High-precision piezo-ejection ocular microdosing: Phase II study on local and systemic effects of topical phenylephrine. (January 2018)

• Record Type: Journal Article
• Authors: Ianchulev, Tsontcho; Weinreb, Robert; Tsai, James C; Lin, Shan; Pasquale, Louis R
• Is Part Of: Therapeutic delivery. Volume 9:Number 1(2018)
• Page Start: 17
• Page End: 27
• Publication Date: 2018-01
• Subjects: adverse events -- microdosing -- ocular drug delivery -- ocular medication -- phenylephrine -- piezo-ejection system -- pupil dilation -- systemic absorption; Drug delivery systems -- Periodicals; Therapeutics -- Periodicals; 615.6
• DOI: 10.4155/tde-2017-0095
• Languages: English
• ISSNs: 2041-5990

Abstract

Aim: Conventional eyedropper-delivered volumes (25–50 µl) exceed the eye's usual tear-film volume (7 µl) and precorneal reservoir capacity, risking overflow and ocular/systemic complications. Piezoelectric high-precision microdosing may circumvent these limitations.Results & methodology: In this masked, nonrandomized, cross-over study, subjects (n = 12) underwent pupil dilation with topical phenylephrine (PE) administered by 32-µl eyedropper (2.5% or 10% formulation) and 8-µl electronic microdosing (10% formulation). Microdosing with PE-10% achieved comparable peak dilation as 10% eyedropper-delivery and superior dilation to 2.5% eyedropper-delivery (p = 0.009) at 75 min. Microdosing significantly reduced 20-min plasma PE levels versus PE10% eyedropper; neither treatment altered heart rate/blood pressure. Eye irritation occurred significantly less frequently with microdosing than PE10% eyedrops.Conclusion: Piezo-ejection PE microdosing achieves comparable biological effect as eyedropper dosing; reduced systemic absorption may decrease risk of systemic side effects.