Stable pharmaceutical formulations of montelukast sodium
OwnerJulia Hrakovsky, Ruth Tenengauzer +2inventors
InventorsJulia Hrakovsky, Ruth Tenengauzer, Grigory Bogomolny, Yehudit Dolitzky
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Abstract
The invention encompasses stable pharmaceutical compositions comprising montelukast or salts thereof and methods of preparing the same.
Claims25
A stable pharmaceutical composition comprising montelukast or a salt thereof and a pharmaceutically acceptable excipient selected from at least one of diluent, binder, disintegrant, lubricant, wetting agent, or glidant, provided that the pharmaceutically acceptable excipient is not microcrystalline cellulose, wherein the montelukast contains its corresponding sulfoxide and the amount of the corresponding sulfoxide has not increased by more than 1% by weight from the initial amount of montelukast after storage at about 40° C. and about 75% relative humidity for 3 months.
A pharmaceutical composition comprising montelukast or a salt thereof and a pharmaceutically acceptable excipient, provided that the pharmaceutically acceptable excipient is not microcrystalline cellulose, wherein the montelukast contains its corresponding sulfoxide and wherein the corresponding sulfoxide is present in an amount of not more than 0.2% by weight of the initial amount of montelukast or a salt thereof immediately after preparation.
Dependencies are inferred from the claim text.