Patent ID: 8309133

Claim:
A stable nanoparticulate composition comprising: (a) particles of erlotinib or a salt thereof having an effective average particle size of less than 1000 nm; and (b) at least one surface stabilizer adsorbed on the surface of the particles of erlotinib or a salt thereof, wherein: (i) the surface stabilizer is free of intermolecular crosslinkage; (ii) the surface stabilizer is selected from the group consisting of Povidone K29/32, docusate sodium, copovidone K25-34, sodium lauryl sulfate, and hypromellose; (iii) erlotinib or a salt thereof is present in an amount selected from the group consisting of from about 99.5% to about 0.001%, from about 95% to about 0.1%, and from about 90% to about 0.5%, by weight, based on the total combined weight of erlotinib or a salt thereof and at least one surface stabilizer, not including other excipients; (iv) the surface stabilizer is present in an amount selected from the group consisting of about 0.5% to about 99.999% by weight, from about 5.0% to about 99.9% by weight, and from about 10% to about 99.5% by weight, based on the total combined dry weight of erlotinib or a salt thereof and at least one surface stabilizer, not including other excipients; (v) the composition is in a solid oral dosage form; and (vi) the composition has: (a) a C max for erlotinib or a salt thereof when assayed in the plasma of a mammalian subject following administration that is greater than the C max for a non-nanoparticulate formulation of erlotinib or a salt thereof administered at the same dosage; (b) the composition has an AUC for erlotinib or a salt thereof when assayed in the plasma of a mammalian subject following administration that is greater than the AUC for a non-nanoparticulate formulation of erlotinib or a salt thereof, administered at the same dosage; or (c) the composition has a T max for erlotinib or a salt thereof when assayed in the plasma of a mammalian subject following administration that is less than the T max for a non-nanoparticulate formulation of erlotinib or a salt thereof, administered at the same dosage.