Methods for solid tumor treatment

Patent metadata

Field	Value
Publication number	US-11458133-B2
Application number	US-202016839737-A
Country	US
Kind code	B2
Filing date	Apr 3, 2020
Priority date	Apr 4, 2016
Publication date	Oct 4, 2022
Grant date	Oct 4, 2022

Abstract

Disclosed herein are methods for treating solid tumors by direct injection into the tumors of chemotherapeutic particles, methods for inhibiting tumor metastasis by administering chemotherapeutic particles to a subject having a tumor, and compositions that include chemotherapeutic particles, small amounts of a polysorbate, and a carrier.

First claim

We claim:

1. A method for treating a solid tumor, comprising administering to a subject with a solid tumor an amount effective of a composition comprising taxane particles to treat the tumor, wherein the composition is directly injected into the tumor, wherein the taxane particles comprise at least 95% taxane or a pharmaceutically acceptable salt thereof, wherein the taxane particles have a specific surface area (SSA) of at least 18 m 2 /g.

2. The method of claim 1 wherein the composition consists of the taxane particles and a pharmaceutically acceptable carrier.

3. The method of claim 2 , wherein the carrier is an aqueous liquid carrier.

4. The method of claim 3 wherein the aqueous liquid carrier is saline.

5. The method of claim 1 , wherein the composition is a suspension.

6. The method of claim 1 , wherein the taxane is paclitaxel, or a pharmaceutically acceptable salt thereof.

7. The method of claim 1 , wherein the tumor is selected from the group consisting of sarcomas, carcinomas, and lymphomas, breast tumors, prostate tumors, head and neck tumors, glioblastomas, bladder tumors, pancreatic tumors, liver tumors, ovarian tumors, colorectal tumors, cutaneous, lymphoid, and gastrointestinal tumors.

8. The method of claim 7 , wherein the tumor is selected from the group consisting of ovarian, bladder, breast, prostate, pulmonary, pancreatic, cutaneous, lymphoid, and gastrointestinal tumors.

9. The method of claim 1 , wherein the taxane is docetaxel, or a pharmaceutically acceptable salt thereof.

10. The method of claim 9 , wherein the tumor is selected from the group consisting of ovarian, bladder, breast, and prostate tumors.

11. The method of claim 1 , wherein the taxane particles comprise at least 98% taxane.

12. The method of claim 11 , wherein the taxane particles have an SSA of between about 18 m 2 /g and about 50 m 2 /g.

13. The method of claim 1 , wherein the taxane is paclitaxel or a pharmaceutically acceptable salt thereof, and wherein the particles have a mean bulk density between about 0.050 g/cm 3 and about 0.12 g/cm 3 .

14. The method of claim 1 , wherein the taxane is paclitaxel or a pharmaceutically acceptable salt thereof, and wherein the paclitaxel particles have a SSA of between about 22 m 2 /g and about 40 m 2 /g.

15. The method of claim 1 , wherein the taxane is docetaxel or a pharmaceutically acceptable salt thereof, and wherein the particles have a mean bulk density between about 0.050 g/cm 3 and about 0.12 g/cm 3 .

16. The method of claim 1 , wherein the taxane is docetaxel or a pharmaceutically acceptable salt thereof, and wherein the docetaxel particles have a SSA of between about 18 m 2 /g and about 50 m 2 /g.

17. The method of claim 16 , wherein the docetaxel particles have a bulk density of between about 0.06 g/cm 3 and about 0.1 g/cm 3 .

18. The method of claim 1 , wherein the particles have a mean particle size number of between about 0.4 μm and about 1.2 μm.

19. The method of claim 5 , wherein the suspension further comprises a polysorbate, wherein the polysorbate is present in the suspension at a concentration of between about 0.01% v/v and about 1.5% v/v.

20. The method of claim 5 , wherein the taxane is present in the suspension at a concentration between about 1 mg/ml and about 40 mg/ml.

21. The method of claim 1 wherein the taxane particles are (i) uncoated; (ii) not embedded, contained, enclosed or encapsulated within a solid excipient; and (iii) not microspheres, liposomes, or microcapsules containing taxane and an excipient.

22. The method of claim 1 , wherein the taxane particles are uncoated and the composition excludes polymers, proteins, polyethoxylated castor oil, and/or polyethylene glycol glycerides composed of mono-, di- and triglycerides and mono- and diesters of polyethylene glycol.

Assignees

• Crititech Inc

Inventors

• Baltezor Mike
• Dizerega Gere
• Decedue Charles
• Campbell Sam
• Mcclorey Matt

Classifications

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61K47/14

  Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters · CPC title

• A61K45/00 Primary

  Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00 · CPC title

• A61K33/243

  Platinum; Compounds thereof · CPC title

• A61K31/7048

  having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin} · CPC title