	US 12,433,900 B2
	Intravitreal corticosteroid extended release implant and methods of use
Andres Garcia, Chapel Hill, NC (US); and Xunpei Liu, Chapel Hill, NC (US)
Assigned to Eyedea Bio, LLC, Chapel Hill, NC (US)
Appl. No. 18/711,575
Filed by Eyedea Bio, LLC, Chapel Hill, NC (US)
PCT Filed Nov. 18, 2022, PCT No. PCT/US2022/080164 § 371(c)(1), (2) Date May 17, 2024, PCT Pub. No. WO2023/092087, PCT Pub. Date May 25, 2023.
Claims priority of provisional application 63/281,052, filed on Nov. 18, 2021.
Prior Publication US 2024/0415850 A1, Dec. 19, 2024
Int. Cl. A61K 31/573 (2006.01); A61K 9/00 (2006.01); A61K 9/10 (2006.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/22 (2006.01); A61K 47/34 (2017.01)

CPC A61K 31/573 (2013.01) [A61K 9/0048 (2013.01); A61K 9/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/22 (2013.01); A61K 47/34 (2013.01)]

17 Claims

1. A multiphasic colloidal suspension composition, the composition comprising: a corticosteroid drug substance and one or more complexation agents, admixed in a dispersal medium so that the corticosteroid drug substance has a release profile having one or more phases of release of the corticosteroid drug substance into the extracellular environment, wherein the one or more complexation agents is formulated as an irregular-shaped particulate having a Braunauer-Emmett-Teller (BET) surface area greater than about 2.0 m²g⁻¹that forms corticosteroid drug substance-complex particulates by noncovalent, reversible binding to the corticosteroid drug substance, and wherein the one or more complexation agents comprises magnesium stearate and a tocopherol compound or calcium stearate and a tocopherol compound; wherein the corticosteroid drug substance is any of: fluocinolone, fluocinolone acetonide, dexamethasone, dexamethasone phosphate, dexamethasone sodium phosphate, triamcinolone, and triamcinolone acetonide, or a salt thereof; further wherein the dispersal medium is a fatty acid methyl esters.