US 12,274,706 B2
Pharmaceutical composition for oral administration containing sulfasalazine and/or a sulfasalazine organic salt, production process and use
Marguerite Mensonides-Harsema, Houston, TX (US); Sebastian Bialleck, Wedel (DE); and Sonja Schuldt-Lieb, Wedel (DE)
Assigned to MEDAC GESELLSCHAFT FUER KLINISCHE, (DE)
Filed by MEDAC GESELLSCHAFT FUER KLINISCHE SPEZIALPRAEPARATE MBH, Wedel (DE)
Filed on May 23, 2023, as Appl. No. 18/201,106.
Application 18/201,106 is a division of application No. 16/766,665, granted, now 11,690,857, previously published as PCT/EP2018/082331, filed on Nov. 23, 2018.
Claims priority of application No. 17203276 (EP), filed on Nov. 23, 2017.
Prior Publication US 2023/0381203 A1, Nov. 30, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/655 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 9/28 (2006.01); A61K 9/48 (2006.01); A61K 9/50 (2006.01); A61K 31/192 (2006.01); A61K 31/405 (2006.01); A61K 31/415 (2006.01); A61K 31/42 (2006.01); A61K 31/519 (2006.01); A61K 31/5415 (2006.01); A61K 31/58 (2006.01); A61K 31/616 (2006.01); A61K 33/242 (2019.01); A61K 39/395 (2006.01)
CPC A61K 31/655 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2095 (2013.01); A61K 9/2886 (2013.01); A61K 9/2893 (2013.01); A61K 9/4808 (2013.01); A61K 9/4833 (2013.01); A61K 9/5089 (2013.01); A61K 31/192 (2013.01); A61K 31/405 (2013.01); A61K 31/415 (2013.01); A61K 31/42 (2013.01); A61K 31/519 (2013.01); A61K 31/5415 (2013.01); A61K 31/58 (2013.01); A61K 31/616 (2013.01); A61K 33/242 (2019.01); A61K 39/3955 (2013.01)] 14 Claims
 
1. A pharmaceutical composition for oral administration comprising:
(I) 2-hydroxy-5-[2-[4-[(2-pyridinylamino)sulfonyl]phenyl]diazenyl]-benzoic acid (sulfasalazine) and/or as sulfasalazine organic salt, the process comprising of the following steps:
A: Providing sulfasalazine,
B: Providing an organic amine containing constituent;
C: Providing one or more pharmaceutical excipients and optionally one or more further active ingredients,
D: Mixing a therapeutically effective amount of sulfasalazine of step A) with a suitable amount of the organic amine containing constituent of step B) and the one or more pharmaceutical excipients and optionally one or more further active ingredient of step C) to form the pharmaceutical composition for oral administration,
wherein the organic amine containing constituent does not represent Tris(hydroxymethyl)aminomethane, and
(II) one or more active ingredients of the further pharmaceutical compositions are selected from the group consisting of a non-steriodal anti-inflammatory agents; a non-selective cyclo-oxygenase COX-1/COX-2 inhibitor a propionic acid, a fenamate, indomethacin, sulindac, ayapropayone, a pyrayoleone, a salicylate, a selective COX-2 inhibitor, a cyclo-oxygenase inhibiting nitric oxide donor (CINODs); glucocorticoid, triamcinolone acetonide, betamethasone dipropionate, budesonide, fluticasone propionate, ciclesonide or mometasone furoate; methotrexate; leflunomide; hydroxychloroquine; d-penicillamine; diacerein; a nutritional supplement; a gold preparation; a cytokine or agonist or antagonist of cytokine function; a monoclonal antibody targeting B-Lymphocyte; MRA-aIL16R; a T-lymphocyte; CTLA4-Ig; HuMax 11-15; a modulator of chemokine receptor function; azathioprine, tofacitinib, a monoclonal antibodie and an interleukin 1 receptor antagonist.