June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Influence of Storage Temperature on Sustained Release Dexamethasone Pharmacokinetics in a Beagle Model
Author Affiliations & Notes
  • Charles D Blizzard
    Ocular Therapeutix, Inc, Bedford, MA
  • Michael McGrath
    Ocular Therapeutix, Inc, Bedford, MA
  • Steve Takach
    Ocular Therapeutix, Inc, Bedford, MA
  • Monica O'Connor
    Ocular Therapeutix, Inc, Bedford, MA
  • Simone Charles
    Ocular Therapeutix, Inc, Bedford, MA
  • Douglas Molla
    Ocular Therapeutix, Inc, Bedford, MA
  • Jennifer Wittbold
    Ocular Therapeutix, Inc, Bedford, MA
  • William Cowe
    Ocular Therapeutix, Inc, Bedford, MA
  • Arthur Driscoll
    Ocular Therapeutix, Inc, Bedford, MA
  • Amar Sawhney
    Ocular Therapeutix, Inc, Bedford, MA
  • Footnotes
    Commercial Relationships Charles Blizzard, Ocular Therapeutix, Inc (E); Michael McGrath, Ocular Therapeutix (E); Steve Takach, Ocular Therapeutix (E); Monica O'Connor, Ocular Therapeutix (E), Ocular Therapeutix (E); Simone Charles, Ocular Therapeutix (E), Ocular Therapeutix (E); Douglas Molla, Ocular Therapeutix (E), Ocular Therapeutix (E); Jennifer Wittbold, Ocular Therapeutix (E), Ocular Therapeutix (E); William Cowe, Ocular Therapeutix (E); Arthur Driscoll, Ocular Therapeutix (E), Ocular Therapeutix (E); Amar Sawhney, Ocular Therapeutix (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 237. doi:
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      Charles D Blizzard, Michael McGrath, Steve Takach, Monica O'Connor, Simone Charles, Douglas Molla, Jennifer Wittbold, William Cowe, Arthur Driscoll, Amar Sawhney; Influence of Storage Temperature on Sustained Release Dexamethasone Pharmacokinetics in a Beagle Model. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):237.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

To evaluate the influence of elevated storage temperature on the release of dexamethasone from a bioresorbable hydrogel punctum plug in a beagle model.

 
Methods
 

The Sustained Release Dexamethasone Punctum Plug (OTX-DP) is comprised of dexamethasone suspended in a bioresorbable polyethylene glycol (PEG) hydrogel matrix and sized for insertion into the vertical canaliculus. Upon insertion, the hydrogel swells to conform to the canaliculus ensuring plug retention. Sustained release of dexamethasone occurs while the plug is retained in the canaliculus. Following treatment, the OTX-DP degrades via hydrolysis and is resorbed.<br /> <br /> OTX-DP samples from a single lot were separated into two test groups. The first test group was stored at refrigerated storage conditions (5 °C) and the second test group was stored at stress conditions (40 °C / 75% RH); each for a period of 3 months. Samples from each group were inserted into beagle canaliculi, with one plug inserted per eye (n=20 eyes per test group). Tear film samples were collected from each test group using Schirmer test strips over a 7 week period and analyzed via HPLC/MS/MS to determine dexamethasone concentrations at each time point.

 
Results
 

The mean concentrations along with the standard errors of dexamethasone in tear film samples were plotted for each test group, as shown in Figure One. The plotted results showed no meaningful difference in in vivo drug release profile over the duration of the study. Each test group maintained >200 ng/mL of dexamethasone in the tear film through 21 days.

 
Conclusions
 

Elevated temperature exposure of drug products can result in differences in product performance with respect to dose delivery. Our results demonstrate no meaningful difference in tear film levels of dexamethasone between the two test groups in a preclinical animal model over the duration of the study after 3 months aging at either refrigerated or stress storage conditions. The storage temperature did not affect either the duration or profile of release of dexamethasone from the OTX-DP.  

 
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