Drug delivery devices and methods for drug delivery

Patent metadata

Field	Value
Publication number	US-2016008271-A1
Application number	US-201414770494-A
Country	US
Kind code	A1
Filing date	Mar 14, 2014
Priority date	Mar 15, 2013
Publication date	Jan 14, 2016
Grant date	—

Abstract

An orifice-free drug delivery device is provided. In an embodiment, the device includes a body having at least one water-permeable wall bounding a reservoir defined within the body. A drug formulation is disposed within the reservoir. The body has an elastic portion and at least one restraining plug closing off an opening of the body. The opening is in fluid communication with the reservoir, and the restraining plug contacts the elastic portion of the body and controls release of the drug from the device by the transient formation of one or more microchannels between the elastic portion of the body and the at least one restraining plug. The elastic portion may define an opening having an inner diameter, which is exceeded by the outer diameter of the restraining plug by at least 3%.

First claim

1 . A drug delivery device comprising:
a body having at least one water-permeable wall bounding a reservoir defined within the body, wherein the body comprises an elastic portion; a drug formulation which comprises a drug, the drug formulation being disposed within the reservoir; and at least one restraining plug closing off an opening of the body, the opening being in fluid communication with the reservoir, wherein the at least one restraining plug contacts the elastic portion of the body and controls release of the drug from the device by the transient formation of one or more microchannels between the elastic portion of the body and the at least one restraining plug.

2 . The drug delivery device of claim 1 , wherein:
the at least one restraining plug has an outer diameter, the elastic portion of the body defines an opening having an inner diameter, and wherein the outer diameter of the restraining plug exceeds the inner diameter of the elastic portion of the body by at least 3%.

3 . The drug delivery device of claim 2 , wherein the outer diameter of the restraining plug exceeds the inner diameter of the elastic portion of the body by at least 5%.

4 . The drug delivery device of claim 2 , wherein the outer diameter of the restraining plug exceeds the inner diameter of the elastic portion of the body by at least 10%.

5 . The drug delivery device of claim 2 , wherein the outer diameter of the restraining plug exceeds the inner diameter of the elastic portion of the body by at least 15%.

6 . The drug delivery device of claim 2 , wherein the outer diameter of the restraining plug exceeds the inner diameter of the elastic portion of the body by at least 20%.

7 . The drug delivery device of claim 2 , wherein the outer diameter of the restraining plug exceeds the inner diameter of the elastic portion of the body by at least 25%.

8 . The drug delivery device of claim 1 , wherein the body further comprises an inelastic portion.

9 . The drug delivery device of claim 1 , wherein the at least one restraining plug is secured within the opening in the elastic portion of the body with an adhesive.

10 . The drug delivery device of claim 1 , wherein the drug formulation is in a solid form.

11 . The drug delivery device of claim 1 , wherein the drug comprises lidocaine or another anesthetic agent.

12 . The drug delivery device of claim 1 , further comprising an osmotic agent.

13 . The drug delivery device of claim 12 , wherein the osmotic agent is a component of the drug formulation.

14 . The drug delivery device of claim 1 , wherein the at least one restraining plug is substantially cylindrical.

15 . The drug delivery device of claim 1 , wherein the at least one restraining plug comprises a wedged, tapered, angled, or rounded surface.

16 . The drug delivery device of claim 1 , wherein the Shore durometer of the elastic portion of the body is from about 40 A to about 60 A, and the Shore durometer of the at least one restraining plug is from about 70 A to about 100 A.

17 . The drug delivery device of claim 1 , wherein the Shore durometer of the elastic portion of the body is from about 45 A to about 55 A, and the Shore durometer of the at least one restraining plug is from about 75 A to about 85 A.

18 . The drug delivery device of claim 1 , wherein the Shore durometer of the elastic portion of the body is about 50 A, and the Shore durometer of the at least one restraining plug is about 80 A.

19 . The drug delivery device of claim 1 , wherein the device is elastically deformable between a relatively straightened shape suitable for insertion through a lumen into a body cavity of a patient and a retention shape suited to retain the device within the body cavity.

20 . A method of administering a drug to a patient, comprising:
inserting the drug delivery device of claim 1 into a lumen or body cavity of a patient; and permitting water influx into the reservoir to develop a hydrostatic pressure in the reservoir effective to form one or more microchannels between the elastic portion of the body and the at least one restraining plug, thereby causing the drug to flow from the reservoir, through the microchannels, and out of the device and into the lumen or body cavity.

21 . The method of claim 20 , wherein the body cavity is the bladder of the patient.

22 . The drug delivery device of claim 1 , wherein the one or more microchannels are not preformed orifices.

23 . A drug delivery device comprising:
a body having at least one water-permeable wall bounding a reservoir defined within the body, wherein the body comprises an elastic portion; a solid drug formulation which comprises a drug, the drug formulation being disposed within the reservoir; and at least one restraining plug closing off an opening of the body, the opening being in fluid communication with the reservoir, wherein the device is configured to permit, in vivo, water to diffuse through the at least one water-permeable wall and into the reservoir to contact and solubilize the solid drug formulation, and wherein the at least one restraining plug contacts the elastic portion of the body and controls release of the drug from the device by the transient formation of one or more microchannels between the elastic portion of the body and the at least one restraining plug.

24 . A drug delivery device comprising:
a body having at least one water-permeable wall bounding a reservoir defined within the body, wherein the at least one water-permeable wall comprises an elastic portion; a solid drug formulation which comprises a drug, the drug formulation being disposed within the reservoir; and at least one restraining plug closing off an opening of the body, the opening being in fluid communication with the reservoir, wherein the at least one restraining plug contacts the elastic portion of the at least one water-permeable wall and controls release of the drug from the device by the transient formation of one or more microchannels between the elastic portion of the at least one water-permeable wall and the at least one restraining plug.

Assignees

• Taris Biomedical Llc

Inventors

• Lee Heejin

Classifications

• A61K9/0034

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

• A61K9/0004 Primary

  Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas · CPC title

• A61K31/167

  having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol · CPC title

• A61M31/00

  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 title

• A61M37/00

  Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04) · CPC title