Ready-to-Infuse Phenylephrine Compositions for Direct Dosing
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Solution Overview
Problem
Current phenylephrine formulations require dilution before use, leading to potential dosing errors and the presence of sulfites that can cause allergic reactions, necessitating a stable, ready-to-infuse, sulfite-free composition.
Innovation Solution
Aqueous phenylephrine injection solutions with citrate buffer and pH adjusters, packaged in flexible plastic containers with oxygen scavengers, ensuring stability and sterility without sulfites, suitable for immediate use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If phenylephrine is formulated as a concentrated intravenous solution requiring dilution, then the product can be stored longer and transported more efficiently, but dosing errors may occur and sulfites must be added as antioxidants
Solution Approach 1:
The patent prepares phenylephrine at the optimal therapeutic concentration (80 mcg/mL or 400 mcg/mL) in advance during manufacturing, eliminating the need for hospital staff to perform dilution calculations and operations. This preliminary action ensures both long-term storage stability and dosing accuracy without requiring sulfite antioxidants.
2Stability of the object's composition
If phenylephrine is formulated with sulfites as antioxidants, then the solution maintains stability during storage, but allergic reactions may occur in susceptible patients
Solution Approach 1:
The patent removes sulfites and other antioxidants from the phenylephrine formulation entirely. Instead, the formulation achieves stability through precise pH control (3.5-5.5 using citric acid buffer) and sterile filtration, eliminating the harmful allergic reactions associated with sulfite additives while maintaining solution stability during storage and infusion.
3Adaptability or versatility
If hospitals compound phenylephrine in variable concentrations, then flexibility in dosing is achieved, but the burden on hospital clean rooms increases and sterility may be compromised
Solution Approach 1:
The patent provides universal, ready-to-use phenylephrine formulations at two standard concentrations (80 mcg/mL for vasodilatory shock, 400 mcg/mL for other indications) that can be directly infused without further preparation. This eliminates the burden on hospital clean rooms while maintaining dosing flexibility through the selection of appropriate concentration and infusion rate adjustment.
4Ease of operation
If phenylephrine solution is diluted before use, then the medication can be administered at appropriate concentrations, but treatment errors may occur during transfer between hospital settings
Solution Approach 1:
The patent makes phenylephrine self-service ready-to-infuse formulations that require no dilution or preparation by hospital staff. The formulations are provided at the exact therapeutic concentration needed, with clear labeling and standardized packaging that eliminates errors during transfer between hospital settings. The product serves itself by being immediately usable without requiring knowledge of dilution calculations or preparation procedures.
Data Source
AI summary
The present invention relates to stable ready-to-infuse sulfite free compositions of phenylephrine or a pharmaceutically acceptable salt thereof and methods for preparing the same.