US 12,403,148 B2
PH stabilized ophthalmic compositions
Thorsteinn Loftsson, Reykjavik (IS); and Zoltán Fülöp, Budapest (HU)
Assigned to Oculis Operations Sàrl, Lausanne (CH)
Filed by Oculis Operations Sarl, Lausanne (CH)
Filed on Sep. 23, 2024, as Appl. No. 18/893,810.
Application 18/893,810 is a continuation of application No. 17/624,311, granted, now 12,097,209, previously published as PCT/EP2020/068398, filed on Jun. 30, 2020.
Claims priority of application No. 19183719 (EP), filed on Jul. 1, 2019; and application No. 20174202 (EP), filed on May 12, 2020.
Prior Publication US 2025/0009762 A1, Jan. 9, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/573 (2006.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/20 (2006.01); A61K 47/40 (2006.01); A61P 27/02 (2006.01); A61P 29/00 (2006.01)
CPC A61K 31/573 (2013.01) [A61K 9/0048 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/20 (2013.01); A61K 47/40 (2013.01); A61P 27/02 (2018.01); A61P 29/00 (2018.01)] 23 Claims
 
1. An aqueous ophthalmic composition comprising:
i) between 1% and 4% weight to volume (w/v) of dexamethasone;
ii) between 5% and 25% w/v of γ-cyclodextrin;
iii) between 0.05% and 1% w/v of sodium thiosulfate; and,
iv) water;
wherein the aqueous ophthalmic composition comprises a microsuspension comprising solid complexes of dexamethasone and γ-cyclodextrin;
wherein the aqueous ophthalmic composition is in a container made of plastic that allows oxidation of its contents; and,
wherein the aqueous ophthalmic composition has a pH of between 4.5 and 6.