Trace elements formulation
AssigneeFresenius Kabi Deutschland GmbH
InventorsMarlene SCHUHMANN, Claudio CRIVARO, Andreas KALTENBECK
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Abstract
The invention provides a sterile, stable injectable formulation containing a pharmaceutically acceptable salt of zinc, iron, manganese, copper, selenium, molybdenum, iodine, chromium, and/or fluorine; a chelating agent, optionally an acid and/or a base as needed for pH adjustment, and water, wherein the pH is about 3.0-4.5. The invention also provides a method for preparing the inventive formulation, a pharmaceutical product which includes a container and the inventive formulation contained therein, and a method for treating or preventing trace element deficiency in a patient by administering a therapeutically effective amount of the inventive formulation.
Claims20
A sterile, injectable formulation comprising at least one trace element selected from zinc, iron, manganese, copper, selenium, molybdenum, iodine, chromium, and fluorine, or a pharmaceutically acceptable salt of the foregoing;
- a chelating agent, optionally an acid and/or a base as needed to adjust the pH, and water, wherein the formulation has a pH of about 3.0-4.5.
A sterile, injectable formulation comprising:
- about 2215 mg/L zinc sulfate heptahydrate,
- about 540 mg/L ferric chloride hexahydrate,
- about 19.8 mg/L manganese chloride tetrahydrate,
- about 102.3 mg/L copper chloride dihydrate,
- about 17.3 mg/L sodium selenite,
- about 4.9 mg/L sodium molybdate dihydrate,
- about 16.6 mg/L potassium iodide,
- about 5.3 mg/L chromic chloride hexahydrate, and
- about 210 mg/L sodium fluoride.
A pharmaceutical product comprising a container and a formulation contained therein, wherein the formulation comprises chromium, copper, fluoride, iodine, iron, manganese, molybdenum, selenium, and zinc;
- a chelating agent, optionally an acid and/or a base as needed to adjust the pH, and water, wherein the formulation has a pH of about 3.0-4.5.
Dependencies are inferred from the claim text.