Vinca Alkaloid Ready-to-Infuse Aqueous Solution
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Solution Overview
Problem
Current pharmaceutical formulations of vinca alkaloid drugs require manipulation, such as reconstitution and dilution, posing risks to hospital personnel and stability issues due to sensitivity to oxygen, air, and temperature, with existing products being unstable at room temperature and prone to handling difficulties.
Innovation Solution
A ready-to-infuse aqueous solution of vinca alkaloid drugs in a flexible infusion container with light protective secondary packaging, stable at room temperature for extended periods, eliminating the need for manipulation and ensuring stability and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vinca alkaloid drugs are formulated as concentrated solutions requiring reconstitution and dilution, then the drug potency is maintained, but the risk of contact with hospital personnel increases and manipulation errors may occur
Solution Approach 1:
The patent applies preliminary action by providing the drug in a ready-to-infuse state at the point of use. The vinca alkaloid is supplied as a diluted aqueous solution in a flexible infusion container that can be directly connected to infusion equipment, eliminating the need for hospital personnel to perform reconstitution and dilution maneuvers. This preliminary preparation resolves the contradiction by maintaining dosage accuracy while removing the harmful contact risk during manipulation.
2Stability of the object's composition
If vinca alkaloid drugs are stored as aqueous solutions at room temperature, then the stability is improved, but the degradation of active agent occurs quickly
Solution Approach 1:
The patent applies parameter changes by optimizing the pH of the aqueous solution to a specific range (pH 3.0-6.0, preferably pH 3.5-5.0) and controlling the concentration of vinca alkaloid (0.01-3.0 mg/ml). These parameter adjustments, combined with using sterile water for injection as the solvent, enable the solution to remain stable at room temperature for extended periods without rapid degradation of the active agent.
3Reliability
If glass vials or ampoules are used for vinca alkaloid drugs, then the drug containment is effective, but the handling and transportation difficulty increases and breaking risk occurs
Solution Approach 1:
The patent applies flexible shells and thin films by replacing traditional rigid glass vials or ampoules with a flexible infusion container made of flexible polymeric material. This flexible container maintains effective drug containment while dramatically improving handling convenience and eliminating breaking risks during transportation and use.
4Stability of the object's composition
If antioxidants and preservatives are added to vinca alkaloid solutions, then the stability and sterility are maintained, but the excipient interactions increase and adverse effects may occur
Solution Approach 1:
The patent applies the taking out principle by removing antioxidants and preservatives from the formulation. The vinca alkaloid solution is prepared using only sterile water for injection as the solvent, without adding any antioxidants or preservatives. This extraction of harmful excipients maintains stability and sterility through proper formulation parameters while eliminating the risk of adverse effects from excipient-drug interactions.
Data Source
AI summary
The present invention relates to a dosage form comprising an aqueous solution of a vinca alkaloid drug or its pharmaceutically acceptable salt in a flexible infusion container, and a light protective secondary packaging containing the flexible infusion container, wherein the dosage form is ready-to-infuse and wherein the aqueous solution is stable at room temperature.