Drug delivery devices with drug-permeable component and methods

Patent metadata

Field	Value
Publication number	US-10286199-B2
Application number	US-201615230733-A
Country	US
Kind code	B2
Filing date	Aug 8, 2016
Priority date	Mar 15, 2013
Publication date	May 14, 2019
Grant date	May 14, 2019

Abstract

Implantable drug delivery devices include a housing having a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure, and a drug contained in the drug reservoir lumen, wherein the first wall structure is impermeable to the drug and the second wall structure is permeable to the drug. Methods of providing controlled release of drug to a patient include deploying a drug delivery device in the patient releasing a drug from the drug reservoir lumen via diffusion through the second wall structure.

First claim

We claim:

1. A drug delivery device comprising:
a compliant housing having a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure, wherein the drug reservoir lumen is closed such that no aperture extends through the housing; and
a drug contained in the drug reservoir lumen,
wherein the first wall structure is impermeable to the drug, and the second wall structure is permeable to the drug,
wherein the first wall structure and the second wall structure are adjacent one another and together form an elongated cylindrical tube, with the second wall structure extending along a length of the cylindrical tube, such that the first wall structure and the second wall structure together form an outer circumferential surface of the cylindrical tube along the length, and
wherein the second wall structure, or both the first and second wall structures, are water permeable, such that the device is configured to release solubilized drug from the closed drug reservoir lumen by diffusion through only a material forming the second wall structure upon the drug being contacted by water that enters the drug reservoir lumen through the second wall structure or through both the first and second wall structures.

2. The device of claim 1 , wherein the device is configured for intravesical insertion and retention.

3. The device of claim 2 , wherein the device is elastically deformable between a relatively straightened shape suited for insertion through a urethra of a patient and into a bladder of the patient and a retention shape suited to retain the device within the bladder.

4. The device of claim 3 , further comprising a retention frame lumen and a retention frame disposed therein.

5. The device of claim 1 , wherein the first wall structure comprises silicone.

6. The device of claim 1 , wherein the material forming the second wall structure comprises a thermoplastic polyurethane.

7. The device of claim 1 , wherein the first wall structure comprises silicone and the material forming the second wall structure comprises a thermoplastic polyurethane.

8. The device of claim 7 , wherein the silicone has a Shore hardness of from 50A to 70A.

9. The device of claim 1 , wherein the first and second wall structures are formed together in a coextrusion process.

10. The device of claim 1 , wherein the drug is in the form of one or more solid drug units.

11. A device for intravesical insertion and controlled release of a drug into a urinary bladder of a patient, the device comprising:
a housing which comprises a first wall structure and a second wall structure which are adjacent one another and together form a cylindrical tube, wherein the first and second wall structures together form an outer circumferential surface of the cylindrical tube, extend between opposed ends of the cylindrical tube, and bound a drug reservoir lumen that is closed such that no aperture extends through the housing; and
a drug in a solid or semisolid form contained in the drug reservoir lumen,
wherein:
the first wall structure is impermeable to the drug,
the second wall structure is permeable to the drug,
the cylindrical tube is elastically deformable between a relatively straightened shape suited for insertion of the device through a urethra of the patient and into the urinary bladder and a retention shape suited to retain the device within the urinary bladder, and
the second wall structure, or both the first and second wall structures, are water permeable, such that the device is configured to release solubilized drug from the closed drug reservoir lumen by diffusion through only a material forming the second wall structure upon the drug being contacted by water that enters the drug reservoir lumen through the second wall structure or through both the first and second wall structures.

12. The device of claim 11 , further comprising a retention frame lumen and a retention frame disposed therein.

13. The device of claim 11 , further comprising end plugs sealing the ends of the cylindrical tube.

14. The device of claim 11 , wherein the drug is in the form of a plurality of solid drug units.

15. The device of claim 11 , wherein the first wall structure comprises silicone and the material forming the second wall structure comprises a thermoplastic polyurethane.

16. The device of claim 11 , wherein the first and second wall structures are formed together in a coextrusion process.

17. A drug delivery device comprising:
a compliant housing having a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure such that no aperture extends through the housing, wherein the first and second wall structures comprise coextruded thermoplastic polymers; and
a drug contained in the drug reservoir lumen,
wherein the first wall structure is water permeable and impermeable to the drug, and the second wall structure is permeable to the drug,
wherein the first wall structure and the second wall structure are adjacent one another and together form an elongated tube, such that both the first and second wall structures bound the closed drug reservoir lumen and form an outer surface of the elongated tube, and
wherein the second wall structure, or both the first and second wall structures, are water permeable, such that the device is configured to release solubilized drug from the closed drug reservoir lumen by diffusion through only a material forming the second wall structure upon the drug being contacted by water that enters the drug reservoir lumen through the second wall structure or through both the first and second wall structures.

18. The device of claim 17 , wherein the device is configured for intravesical insertion and retention.

19. The device of claim 18 , wherein the device is elastically deformable between a relatively straightened shape suited for insertion through a urethra of a patient and into a bladder of the patient and a retention shape suited to retain the device within the bladder.

20. The device of claim 17 , wherein the first wall structure comprises silicone and the material forming the second wall structure comprises a thermoplastic polyurethane.

21. The device of claim 17 , wherein the drug is in the form of one or more solid drug units.

Assignees

• Taris Biomedical Llc

Inventors

• Lee Heejin
• Daniel Karen
• Sansone Matthew

Classifications

• A61K9/0024

  Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L) · CPC title

• A61K31/7068

  having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid · CPC title

• A61K31/438

  The ring being spiro-condensed with carbocyclic or heterocyclic ring systems · CPC title

• A61M31/002 Primary

  Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50) · CPC title

• A61K9/0034

  Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants · CPC title