Solid forms of treprostinil
AssigneeUnited Therapeutics Corporation
InventorsKen Phares, Michael Scannell
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Abstract
There is provided individual polymorphic forms of treprostinil and pharmaceutical formulations comprising the same, methods of making and using the same
Claims29
A crystalline treprostinil monohydrate Form A, characterized by an X-ray powder diffractogram comprising the following peaks:
- 11.6, 16.2, and 20.0 °2θ±0.2 °2θ, as determined on a diffractometer using Cu-Kα radiation at a wavelength of 1.54059 Å and having a purity of at least 90% aside from residual solvents.
A crystalline treprostinil monohydrate Form B, characterized by an X-ray powder diffractogram comprising the following peaks:
- 5.9, 12.1, and 24.4 °2θ±0.2 °2θ, as determined on a diffractometer using Cu-Kα radiation at a wavelength of 1.54059 Åhaving a purity of at least 90% aside from residual solvents.
A composition comprising substantially one form of treprostinil monohydrate Form A or treprostinil monohydrate Form B.
A pharmaceutical formulation comprising a therapeutically effective amount of treprostinil monohydrate Form A or treprostinil monohydrate Form B and a pharmaceutically acceptable carrier.
A method of treating a medical condition, comprising administering to a subject in need thereof a pharmaceutical formulation which comprises a therapeutically effective amount of treprostinil monohydrate Form A or treprostinil monohydrate Form B, wherein the medical condition is selected from the group consisting of pulmonary hypertension, congestive heart failure, peripheral vascular disease, severe intermittent claudication, immunosuppression, proliferative diseases, asthma, lung cancer, liver cancer, brain cancer, pancreatic cancer, kidney cancer, prostate cancer, breast cancer, colon cancer, head-neck cancer, ischemic lesions, neuropathic foot ulcers, pulmonary fibrosis, interstitial lung disease and a disease or condition that causes kidney malfunction or failure.
A treprostinil Form C, characterized by an X-ray powder diffractogram comprising the following peak:
- 6.55 °2θ±0.2 °2θ, as determined on a diffractometer using Cu-Kα radiation at a wavelength of 1.54059 Åhaving a purity of at least 90% aside from residual solvents.
Dependencies are inferred from the claim text.