US 11,911,400 B1
In-vial deposition of a stable, sterile and crystalline O-acetyl salicylic acid (aspirin)
Nagesh R. Palepu, Southampton, PA (US)
Assigned to RHOSHAN PHARMACEUTICALS, INC., Glen Mills, PA (US)
Filed by RHOSHAN PHARMACEUTICALS, INC., Glen Mills, PA (US)
Filed on Mar. 17, 2021, as Appl. No. 17/204,559.
Application 17/204,559 is a division of application No. 16/698,386, filed on Nov. 27, 2019, granted, now 10,959,955.
Application 16/698,386 is a continuation in part of application No. PCT/US2018/034866, filed on May 29, 2018.
Claims priority of provisional application 62/512,367, filed on May 30, 2017.
Int. Cl. A61K 31/616 (2006.01); A61K 9/00 (2006.01); A61K 47/26 (2006.01); A61K 9/19 (2006.01)
CPC A61K 31/616 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0024 (2013.01); A61K 9/19 (2013.01); A61K 47/26 (2013.01)] 27 Claims
OG exemplary drawing
 
1. A method of providing aspirin therapy, comprising:
a) providing a lyophilized mixture comprising crystalline aspirin in free acid form, a bulking agent and a surfactant, wherein the lyophilized mixture is made without adding any basifying agent;
b) reconstituting the lyophilized mixture with water containing a basifying agent present in an amount sufficient to provide the resultant aspirin solution with a pH of at least about 5.5, wherein the water containing the basifying agent is separate from the crystalline aspirin prior to reconstituting; and
c) parenterally administering an effective amount of the aspirin solution resulting from step b) to a mammal in need thereof.