Salt-Activatable Dissolvable Polymeric Eye Inserts

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Solution Overview

Problem

Current ophthalmic formulations, such as topical drops and inserts, face challenges with short retention time on the ocular surface, leading to poor compliance and side effects like blurred vision due to their design and slow dissolution, which can cause discomfort and irritation.

Innovation Solution

A polymeric eye insert comprising 5% to 50% w/w gelling agent monovalent alginate, one or more humectants, and mucoadhesive polymers that are biocompatible with the ocular surface, with a variable dissolution time adjusted by exposure to different concentrations of multivalent salt solutions, allowing for extended release of lubricants and drugs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If topical ophthalmic formulations are administered frequently to maintain therapeutic effect, then treatment efficacy is improved, but patient compliance deteriorates due to poor compliance with multiple applications

Engineering Contradiction:

Improvetreatment efficacyVSAvoidpatient compliance

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The insert is prepared in advance with controlled dissolution properties, allowing it to release medication over an extended period automatically after insertion, eliminating the need for frequent manual applications by the patient

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The insert self-regulates medication release through its dissolution mechanism, maintaining therapeutic levels without requiring patient intervention or adherence to complex dosing schedules

Inventive Principle:

Principle #25Self-service

2Duration of action of moving object

If inserts remain in the eye for extended periods to provide continuous delivery, then treatment duration is improved, but side effects worsen due to blurred vision and discomfort

Engineering Contradiction:

Improvecontinuous delivery durationVSAvoidblurred vision and discomfort

Core Design Contradiction:

Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The dissolution rate parameter of the insert is precisely controlled through polymer selection and formulation, enabling the insert to dissolve completely within a optimized time frame that provides continuous medication delivery while avoiding prolonged presence that causes blurred vision and discomfort

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The insert utilizes composite polymer materials with specific dissolution characteristics that balance extended medication release with controlled disintegration, preventing the formation of hard, inelastic structures that cause patient discomfort

Inventive Principle:

Principle #40Composite materials

3Ease of operation

If rod-shaped inserts are used for ease of insertion, then ease of operation is improved, but patient comfort deteriorates due to hard and inelastic structure causing foreign body sensation

Engineering Contradiction:

Improveease of insertionVSAvoidforeign body sensation

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The insert employs a flexible, thin film structure that can conform to the ocular surface, eliminating the hard, inelastic rod structure that causes foreign body sensation while maintaining ease of insertion through its adaptable form

Inventive Principle:

Principle #30Flexible shells and thin films

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The polymeric eye insert reduces dosing frequency, improves patient compliance, and provides extended relief from ocular symptoms by adjusting dissolution time and minimizing side effects like blurred vision, while being comfortable and effective for treating dry eye and other ocular conditions.

Implementation Method 1

5% to 50% w/w gelling agent monovalent alginate... wherein the polymeric eye insert has a variable dissolution time with exposure of the polymeric eye insert to a different concentration of a multivalent salt solution

Methodology Applied

Scientific EffectGel formation and dissolution: Gel

Implementation Method 2

variable dissolution time with exposure of the polymeric eye insert to a different concentration of a multivalent salt solution

Methodology Applied

Scientific EffectIon exchange and crosslinking: Ion Exchange

Implementation Method 3

one or more mucoadhesive polymers that are biocompatible with the ocular surface and tear film of the eye

Methodology Applied

Scientific EffectMucoadhesion: Adhesive

Implementation Method 4

one or more humectants

Methodology Applied

Scientific EffectHumectancy: Absorption (physical)

Data Source

PatentUS20240207173A1Salt activatable dissolvable polymeric eye inserts and kit of the same

Publication Date: 2024.06.27 ALCON INC

AI summary

Polymeric eye inserts are provided that may be dissolvable when placed in the cul-de-sac of the eye. These inserts may contain one or more mucoadhesive polymers, a sodium alginate as well as at least one humectant so that, when inserted into the eye, they may absorb tears, and dissolve and slowly release lubricant into the tear film to lubricate and protect the ocular surface for an extended duration of time. The sodium alginate containing eye insert may vary dissolution time on the ocular surface for a longer lasting relief, may reduce dosing frequency and patient burden typically associated with topical drop usage. These polymeric eye inserts also may include one or more pharmaceutically active agents.