Tramadol Ophthalmic Composition pH Range for Plastic-Container Stability
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Solution Overview
Problem
There is a lack of knowledge about the stability of ophthalmic preparations containing tramadol, necessitating a composition with improved stability for ophthalmic use.
Innovation Solution
An ophthalmic composition with a pH of 4.0 to 6.8, containing tramadol or its salt, stored in a plastic container made of materials like polyethylene, polypropylene, or cyclic olefin copolymer, optionally with a buffer, to enhance stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If tramadol is stored in a plastic container for ophthalmic use, then ease of operation and patient comfort are improved, but stability of the composition deteriorates due to unknown interactions between tramadol and plastic materials
Solution Approach 1:
The patent applies parameter changes by optimizing the pH range to 4.0-6.8 and controlling tramadol concentration at 0.01-10 w/v%, which stabilizes the composition during storage in plastic containers without compromising ease of operation
Solution Approach 2:
The patent introduces buffering agents as intermediary substances that mediate between the tramadol and plastic container environment, maintaining pH stability and preventing degradation while allowing plastic container use
2Stability of the object's composition
If the pH of the ophthalmic composition is adjusted to stabilize tramadol, then stability is improved, but the composition may become less compatible with ocular tissues
Solution Approach 1:
The patent optimizes the pH range to 4.0-6.8, which balances stability requirements with ocular compatibility, ensuring the composition remains stable while avoiding harmful effects on eye tissues
Solution Approach 2:
The patent applies local quality by adjusting specific parameters (pH and concentration) to create optimal conditions at the molecular level while maintaining overall compatibility with the biological system
Data Source
AI summary
The present invention relates to an ophthalmic composition containing tramadol or a salt thereof, in which the ophthalmic composition has a pH of 4.0 to 6.8 and is stored in a container in which a portion in contact with the ophthalmic composition is partly or entirely formed of plastic.