Formulations of a compound modulating kinases
AssigneesPlexxikon Inc., Daiichi Sankyo Company, Limited
InventorsPrabha N. Ibrahim, Hamid Rezaei, Gary Conard Visor, Tomoari Kamo, Hiroshi Yamakose
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Abstract
Provided are compositions comprising Compound I having the following structure: or a pharmaceutically acceptable salt thereof, and a solubilizing agent; methods of making the same; and methods of using the same.
Claims32
A method for treating a subject suffering from or at risk of a disease or condition mediated by a protein kinase selected from c-fms, c-kit, Flt3 or combinations thereof and/or macrophages or microglia, comprising administering to the subject a therapeutically effective amount of a composition comprising:
- 40% to 60% W/W of Compound I having the following structure:
- and wherein Compound I is a crystalline HCl salt characterized by an X-ray powder diffractogram comprising peaks (±0.2°) at 7.3, 23.3 and 28.2°2θ as determined on a diffractometer using Cu-Kα radiation;
- 20% to 35% W/W of a poloxamer;
- 10% to 22% W/W of an excipient;
- 1% to 5% W/W of a disintegrant;
- and 0.5% to 3% W/W of a lubricant;
- and wherein the disease or condition is selected from osteoporosis, neurofibromatosis, Alzheimer's disease, progressive supranuclear palsy, epilepsy, brain trauma, tauopathies, non-small cell lung cancer, anterior eye disease, posterior eye disease, lysosomal storage disease, multiple sclerosis, neuro-inflammation, neuroinflammatory disorders, complex regional pain syndrome, binswager type dementia, dementia with lewy bodies, vascular dementias, multi infarct dementia, fronto temporal dementia, pseudo-dementia, HIV, cerebral palsy, glaucoma, bladder cancer, ovarian cancer, prostate cancer, pancreatic cancer, colorectal cancer, acute myeloid leukemia, chronic lymphocytic leukemia, monocytic leukemia, breast cancer, cholangiocarcinoma, endometrial cancer, esophageal cancer, glioma, glioblastoma, giant cell tumors, hepatocellular carcinoma, Hodgkin lymphoma, melanoma, mesothelioma, renal cell carcinoma, malignant peripheral nerve sheath tumors (MPNST), plexiform neurofibromas, salivary gland tumors, gastrointestinal stromal tumors (GIST), pigmented villonodular synovitis (PVNS), tenosynovial giant cell tumor (TGCT), giant cell tumors of the tendon sheath (GCT-TS), schizophrenia, catatonia, brain calcification, retinitis pigmentosa, and chronic traumatic encephalopathy.
The method of 1, said method further comprising administering to the subject a PD-L1 inhibitor, a PD-1 inhibitor, an IDO inhibitor, a monoclonal antibody, or a FLT3 kinase inhibitor.
Dependencies are inferred from the claim text.