	US 11,730,728 B2
	Atropine pharmaceutical compositions
Irfan A. Mohammed, Cherry Hill, NJ (US); Tushar Hingorani, Bridgewater, NJ (US); and Kumaresh Soppimath, Skillman, NJ (US)
Assigned to VYLUMA INC., Bridgewater, NJ (US)
Filed by VYLUMA INC., Bridgewater, NJ (US)
Filed on Aug. 31, 2020, as Appl. No. 17/7,900.
Application 17/007,900 is a division of application No. 16/280,552, filed on Feb. 20, 2019, granted, now 11,071,732.
Application 16/280,552 is a division of application No. 15/976,279, filed on May 10, 2018, granted, now 10,251,875, issued on Apr. 9, 2019.
Claims priority of provisional application 62/505,027, filed on May 11, 2017.
Prior Publication US 2020/0397776 A1, Dec. 24, 2020
Int. Cl. A61K 31/46 (2006.01); A61K 9/00 (2006.01); A61K 47/38 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2017.01); A61K 9/08 (2006.01)

CPC A61K 31/46 (2013.01) [A61K 9/0048 (2013.01); A61K 9/08 (2013.01); A61K 47/02 (2013.01); A61K 47/183 (2013.01); A61K 47/38 (2013.01)]

22 Claims

1. A storage-stable preservative-free ophthalmic atropine composition, comprising:

an aqueous solution comprising low-dose atropine or a pharmaceutically acceptable salt thereof, a low-strength buffer, a tonicity agent other than a pharmaceutically acceptable salt, and a cellulosic viscosity modifier;

wherein the low-strength buffer has a concentration of equal or less than 50 mM, and wherein the low-dose atropine or pharmaceutically acceptable salt thereof is present at a concentration of equal or less than 0.05 wt %;

wherein the ophthalmic atropine composition contains not more than 0.01 wt % of a preservative;

wherein the ophthalmic atropine composition has a pH of between 5.0 and 6.0; and

wherein the ophthalmic atropine composition, after storage for two months at 25° C. and 60% relative humidity, contains equal or less than 0.35% tropic acid formed from degradation of the atropine.