Liquid levothyroxine formulations
First Claim
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1. A pharmaceutical solution comprising:
- from 0.001% w/v to 0.01% w/v of a levothyroxine;
from 75% w/w to 95% of glycerol;
from 0.01% w/w to 1.5% w/w of an ethylenediaminetetraacetic acid (EDTA); and
an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w, andwherein the solution is storage stable.
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Abstract
Embodiments of the present invention provide levothyroxine solutions that consist of from about 0.001% w/v to about 0.01% w/v of a levothyroxine; at least 70% w/w of a glycerol; less than 30% w/w of a water; and from about 0.01% w/w to about 1.5% w/w of an ethylenediaminetetraacetic acid (EDTA). Such levothyroxine solutions are characterized by exhibiting levothyroxine storage stability.
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Citations
19 Claims
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1. A pharmaceutical solution comprising:
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from 0.001% w/v to 0.01% w/v of a levothyroxine; from 75% w/w to 95% of glycerol; from 0.01% w/w to 1.5% w/w of an ethylenediaminetetraacetic acid (EDTA); and an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w, and wherein the solution is storage stable. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A pharmaceutical solution comprising:
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0.002% w/v, 0.004% w/v, 0.006% w/v, 0.008% w/v, or 0.01% w/v of a levothyroxine; from 75% w/w to 95% w/w glycerol; from 0.05% w/w to 1.5% w/w of an EDTA; and an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w, and wherein the solution is storage stable. - View Dependent Claims (9, 10, 11, 12, 13)
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14. A pharmaceutical solution comprising:
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0.002% w/v or 0.004% w/v of a levothyroxine; from 75% w/w to 95% w/w glycerol; from 0.05% w/w to 1.0% w/w of an EDTA, an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w, and wherein the solution is storage stable. - View Dependent Claims (15, 16, 17)
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18. A pharmaceutical solution comprising:
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from 0.002% w/v to 0.006% w/w of a levothyroxine sodium; from 90% w/w to 95% w/w glycerol; an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w; and 0.08% w/w of an EDTA, and wherein the solution is storage stable. - View Dependent Claims (19)
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Specification