An Evaluation of Amoxicillin/Clavulanate Stability in Aqueous Systems, Including Its Suitability for Outpatient Parenteral Antimicrobial Therapy (OPAT)
Contact us if these videos are not relevant.
Contact us if these videos are not relevant.
View abstract on PubMed
Summary
This summary is machine-generated.Amoxicillin/clavulanate stability is adequate for Outpatient Parenteral Antimicrobial Therapy (OPAT) at 1 mg/mL and potentially 7.5 mg/mL at 2.9 °C. Higher concentrations and room temperature significantly reduce shelf-life, limiting administration times.
Area Of Science
- Pharmacology
- Clinical Pharmacy
- Drug Stability
Background
- Amoxicillin/clavulanate is a critical antibiotic combination for various infections.
- Outpatient Parenteral Antimicrobial Therapy (OPAT) requires stable antibiotic formulations for home administration.
- Evaluating the stability of amoxicillin/clavulanate at clinical concentrations is essential for OPAT efficacy and safety.
Purpose Of The Study
- To determine the shelf-life of amoxicillin at clinical concentrations in the presence of clavulanate.
- To assess the suitability of amoxicillin/clavulanate for Outpatient Parenteral Antimicrobial Therapy (OPAT) based on stability data.
Main Methods
- Developed and validated a stability-indicating High-Performance Liquid Chromatography (HPLC) assay.
- Conducted kinetic studies at amoxicillin concentrations of 1 mg/mL and 15 mg/mL across a temperature range of 40-60 °C.
- Investigated stability in elastomeric infusers at 2.9 °C with varying pH levels for different amoxicillin concentrations (1 mg/mL, 7.5 mg/mL, 15 mg/mL).
Main Results
- Amoxicillin and clavulanate demonstrated linear concentration relationships and baseline separation from degradation products.
- At 1 mg/mL, amoxicillin had a shelf-life of 22.8 hours at 25 °C, and clavulanate had 4.0 hours.
- Stability was adequate at 2.9 °C for 1 mg/mL and 7.5 mg/mL concentrations, but not for 15 mg/mL. Lowering pH significantly improved shelf-life at refrigerated temperatures.
Conclusions
- Amoxicillin/clavulanate exhibits sufficient stability at 2.9 °C for OPAT at 1 mg/mL and potentially 7.5 mg/mL.
- Higher concentrations (15 mg/mL) and storage at 25 °C result in limited shelf-life, impacting administration duration.
- Optimizing pH and temperature is crucial for extending the stability of amoxicillin/clavulanate in OPAT settings.
Contact us if these videos are not relevant.
Contact us if these videos are not relevant.
Related Concept Videos
Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...