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Ther Deliv. 2018 Jan;9(1):17-27. doi: 10.4155/tde-2017-0095. Epub 2017 Oct 27.

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

Author information

1
New York Eye & Ear Infirmary of Mount Sinai, New York, NY, USA.
2
Hamilton Glaucoma Center & Shiley Eye Institute, UCSD, San Diego, CA, USA.
3
UCSF Medical Center, San Francisco, CA, USA.
4
Glaucoma Service, Massachusetts Eye & Ear, Boston, MA, USA.
5
Channing Division of Network Medicine, Brigham & Women's Hospital, Boston, MA, USA.

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.

KEYWORDS:

adverse events; microdosing; ocular drug delivery; ocular medication; phenylephrine; piezo-ejection system; pupil dilation; systemic absorption

PMID:
29076771
DOI:
10.4155/tde-2017-0095
[Indexed for MEDLINE]
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