Oral dosage forms of ibrutinib
AssigneeHikma Pharmaceuticals USA Inc.
InventorsMahmoud Ghannam, Shahin Fesharaki, Mohammad Al Hreebat, Ahmad Arif Mohammad
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Abstract
Stable and bioavailable oral dosage forms of ibrutinib, the dosage forms comprising ibrutinib and an acidifying agent. The dosage forms can further comprise a binder, such as sodium alginate, a surfactant, a lubricant, a filler and/or a disintegrant. Methods of treating cancers, particularly blood cancers, and graft versus host disease comprising administering to a patient in need thereof a dosage form comprising ibrutinib and an acidifying agent.
Claims28
A solid oral dosage formulation comprising ibrutinib and an acidifying agent, wherein the ibrutinib has a particle size d90 of from about 75 to about 105 microns, and wherein the oral dosage formulation releases about 70% or more of the ibrutinib within about 45 minutes when measured in either 900 mL of 3.0% w/v Polysorbate 20 in 50 mM phosphate buffer, pH 6.8, paddles at 75 rpm or 900 mL of 0.1 N HCl, paddles at 50 rpm.
A solid oral dosage formulation comprising ibrutinib having a particle size d90 of from about 75 to about 105 microns, an acidifying agent present in an amount of about 1.0 to about 5.0 weight percent, a binder present in an amount of from about 1.0 to about 10 weight percent, and an ionic surfactant present in an amount of from about 0.1 to about 2 weight percent, wherein the oral dosage formulation releases about 70% or more of the ibrutinib within about 45 minutes when measured in either 900 mL of 3.0% w/v Polysorbate 20 in 50 mM phosphate buffer, pH 6.8, paddles at 75 rpm or 900 mL of 0.1 N HCl, paddles at 50 rpm.
A solid oral dosage formulation consisting essentially of ibrutinib, an acidifying agent, a binder, an ionic surfactant, a lubricant, a filler, and a disintegrant, wherein the ibrutinib has a particle size d90 of from about 75 to about 105 microns, and wherein the dosage formulation releases about 70% or more of the ibrutinib within about 45 minutes when tested in either 900 mL of 3.0% w/v Polysorbate 20 in 50 mM phosphate buffer, pH 6.8, paddles at 75 rpm or 900 mL of 0.1 N HCl, paddles at 50 rpm.
Dependencies are inferred from the claim text.