US 12,268,684 B2
Pharmaceutical composition for nasal delivery
Jonas Sävmarker, Uppsala (SE); Robert Rönn, Uppsala (SE); and Andreas Fischer, Uppsala (SE)
Assigned to OREXO AB, Uppsala (SE)
Filed by Orexo AB, Uppsala (SE)
Filed on Dec. 18, 2023, as Appl. No. 18/542,954.
Application 18/542,954 is a continuation of application No. 17/172,635, filed on Feb. 10, 2021, granted, now 11,883,392.
Application 17/172,635 is a continuation of application No. 16/939,717, filed on Jul. 27, 2020, abandoned.
Application 16/939,717 is a continuation of application No. 16/876,468, filed on May 18, 2020, granted, now 10,729,687, issued on Aug. 4, 2020.
Application 16/876,468 is a continuation in part of application No. 16/506,023, filed on Jul. 9, 2019, granted, now 10,653,690, issued on May 19, 2020.
Prior Publication US 2024/0252485 A1, Aug. 1, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/33 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 31/485 (2006.01)
CPC A61K 31/485 (2013.01) [A61K 9/0043 (2013.01); A61K 9/1652 (2013.01); A61K 9/1682 (2013.01)] 35 Claims
 
1. A solid pharmaceutical composition in the form of a spray-dried powder comprising:
a pharmacologically-effective amount of nalmefene or a pharmaceutically-acceptable salt thereof; and
a pharmaceutically-acceptable carrier material comprising a combination of:
(i) a disaccharide selected from the group consisting of maltitol, trehalose, sucralose, sucrose, isomalt, maltose, and lactose; and
(ii) a dextrin;
wherein the composition is essentially free of water and is suitable for nasal delivery of nalmefene or the pharmaceutically-acceptable salt thereof, and the nalmefene or pharmaceutically-acceptable salt thereof is less than about 15% chemically degraded after storage for 3 months at 75% relative humidity and 40° C.