Preservative-Free Prostaglandin Ophthalmic Solution via Polymeric Delivery
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Solution Overview
Problem
Current ophthalmic solutions containing prostaglandins for glaucoma treatment face challenges such as the need for preservative agents like benzalkonium chloride, which are toxic and allergenic, and require cold storage due to instability at room temperature, while also needing to be compatible with plastic packaging and maintain effectiveness in reducing intraocular pressure.
Innovation Solution
A polymeric delivery system comprising a prostaglandin solution without anti-microbial preservatives, using a solubilizing agent, carbomer as a gelling agent, and a co-gelling/co-solubilizing agent to achieve stability and effectiveness similar to solutions with benzalkonium chloride, while being compatible with LDPE packaging and maintaining intraocular pressure reduction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If preservative agents like benzalkonium chloride are used in prostaglandin eye drops, then the solution remains stable and effective over time, but the solution becomes toxic and allergenic to eye tissues during long-term use
Solution Approach 1:
The invention removes the harmful preservative agent (benzalkonium chloride) from the ophthalmic solution while maintaining stability through alternative means - specifically through optimized prostaglandin formulation and packaging in a sterile single-use system that eliminates the need for preservatives
Solution Approach 2:
The invention employs single-use disposable eye drop containers that are sterile-packaged and intended for one-time use only, eliminating the need for preservative agents while ensuring solution stability and preventing contamination
2Stability of the object's composition
If prostaglandins are solubilized using conventional methods, then the active ingredient becomes soluble in water-based eye drops, but the solution requires cold storage to maintain stability
Solution Approach 1:
The invention modifies the chemical parameters of the prostaglandin formulation, including pH adjustment and use of specific solubilizing agents, to achieve room temperature stability without requiring cold storage conditions
3Object-affected harmful factors
If preservative agents are eliminated from the formula, then the solution becomes less toxic to eye tissues, but the solution becomes more susceptible to microbial contamination
Solution Approach 1:
The invention uses single-use sterile-packaged eye drop containers that prevent microbial contamination through sterile packaging and immediate use, eliminating the need for preservative agents while maintaining protection against contamination
4Ease of operation
If the ophthalmic solution is packaged in multidoses, then the packaging is more economical and convenient, but the solution requires preservative agents that are toxic during long-term use
Solution Approach 1:
The invention employs single-use disposable eye drop containers that are convenient to use and dispose of, eliminating the need for preservative agents while maintaining ease of operation through simple single-dose packaging
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 solution provides a stable, preservative-free ophthalmic solution that maintains effectiveness in reducing intraocular pressure over 18-24 months at room temperature, is compatible with LDPE packaging, and is less aggressive to eye tissues, offering a more tolerable and prolonged release of the active ingredient.
Implementation Method 1
prostaglandins have a first disadvantage which is that of not being soluble in water, so that their solution within the eye drops necessarily goes through a prior solubilization step
Implementation Method 2
a carbomer type gelling agent; an agent inhibiting carbomer polymerization
Data Source
Figure 1
Figure 2A~2B
Figure 2C
AI summary
The present invention relates to an ophthalmic solution which comprises: - at least one prostaglandin; - a solubilizing agent; - a carbomer gelling agent; - a carbomer-polymerization-inhibiting agent; - a co-gelling/co-solubilizing agent.