Implantable drug delivery devices for localized drug delivery

Patent metadata

Field	Value
Publication number	US-11173291-B2
Application number	US-202016826043-A
Country	US
Kind code	B2
Filing date	Mar 20, 2020
Priority date	Mar 20, 2020
Publication date	Nov 16, 2021
Grant date	Nov 16, 2021

Abstract

Provided herein are drug implants comprising a therapeutically active agent for the treatment of disease in a subject. In some cases, the drug implant may comprise a polymer matrix and a therapeutically active agent disposed therein. Additionally provided are methods for manufacturing the drug implants and methods of treating diseases with the implants. In some cases, the drug implant may comprise bicalutamide, e.g., for use in the treatment of prostate cancer.

First claim

What is claimed is:

1. A drug/polymer composite prostate implant comprising: a silicone rubber matrix having a Shore A hardness of at least 30 durometer; and bicalutamide in solid form having a D90 of less than 15 microns dispersed in the silicone rubber matrix at an amount of at least 30% w/w of the total implant, wherein the prostate implant releases between 0.6 μg/day and 10 μg/day of the bicalutamide at 2-years after implantation in a subject.

2. The prostate implant of claim 1 , wherein the solid form has a median particle size of less than 10 microns.

3. The prostate implant of claim 1 , wherein the silicone has a curing temperature less than a melting point of bicalutamide.

4. The prostate implant of claim 1 , wherein at least 50% of the bicalutamide remains in the silicone rubber matrix after 100 days of implantation.

5. The prostate implant of claim 1 , wherein the silicone rubber matrix is a liquid silicone rubber.

6. The prostate implant of claim 1 , wherein a volume of the prostate implant is at least 10 mm 3 .

7. The prostate implant of claim 1 , wherein a length of the prostate implant is from 1 mm to 30 mm.

8. The prostate implant of claim 1 , wherein a length of the prostate implant is from 5 mm to 25 mm.

9. The prostate implant of claim 1 , wherein a diameter of the prostate implant is from 0.1 mm to 1.5 mm.

10. The prostate implant of claim 1 , wherein the bicalutamide is dispersed in the silicone rubber matrix at an amount of at least 40% w/w of the total implant.

11. The prostate implant of claim 1 , wherein at least 50% of an outer surface of the silicone rubber matrix is uncoated.

12. The prostate implant of claim 1 , wherein the prostate implant is deliverable using a canula of a needle.

13. The prostate implant of claim 1 , consisting essentially of the silicone rubber matrix and the bicalutamide dispersed in the silicone rubber matrix.

14. The prostate implant of claim 1 , wherein the bicalutamide is in crystalline form.

15. The prostate implant of claim 1 , wherein the bicalutamide is in solid, amorphous form.

16. The prostate implant of claim 1 , wherein the outer surface of the prostate implant silicone rubber matrix is coated.

Assignees

• Univ California
• Alessa Therapeutics Inc

Inventors

• Rairkar Maithili
• Desai Pujan
• Schuler Carlos
• Daud Maxime
• Rappaport Maxime D
• Munster Pamela
• Maroney John
• Mclaughlin Margaret
• Casab Tobias H
• Hall Keith
• Thomas Scott

Classifications

• A61M37/0069

  Devices for implanting pellets, e.g. markers or solid medicaments (for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027) · CPC title

• A61K9/146

  with organic macromolecular compounds · CPC title

• A61K47/34

  Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) · CPC title

• A61K31/277 Primary

  having a ring, e.g. verapamil · CPC title

• A61B10/0241

  for prostate · CPC title