Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant...

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Biodegradable Sustained Release Drug

Delivery Systems Fabricated using a

Dissolvable Hydrogel Template Technology

for the Treatment of Ocular Indications

Financial Disclosures

Presentation Overview

Drawback of Current Microparticle Technology Broad Particle Size Distribution

Current Microemulsion

Advantages of Ohr SR Microfabrication Narrow Particle Size Distribution

Current Microemulsion

Ohr SR Microfabrication

Ohr Technology vs. Other Ocular SR Systems

Characteristic

Bevacizumab Ranibizumab Aflibercept

External Systems

Implant Systems

Micro-emulsion

Ohr

Injectable through small gauge needle + + - - + + +

Sustained release (4-6 months) - - + + + + + +

Biodegradable: Does not require removal + + - - - - + + + +

Initial release is controlled and tunable - - - - - - + - + +

Simple formulation and process designed for fragile biologics

+ + + + - - + +

High drug loading capability - - - + - + +

Load different drugs into same particle - - - - - - - - + +

Microfabricated Microparticles Using a

Dissolvable Hydrogel Template Microparticles are Released by Dissolving Hydrogel Template in Water

Hydrogel template

Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular Drug Delivery. The AAPS Journal. 2010;12(3):348-360.

Routes of Administration

Ohr Sustained Release Therapeutics

0 1 2 3 4 5 6

0

2 0

4 0

6 0

8 0

1 0 0

M o n th s

Cu

mu

lati

ve

Re

lea

se

(%

)

Ophthalmic Indication: Glaucoma Tunable release capabilities for a hydrophilic drug molecule

Burst Release

1 Month 3 Month 4 Month

Different formulations to meet desired target profiles

0 2 4 6 8 1 0

0

2 0

4 0

6 0

8 0

1 0 0

D a y s

Cu

mu

lati

ve

Re

lea

se

(%

)

Ophthalmic Indication: Glaucoma Layering process reduces burst release for a hydrophilic drug molecule

Layered Formulations

Non-Layered Formulation

0 1 2 3 4 5 6

0

2 0

4 0

6 0

8 0

1 0 0

M o n th s

Cu

mu

lati

ve

Re

lea

se

(%

)

Ophthalmic Indication: Glaucoma Layering process reduces burst release

Burst Release

1 Month 3 Month 4 Month

Before Layering

0 2 4 6 8 1 0

0

2 0

4 0

6 0

8 0

1 0 0

M o n th s

Cu

mu

lati

ve

Re

lea

se

(%

)

Ophthalmic Indication: Inflammation Tunable release profile obtained using biodegradable polymers

Polymer B

Polymer A

Polymer

A+B

0 1 2 3 4 5

0

2 0

4 0

6 0

8 0

1 0 0

M o n th s

Cu

mu

lati

ve

Re

lea

se

(%

)

Ophthalmic Indication: Steroid-Induced Glaucoma Sustained release obtained for a hydrophobic drug molecule

OHR1031

57% Drug Load

Ophthalmic Indication: Retinal Diseases Sustained release obtained for a biologic ~150 kDa

0 1 2 3

0

2 0

4 0

6 0

8 0

1 0 0

M o n th s

Cu

mu

lati

ve

Re

lea

se

(%

)

Polymer 1

Polymer 2

Summary

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