Orally disintegrating tablet comprising amorphous solid dispersion of nilotinib and in vitro characterization thereof

A kit for sale to a user, the kit comprising a pharmaceutical composition and a package insert;

• wherein the pharmaceutical composition is in the form of an orally disintegrating tablet that comprises an amorphous solid dispersion;
• wherein the amorphous solid dispersion comprises nilotinib and one or more polymers;
• wherein the orally disintegrating tablet comprises 10 mg to 100 mg nilotinib;
• wherein the orally disintegrating tablet is characterized by a disintegration time of 40 seconds or less, as determined according to USP <701> Disintegration, using a basket-rack apparatus with disks in a medium of distilled water;
• wherein the package insert informs the user that the pharmaceutical composition can be administered with food;
• and
• wherein the package insert further indicates to the user a dosage that is at least 50% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation.

A kit for sale to a user, the kit comprising a pharmaceutical composition and a package insert;

• wherein the pharmaceutical composition is in the form of an orally disintegrating tablet that comprises an amorphous solid dispersion;
• wherein the amorphous solid dispersion comprises nilotinib and one or more polymers;
• wherein the orally disintegrating tablet comprises 10 mg to 100 mg nilotinib;
• wherein the orally disintegrating tablet is characterized by a disintegration time of 40 seconds or less, as determined according to USP <701> Disintegration, using a basket-rack apparatus with disks in a medium of distilled water;
• wherein the package insert informs a user of the kit that the pharmaceutical composition can be administered with or without food;
• and
• wherein the package insert further indicates to the user a dosage that is at least 50% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation.

A kit for sale to a user, the kit comprising a pharmaceutical composition and a package insert;

• wherein the pharmaceutical composition is in the form of an orally disintegrating tablet that comprises an amorphous solid dispersion;
• wherein the amorphous solid dispersion comprises nilotinib and one or more polymers;
• wherein the orally disintegrating tablet comprises 10 mg to 100 mg nilotinib;
• wherein the orally disintegrating tablet is characterized by a disintegration time of 40 seconds or less, as determined according to USP <701> Disintegration, using a basket-rack apparatus with disks in a medium of distilled water;
• and
• wherein the package insert does not include a warning that the pharmaceutical composition should not be administered with food;
• and
• wherein the package insert further indicates to the user a dosage that is at least 50% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation.