Implantable Drug Delivery Devices and Methods of Making the Same

• US 20100331770A1
• Filed: 06/28/2010
• Published: 12/30/2010
• Est. Priority Date: 06/26/2009
• Status: Active Grant

• Current Assignee: Taris Biomedical LLC (Johnson & Johnson)
• Original Assignee: Taris Biomedical LLC (Johnson & Johnson)
• Inventors: Lee, Heejin, Larrivee-Elkins, Cheryl
• Granted Patent: US 10,543,166 B2
• Time in Patent Office: Days
• US Class Current: 604/57
• CPC Class Codes: A61K 31/16 Amides, e.g. hydroxamic acids
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• 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 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/2004 Excipients; Inactive ingredients
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61M 2202/06 Solids
• 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
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 23/02 Local anaesthetics
• CPC Class Codes: B65B 1/16 by pneumatic means, e.g. by suction

Abstract

A drug delivery device is provided that includes a device body, a number of solid, compressed drug tablets, and a retention frame. The device body includes a drug reservoir lumen and a retention frame lumen. The number of solid, compressed drug tablets are positioned in the drug reservoir lumen, and the retention frame is positioned in the retention frame lumen. The drug tablets may be mini-tablets aligned in the drug reservoir lumen, with an interstice formed between any two adjacent drug tablets facilitating deformation of the device body. Systems and method are also provided for loading a drug delivery device. In one embodiment, the method includes positioning one or more solid drug units upstream of the drug delivery device; and driving the drug units into the drug delivery device with a flow of pressurized gas.

Claims

1. A drug delivery device comprising:

a device body comprising a drug reservoir lumen and a retention frame lumen;

a plurality of solid, compressed drug tablets positioned in the drug reservoir lumen; and

a retention frame positioned in the retention frame lumen.

2. The drug delivery device of claim 1, further comprising an interstice formed between any two adjacent drug tablets, the interstice facilitating deformation of the device body.

3. The drug delivery device of claim 1, wherein the drug tablets are mini-tablets aligned in the drug reservoir lumen.

4. The drug delivery device of claim 1, wherein the drug tablets comprise lidocaine hydrochloride in tablet form.

5. The drug delivery device of claim 1, wherein the drug tablets comprise lidocaine base in tablet form.

6. The drug delivery device of claim 1, wherein the device body comprises:

a drug reservoir tube that defines the drug reservoir lumen; and

a retention frame tube that defines the retention frame lumen, the retention frame tube longitudinally aligned and coupled to the drug reservoir tube.

7. The drug delivery device of claim 6, wherein the drug reservoir tube and the retention frame tube are formed together by an extrusion process or a molding process.

8. The drug delivery device of claim 7, wherein the two tubes comprise a water permeable silicone.

9. The drug delivery device of claim 1, wherein the device body comprises an aperture in fluid communication with the drug reservoir lumen.

10. The drug delivery device of claim 1, wherein the retention frame is configured to spontaneously assume a pretzel-like shape.

11. The drug delivery device of claim 1, wherein the retention frame comprises an elastic wire.

12. A method for loading a drug delivery device, the method comprising:

positioning one or more solid drug units upstream of the drug delivery device; and

driving the drug units into the drug delivery device with a flow of pressurized gas.

13. The method of claim 13, wherein the drug delivery device comprises an elastic tube.

14. The method of claim 13, wherein positioning one or more drug units upstream of the drug delivery device further comprises orienting the drug units to enter the drug delivery device.

15. The method of claim 13, wherein positioning one or more drug units upstream of the drug delivery device further comprises aligning the drug units in a row adjacent to an entry into the drug delivery device.

16. The method of claim 13, wherein driving the drug units into the drug delivery device with a flow of pressurized gas comprises directing a positive pressure gas flow toward an entry of the drug delivery device.

17. The method of claim 13, wherein driving the drug units into the drug delivery device with a flow of pressurized gas comprises depressing a syringe filled with air.

18. The method of claim 13, wherein driving the drug units into the drug delivery device with a flow of pressurized gas comprises operating a vacuum associated with an exit of the drug delivery device.

19. The method of claim 13, wherein driving the drug units into the drug delivery device with a flow of pressurized gas further comprises blocking at least one orifice of the drug delivery device to impede the flow of pressurized gas from escaping.

20. The method of claim 13, further comprising stopping the drug units from exiting the drug delivery device.

21. The method of claim 13, further comprising permitting the flow of pressurized gas to travel about outer peripheries of the drug units.

22. The method of claim 13, further comprising filtering the flow of pressurized gas before the gas enters the drug delivery device to remove contaminants.

23. The method of claim 13, further comprising filtering the flow of pressurized gas after the gas exits the drug delivery device to remove at least a portion of any drug particles and/or excipient particles entrained in the pressurized gas.

24. A system for loading a drug delivery device, comprising:

an entry channel in communication with the drug delivery device, the entry channel comprising a drug entry opening;

a drug unit source in communication with the entry channel via the drug entry opening; and

a pressurized gas source in communication with the entry channel from a location upstream of the drug entry opening, wherein the pressurized gas source is operable to direct a flow of pressurized gas through the entry channel.

25. The system of claim 24, further comprising:

a drug unit source valve operable to selectively permit or prevent drug units from passing through the drug entry opening;

a pressurized gas source valve operable to selectively permit or prevent the flow of pressurized gas from passing through the entry channel; and

a controller operable to control the drug unit source valve and the pressurized gas source valve.