Cyclosporin A Ophthalmic Emulsion Stability

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Solution Overview

Problem

Current ophthalmic compositions for treating dry eye disease and other conditions related to immune response or inflammatory responses lack effective delivery and stability, particularly in maintaining therapeutic concentrations of cyclosporin A while ensuring comfort and preventing contamination.

Innovation Solution

A composition comprising cyclosporin A, polysorbate 80, polyoxyethylene stearate, and an oil, formulated as an ophthalmically acceptable emulsion with specific concentrations and additives like buffers, thickening agents, and preservatives to achieve therapeutic efficacy and stability, suitable for topical administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If cyclosporin A is formulated in conventional ophthalmic compositions, then therapeutic effect is achieved, but delivery effectiveness and stability are insufficient

Engineering Contradiction:
ImprovestabilityVSAvoidtherapeutic concentration
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent employs a composite emulsion system combining multiple components: cyclosporin A (active ingredient), polysorbate 80 (surfactant), polyoxyethylene stearate (emulsifier), and oil phase. This composite formulation enhances both stability and therapeutic concentration delivery by leveraging synergistic interactions between components, where the emulsion structure protects cyclosporin A from degradation while facilitating sustained release at the ocular surface.

Inventive Principle:
Principle #40Composite materials

2Reliability

If higher concentrations of cyclosporin A are used, then therapeutic efficacy improves, but formulation stability and comfort deteriorate

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidcomfort
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent optimizes the concentration parameters of all formulation components to achieve therapeutic efficacy while maintaining comfort. Specifically, cyclosporin A is formulated at concentrations that provide therapeutic benefit without causing excessive irritation, while polysorbate 80 and polyoxyethylene stearate are adjusted to ensure proper emulsion stability and ocular tolerance. The oil phase composition is also tuned to balance drug delivery with patient comfort.

Inventive Principle:
Principle #35Parameter changes

3Duration of action of stationary object

If conventional emulsion formulations are used, then basic delivery is achieved, but prevention of contamination and ensuring long-term stability is insufficient

Engineering Contradiction:
Improvestability durationVSAvoidcontamination
Core Design Contradiction:
Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates preservatives as intermediary substances that protect the emulsion formulation from microbial contamination without interfering with the therapeutic action of cyclosporin A. These preservatives act as a barrier against potential contaminants, enabling the formulation to maintain stability over extended storage periods while ensuring patient safety during use.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS8906861B2Pharmaceutical compositions comprising cyclosporins
Publication Date: 2014.12.09 SAINT REGIS MOHAWK TRIBE

AI summary

A composition is described herein comprising cyclosporin A, polysorbate 80, a polyoxyethylene stearate, and an oil; wherein the composition is an emulsion which is ophthalmically acceptable. Methods of treating diseases or conditions using said compositions, and medicaments related thereto, are also disclosed herein.