Combination therapy with p38 MAP kinase inhibitors and their pharmaceutical compositions
AssigneesBoehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim France
InventorsStefan Simianer, Pascal Bilbault, Michael L. Cappola, Susan Lynn Way
Life of this patent
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Abstract
The present invention relates to pharmaceutical combinations therapies based on p38 kinase inhibitors and another active ingredient, pharmaceutical compositions comprising such combinations, processes for preparing them and their use in the treatment of cytokine mediated diseases.
Claims17
A pharmaceutical composition comprising one or more active ingredients A together with one or more p38 kinase inhibitor B, optionally combined with conventional excipients and/or carriers,
- wherein A is chosen from one or more NSAIDs, immunosuppressive drugs, immunomodulatory drugs, cytostatic drugs, angiogenesis inhibitors, biological agents, steroids, vitamin D3 analogs, retinoinds and inhibitors of cell adhesion molecules chosen from LFA-1 and ICAM-1;
- and wherein B is chosen from
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- or the pharmaceutically acceptable salts thereof.
A pharmaceutical composition comprising an active ingredients A together with one or more p38 kinase inhibitor B, optionally combined with conventional excipients and/or carriers,
- wherein A is chosen from budesonide, Vitamin D, 5-ASA drugs, glucocorticosteroids glucocorticosteroids chosen from betamethasone, dexamethasone, methylprednisolone, prednisolone and deflazacort, retinoids, methotrexate, pimecrolimus, tacrolimus, ascomycine, daclizumab, anti-CD4, anti CD80, anti-CD25, peptide T, LFA3TIP, DAB389, anti LFA3-IgC1, CTLA-4Ig, E-selectin inhibitors, alefacept, infliximab, etanercept, efalizumab, macrolids, ICAM-1 ISIS 2302, ISIS 8 (anti ICAM 1), DAB IL-2, DAB389 IL-2, basiliximab, hydroxychloroquine, D-penicillamine, sulfasalazine, auranofin, gold sodium thiomalate, minocycline, dapsone, chlorambucil, mercaptopurine, tacrolimus, sirolimus, mycophenolate mofetil, leflunomide, cyclophosphamide, compounds directed against VEGF, taxol, pentoxyfylline, thalidomide, interferon beta-1B and alpha-interferon, Adalimumab (D2E7), CDP 571, and Ro 45-2081 (Lenercept), with IL-1 receptor antagonists, NSAIDs chosen from acetaminophen, aspirin, ibuprofen, choline magnesium salicylate, choline salicylate, diclofenac, diflunisal, etodolac, fenoprofen calcium, flurbiprofen, indomethacin, ketoprofen, carprofen, indoprofen, ketorolac tromethamine, magnesium salicylate, meclofenamate sodium, mefenamic acid, oxaprozin, piroxicam, sodium salicylate, sulindac, tolmetin, meloxicam, rofecoxib, celecoxib, etoricoxib, valdecoxib, nabumetone, naproxen, lornoxicam, nimesulide, indoprofen, remifenzone, salsalate, tiaprofenic acid, flosulide,
- and wherein B is chosen from
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- or the pharmaceutically acceptable salts thereof.
A pharmaceutical composition comprising BIRB 796 BS, Lactose Monohydrate, Povidone K30, Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon Dioxide and Magnesium Stearate, wherein the amount of each is chosen from:
- 3 Ingredients mg mg mg mg mg mg BIRB 796 5 20 25 50 100 200 BS Tablets Lactose 55.000 40.000 50.000 100.000 200.000 400.000 Monohydrate Povidone 3.1600 3.158 3.9475 7.8950 15.790 31.580 K30 Micro- 30.000 30.000 37.500 75.000 150.000 300.000 crystalline Cellulose Pregelatin- 3.590 3.592 4.490 8.980 17.960 35.920 ized Starch Sodium 2.000 2.000 2.500 5.000 10.000 20.000 Starch Glycolate Colloidal 0.500 0.500 0.625 1.250 2.500 5.000 Silicon Dioxide and Magnesium 0.750 0.750 0.9375 1.875 3.750 7.500 Stearate.
A method of treating rheumatoid arthritis comprising administering to a patient in need thereof a therapeutically effective amount of a composition comprising one or more active ingredient A together with one or more p38 kinase inhibitor B, optionally combined with conventional excipients and/or carriers,
- wherein A is chosen from one or more NSAIDs, immunosuppressive drugs, immunomodulatory drugs, cytostatic drugs, angiogenesis inhibitors, biological agents, glucocorticosteroids and inhibitors of cell adhesion molecules chosen from LFA-1 and ICAM-1;
- and wherein B is chosen from
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- or the pharmaceutically acceptable salts thereof.
A method of treating psoriasis comprising administering to a patient in need thereof a therapeutically effective amount of a composition comprising one or more active ingredient A together with one or more p38 kinase inhibitor B, optionally combined with conventional excipients and/or carriers,
- wherein A is chosen from one or more retinoids, immunosuppressive drugs, immunomodulatory drugs, biological agents, steroids, Vitamin D analogs and inhibitors of cell adhesion molecules, or A is a therapy chosen from ultraviolet B (UVB), psoralens ultraviolet A (PUVA) each optionally administered with retinoids, methotrexate or cyclosporin+retinoids;
- and wherein B is chosen from
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- or the pharmaceutically acceptable salts thereof.
A method of treating Crohn's disease comprising administering to a patient in need thereof a therapeutically effective amount of a composition comprising one or more active ingredient A together with one or more p38 kinase inhibitor B, optionally combined with conventional excipients and/or carriers,
- wherein A is chosen from one or more steroids, 5-ASA drugs, immunosuppressants, antivirals, biological agents and adhesion molecule inhibitors;
- and wherein B is chosen from
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- or the pharmaceutically acceptable salts thereof.
Dependencies are inferred from the claim text.