Durlobactam is a pharmaceutical active pharmaceutical ingredient (API) belonging to the β-lactamase inhibitor class. It is a diazabicyclooctane (DBO) β-lactamase inhibitor developed to restore the activity of certain β-lactam antibiotics against resistant Gram-negative bacteria.
Durlobactam is a synthetic, non-β-lactam β-lactamase inhibitor. It inhibits a broad range of serine β-lactamases, including enzymes that can contribute to resistance against β-lactam antibiotics.
Durlobactam is commercially used in combination with sulbactam in the antibacterial medicine sulbactam/durlobactam for appropriate serious infections caused by susceptible bacteria.
Durlobactam is a small-molecule pharmaceutical API used in the manufacture of antibacterial pharmaceutical formulations. Its primary role is to inhibit β-lactamase enzymes and protect sulbactam from enzymatic degradation.
Durlobactam binds to and inhibits susceptible serine β-lactamases, including class A, class C and some class D β-lactamases. By inhibiting these enzymes, it helps prevent degradation of the accompanying β-lactam antibacterial agent and can restore or enhance antibacterial activity.
Durlobactam is used in combination with sulbactam for the treatment of:
The approved indication and use depend on the applicable regulatory labeling.
Durlobactam is a synthetic small-molecule compound supplied as a pharmaceutical-grade active ingredient. Its physicochemical characteristics support its formulation as an antibacterial β-lactamase inhibitor.
Durlobactam API intended for pharmaceutical manufacturing should be produced under appropriate GMP controls and tested according to applicable regulatory requirements. Quality evaluation may include identity, assay, related substances, water content, residual solvents, elemental impurities and other relevant quality attributes.
Durlobactam is a specialized antibacterial API used in combination with sulbactam in formulations targeting resistant Gram-negative bacterial infections. Pharmaceutical manufacturers and formulation developers can evaluate Durlobactam based on applicable regulatory requirements, analytical documentation, quality specifications and batch-specific Certificate of Analysis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |