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Published on: March 3, 2023
Levofloxacin: Insights Into Antibiotic Resistance and Product Quality
Ensieh Izadi1, Gull Afshan2, Rahul P Patel1
1Division of Pharmacy, School of Medicine, University of Tasmania, Hobart, TAS, Australia.
Abstract:
Counterfeit and substandard medicines are recognized as one of serious threats to public health. The product quality of antibacterial medicine will compromise patients' recovery and increase the chance of antibacterial resistance. The review aims to provide a summary of low quality levofloxacin issues and the risk factors as well as suggesting the aspects of product quality that need to be regulated strictly. Quality of the active ingredient, levofloxacin, has an important role to contribute to successful therapy. The poor quality of raw material, directly and indirectly, causes treatment failure as the presence of insufficient dose, mislabeled content, and poor dissolution characteristics can lead to lower bioavailability. Identifying and reporting these factors can potentially help in improving the quality of drug marketed in various developing countries and may also reduce the incidences of treatment failure. Dissolution test is used for testing the dissolution profiles and the rate of drug release from solid formulation such as oral formulations, thus providing information regarding the in vivo performance of a formulation and its bioequivalence. On the other hand, quality-testing procedures are used for comparing the quality of products.
Insights
Substandard antibacterial medicines like levofloxacin threaten public health, leading to treatment failures and resistance. Improving drug quality control, especially for active ingredients, is crucial for patient safety and effective therapy.
Area of Science:
- Pharmaceutical Sciences
- Public Health
- Medicinal Chemistry
Background:
- Counterfeit and substandard medicines pose significant public health risks.
- Compromised antibacterial medicine quality can impede patient recovery and foster antimicrobial resistance.
- Levofloxacin quality is critical for therapeutic success, with substandard raw materials causing treatment failure.
Purpose of the Study:
- To summarize issues and risk factors associated with low-quality levofloxacin.
- To identify key product quality aspects requiring strict regulation.
- To aid in improving drug quality in developing countries and reducing treatment failures.
Main Methods:
- Review of existing literature on substandard levofloxacin.
- Analysis of factors contributing to poor drug quality, including raw material issues.
- Discussion of quality control methods like dissolution testing and general quality-testing procedures.
Main Results:
- Poor quality of the active ingredient (levofloxacin) leads to insufficient dosage, mislabeling, and poor dissolution.
- These quality defects result in reduced bioavailability and treatment failure.
- Identifying and reporting these factors can guide regulatory improvements.
Conclusions:
- Strict regulation of levofloxacin product quality is essential.
- Enhanced quality control measures, including dissolution testing, are vital for ensuring drug efficacy.
- Addressing substandard medicines can improve patient outcomes and combat antimicrobial resistance.
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