Stabilized formulation of parathyroid hormone
The invention relates to PTH formulations in which the PTH is present with at least one divalent cation effective to stabilize the PTH.
1 . An injectable formulation comprising parathyroid hormone, an aqueous vehicle, and at least one divalent cation in an amount effective to stabilize the parathyroid hormone.
2 . The injectable formulation according to claim 1 , wherein the divalent cation is cationic magnesium, zinc, or a combination thereof.
3 . The injectable formulation according to claim 1 , wherein the divalent cation is present as a zinc chloride salt.
4 . The injectable formulation according to claim 1 , wherein the divalent cation is present at a concentration within the range from about 10 to about 50 mM.
5 . The injectable formulation according to claim 4 , wherein the divalent cation is present at a concentration within the range from about 20 to about 40 mM
6 . The injectable formulation according to claim 1 , wherein the PTH is present in a unit dose.
7 . The injectable formulation according to claim 1 , wherein the PTH is present in amount effective for administration of more than one unit dose.
8 . A lyophilized formulation which, upon reconstitution in an aqueous vehicle, produces an injectable formulation according to claim 1 .
9 . A device for use in delivering a drug by injection, the device comprising a lyophilized formulation of the injectable formulation according to claim 7 , and an aqueous vehicle for reconstituting the lyophilized formulation.
10 . A device for use in delivering a drug by injection, the device comprising a lyophilized formulation according to claim 8 , and an aqueous vehicle for reconstituting the lyophilized formulation.
11 . A PTH formulation comprising an aqueous vehicle, PTH at a concentration within the range from about 1 mg/mL to about 2 mg/mL and zinc chloride at a concentration in the range from about 20 to about 40 mM.
12 . A process for preparing a formulation comprising stabilized PTH, comprising the step of combining PTH, an amount of at least one divalent cation effective to stabilize said PTH, and water.
13 . A process for preparing an injectable formulation comprising stabilized PTH, comprising the step of reconstituting, in an aqueous vehicle, a lyophilized preparation comprising PTH and at least one divalent cation in an amount effective to stabilize the reconstituted PTH.
14 . A process for preparing an injectable formulation comprising stabilized PTH, comprising the step of reconstituting, in an aqueous vehicle, a lyophilized preparation comprising PTH, wherein said vehicle comprises at least one divalent cation in an amount effective to stabilize the reconstituted PTH.
15 . A method of treating osteoporosis comprising the steps of administering to a subject in need thereof a formulation according to claim 1 .
16 . The method of claim 15 , wherein said subject is a human.
17 . A method of diagnosing hypoparathyroidism comprising the steps of
(a) administering to a subject in need thereof a PTH formulation according to claim 1; and
(b) determining the effect of the administered PTH on urinary cAMP levels, with cAMP elevation being indicative of a hypoparathyroid condition.
18 . The method of claim 17 , wherein said subject is a human.