Storage stable thyroxine active drug formulations and methods for their production
View Patent ↗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.
1. A storage stable pharmaceutical composition in unit dosage form which comprises levothyroxine sodium in a therapeutically effective amount, mannitol in the amount of about 58% of the total weight of said composition, and sucrose in an amount of about 14% of the total weight of said composition.
2. A composition of claim 1 which comprises at least one further pharmaceutical excipient.
3. A storage stable oral pharmaceutical composition in unit dosage form 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 wherein said stabilizing amount of mannitol is from about 25% to about 70% of the total weight of said composition and wherein said stabilizing amount of sucrose is from about 20% to about 40% of the total weight of said composition.
4. A method for the treatment of thyroid disorders comprising orally administering the composition of claims 1 or 3 to a human.
5. A composition of claims 1 or 3 which is a solid oral dosage form.
6. A composition of claims 1 or 3 which is a tablet.