Drug delivery devices with drug-permeable component and methods

• US 10,315,019 B2
• Filed: 03/17/2014
• Issued: 06/11/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Taris Biomedical LLC (Johnson & Johnson)
• Original Assignee: Taris Biomedical LLC (Johnson & Johnson)
• Inventors: Lee, Heejin, Daniel, Karen, Sansone, Matthew
• Primary Examiner(s): Osinski, Bradley J
• Assistant Examiner(s): Shah, Nilay J
• Application Number:
  US14/216,112
• Publication Number:
  US 20140276636A1
• Time in Patent Office: 1,912 Days
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/407 condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
• CPC Class Codes: A61K 31/438 The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/555 containing heavy metals, e.g. hemin, hematin, melarsoprol
• CPC Class Codes: A61K 31/7068 having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
• CPC Class Codes: A61K 33/243 Platinum; Compounds thereof
• CPC Class Codes: A61K 9/0024 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 Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 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 Class Codes: A61M 31/007 Injectors for solid bodies, e.g. suppositories

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.

Claims

1. An intravesical drug delivery device comprising:

a 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

one or more solid drug units comprising a high weight fraction of a drug, the one or more solid drug units being contained in the drug reservoir lumen,

wherein the first wall structure is impermeable to the drug, and the second wall structure is formed of a material that is permeable to the drug,

wherein the first wall structure is an elongated cylindrical tube and the second wall structure is an end wall in the form of a disk stabilized in a lumen of the elongated cylindrical tube, and

wherein 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 the material forming the second wall structure upon the one or more solid drug units being contacted by water that enters the drug reservoir lumen through 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 second wall structure comprises a thermoplastic polyurethane.

7. The device of claim 1, wherein the disk is sandwiched between an inner washer and an outer washer.

8. The device of claim 1, wherein the drug is a low solubility drug.

9. The device of claim 1, wherein the drug is a high solubility drug.

10. The device of claim 1, wherein the drug comprises lidocaine, gemcitabine, docetaxel, carboplatin, cisplatin, oxaliplatin, trospium, tolterodine, oxybutynin, or mitomycin C.

11. The device of claim 1, wherein the device is configured to be free floating in a patient'"'"'s bladder upon deployment.

12. The device of claim 1, wherein:

the first wall structure comprises silicone having a Shore hardness of from 50A to 70A, and

the second wall structure comprises a thermoplastic polyurethane having a Shore hardness of from 70A to 65D.

13. An intravesical drug delivery device, comprising:

a 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 wall structure is an elongated cylindrical tube and the second wall structure is an end wall disposed at one end or both ends of the cylindrical tube, and wherein the first and second wall structures are water permeable; and

a drug in solid form contained in the drug reservoir lumen,

wherein the second wall structure comprises a thermoplastic polyurethane,

wherein the device is configured, upon deployment in a bladder of a patient, to permit water to diffuse into the closed drug reservoir lumen and solubilize the drug and then to permit the solubilized drug to diffuse through the thermoplastic polyurethane forming the second wall structure but not through the first wall structure, which is impermeable to the drug, and

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

14. The device of claim 13, further comprising a retention frame lumen and a retention frame disposed therein.

15. The device of claim 13, wherein the first wall structure comprises silicone.

16. The device of claim 15, wherein the silicone has a Shore hardness of from 50A to 70A.

17. The device of claim 16, wherein the second wall structure comprises a thermoplastic polyurethane having a Shore hardness of from 70A to 65D.

18. The device of claim 13, wherein the second wall structure is in the form of a disk stabilized in a lumen of the elongated cylindrical tube.

19. The device of claim 18, wherein the disk is sandwiched between an inner washer and an outer washer.