Systems and methods for preservative removal from ophthalmic formulations comprising complexing agents

A complexing agent and preservative technology, applied in the field of removing preservatives and applying ophthalmic reagents, can solve problems such as dosage changes and reducing the shelf life of eye drop preparations

Inactive Publication Date: 2021-02-12
ティアークリアーコープ
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Other existing methods may absorb ophthalmic agents over time, resulting in dose variations over time of action, which may reduce the shelf life of eye drop formulations

Method used

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  • Systems and methods for preservative removal from ophthalmic formulations comprising complexing agents
  • Systems and methods for preservative removal from ophthalmic formulations comprising complexing agents
  • Systems and methods for preservative removal from ophthalmic formulations comprising complexing agents

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0159] The concentration of latanoprost in the droplets of solution A that passed through the porous polymer hydrogel B was at least 80% of the original concentration of latanoprost in solution A. The droplets more preferably have 90% of the original concentration of latanoprost in solution A. And most preferably >95% of the original concentration of latanoprost in solution A.

[0160] Furthermore, the concentration of total BAK in droplets of solution A passing through porous polymer hydrogel B was less than 50% of the original solubility of BAK in solution A. The droplets more preferably have less than 20% of the original concentration of BAK in solution A, and even more preferably have less than 5% of the original concentration of BAK in solution A. Most preferably have <1% of the original concentration of BAK in solution A or below the detection limit of one skilled in the art of the original concentration of BAK in solution A.

[0161] Furthermore, the concentration of ...

Embodiment

[0166] It should be understood that the examples and embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the claimed invention. It should also be understood that from the examples and embodiments described herein, various modifications or changes will occur to those skilled in the art, which are included within the spirit and scope of the present application and the scope of the appended claims. All publications, patents, and patent applications cited herein are hereby incorporated by reference in their entirety for all purposes.

[0167] It should be understood that various ophthalmic agents can be used in any aspect of the provided disclosure. It should be understood that various cyclodextrins can be used in any aspect of the provided disclosure to complex ophthalmic agents in aqueous solution. It should be understood that various preservatives can be used in any aspect of the provided disclosure to make the original so...

Embodiment 2

[0182] Comparative solution B (without CD) was prepared in the following manner.

[0183] 0.1 gm (2.313 × 10 -4 mol) latanoprost was mixed with 2000 mL of distilled water and stirred at high speed under nitrogen atmosphere for several hours to ensure complete dissolution. 0.4 gm of benzalkonium chloride (BAK) was added to the solution and mixing was continued at 25°C to ensure a homogeneous clear solution. The concentration of latanoprost in solution B was 0.005% and the BAK was 0.02% by weight.

[0184] US Patent No. 10,123,904, which is incorporated herein by reference in its entirety, previously described a procedure demonstrating selective absorption of BAK preservatives from Solution B (both prepared as described herein) through porous polymeric hydrogel B. Another procedure (analytical method) is to use quantitative HPLC using the partition coefficient method or a simple equilibration test to compare the area under the curve (AUC) of the starting solution of drug and B...

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Abstract

Systems and methods for removing a preservative from a solution, emulsion, or suspension may include an ophthalmic agent, a complexing agent, and a matrix. A method for administering an ophthalmic agent may include: providing a solution, emulsion, or suspension comprising a hydrophobic ophthalmic agent, a preservative, and a complexing agent, wherein the complexing agent is configured to host thehydrophobic ophthalmic agent; and providing a polymeric matrix, wherein the complexing agent is configured to reduce an affinity of the ophthalmic agent for the polymeric matrix and wherein the polymeric matrix is configured to selectively absorb the preservative when the solution, emulsion, or suspension is passed therethrough.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Application No. 62 / 802,132, filed February 6, 2019, and US Provisional Application No. 62 / 941,398, filed November 27, 2019, both of which are incorporated by reference Incorporated into the disclosure content of this application. Background technique [0003] The present disclosure generally relates to systems and methods for the removal of preservatives and from fluids containing ophthalmic agents. [0004] In at least some aspects, existing methods of removing preservatives from fluids containing ophthalmic agents prior to administration to the eye may be less than ideal. Patients with chronic diseases can use eye drops instilled daily, such as for the treatment of glaucoma. To prevent bacterial growth, commercially available eye drop formulations often use preservatives to address possible bacterial contamination. [0005] Chronic disease may require daily inst...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/52A61K31/724A61K47/18
CPCA61K9/08A61K9/107A61K9/10A61K9/0048A61K31/573A61K31/5575A61K45/00A61K47/32A61K47/6951A61P27/02A61F9/0008A61K38/13B65D51/24A61J1/1443A61J1/1468A61K47/18A61K47/40B01D39/1676A61K47/186A61P27/06A61J1/1456
Inventor 迈克尔·T·马兰加霍华德·L·戈卢布
Owner ティアークリアーコープ
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