US 12,064,430 B2
Kinase inhibitor salts and compositions thereof
Fang-Yu Liu, San Jose, CA (US); K. C. Sung, Tainan (TW); Chin-Yao Yang, Tainan (TW); Chi-Cheng Lin, Tainan (TW); Yi-Hsin Lin, Tainan (TW); and Li Qiao, San Jose, CA (US)
Assigned to Handa Oncology, LLC, San Jose, CA (US)
Filed by Handa Oncology, LLC, San Jose, CA (US)
Filed on Jan. 13, 2023, as Appl. No. 18/096,598.
Application 18/096,598 is a continuation of application No. 17/321,864, filed on May 17, 2021.
Application 17/321,864 is a continuation of application No. 17/167,719, filed on Feb. 4, 2021, granted, now 11,052,088, issued on Jul. 6, 2021.
Application 17/167,719 is a continuation of application No. 16/701,941, filed on Dec. 3, 2019, granted, now 11,007,195, issued on May 18, 2021.
Application 16/701,941 is a continuation of application No. PCT/US2019/036947, filed on Jun. 13, 2019.
Claims priority of provisional application 62/811,368, filed on Feb. 27, 2019.
Claims priority of provisional application 62/791,356, filed on Jan. 11, 2019.
Claims priority of provisional application 62/685,411, filed on Jun. 15, 2018.
Prior Publication US 2023/0142737 A1, May 11, 2023
Int. Cl. A61K 31/506 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61P 35/02 (2006.01)
CPC A61K 31/506 (2013.01) [A61K 9/0053 (2013.01); A61K 9/20 (2013.01); A61K 9/48 (2013.01); A61P 35/02 (2018.01)] 19 Claims
 
1. 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 15 wt % to about 33 wt % of cabozantinib lauryl sulfate salt; (ii) about 19 wt % to about 80 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.