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US 9,168,256 B2Granted
Stable solid dosage forms of aminopterin
AssigneeAminopterin LLC
InventorsAbsar Faruqui, John A. Zebala, Barton A. Kamen
Life of this patent
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Abstract
There is disclosed stable pharmaceutical compositions containing pharmaceutically acceptable salts of aminopterin surface deposited onto solid excipients. The stable pharmaceutical compositions are hermetically sealed from the atmosphere. The formation of degradation products of aminopterin is reduced or eliminated.
Claims13
A stable pharmaceutical composition of aminopterin disodium salt, wherein the composition comprises
- a plurality of granules having a solid body and a surface, wherein the solid body consists of microcrystalline cellulose and lactose monohydrate, and wherein the surface of the solid body consists of aminopterin disodium salt, and
- an excipient comprising lactose, silicon dioxide, sodium croscarmellose,
- magnesium stearate, and no aminopterin disodium salt,
- wherein the granules are coated by the excipient, and wherein the aminopterin disodium salt comprises 0.01 to 10 weight percent of the composition.
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A method for preparing a stable pharmaceutical composition of an aminopterin salt, comprising:
- (a) mixing a solution consisting of an aminopterin salt and a solvent;
- (b) adding the solution of step (a) to a solid body consisting of microcrystalline cellulose and lactose monohydrate to form a wet granulation;
- and
- (c) drying the wet granulation to form granules.
1 more element
Dependencies are inferred from the claim text.