Paraffin
keywords: Insertion tests; Microneedles; Optical coherence tomography; Polymeric films