Ready-to-Use IV Diltiazem Solution for Extended Stability
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Solution Overview
Problem
Current diltiazem hydrochloride IV solutions require frequent dilution before use, leading to risks of microbial contamination, calculation errors, and physicochemical instability, necessitating disposal within 24 hours.
Innovation Solution
A ready-to-use, stable diltiazem solution at concentrations between 0.5 to 2.0 mg/ml, preferably 1.0 mg/ml, is formulated without stabilizers like sorbitol, and packaged in flexible sterile containers, maintaining stability for up to 12-24 months under refrigeration and at least one month at room temperature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If diltiazem hydrochloride is provided as a concentrated solution (5 mg/ml) requiring dilution before use, then the solution can be stored for extended periods, but the dilution process introduces microbial contamination risk and calculation errors
Solution Approach 1:
The patent applies preliminary action by pre-diluting the diltiazem hydrochloride to the desired concentration (1 mg/ml) during the manufacturing process, rather than requiring end-users to perform dilution. This pre-prepared diluted solution is then sterile-filled and packaged, eliminating the need for on-site dilution operations while maintaining extended shelf life through controlled formulation conditions
2Ease of operation
If diltiazem solution is diluted immediately prior to use, then the solution can be administered to patients, but the solution becomes unstable and must be discarded within 24 hours
Solution Approach 1:
The patent applies parameter changes by optimizing the formulation parameters of the diluted diltiazem solution, specifically adjusting pH to a range of 3.0-6.0 and controlling osmolality, to achieve enhanced stability. These parameter modifications allow the diluted solution to maintain its chemical integrity and potency for extended periods (up to 24 months under refrigeration) without requiring immediate use
3Ease of operation
If diltiazem is provided as a ready-to-use diluted solution, then the need for on-site dilution is eliminated, but the solution requires stabilizers like sorbitol which may not be desirable for all patients
Solution Approach 1:
The patent applies the extraction principle by removing the stabilizing sugar component (sorbitol or other carbohydrates) from the formulation while maintaining solution stability through alternative means, specifically pH control (3.0-6.0) and osmolality adjustment. This creates a sugar-free ready-to-use diltiazem solution that eliminates the harmful effects of sugar-related complications while preserving the convenience of immediate administration
Data Source
AI summary
A ready-to-use intravenous (IV) diltiazem composition that can be stored for extended periods.