Preservative Removal from Eye Drops

Patent metadata

Field	Value
Publication number	US-2017224531-A1
Application number	US-201515502876-A
Country	US
Kind code	A1
Filing date	Aug 12, 2015
Priority date	Aug 13, 2014
Publication date	Aug 10, 2017
Grant date	—

Abstract

A BAK removal device is constructed as a plug of microparticles of a hydrophilic polymeric gel that displays a hydraulic permeability greater than 0.01 Da. The polymer hydrophilic polymeric gel comprises poly(2-hydroxyethyl methacrylate) (pHEMA). The particles are 2 to 100 μm and the plug has a surface area of 30 mm 2 to 2 mm 2 and a length of 2 mm to 25 mm and wherein the microparticles of a hydrophilic polymeric gel has a pore radius of 3 to 60 μm.

First claim

We claim:

1 . A preservative removing device, comprising a porous hydrophilic polymeric matrix, wherein the porous hydrophilic polymeric matrix comprises a material with a hydraulic permeability greater than 0.01 Da and fits an outlet of a container for a solution, emulsion, or suspension, wherein the porous hydrophilic polymeric matrix rapidly and selectively removes a preservative from the solution, emulsion, or suspension.

2 . The preservative removing device according to claim 1 , wherein the porous hydrophilic polymeric matrix has a partition coefficient for the preservative from the solution, emulsion, or suspension of at least 100.

3 . The preservative removing device according to claim 1 , wherein the device is made of rough edged particles.

4 . The preservative removing device according to claim 1 , wherein the porous hydrophilic polymeric matrix is preloaded with the preservative at 1 to 90% of saturation of the preservative in the porous hydrophilic polymeric matrix.

5 . The preservative removing device according to claim 1 , wherein the porous hydrophilic polymeric matrix comprises poly hydroxyl ethyl methacrylate (pHEMA), poly hydroxyl ethyl methacrylate-co-methacrylic acid, or a combination thereof.

6 . The preservative removing device according to claim 1 , wherein the porous hydrophilic polymeric matrix has interconnected pores, wherein the pores have an average radius of 1 to 60 μm.

7 . The preservative removing device according to claim 1 , wherein the porous hydrophilic polymeric matrix is partitioned as microparticles with cross-sections of 2 to 100 μm.

8 . The preservative removing device according to claim 1 , wherein the hydraulic permeability is greater than 1 Da

9 . The preservative removing device according to claim 1 , wherein the preservative is benzalkonium chloride (BAK).

10 . The preservative removing device according to claim 9 , wherein the hydrophilic polymeric gel is preloaded with the BAK at a concentration of one to 100 times that of the solution, emulsion, or suspension in the container.

11 . The preservative removing device according to claim 9 , wherein the porous hydrophilic polymeric matrix 1 is preloaded with a second preservative.

12 . The preservative removing device according to claim 1 , wherein the porous hydrophilic polymeric matrix includes a hydrophilic drug at a level below saturation.

13 . The preservative removing device according to claim 1 , further comprising antibacterial microparticles.

14 . The preservative removing device according to claim 13 , wherein the antibacterial microparticles comprise silver.

15 . The preservative removing device according to claim 9 , further comprising an oxygen scavenger.

16 . A multi-dosing device for delivery of an ophthalmic solution, comprising a compressible bottle; a preservative removing device according to claim 1 comprising a porous hydrophilic polymeric matrix, a solution comprising an ophthalmic agent, a preservative, and, optionally, a preservative source to maintain the preservative concentration in the solution, wherein the bottle comprises an outlet extension, wherein the preservative removing device when dry has dimensions smaller than the internal dimensions of the outlet extension, wherein the preservative removing device when wet has dimensions larger than the internal dimensions of the outlet extension.

17 . The multi-dosing device according to claim 16 , wherein the preservative source is a pHEMA membrane included at 1-10% by volume of the solution volume, wherein the pHEMA membrane includes the preservative at a concentration equal to the solution.

18 . The multi-dosing device according to claim 16 , wherein the porous hydrophilic polymeric matrix comprises poly hydroxyl ethyl methacrylate (pHEMA).

19 . The multi-dosing device according to claim 16 , wherein the preservative is benzalkonium chloride (BAK).

20 . The multi-dosing device according to claim 16 , wherein the ophthalmic agent comprises timolol, dorzolamide, dexamethasone phosphate, dexamethasone, or latanoprost.

21 . A method of administering an ophthalmic agent, comprising:
providing a compressible bottle comprising a preservative removing device according to claim 1 at the outlet of the compressible bottle; providing a solution comprising an ophthalmic agent and a preservative; and applying pressure to the compressible bottle, wherein the solution is forced through the preservative removing device according to claim 1 , wherein at least 50 percent of the preservative is removed from the solution and wherein at least 50 percent of the ophthalmic agent is retained by the solution.

22 . The method of claim 21 , wherein the preservative removing device according to claim 1 is preloaded with the preservative.

Assignees

• Univ Florida

Inventors

• Chauhan Anuj
• Hsu Kuan-Hui

Classifications

• A61F9/00

  Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand (caps with means for protecting the eyes A42B1/0181; visors for helmets A42B3/22; eye baths A61H35/02; sunglasses or goggles having the same features as spectacles G02C) · CPC title

• C08J2205/044

  Micropores, i.e. average diameter being between 0,1 micrometer and 0,1 millimeter · CPC title

• B01J20/261

  obtained by reactions only involving carbon to carbon unsaturated bonds (macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds per se C08F) · CPC title

• A61F9/0008 Primary

  Introducing ophthalmic products into the ocular cavity or retaining products therein (putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00) · CPC title

• A61K47/186

  Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide · CPC title