Storage stable thyroxine active drug formulations and methods for their production
First Claim
1. A storage stable pharmaceutical composition which comprises a therapeutically effective amount of a thyroxine active drug, a stabilizing amount of an alditol, a stabilizing amount of a saccharide, and optionally further comprises other pharmaceutically acceptable excipients.
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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 the9 preferred saccharide. Additional preferred excipients include, for example, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and sodium lauryl sulfate.
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Citations
22 Claims
- 1. A storage stable pharmaceutical composition which comprises a therapeutically effective amount of a thyroxine active drug, a stabilizing amount of an alditol, a stabilizing amount of a saccharide, and optionally further comprises other pharmaceutically acceptable excipients.
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10. A storage stable pharmaceutical composition which comprises a therapeutically effective amount of a thyroxine active drug, an alditol in the amount of about 5% to about 90% of the total weight of said composition, and a saccharide in an amount of about 5% to about 70% of the total weight of said composition.
- 12. A storage stable oral pharmaceutical composition which comprises a therapeutically effective amount of levothyroxine sodium, a stabilizing amount of mannitol, a stabilizing amount of sucrose, and optionally further comprises other pharmaceutically acceptable excipients.
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15. A storage stable oral pharmaceutical composition which comprises a therapeutically effective amount of levothyroxine sodium, mannitol in an amount of about 5% to about 90% of the total weight of said composition, sucrose in an amount of about 5% to about 70% of the total weight of said composition, and optionally further comprises microcrystalline cellulose, polyvinylpyrrolidone, crospovidone, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide.
Specification