IP Library › Granted Patent US 12,648,914
Granted Patent B2
US 12,648,914 · App. 17/457,248 · Granted Jun 9, 2026

Injectable sustained release composition and method of using the same for treating inflammation in joints and pain associated therewith

Inventors: James A. Helliwell (Victoria, CA); Amanda M. Malone (Victoria, CA); Thomas J. Smith (Santa Monica, CA); Marc M. Baum (Pasadena, CA)
Assignee: Eupraxia Pharmaceuticals USA LLC
A61K9/5026A61K9/0024A61K31/56A61K31/58
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Quick Facts
Patent No.
US 12,648,914
App. No.
17/457,248
Granted
Jun 9, 2026
Kind
B2
Abstract

Described herein are injectable corticosteroid-loaded microparticles, pharmaceutical composition thereof and methods for reducing inflammation or pain in a body compartment such as a joint, an epidural space, a vitreous body of an eye, a surgically created space, or a space adjacent to an implant.

Claims (11)

1 . A unit dosage form comprising:

a plurality of microparticles, each microparticle including:

(1) a crystalline drug core of more than 70% by weight of the microparticle; and

(2) a polymeric shell encapsulating the crystalline drug core,

wherein the crystalline drug core consists of one or more crystals of a corticosteroid selected from fluticasone, fluticasone furoate, and fluticasone propionate, and the polymeric shell is polyvinyl alcohol (PVA) and is in contact but immiscible with the crystalline drug core; wherein the plurality of microparticles have a mean diameter in the range of 50 μm to 150 μm and a standard deviation of less than 50% of the mean diameter; and

wherein the plurality of microparticles are heat-treated at 210-230° C. for at least one hour and the unit dosage form releases the corticosteroid over a period of 2-12 months while maintaining a minimum therapeutically effective concentration of the corticosteroid within a body compartment.

2 . The unit dosage form according to claim 1 , wherein the body compartment is a joint, an epidural space, an intravitreal space, a surgically created space, or a space adjacent to an implant.

3 . The unit dosage form according to claim 1 , wherein, within the sustained release period of 2-12 months, the corticosteroid is released locally within the body compartment and provides below a quantifiable limit of plasma corticosteroid 7 days after injection.

4 . The unit dosage form according to claim 1 , wherein each microparticle of the plurality of microparticles comprises 90-98% w/w of crystalline drug core and 2-10% w/w of polymeric shell.

5 . An extended release formulation comprising a plurality of microparticles having a core/shell morphology and been heat-treated at 210-230° C. for at least one hour, wherein each microparticle includes: (1) a crystalline drug core of more than 70% by weight of the microparticle, wherein the crystalline drug core consists of one or more crystals of fluticasone, a salt or ester thereof; and (2) a polymeric shell encapsulating the crystalline drug core, whereby the polymeric shell is PVA and is in contact but immiscible with the crystalline drug core, wherein said plurality of microparticles have a mean diameter of between 80 μm and 150 μm.

6 . The extended release formulation according to claim 5 , wherein the fluticasone, salt or ester thereof is selected from fluticasone, fluticasone furoate, and fluticasone propionate.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 13, 2026
From: HELLIWELL, JAMES A.; MALONE, AMANDA M.; SMITH, THOMAS J.; BAUM, MARC M.
To: EUPRAXIA PHARMACEUTICALS USA LLC
Reel/Frame 074651/0513 →
RELEASE OF SECURITY INTEREST Recorded Apr 4, 2025
From: YABEMA CAPITAL LIMITED
To: EUPRAXIA PHARMACEUTICALS INC.; EUPRAXIA PHARMACEUTICALS USA, LLC
Reel/Frame 070732/0043 →
SECURITY INTEREST Recorded Aug 8, 2024
From: EUPRAXIA PHARMACEUTICALS INC.; EUPRAXIA PHARMACEUTICALS USA, LLC
To: YABEMA CAPITAL LIMITED
Reel/Frame 068229/0087 →
Continuity (4)
Continuation 15975577 · May 9, 2018
Division 14222082 · Mar 21, 2014
Provisional Application 61804185 · Mar 21, 2013
Related Publication 20220087943A1 · Mar 24, 2022
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