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US 9,867,840 B2Granted
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 complex regional pain syndrome comprising orally administering a dosage form to a human being in need thereof, wherein the dosage form comprises:
- a) zoledronic acid which is free of Ion 1 and Ion 2;
- or
- b) one of the following:
- 1) zoledronic acid and
- in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w;
- or
- 2) zoledronic acid and
- in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w;
- or
- 3) zoledronic acid and a combination of Ion 1 in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w, and Ion 2 in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w;
- wherein the dosage form is free of therapeutically active agents that are not zoledronic acid in a salt form or in an acid form, Ion 1 in a salt form, or Ion 2 in a salt form;
- wherein any amount in % w/w is based upon the total weight of zoledronic acid, Ion 1, Ion 2, and any corresponding counter ions;
- wherein the bioavailability of zoledronic acid in the dosage form to the human being is about 1.1% to 2.4%;
- and
- wherein oral administration of the dosage form to the human being in a fasted state results in an area under the plasma concentration curve (AUC) of zoledronic acid of about 50 ng·hr/mL to about 500 ng·hr/mL, measured over a 24-hour period.
12 more elements
A dosage form comprising:
- a) zoledronic acid which is free of Ion 1 and Ion 2;
- or
- b) one of the following:
- 1) zoledronic acid and
- in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w;
- or
- 2) zoledronic acid and
- in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w;
- or
- 3) zoledronic acid and a combination of Ion 1 in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w, and Ion 2 in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w;
- wherein the dosage form is free of therapeutically active agents that are not zoledronic acid in a salt form or in an acid form, Ion 1 in a salt form, or Ion 2 in a salt form;
- wherein any amount in % w/w is based upon the total weight of zoledronic acid, Ion 1, Ion 2, and any corresponding counter ions;
- wherein the bioavailability of zoledronic acid in the dosage form to a human being is about 1.1% to 2.4%;
- and
- wherein oral administration of the dosage form to the human being in a fasted state results in an area under the plasma concentration curve (AUC) of zoledronic acid of about 50 ng·hr/mL to about 500 ng·hr/mL, measured over a 24-hour period.
12 more elements
Dependencies are inferred from the claim text.