Amorphous solid dispersions of dasatinib and uses thereof
AssigneeNanocopoeia, LLC
InventorsChristian F. Wertz, Tzehaw Chen
Life of this patent
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Abstract
Amorphous solid dispersions and pharmaceutical compositions of the protein kinase inhibitor dasatinib. The pharmaceutical compositions may be used in methods of treating a proliferative disorder such as cancer, or in methods of delivering dasatinib to patients without regard to whether the patient is concurrently administered a gastric acid-reducing agent, or without regard to whether the patient has an elevated gastric pH. The compositions may be particularly suitable for patients afflicted by achlorhydria or hypochlorhydria, or Helicobacter pylori infection.
Claims28
A method of treating a proliferative disorder in a patient in need thereof, the method comprising:
- (a) administering to the patient a pharmaceutical composition comprising an amorphous solid dispersion, the amorphous solid dispersion comprising dasatinib and a polymer or copolymer of N-vinylpyrrolidone;
- and
- (b) co-administering to the patient a gastric acid-reducing agent without a detrimental reduction in the exposure of dasatinib.
A treatment regimen for treating a proliferative disorder in a patient in need thereof, the regimen comprising:
- (a) administering to the patient a first dose, the first dose comprising a standard dosage of a proton pump inhibitor or an H2 antagonist;
- and
- (b) within 12 hours after the first dose, administering a second dose to the patient, the second dose comprising a therapeutically effective amount of a pharmaceutical composition comprising an amorphous solid dispersion, the amorphous solid dispersion comprising dasatinib and a polymer or copolymer of N-vinylpyrrolidone;
- wherein the therapeutically effective amount comprises 20 mg to 140 mg dasatinib;
- and
- wherein the second dose provides a therapeutically relevant exposure of dasatinib to the patient.
Dependencies are inferred from the claim text.