Tebipenem Pivoxil is an orally administered carbapenem antibiotic prodrug. It is the pivaloyloxymethyl ester of tebipenem and is converted after oral administration to the active antibacterial agent tebipenem. It belongs to the β-lactam carbapenem class and was developed for oral treatment of bacterial infections.
Tebipenem Pivoxil was approved in Japan in 2009 and marketed as Orapenem. Japanese regulatory documentation identifies the active pharmaceutical ingredient as Tebipenem Pivoxil with molecular formula C22H31N3O6S2 and molecular weight 497.63.
Tebipenem Pivoxil is an oral prodrug designed to improve the oral delivery of tebipenem. Following administration, the ester bond is cleaved and active tebipenem becomes available.
The API has the following key chemical identifiers:
PMDA specifically describes the API as a white crystalline powder.
Tebipenem Pivoxil is used as an oral carbapenem antibiotic and has been marketed in Japan for bacterial infections including otorhinolaryngological infections, otitis media and bacterial pneumonia.
Its active metabolite, tebipenem, exerts antibacterial activity by interfering with bacterial cell-wall synthesis. Current U.S. regulatory material also describes tebipenem pivoxil as a prodrug that is converted to tebipenem following oral administration.
Tebipenem Pivoxil requires careful quality control because carbapenem APIs can be sensitive to environmental conditions. PMDA stability data showed increases in related substances and decreases in content under elevated temperature, high humidity and light-stress conditions.
Quality-control testing can include:
Published analytical research has specifically identified multiple Tebipenem Pivoxil related substances for API quality control.
Swapnroop provides pharmaceutical API solutions with quality-focused analytical testing, technical documentation and supply support for pharmaceutical development and manufacturing requirements.
Tebipenem Pivoxil can be supported with appropriate product specifications, CoA and technical documentation according to the intended pharmaceutical application.
Tebipenem Pivoxil should be protected from moisture, heat and light. PMDA's API stability program used double polyethylene bags, an aluminium bag and fibre drums for long-term storage at 5 ± 3°C. The stability assessment also demonstrated sensitivity to elevated temperature, humidity and light.
For commercial material, the actual storage condition should follow the approved specification and stability data associated with the supplied batch.
Available documentation can include:
Swapnroop focuses on quality-oriented pharmaceutical API solutions with analytical testing and technical documentation. Tebipenem Pivoxil can be supplied according to agreed specifications and customer requirements for pharmaceutical development and manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% |
| Water Content | 0–2.0 mol |
| Specific Rotation | +10.3° to +10.7° |