Non-aqueous Anticancer Suspension for Stable Ready-to-Use Injection
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Solution Overview
Problem
Current lyophilized anticancer drug formulations require complex reconstitution processes, are prone to degradation in aqueous solutions, and lack a stable, easy-to-handle, ready-to-use injectable form, posing challenges in administration and stability.
Innovation Solution
Development of a non-aqueous injectable suspension of water-soluble anticancer agents, comprising stabilizing agents and a non-aqueous vehicle, which is stable at room temperature and ready to use or ready to dilute, eliminating the need for complex reconstitution procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If lyophilized anticancer drug formulations are used, then storage stability is improved, but administration complexity increases due to required reconstitution procedures
Solution Approach 1:
The patent changes the physical state parameter of the formulation from lyophilized powder to liquid suspension, and changes the chemical composition parameter by using non-aqueous vehicles instead of aqueous solutions. This allows the drug to be supplied in a ready-to-use liquid form that maintains stability without requiring reconstitution, thus resolving the contradiction between storage stability and administration complexity
Solution Approach 2:
The patent introduces non-aqueous vehicles (such as oils or esters) as intermediaries to suspend the anticancer drug particles. This intermediary medium allows the drug to remain stable in liquid form without requiring water-based reconstitution, thereby simplifying administration while maintaining storage stability
2Quantity of substance
If aqueous solutions of anticancer agents are used, then solubility is improved, but drug degradation increases due to hydrolysis
Solution Approach 1:
The patent changes the chemical composition parameter by replacing aqueous vehicles with non-aqueous vehicles. This parameter change maintains adequate drug solubility and suspension stability while eliminating the hydrolysis pathway that causes drug degradation in aqueous environments, thus resolving the contradiction between solubility and drug stability
Solution Approach 2:
The patent creates an inert chemical environment by using non-aqueous vehicles that do not participate in hydrolysis reactions. This inert environment protects the anticancer drug from degradation while still allowing the drug to remain in a usable liquid suspension form, resolving the contradiction between solubility and stability
3Ease of operation
If non-aqueous suspension is used, then ease of administration is improved, but formulation complexity increases due to stabilizing agent requirements
Solution Approach 1:
The patent employs stabilizing agents that automatically perform the function of preventing drug precipitation and aggregation in the non-aqueous suspension. These self-acting stabilizers maintain formulation stability without requiring complex external control mechanisms or additional processing steps, thus resolving the contradiction between ease of administration and formulation complexity
Data Source
AI summary
The present invention provides a non-aqueous suspension of anticancer agent, particularly injectable suspension. The present invention particularly provides a non-aqueous injectable suspension of anticancer agent comprising therapeutically effective amount of water-soluble anticancer agent, with or without stabilizing agent, non-aqueous vehicle and optionally one or more inactive excipients and also provides process for preparing the same.