Dosage forms of halofuginone and methods of use
AssigneeHalo Therapeutics
InventorsErnest D. Bush, Diane Mcguire, Marc B. Blaustein
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Abstract
Oral and parenteral dosage forms comprising halofuginone, including enteric-coated solid oral dosage forms, subcutaneous dosage forms and intravenous dosage forms, for administration to subjects in need thereof, e.g., subjects having been identified with musculoskeletal disorders, fibrotic diseases, malaria, or cancer are described herein.
Claims24
An oral dosage form comprising halofuginone, or a pharmaceutically acceptable salt thereof, e.g., halofuginone hydrobromide, dissolvable in a basic solution (e.g., pH greater than 6.8, greater than 8, greater than 8.5), wherein not more than 10% of the oral dosage form dissolves in an acidic solution (e.g., pH less than 6.8, less than 6, less than 5, less than 4, less than 3).
(canceled)
A method of treating a disorder in a patient in need thereof, the method comprising administering an enteric-coated oral dosage form comprising 0.01 to 10 mg of halofuginone, or a pharmaceutically acceptable salt thereof, e.g., halofuginone hydrobromide, to thereby treat the disorder.
13-23. (canceled)
An enteric-coated oral dosage form comprising halofuginone, or a pharmaceutically acceptable salt thereof, e.g., halofuginone hydrobromide, for use in treating a subject having been identified with a musculoskeletal disorder.
(canceled)
An oral dosage form comprising halofuginone, or a pharmaceutically acceptable salt thereof, e.g., halofuginone hydrobromide, for administration to a subject at a dose of at least 0.05 mg halofuginone per kilogram of subject weight, wherein the subject does not experience gastrointestinal distress (e.g., nausea, vomiting, pain) within eight hours (e.g., within six hours, e.g., within four hours, e.g., within two hours, e.g., within one hour) of administration.
34-44. (canceled)
Dependencies are inferred from the claim text.