US 12,465,593 B2
Pharmaceutical composition
Nicola Frances Bateman, Macclesfield (GB); Paul Richard Gellert, Macclesfield (GB); and Kathryn Jane Hill, Macclesfield (GB)
Assigned to AstraZeneca AB, Söderatälje (SE); and Array BioPharma, Inc., Boulder, CO (US)
Filed by ASTRAZENECA AB, Södertälje (SE); and Array BioPharma, Inc., Boulder, CO (US)
Filed on Oct. 10, 2023, as Appl. No. 18/484,337.
Application 18/484,337 is a division of application No. 17/313,312, filed on May 6, 2021, granted, now 11,813,246.
Application 17/313,312 is a continuation of application No. 16/597,237, filed on Oct. 9, 2019, abandoned.
Application 16/597,237 is a continuation of application No. 16/023,102, filed on Jun. 29, 2018, abandoned.
Application 16/023,102 is a continuation of application No. 15/348,053, filed on Nov. 10, 2016, abandoned.
Application 15/348,053 is a continuation of application No. 14/884,343, filed on Oct. 15, 2015, abandoned.
Application 14/884,343 is a continuation of application No. 13/747,853, filed on Jan. 23, 2013, abandoned.
Application 13/747,853 is a continuation of application No. 13/293,368, filed on Nov. 10, 2011, abandoned.
Application 13/293,368 is a continuation of application No. 12/411,865, filed on Mar. 26, 2009, abandoned.
Claims priority of provisional application 61/040,372, filed on Mar. 28, 2008.
Prior Publication US 2024/0041835 A1, Feb. 8, 2024
Int. Cl. A61K 31/4184 (2006.01); A61K 9/00 (2006.01); A61K 9/14 (2006.01); A61K 9/48 (2006.01); A61K 47/22 (2006.01); A61K 47/36 (2006.01); C07D 235/06 (2006.01)
CPC A61K 31/4184 (2013.01) [A61K 9/0053 (2013.01); A61K 9/145 (2013.01); A61K 9/146 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 47/22 (2013.01); A61K 47/36 (2013.01); C07D 235/06 (2013.01)] 4 Claims
 
1. A process for stabilizing a hydrogen sulphate salt of 6-(4-bromo-2-chlorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)amide against dissociation into its free base form, the process comprising:
dispersing a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide into a carrier matrix consisting of Vitamin E TPGS, in order to obtain a homogenous mixture of finely divided particles that are dispersed throughout the carrier matrix, wherein the homogenous mixture is semi-solid or solid at ambient temperature and consists of:
(i) about 15 to about 25 parts of a hydrogen sulphate salt of 6-(4-bromo-2-chlorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)amide; and
(ii) about 75 to about 85 parts of Vitamin E TPGS;
wherein both parts are by weight and the sum of the parts (i)+(ii)=100.