ORB-101 Prednisone
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Responding to Market Trends
Market Needs:
Taste-masked & Immediate Release
Palatable
Mask bitter and distasteful APIs
Eliminate granular or “yucky” feel
Accurate dosing
Provide dosing precision
without sacrificing taste
Age-appropriate drug format
Adapt for pediatrics and geriatrics
with difficulties in swallowing
Microcapsule powders:
•
•
•
•
Complete release after taste-masking
Palatable, titratable, fillable fine powder
High drug loading
Single step processing
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Prednisone: The Challenge + Opportunity
Dosage forms commonly
prescribed to children:
Prednisone oral solution USP 5mg/5mL
Prednisone Intensol® 5mg/1mL concentrate
Advantage --- it’s easy to precisely dose
Disadvantage --- it tastes extremely foul
ORB-101 effectively taste-masks prednisone and
offers both format flexibility and dose precision
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Microcapsule Powders for
Pediatric and Geriatric Products
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Process for Producing
Taste-Masked Powders
* Precision Particle Fabrication Technology
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
ORB-101 Significantly Delays Initial Release
Syrup
Micrograph
First 2 minutes of
dissolution @ neutral pH
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
ORB-101 Drug Core is Amorphous
Micrograph
DSC
Amorphous drug aids in fast dissolution
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Target Product
Profile
PredniSONE Intensol TM
Oral Solution
ORB-101
Indication
Asthma, Bronchiolitis,
Eczema, Atopic,
Dermatitis, etc.
Asthma, Bronchiolitis,
Eczema, Atopic,
Dermatitis, etc.
Delivery route
Oral
Oral
Dosage form
Liquid suspension
Liquid suspension
(Concentrate)
Dose (mg/mL)
5
5
Drug taste-masked (%)
at 1 minute
at 2 minutes
94.8%
84.2%
36.7%
29.3%
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Beyond ORB-101
Develop taste-making
powders for additional foultasting drugs
Font size is highest for API with most
references citing foul tasting
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Applicable Patent Portfolio
• US Provisional Patent Application Docket No. 13-21122, titled “Tastemasking
Drug Formulations”
• US Patent No. 6,669,961 titled "Microparticles" TF00058-US
• US Divisional Patent Application Serial No. 10/624,029, titled "Microparticles"
TF00058-DIV: Issued US Patent 7368130
• European Patent Application Serial No. 01964090.3, titled "Microparticles"
TF00058-EP-Allowed
• Republic of Korea patent Application Serial No. 10-2003-7002225, titled
"Microparticles" TF00058-KR: Issued Patent 0867392
• US Patent Application Serial No. 10/728,190, titled "Microparticles" TF03040US: Issued Patent 7309500
• US Continuing Patent Application Serial No. 11/939,262, titled "Microparticles"
TF03040-CON: Continuation of TF03040-US
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Notes and Legal Statement
•
Trademarks. PredniSONE Intensol™ Oral Solution is a trademarked property.
•
Copyright. Copyright © 2014 Orbis Biosciences, Inc. All Rights Reserved. This
material is for informational purposes only. Any disclosure, publication,
reproduction, or other use is strictly prohibited.
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.
Copyright © 2014 Orbis Biosciences, Inc. All rights reserved.

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