Liquid parenteral compositions of levothyroxine
AssigneeFtf Pharma Private Limited
InventorsKinjal PARIKH, Malay PATEL, Jayanta Kumar MANDAL
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Abstract
Levothyroxine sodium for injection is particularly useful when thyroid replacement is needed on an urgent basis, for short term thyroid replacement, and/or when oral administration is not possible, such as for a patient in a state of myxedema coma. The present invention is therefore related to the liquid parenteral compositions comprising Levothyroxine or its pharmaceutically acceptable salt. In particular, the present invention describes ready to dilute liquid compositions which may be diluted using suitable diluent before administering to the patient in need thereof.
Claims20
A liquid parenteral composition of levothyroxine comprising:
- about 20 meg to about 2500 mg levothyroxine or its pharmaceutically acceptable salt;
- an antioxidant;
- a pH adjusting agent;
- and
- a vehicle.
A liquid parenteral composition of levothyroxine comprising:
- about 20 mcg to about 2500 mcg levothyroxine or its pharmaceutically acceptable salt;
- an antioxidant selected from α-tocopherol acetate, ascorbic acid, citric acid or its salts, erythorbic acid, butylated hydroxytoluene (BHT), d-α-tocopherol natural, monothioglycerol, thioglycolic acid, sodium bisulfite, sodium sulfite, sodium metabisulfite, potassium metabisulfite, acetone sodium bisulfite, ascorbyl palmitate, cysteine or its salts, d-α-tocopherol synthetic, nordihydroguaiaretic acid, sodium formaldehyde sulfoxylate, sodium thiosulfate, acetylcysteine, ascorbyl palmitate, butylated hydroxyanisole (BHA), dithiothreitol, propyl gallate, thiourea and combinations thereof;
- a pH adjusting agent selected from sodium hydroxide, potassium hydroxide, calcium hydroxide, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, magnesium carbonate, lithium carbonate, cesium carbonate and combinations thereof;
- a solvent selected from propylene glycol, polyethylene alcohol, propylene glycol esters, polyethylene glycols, glycerin and combinations thereof;
- optionally a stabilizing agent selected from salts of iodide;
- optionally a chelating agent selected from edetate disodium (disodium EDTA), edetate disodium (disodium EDTA) anhydrous, edetate sodium, edetate calcium disodium, edetate calcium disodium anhydrous, edetic acid and combinations thereof;
- and
- a vehicle selected from water for injection.
A liquid parenteral composition of levothyroxine comprising:
- about 20 meg to about 2500 mcg levothyroxine or its pharmaceutically acceptable salt;
- a buffering agent;
- a solvent;
- a vehicle;
- and
- optionally a pH adjusting agent.
Dependencies are inferred from the claim text.