April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
In Vitro / In Vivo Correlation of Travoprost Release from a Biodegradable Hydrogel Punctum Plug for the Treatment of Glaucoma
Author Affiliations & Notes
  • Monica OConnor
    Ocular Therapeutix, Bedford, MA
  • Charles D Blizzard
    Ocular Therapeutix, Bedford, MA
  • Michael Bassett
    Ocular Therapeutix, Bedford, MA
  • Ankita Desai
    Ocular Therapeutix, Bedford, MA
  • Steve Takach
    Ocular Therapeutix, Bedford, MA
  • Doug Molla
    Ocular Therapeutix, Bedford, MA
  • Bill Cowe
    Ocular Therapeutix, Bedford, MA
  • Jennifer Wittbold
    Ocular Therapeutix, Bedford, MA
  • Arthur Driscoll
    Ocular Therapeutix, Bedford, MA
  • Amarpreet Sawhney
    Ocular Therapeutix, Bedford, MA
  • Footnotes
    Commercial Relationships Monica OConnor, Ocular Therapeutix (E); Charles Blizzard, Ocular Therapeutix (E); Michael Bassett, Ocular Therapeutix (E); Ankita Desai, Ocular Therapeutix (E); Steve Takach, Ocular Therapeutix (E); Doug Molla, Ocular Therapeutix (E); Bill Cowe, Ocular Therapeutix (E); Jennifer Wittbold, Ocular Therapeutix (E); Arthur Driscoll, Ocular Therapeutix (E); Amarpreet Sawhney, Ocular Therapeutix (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 473. doi:
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      Monica OConnor, Charles D Blizzard, Michael Bassett, Ankita Desai, Steve Takach, Doug Molla, Bill Cowe, Jennifer Wittbold, Arthur Driscoll, Amarpreet Sawhney; In Vitro / In Vivo Correlation of Travoprost Release from a Biodegradable Hydrogel Punctum Plug for the Treatment of Glaucoma. Invest. Ophthalmol. Vis. Sci. 2014;55(13):473.

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

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Abstract
 
Purpose
 

To demonstrate an in vitro / in vivo correlation (IVIVC) of sustained release travoprost from biodegradable hydrogel punctum plugs in an animal model compared to dissolution testing.

 
Methods
 

The Travoprost Punctum Plug (OTX-TP3) is comprised of travoprost encapsulated in polylactide microparticles that are entrapped within a dried biodegradable PEG hydrogel matrix and sized for insertion into the vertical canaliculus. Upon insertion the hydrogel swells to conform to the vertical canaliculus to ensure plug retention and release travoprost for a period of 3 months. Drug release rate from OTX-TP3 was assessed in vitro in PBS at pH 7.4, incubated at 37 C through complete dissolution and in vivo after subcutaneous implantation of two plugs in the scapular region of Sprague Dawley rats (n=40). Excision of 10 plugs from 5 rats per time point was performed and drug content per plug was determined via extraction and RP-HPLC.

 
Results
 

The daily in vitro and in vivo release of travoprost from OTX-TP3 was plotted over the duration of the studies (Figure One). Results demonstrate a sustained drug release relationship between the two studies and establish a 3-month drug release profile in an animal model correlating to conventional in vitro dissolution testing (Figure Two). For dose comparison purposes the daily amount of travoprost administered in a Travatan Z eye drop (from Travatan Z NDA #21-994) is presented in Figure One.

 
Conclusions
 

The in vivo release results show good agreement with standard in vitro dissolution testing and demonstrate a suitable model for the development of an IVIVC. Sustained release of travoprost from biodegradable plugs can deliver travoprost for a period of 3 months in an in vivo animal model that meets or exceeds the daily dose from eye drops.

     
Keywords: 503 drug toxicity/drug effects • 607 nanotechnology • 633 outflow: trabecular meshwork  
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