Vancomycin Aqueous Composition for Storage-Stable IV Dosing

The patent changes the formulation parameters by replacing the frozen storage requirement with a refrigerated storage system (2° C. to 8° C.). This is achieved by modifying the excipient composition - specifically using mannitol instead of glucose and adjusting the pH range to 3.5-6.5, which allows the solution to remain stable without freezing. The vancomycin concentration is maintained at 5 mg/mL in the final diluted form, but the concentrate contains higher concentration for dosing flexibility.

The patent employs single-use disposable IV bags containing the vancomycin solution. Each bag is pre-filled with a specific dose concentration (5-50 mg/mL) and is intended for single administration only. This eliminates the need for sterilization and complex storage infrastructure while maintaining stability, as each unit is sealed and sterile until use. The disposable nature also eliminates cross-contamination risks.

The patent removes the harmful excipients N-acetyl-D-alanine and PEG400 from the formulation. Instead, it uses mannitol as the primary excipient and adjusts the pH with hydrochloric acid and/or sodium hydroxide to the safe range of 3.5-6.5. This extraction of harmful components eliminates the fetal malformation risk while preserving the solution's stability and ease of administration.

The patent converts the challenge of formulating a stable vancomycin solution without harmful excipients into a benefit by using mannitol, which provides both stabilizing properties and safety for pregnant women. The pH adjustment system using common pharmaceutical agents (HCl and NaOH) creates a safe formulation that is both effective and non-toxic, turning the limitation into a safety advantage.

The patent creates a dynamic dosing system where the vancomycin concentrate can be adjusted to different final concentrations (5-50 mg/mL) based on patient needs. The concentrate is prepared at a higher concentration (e.g., 50 mg/mL) and can be diluted to various therapeutic levels, allowing clinicians to adapt the dose to different patient weights, infection severities, and renal functions. This dynamic adjustment capability provides both ease of use and dosing flexibility.

The patent segments the vancomycin product into a concentrate form that can be divided into different dosage units. Instead of providing fixed-dose pre-mixed bags, the concentrate allows clinicians to segment the total volume into appropriate doses for individual patients. This segmentation enables customization of dose volume and concentration while maintaining a simple single-bag administration process.