US 12,311,027 B2
Pharmaceutical compositions having improved storage stability
Jason M. Perry, Cambridge, MA (US); Daniel R. Deaver, Franklin, MA (US); Magali B. Hickey, Westwood, MA (US); Julius F. Remenar, Framingham, MA (US); Jennifer Vandiver, Arlington, MA (US); Michael J. Palmieri, Jr., Hopkington, MA (US); and Zhengzheng Pan, Arlington, MA (US)
Assigned to Alkermes Pharma Ireland Limited, Dublin (IE)
Filed by ALKERMES PHARMA IRELAND LIMITED, Dublin (IE)
Filed on Mar. 27, 2024, as Appl. No. 18/618,311.
Application 15/705,237 is a division of application No. 14/882,069, filed on Oct. 13, 2015, granted, now 9,861,699, issued on Jan. 9, 2018.
Application 14/882,069 is a division of application No. 14/031,842, filed on Sep. 19, 2013, granted, now 9,193,685, issued on Nov. 24, 2015.
Application 18/618,311 is a continuation of application No. 17/398,801, filed on Aug. 10, 2021, granted, now 11,969,469.
Application 17/398,801 is a continuation of application No. 16/834,565, filed on Mar. 30, 2020, granted, now 11,097,006, issued on Aug. 24, 2021.
Application 16/834,565 is a continuation of application No. 16/425,150, filed on May 29, 2019, granted, now 10,639,376, issued on May 5, 2020.
Application 16/425,150 is a continuation of application No. 15/705,237, filed on Sep. 14, 2017, granted, now 10,342,877, issued on Jul. 9, 2019.
Claims priority of provisional application 61/780,862, filed on Mar. 13, 2013.
Claims priority of provisional application 61/702,881, filed on Sep. 19, 2012.
Prior Publication US 2024/0307542 A1, Sep. 19, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. C07D 215/227 (2006.01); A61K 9/00 (2006.01); A61K 9/10 (2006.01); A61K 31/496 (2006.01); A61K 31/5513 (2006.01); A61K 47/26 (2006.01)
CPC A61K 47/26 (2013.01) [A61K 9/0019 (2013.01); A61K 9/10 (2013.01); A61K 31/496 (2013.01); A61K 31/5513 (2013.01); C07D 215/227 (2013.01)] 15 Claims
 
1. A pharmaceutical composition comprising:
(a) Compound 1

OG Complex Work Unit Chemistry
(b) sorbitan laurate;
(c) polysorbate 20; and
(d) an aqueous vehicle;
wherein the pharmaceutical composition comprises less than 10 parts per million of a hydrolysis product of Compound 1; and
wherein the ratio of components (b) to (c) is approximately 5 to 2, by weight.