June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Biodegradable Sustained-Release Drug Delivery Systems Fabricated using a Dissolvable Hydrogel Template Technology for the Treatment of Ocular Indications
Author Affiliations & Notes
  • Nikita Malavia
    Ohr Pharmaceutical Inc., San Diego, CA
  • Laxma Reddy
    Ohr Pharmaceutical Inc., San Diego, CA
  • Istvan Szinai
    Ohr Pharmaceutical Inc., San Diego, CA
  • Norman Betty
    Ohr Pharmaceutical Inc., San Diego, CA
  • Justin Pi
    Ohr Pharmaceutical Inc., San Diego, CA
  • Jeremiah Kanagaraj
    Ohr Pharmaceutical Inc., San Diego, CA
  • Alisha Simonian
    Ohr Pharmaceutical Inc., San Diego, CA
  • Robert Jennings
    Ohr Pharmaceutical Inc., San Diego, CA
  • Glenn Stoller
    Ohr Pharmaceutical Inc., San Diego, CA
  • Footnotes
    Commercial Relationships Nikita Malavia, Ohr Pharmaceutical Inc. (E); Laxma Reddy, Ohr Pharmaceutical Inc. (E); Istvan Szinai, Ohr Pharmaceutical Inc. (E); Norman Betty, Ohr Pharmaceutical Inc. (E); Justin Pi, Ohr Pharmaceutical Inc. (E); Jeremiah Kanagaraj, Ohr Pharmaceutical Inc. (E); Alisha Simonian, Ohr Pharmaceutical Inc. (E); Robert Jennings, Ohr Pharmaceutical Inc. (E); Glenn Stoller, Ohr Pharmaceutical Inc. (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 1296. doi:
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      Nikita Malavia, Laxma Reddy, Istvan Szinai, Norman Betty, Justin Pi, Jeremiah Kanagaraj, Alisha Simonian, Robert Jennings, Glenn Stoller; Biodegradable Sustained-Release Drug Delivery Systems Fabricated using a Dissolvable Hydrogel Template Technology for the Treatment of Ocular Indications. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1296.

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

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Abstract
 
Purpose
 

Biodegradable drug delivery systems can provide a continuous drug supply to target sites for extended periods. These systems dramatically improve compliance by decreasing the burden of repeated injections in ocular diseases. A dissolvable hydrogel template technology was used to produce biodegradable microparticles custom designed in three dimensions for sustained release drug delivery.

 
Methods
 

In this study OHR1031, a small molecule drug for glaucoma, was incorporated into microparticles using a dissolvable hydrogel template technology. The drug was dissolved into a PLGA polymer-solvent mixture. The mixture was applied to templates with wells of uniform size that define the resulting microparticle size and shape. Templates were dissolved in water. Microparticles were recovered by filtration and dried. Particle size analysis was performed using a laser light scattering instrument. An in vitro release study was conducted in phosphate buffered saline at 37oC using conditions to ensure drug solubility did not impact drug release rates. Drug content in the microparticles and release media was measured by HPLC.

 
Results
 

In this example, microparticles obtained using the dissolvable template technology had a median particle size of 60 μm with 80% of the particles within 10 μm (Figure 1). OHR1031 content in the microparticles was 57% w/w with almost 100% incorporation efficiency. Drug release rate was nearly zero-order for over three months with virtually no initial burst (Figure 2).

 
Conclusions
 

The hydrogel template technology is amenable to small molecules and biologics. It provides a means to achieve high drug content in biodegradable materials with high incorporation efficiency. Microparticles are recovered from readily soluble hydrogel templates. Any water insoluble material can be chosen as the microparticle matrix to achieve the desired release durations. The technology allows for precise control of size and shape of template wells in every dimension. The resulting microparticles have a narrow size distribution reflecting the size and shape of template wells. These attributes enable microparticle injection using narrow bore needles into sensitive ocular spaces of long acting drug products.  

 
Particle size distribution of microparticles recovered from a dissolvable template
 
Particle size distribution of microparticles recovered from a dissolvable template
 
 
In vitro release of OHR1031 from PLGA microparticles
 
In vitro release of OHR1031 from PLGA microparticles

 
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