Levothyroxine compositions and methods
First Claim
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1. A pharmaceutical composition comprising a levothyroxine salt and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition exhibits a levothyroxine (T4) plasma Cmax of between from about 10 μ
- g/dl to about 20 μ
g/dl as determined by a standard Cmax test.
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Abstract
The present invention generally relates to stable pharmaceutical compositions, and methods of making and administering such compositions. In one aspect, the invention features stabilized pharmaceutical compositions that include pharmaceutically active ingredients such as levothyroxine (T4) sodium and liothyronine (T3) sodium (thyroid hormone drugs), preferably in an immediate release solid dosage form. Also provided are methods for making and using such immediate release and stabilized compositions.
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Citations
52 Claims
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1. A pharmaceutical composition comprising a levothyroxine salt and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition exhibits a levothyroxine (T4) plasma Cmax of between from about 10 μ
- g/dl to about 20 μ
g/dl as determined by a standard Cmax test. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
- g/dl to about 20 μ
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48. A pharmaceutical composition in tablet form comprising levothyroxine sodium, the composition comprising:
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a) between from about 1 μ
g/tablet to about 1000 μ
g/tablet levothyroxine sodium (USP),b) between from about 100 mg/tablet to about 110 mg/tablet of microcrystalline β
-cellulose, NF (Ceolus) having a bulk density of between from about 0.10 g/cm3 to about 0.35 g/cm3,c) between from about 25 mg/tablet to about 50 mg/tablet of crosscarmellose sodium, NF (Ac-di-sol); and
d) between from about 0.5 mg/tablet to about 5 mg/tablet of magnesium stearate, NF.
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49. A method of preparing a solid dosage form of a pharmaceutically active ingredient comprising forming a blend comprising the pharmaceutically active ingredient and β
- -sheet form of microcrystalline cellulose, and forming therefrom a solid dosage by compressing the blend in a tableting machine.
- View Dependent Claims (50, 51, 52)
Specification