Vancomycin Hydrochloride Oral Liquid for Contamination Control
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Solution Overview
Problem
Current methods for administering vancomycin hydrochloride, such as mixing powder with sterile water for injection, are cumbersome, time-consuming, and prone to contamination, leading to potential infection and decreased patient compliance, especially in pediatric and geriatric populations.
Innovation Solution
A non-sterile stable liquid oral formulation of vancomycin hydrochloride, comprising vancomycin hydrochloride, citric acid, and a preservative, is developed, which is homogenous and stable for at least 30 days at ambient and refrigerated conditions, enhancing stability and patient compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If vancomycin hydrochloride powder is mixed with sterile water for injection, then the medication can be administered, but the process is cumbersome, time-consuming, and prone to contamination
Solution Approach 1:
The patent applies preliminary action by pre-formulating vancomycin hydrochloride in a stable liquid oral formulation that is ready for immediate administration. The formulation is prepared in advance with all necessary components (vancomycin hydrochloride, citric acid, and preservative) already mixed and stabilized, eliminating the need for bedside reconstitution and reducing contamination risk during administration.
Solution Approach 2:
The patent introduces an intermediary substance - a preservative system comprising citric acid and additional preservatives - that mediates between the vancomycin hydrochloride and the aqueous environment. This intermediary protects the formulation from contamination and degradation, enabling stable liquid formulation without requiring sterile water for injection.
2Stability of the object's composition
If vancomycin hydrochloride is formulated as a stable liquid oral formulation with preservatives, then stability and ease of administration are improved, but the formulation complexity increases
Solution Approach 1:
The patent applies parameter changes by optimizing the pH of the formulation through citric acid addition. By controlling the pH parameter within a specific range, the formulation achieves enhanced stability of vancomycin hydrochloride while maintaining palatability and preventing precipitation. This single parameter optimization enables a simpler formulation approach compared to multiple stabilizing agents.
Solution Approach 2:
The patent creates a composite liquid oral formulation combining vancomycin hydrochloride with citric acid and preservatives in specific concentrations. This composite formulation achieves synergistic effects where the components work together to provide stability, prevent contamination, and maintain drug efficacy, resulting in a practically simple single-bottle ready-to-administer product.
3Quantity of substance
If intravenously-administered vancomycin is used, then systemic delivery is achieved, but it cannot penetrate the colon to reach therapeutic concentrations
Solution Approach 1:
The patent applies the taking out principle by extracting vancomycin from the intravenous administration route and reformulating it specifically for oral delivery. The formulation is designed to be taken orally and delivered directly to the colon, bypassing the liver first-pass metabolism and achieving high local concentrations at the target site without requiring systemic circulation.
Solution Approach 2:
The patent utilizes the hydraulic principle of oral fluid delivery to transport the vancomycin formulation through the gastrointestinal tract. The liquid formulation is swallowed and moves through the digestive system via peristalsis, delivering the medication directly to the colon where C. difficile infections occur, achieving target site concentration without intravenous injection.
Data Source
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AI summary
The invention relates to stable vancomycin hydrochloride powder for oral liquid formulations. Also provided herein are methods of using vancomycin oral liquid formulations for the treatment of certain diseases such as Clostridium difficile pseudomembranous colitis and Staphylococcal enterocolitis as well as kits and related products thereof.