Storage stable thyroxine active drug formulations and methods for their production
First Claim
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1. A storage stable oral pharmaceutical composition in unit dosage form which comprises:
- (a) a therapeutically effective amount of levothyroxine sodium;
(b) about 58% by weight mannitol;
(c) about 14% by weight sucrose;
(d) about 25% by weight microcrystalline cellulose;
(e) about 1.5% by weight polyvinylpyrrolidone;
(f) about 1.4% by weight magnesium stearate;
(g) about 0.3% by weight colloidal silicon dioxide; and
(h) about 0.1% by weight sodium lauryl sulfate.
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Abstract
This invention provides a storage-stable dosage form of a thyroxine active drug composition which exhibits an improved stability. The formulation contains a thyroxine active drug substance, an alditol, and a saccharide, and, optionally, additional pharmaceutically accepted excipients. Levothyroxine sodium is the preferred active drug substance, mannitol is the preferred alditol, and sucrose is the preferred saccharide. Additional preferred excipients include, for example, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and sodium lauryl sulfate.
49 Citations
2 Claims
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1. A storage stable oral pharmaceutical composition in unit dosage form which comprises:
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(a) a therapeutically effective amount of levothyroxine sodium;
(b) about 58% by weight mannitol;
(c) about 14% by weight sucrose;
(d) about 25% by weight microcrystalline cellulose;
(e) about 1.5% by weight polyvinylpyrrolidone;
(f) about 1.4% by weight magnesium stearate;
(g) about 0.3% by weight colloidal silicon dioxide; and
(h) about 0.1% by weight sodium lauryl sulfate.
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2. A storage stable oral pharmaceutical composition in unit dosage form which comprises:
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(a) a therapeutically effective amount of levothyroxine sodium;
(b) about 39% by weight mannitol;
(c) about 23% by weight sucrose;
(d) about 28% by weight microcrystalline cellulose;
(e) about 1.5% by weight polyvinylpyrrolidone;
(f) about 6% by weight crospovidone;
(g) about 2% by weight magnesium stearate;
(h) about 0.3% by weight colloidal silicon dioxide; and
(i) about 0.1% by weight sodium lauryl sulfate.
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Specification