US2022409430A1PendingUtilityA1

Systems and methods for preservative removal from ophthalmic formulations

69
Assignee: TEARCLEAR CORPPriority: Aug 5, 2020Filed: Sep 2, 2022Published: Dec 29, 2022
Est. expiryAug 5, 2040(~14.1 yrs left)· nominal 20-yr term from priority
A61K 31/498A61K 31/222A61F 9/0008A61K 47/186B01J 20/28047B01J 20/267B01J 20/261B01D 69/147
69
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Claims

Abstract

A system comprising a preservative-removing polymeric matrix comprising an active matrix component and an inactive matrix component. A method for administering an ophthalmic agent comprises providing a solution, emulsion, or suspension comprising an ophthalmic agent, and a preservative; and providing a preservative-removing polymeric matrix comprising an active matrix component and an inactive matrix component, and wherein the polymeric matrix is configured to selectively absorb the preservative when the solution, emulsion, or suspension is passed therethrough.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for administering an ophthalmic agent, comprising:
 providing a solution, emulsion, or suspension comprising an ophthalmic agent and a preservative in a container suitable for drop-wise dispensing;   providing a polymeric matrix, wherein the polymeric matrix is configured to selectively absorb the preservative when the solution, emulsion, or suspension is passed therethrough, and wherein the polymeric matrix comprises an active matrix component and an inactive matrix component; and   dispensing at least one drop of the solution, emulsion, or suspension comprising an ophthalmic agent, said solution, emulsion, or suspension having passed through the polymeric matrix.   
     
     
         2 . The method of  claim 1 , wherein the inactive matrix component has substantially no affinity for the ophthalmic agent or the preservative. 
     
     
         3 . The method of  claim 1 , wherein the active matrix component is a polymeric hydrogel. 
     
     
         4 . The method of  claim 1 , wherein the inactive matrix component is a polyolefin. 
     
     
         5 . The method of  claim 4 , wherein the polyolefin is a polyethylene, polypropylene or copolymers thereof. 
     
     
         6 . The method of  claim 4 , wherein the polyolefin is a low-density polyethylene (LDPE). 
     
     
         7 . The method of  claim 1 , wherein the solution, emulsion, or suspension comprising an ophthalmic agent and a preservative is contained in a container suitable for drop-wise dispensing. 
     
     
         8 . The method of  claim 1 , wherein the ophthalmic agent comprises latanoprost. 
     
     
         9 . The method of  claim 1 , wherein the ophthalmic agent comprises timolol and brimonidine. 
     
     
         10 . The method of  claim 1 , wherein the ophthalmic agent comprises brimonidine. 
     
     
         11 . The method of  claim 1 , wherein the preservative is an ionic preservative. 
     
     
         12 . The method of  claim 1 , wherein the polymeric matrix is a hydrogel and the preservative is benzalkonium chloride. 
     
     
         13 . The method of  claim 1 , wherein the polymeric matrix comprises 2-hydroxyethylmethacrylate, tert-butyl methacrylate, or a combination thereof. 
     
     
         14 . The method of  claim 1 , wherein the polymeric matrix comprises a crosslinker. 
     
     
         15 . The method of  claim 14 , wherein the crosslinker is SR-9035. 
     
     
         16 . The method of  claim 1 , wherein the solution, emulsion, or suspension is disposed within a chamber of a compressible bottle, and the polymeric matrix is disposed between the chamber and an outlet of a compressible bottle. 
     
     
         17 . The method of  claim 16 , wherein compression of the compressible bottle passes the solution, emulsion, or suspension through the polymeric matrix to the outlet. 
     
     
         18 . The method of  claim 1 , wherein the concentration of the ophthalmic agent after passing though the polymeric matrix is at least 95% of the concentration of the ophthalmic agent before passing through the polymeric matrix. 
     
     
         19 . The method of  claim 1 , wherein the concentration of the preservative after passing though the polymeric matrix is less than 10% of the concentration of the preservative before passing through the polymeric matrix. 
     
     
         20 . The method of  claim 1 , wherein the polymeric matrix is a hydrogel formed from a polyvinyl alcohol crosslinked with a crosslinking agent.

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