Storage stable thyroxine active drug formulations and methods for their production
First Claim
1. A storage stable pharmaceutical composition in unit dosage form which comprises a therapeutically effective amount of a thyroxine active drug, a stabilizing amount of an alditol, a saccharide selected from the group consisting of sucrose, and glucose, in an amount of about 20% to about 40%, and optionally further comprises other pharmaceutically acceptable excipients.
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0 Petitions
Accused Products
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.
61 Citations
15 Claims
- 1. A storage stable pharmaceutical composition in unit dosage form which comprises a therapeutically effective amount of a thyroxine active drug, a stabilizing amount of an alditol, a saccharide selected from the group consisting of sucrose, and glucose, in an amount of about 20% to about 40%, and optionally further comprises other pharmaceutically acceptable excipients.
- 8. A storage stable oral pharmaceutical composition in unit dosage form which comprises a therapeutically effective amount of levothyroxine sodium, a stabilizing amount of mannitol, sucrose in an amount of about 20% to about 40%, and optionally further comprises other pharmaceutically acceptable excipients.
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12. A storage stable oral pharmaceutical composition in unit dosage form 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 20% to about 40% 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
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- Resources
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Current AssigneeMylan Pharmaceuticals Incorporated (Pfizer Inc.)
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Original AssigneeMylan Pharmaceuticals Incorporated (Pfizer Inc.)
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InventorsWargo, David John, Hanshew, Dwight D. Jr.
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Primary Examiner(s)Page, Thurman K.
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Assistant Examiner(s)Oh, Simon J.
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Application NumberUS10/443,135Publication NumberTime in Patent Office831 DaysField of Search424/400, 424/464, 424/465, 424/468, 424/489, 424/499, 424/502, 514/567US Class Current424/465CPC Class CodesA61K 31/198 Alpha-amino acids, e.g. ala...A61K 9/1623 Sugars or sugar alcohols, e...A61K 9/2018 Sugars, or sugar alcohols, ...A61K 9/205 Polysaccharides, e.g. algin...A61K 9/2054 Cellulose; Cellulose deriva...A61K 9/2077 Tablets comprising drug-con...
