Ready-to-Use Ketamine Premix for Stable Preservative-Free IV Infusion
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Solution Overview
Problem
Current ketamine formulations require reconstitution and dilution before administration, risking contamination and dosing errors, and lack a stable, preservative-free, ready-to-use intravenous form with prolonged shelf-life.
Innovation Solution
A sterile, ready-to-use, preservative-free ketamine solution in an infusion container, formulated for prolonged stability without benzethonium chloride, using specific pH and tonicity adjustments, and compatible packaging materials to maintain sterility and efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If ketamine is provided as a concentrated solution requiring reconstitution and dilution, then the product can be stored longer, but the risk of contamination and dosing errors increases
Solution Approach 1:
The ketamine solution is pre-diluted to the final therapeutic concentration during manufacturing, eliminating the need for reconstitution and dilution at the point of use. This preliminary action ensures accurate dosing and reduces contamination risk while maintaining shelf-life through sterile manufacturing processes
Solution Approach 2:
The invention uses single-use pre-filled syringes and disposable infusion bags containing pre-diluted ketamine. These disposable containers are sterile, ready-to-use, and eliminate cross-contamination risks between patients while maintaining drug stability throughout the intended use period
2Duration of action of stationary object
If a preservative such as benzethonium chloride is added to ketamine formulation, then the shelf-life is extended, but the product contains harmful additives
Solution Approach 1:
The invention removes preservatives and antimicrobial agents from the ketamine formulation entirely. Instead of adding harmful substances to extend shelf-life, the formulation relies on sterile manufacturing, proper packaging, and controlled storage conditions to maintain stability without benzethonium chloride or similar additives
Solution Approach 2:
The invention optimizes pH and other formulation parameters to enhance the inherent stability of ketamine in aqueous solution. By adjusting parameters such as pH to ranges that maximize chemical stability, the formulation achieves extended shelf-life without requiring preservatives
3Device complexity
If ketamine is provided in single-use vials requiring dilution, then the formulation can be simple, but the administration process becomes complex and time-consuming
Solution Approach 1:
The invention combines the ketamine drug substance with the diluent and final formulation components into a single pre-filled container. This merging eliminates multiple steps (reconstitution, dilution, mixing) and provides a ready-to-administer solution that maintains formulation simplicity while dramatically improving ease of operation
Solution Approach 2:
The pre-filled syringes and infusion bags serve multiple functions: they contain the drug substance, provide the diluent, ensure proper dosing, maintain sterility, and enable immediate administration. This multi-functionality simplifies the overall administration process while maintaining formulation integrity
Data Source
AI summary
The invention relates to a sterile, ready-to-use, stable aqueous solution of ketamine suitable for direct intravenous infusion to a patient in need thereof, wherein the composition is disposed within a sealed infusion container as a premixture. The invention further relates to aqueous solutions of ketamine that are free of antimicrobials such as benzethonium chloride and are shelf-stable. The pharmaceutical compositions can be used, for example, wherein the subject is in need of anesthesia for a diagnostic or a surgical procedure.