Co-Lyophilized Antibiotic Composition for Consistent Fixed Dosing
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Solution Overview
Problem
Durlobactam sodium, a β-lactamase inhibitor, has poor flow properties and is highly hygroscopic, leading to processing challenges and user errors in administering fixed dosage combinations with sulbactam sodium, resulting in inconsistent dosing and chemical waste.
Innovation Solution
Co-lyophilizing durlobactam sodium and sulbactam sodium together to improve flow properties, allowing for fixed dosage combinations with minimal powder adhesion and maintaining stability over time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If durlobactam sodium is formulated as a dry powder in glass vials, then fixed dosage combinations with sulbactam sodium are possible, but significant powder adhesion to filling equipment occurs due to poor flow properties and high hygroscopicity
Solution Approach 1:
The patent combines durlobactam sodium and sulbactam sodium into a single lyophilized powder mixture in one vial, eliminating the need for separate vials and manual combination. This merging approach resolves the adhesion problem by creating a unified formulation that flows more predictably and reduces dosing inconsistency caused by separate handling of multiple powders.
Solution Approach 2:
The patent modifies the physical state and composition parameters of the formulation by using lyophilization (freeze-drying) to create a porous, low-moisture powder structure. This parameter change improves flow properties and reduces hygroscopicity, allowing consistent dosing while maintaining the fixed dosage combination.
2Adaptability or versatility
If separate vials of durlobactam sodium and sulbactam sodium are used, then formulation flexibility is maintained, but processing complexity and user error risk increase
Solution Approach 1:
The patent merges two separate vials into one combined vial containing both durlobactam sodium and sulbactam sodium in fixed dosage. This eliminates the complexity of handling, reconstituting, and combining multiple vials, while maintaining formulation flexibility through pre-established fixed dosage ratios suitable for various infections.
3Adaptability or versatility
If manual reconstitution and combination of multiple vials is performed, then dosing adjustment flexibility is maintained, but time consumption and chemical waste increase
Solution Approach 1:
The patent performs the dosing combination action in advance during manufacturing by pre-mixing durlobactam sodium and sulbactam sodium in fixed dosages within the vial. This preliminary action eliminates the need for manual reconstitution and combination at the point of use, significantly reducing processing time and minimizing chemical waste from partial vial usage.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The co-lyophilized fixed dosage combinations of durlobactam-sulbactam exhibit improved flow properties and stability, enabling reliable and consistent dosing with minimal impurity increase, suitable for treating multidrug-resistant bacterial infections.
Implementation Method 1
co-lyophilizing durlobactam sodium and sulbactam sodium together improves the flow properties
Data Source
AI summary
Provided herein are fixed dosage combinations of durlobactam and sulbactam along with their use in treating one or more bacterial infections.