Formulations for treating bladder cancer

Abstract

Compositions and methods for making and using proliposomal and liposomal formulations of chemotherapeutic agents are disclosed. The proliposomal and liposomal formulations of chemotherapeutics, as well as medicaments and dosage forms that include such formulations, can be used with treatment regimens for bladder cancer and urothelial cancer. Hence, the formulations, medicaments, and dosage forms of the invention are suitable to treat bladder cancers by intravesical administration and to treat urothelial cancers. The formulations according to the invention include (a) a taxane (e.g., paclitaxel, docetaxel) or cisplatin, (b) a first phospholipid, dipalmitoyl phosphatidylcholine (DMPC), and (c) a second phospholipid, dimyrsityl phosphatidyl glycerol sodium (DMPG). The proliposomal formulations form liposomes upon contact with an aqueous vehicle.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a divisional application of U.S. application Ser. No. 16 / 066,836, filed Jun. 28, 2018; which is a 371 of PCT International Application No. PCT / US2017 / 012720, filed Jan. 9, 2017; which claims priority to U.S. Applications Nos. 62 / 275,941 and 62 / 275,936, both filed on Jan. 7, 2016, and 62 / 421,137, filed on Nov. 11, 2016, all of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The inventions described herein relate to proliposomal and liposomal formulations of therapeutic drugs, and their use in the treatment of bladder cancer.BACKGROUND[0003]The administration of chemotherapeutic drugs for the treatment of bladder cancer generally involves intravesicular administration of the drugs directly into the bladder, using a urinary catheter. However, this approach to administering drugs presents an obstacle to using drugs such as paclitaxel (Taxol®) to treat bladder cancer (Hadaschik et al., “Paclitaxel and...

AI Technical Summary

Problems solved by technology

However, this approach to administering drugs presents an obstacle to using drugs such as paclitaxel (Taxol®) to treat bladder cancer (Hadaschik et al., “Paclitaxel and cisplatin as intravesical agents against non-muscle-invasive bladder cancer”BJUI.

While paclitaxel can be dissolved in dimethyl sulfoxide (DMSO), the amount of DMSO required to keep in solution an effective dose for bladder cancer treatment is not pharmaceutically acceptable.

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