STABLE PHARMACEUTICAL COMPOSITIONS OF THYROID HORMONE DRUG
First Claim
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1. A stable pharmaceutical composition comprising a thyroid hormone drug or a pharmaceutically acceptable salt thereof, one or more carbohydrates, and one or more pharmaceutically acceptable excipients, wherein the composition retains at least 95% of the potency of thyroid hormone drug after storage for 24 months at 25°
- C. and 75% relative humidity.
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Abstract
The present invention relates to pharmaceutical compositions comprising a thyroid hormone drug. The invention also relates to processes for the preparation of such compositions.
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19 Claims
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1. A stable pharmaceutical composition comprising a thyroid hormone drug or a pharmaceutically acceptable salt thereof, one or more carbohydrates, and one or more pharmaceutically acceptable excipients, wherein the composition retains at least 95% of the potency of thyroid hormone drug after storage for 24 months at 25°
- C. and 75% relative humidity.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
- 11. A stable pharmaceutical tablet composition comprising a thyroid hormone drug or a pharmaceutically acceptable salt thereof having a break-line, wherein the break-line allows the tablet to be divided in two equal parts having substantially equal amounts of the thyroid hormone drug.
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16. A stable pharmaceutical composition comprising a levothyroxine sodium, one or more carbohydrates, and one or more pharmaceutically acceptable excipients, wherein the concentration of tetraiodothyroacetic acid is not more than 0.3% w/w after storage for 3 months at 40°
- C./75% relative humidity.
- View Dependent Claims (17, 18, 19)
Specification