Pharmaceutical formulation comprising levothyroxine sodium
First Claim
Patent Images
1. A pharmaceutical formulation in unit dose form which is a “
- 50 μ
g tablet”
of active ingredient comprising;
0.0425-0.0575 mg levothyroxine sodium, 50-60 mg microcrystalline cellulose which has a mean particle size of less than 125 μ
m, 12-17 mg pregelatinised starch which is produced by subjecting moistened starch to mechanical pressure in order to rupture some or all of its starch granules and subsequent drying, 2-3 mg talc, 1-2 mg colloidal anhydrous silica, and 0.5-1.0 mg magnesium stearate.
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Accused Products
Abstract
There is provided a stable pharmaceutical formulation comprising (a) an effective amount of levothyroxine sodium, (b) microcrystalline cellulose which has a mean particle size of less than 125 μm and is present in an amount of 60 to 85% w/w based upon the total weight of the formulation, and (c) pregelatinised starch present in an amount of 5 to 30% w/w based upon total weight of the formulation. There is also provided a process for the preparation of such a formulation.
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Citations
2 Claims
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1. A pharmaceutical formulation in unit dose form which is a “
- 50 μ
g tablet”
of active ingredient comprising;
0.0425-0.0575 mg levothyroxine sodium, 50-60 mg microcrystalline cellulose which has a mean particle size of less than 125 μ
m, 12-17 mg pregelatinised starch which is produced by subjecting moistened starch to mechanical pressure in order to rupture some or all of its starch granules and subsequent drying, 2-3 mg talc, 1-2 mg colloidal anhydrous silica, and 0.5-1.0 mg magnesium stearate.
- 50 μ
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2. A pharmaceutical formulation in unit dose form which is a “
- 100 μ
g tablet”
of active ingredient comprising;
0.085-0.115 mg levothyroxine sodium, 100-120 mg microcrystalline cellulose which has a mean particle size of less than 125 μ
m, 24-34 mg pregelatinised starch which is produced by subjecting moistened starch to mechanical pressure in order to rupture some or all of its starch granules and subsequent drying, 4-6 mg talc, 2-4 mg colloidal anhydrous silica, and 1-2 mg magnesium stearate.
- 100 μ
Specification
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Current AssigneeAspen Global Incorporated (Aspen Pharmacare Holdings Limited)
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Original AssigneeAspen Global Incorporated (Aspen Pharmacare Holdings Limited)
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InventorsSchlehahn, Hendrik, Konieczna, Malgorzata, Krohn, Heiner, Roman, Wanda, Strozyk, Malgorzata Anna
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Primary Examiner(s)VU, JAKE MINH
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Application NumberUS10/564,148Publication NumberTime in Patent Office2,525 DaysField of Search424/465US Class Current424/465CPC Class CodesA61K 31/198 Alpha-amino acids, e.g. ala...A61K 9/2054 Cellulose; Cellulose deriva...A61K 9/2059 Starch, including chemicall...A61P 5/14 of the thyroid hormones, e....A61P 5/18 of the parathyroid hormones
