Compositions Comprising Ephedrine Or An Ephedrine Salt And Methods Of Making And Using Same

What is this patent about?

’752 is related to the field of pharmaceutical formulations, specifically addressing the need for a stable, ready-to-use injectable solution of ephedrine sulfate . Current FDA-approved formulations require dilution before administration, which is inconvenient, time-consuming, and prone to errors and contamination. The background highlights the clinical shortcomings of existing ephedrine sulfate products, including short shelf lives and the risks associated with aseptic compounding and dilution procedures.

The underlying idea behind ’752 is to create a pre-diluted, sterile, and shelf-stable ephedrine sulfate formulation that eliminates the need for on-site dilution. This is achieved by carefully controlling the composition, specifically the concentrations of ephedrine sulfate and sodium chloride in water, while excluding preservatives and chelating agents that can cause adverse reactions. The formulation is designed to maintain its stability and potency over an extended period, even under accelerated storage conditions.

The claims of ’752 focus on a packaged pharmaceutical product containing a sterilized ready-to-use ephedrine composition . The key elements include a specific concentration of ephedrine sulfate (5 mg/mL), sodium chloride (9 mg/mL), the absence of preservatives, and a controlled pH. The claims also specify performance criteria after storage, including maintaining a high percentage of the initial ephedrine sulfate concentration, a stable pH, and acceptable bacterial endotoxin levels.

In practice, the invention involves combining ephedrine sulfate, sodium chloride, and water under sterile conditions to create a solution with the specified concentrations and pH. This solution is then packaged in a syringe or single-use container and sterilized. The absence of preservatives and chelating agents simplifies the formulation and reduces the risk of adverse reactions, while the specific concentrations and sterilization process ensure stability and sterility.

The differentiation from prior approaches lies in the combination of ready-to-use convenience, long-term stability, and the exclusion of potentially harmful excipients. Unlike existing products that require dilution and may contain preservatives, ’752 provides a safe and efficient solution for administering ephedrine sulfate in clinical settings, reducing the risk of errors, contamination, and adverse patient reactions. The focus on a simple, stable formulation is a key departure from more complex approaches.