Compositions for oral administration of zoledronic acid or related compounds for treating complex regional pain syndrome
AssigneeAntecip Bioventures II LLC
InventorHerriot Tabuteau
Life of this patent
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Abstract
Oral dosage forms of osteoclast inhibitors, such as zoledronic acid, in an acid or a salt form can be used to treat or alleviate pain or related conditions, such as complex regional pain syndrome.
Claims30
A method of treating pain associated with complex regional pain syndrome comprising orally administering a dosage form comprising zoledronic acid to a human being suffering from complex regional pain syndrome incited by a fracture;
- wherein the dosage form is administered 2, 3, or 4 times within a period of about one month so that a total of about 200 mg/m2 to about 400 mg/m2 of the zoledronic acid is administered to the human being;
- wherein an AUC of zoledronic acid in the human being, measured over a period of one month from the first time the dosage form is orally administered, is about 500 ng·h/mL to about 1000 ng·h/mL;
- wherein the dosage form provides a bioavailability of zoledronic acid of about 1.1% to about 1.8% to the human being;
- wherein the human being fasts for at least one hour before the zoledronic acid is orally administered and for at least one hour after the zoledronic acid is orally administered;
- and
- wherein the human being remains upright for at least about 30 minutes after the zoledronic acid is orally administered.
A method of treating pain associated with complex regional pain syndrome comprising orally administering a dosage form to a human being suffering from complex regional pain syndrome incited by a fracture;
- wherein the dosage form is prepared by a method comprising combining 1) about 40 mg to about 200 mg of zoledronic acid with 2) an excipient, a disintegrating agent, a diluent, a binder, a lubricant, a flavoring agent, a coating, a capsule, or a combination thereof;
- wherein the dosage form is orally administered 2 to 9 times at an interval that is at least about once weekly;
- and
- wherein, beginning when the dosage form is first orally administered, an AUC of zoledronic acid in the human being, measured over a period of one month, is about 500 ng·h/mL to about 1000 ng·h/mL;
- wherein the dosage form provides a bioavailability of zoledronic acid of about 1% to about 3% to the human being;
- wherein the human being fasts for at least about two hours before the zoledronic acid is orally administered and for at least one hour after the zoledronic acid is orally administered;
- and
- wherein the human being remains upright for at least about one hour after the zoledronic acid is orally administered.
A method of treating pain associated with complex regional pain syndrome comprising orally administering a dosage form comprising zoledronic acid in an acid form or a salt form to a human being suffering from complex regional pain syndrome precipitated by a fracture;
- wherein an AUC of zoledronic acid in the human being, measured over a period of one month, is about 500 ng·h/mL to about 1000 ng·h/mL;
- wherein the bioavailability of zoledronic acid in the dosage form is about 1.1% to about 1.5%, as determined when orally administered to a human being who has fasted for eight hours;
- wherein the human being has an average weekly pain intensity of at least 4, on the 0-10 numeric rating scale, prior to receiving the zoledronic acid;
- wherein the human being fasts for at least 30 minutes before the zoledronic acid is orally administered and for at least 30 minutes after the zoledronic acid is orally administered;
- and
- wherein the human being remains upright for at least about 30 minutes after the zoledronic acid is orally administered.
Dependencies are inferred from the claim text.