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Biodegradable Sustained Release Drug Delivery Systems Fabricated using a Dissolvable Hydrogel Template Technology for the Treatment of Ocular Indications

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Page 1: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

Biodegradable Sustained Release Drug

Delivery Systems Fabricated using a

Dissolvable Hydrogel Template Technology

for the Treatment of Ocular Indications

Page 2: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

Financial Disclosures

Page 3: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

Presentation Overview

Page 4: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

Drawback of Current Microparticle Technology Broad Particle Size Distribution

Current Microemulsion

Page 5: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

Advantages of Ohr SR Microfabrication Narrow Particle Size Distribution

Current Microemulsion

Ohr SR Microfabrication

Page 6: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

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 - - - - - - - - + +

Page 7: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

Microfabricated Microparticles Using a

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

Hydrogel template

Page 8: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

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

Routes of Administration

Page 9: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

Ohr Sustained Release Therapeutics

Page 10: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

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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

Page 11: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

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

Layered Formulations

Non-Layered Formulation

Page 12: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

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Ophthalmic Indication: Glaucoma Layering process reduces burst release

Burst Release

1 Month 3 Month 4 Month

Before Layering

Page 13: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

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Ophthalmic Indication: Inflammation Tunable release profile obtained using biodegradable polymers

Polymer B

Polymer A

Polymer

A+B

Page 14: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

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

OHR1031

57% Drug Load

Page 15: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

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

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Polymer 1

Polymer 2

Page 16: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel

Summary

Page 17: Biodegradable Sustained Release Drug Delivery Systems … · 2018. 1. 5. · Systems Implant Systems Micro-emulsion Ohr ... Microfabricated Microparticles Using a Dissolvable Hydrogel