Ocular Corticosteroid Composition With Oxygen Scavengers for pH Stability

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Solution Overview

Problem

Current ocular treatments face challenges in delivering effective drug doses due to passive diffusion limitations, and cyclodextrin-based eye drops experience pH instability during storage, necessitating a method to stabilize the pH and prevent drug oxidation.

Innovation Solution

The addition of an additive, such as antioxidants or oxygen scavengers, to the aqueous composition comprising a corticosteroid, particularly at concentrations between 0.15% and 0.6% (w/v), stabilizes the pH by preventing oxidation of the corticosteroid.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If cyclodextrin-based eye drops are stored in LDPE vials for several months, then the pH of the composition decreases over time, but this pH instability compromises the drug efficacy and safety

Engineering Contradiction:
Improvestorage stabilityVSAvoidpH stability
Core Design Contradiction:
Duration of action of stationary objectVSStability of the object's composition

Solution Approach 1:

The patent introduces an oxygen scavenger (such as sodium bisulfite, sodium metabisulfite, or ascorbic acid) as an intermediary substance that reacts with dissolved oxygen in the aqueous composition, thereby preventing oxidation of the corticosteroid drug and stabilizing the pH during storage. This mediator eliminates the harmful oxidation process without requiring changes to the storage container or conditions.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the corticosteroid is exposed to oxygen during storage, then oxidation occurs leading to drug degradation, but preventing oxidation requires adding stabilizing additives to the composition

Engineering Contradiction:
Improvedrug stabilityVSAvoidcomposition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs small amounts of inexpensive, short-acting oxygen scavengers (such as sodium bisulfite or ascorbic acid at concentrations of 0.01-0.5% w/v) that are consumed during storage to prevent oxidation. These disposable stabilizing agents effectively protect the corticosteroid without requiring complex formulation systems or expensive materials.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 method effectively maintains pH stability for over six months, ensuring the corticosteroid's efficacy in ocular treatments by preventing degradation and maintaining drug solubility.

Implementation Method 1

the addition of an additive to prevent oxidation of the corticosteroid

Methodology Applied
Scientific EffectOxidation: Oxidation

Data Source

PatentUS12397001B2Treatment of ocular inflammation with ophthalmic compositions
Publication Date: 2025.08.26 OCULIS OPERATIONS SARL

AI summary

The present disclosure relates to a method for stabilizing the pH of an aqueous composition comprising a drug which is prone to oxidation, said method comprising the addition of an additive to prevent oxidation of the drug which is prone to oxidation. In particular, the present disclosure relates to a method for stabilizing the pH of an aqueous composition comprising a corticosteroid, said method comprising the addition of an additive to prevent oxidation of the corticosteroid. The present disclosure also relates to a composition comprising a corticosteroid and an additive to prevent oxidation of the corticosteroid.