Kinase inhibitor salts and compositions thereof
AssigneeHanda Oncology, LLC
InventorsFang-Yu Liu, K.C. Sung, Chin-Yao Yang, Chi-Cheng Lin, Yi-Hsin Lin, Li Qiao
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Abstract
The present invention relates methods for treating thyroid cancer, renal cell carcinoma or hepatocellar carcinoma comprising orally administering to a patient in need of such therapy a therapeutic amount of cabozantinib lauryl sulfate salt, preferably in a capsule form. The method allows the administration of the therapeutic amount of cabozantinib lauryl sulfate salt in a fed state or a fasted state and the administration does not exhibit a food effect.
Claims19
A method for treating thyroid cancer, renal cell carcinoma or hepatocellar carcinoma comprising orally administering to a patient in need of such therapy one or more capsules comprising a therapeutically effective amount of cabozantinib lauryl sulfate salt wherein each capsule comprises 5 mg to 200 mg of cabozantinib free base in the form of cabozantinib lauryl sulfate and wherein each capsule further comprises:
- (i) about 10 wt % to about 33 wt % of cabozantinib lauryl sulfate salt;
- (ii) about 19 wt % to about 90 wt % of at least one pharmaceutically acceptable non-ionic surfactant with a hydrophilic-lipophilic balance (HLB) value of 10 or greater selected from a group consisting of vitamin E polyethylene glycol succinate, a poloxamer, a polyethoxylated castor oil, a polyoxyethylene hydrogenated castor oil, a polyoxylglycerides, a polyoxyethylene stearate and combinations of the foregoing and
- (iii) optionally one or more additional pharmaceutically acceptable excipients selected from the group consisting of a stabilizer, a filler, a viscosity enhancing agent, a binder, a disintegrant, a lubricant, a glidant, a flavoring agent, and combinations thereof;
- the capsule exhibits a dissolution rate of at least 70% after 60 minutes of testing using a USP Type II Apparatus (Paddle) with a 0.1 N HCl at 75 rpm, with or without a sinker at 37° C. and wherein the patient's cabozantinib AUC0-∞ or cabozantinib AUC0-24 does not change by more than 30% when the capsule is administered to the patient in a fed state compared to when the capsule is administered to the patient in a fasted state.
Dependencies are inferred from the claim text.