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Published on: August 20, 2015
Bioavailability study of tablet Bezafibrate 200 mg (Lipocor)
Obaid Ali1, M A S Khan, Roohi Obaid
1Ministry of Health, Govt. of Pakistan, Karachi, Pakistan.
Pakistan Journal of Pharmaceutical Sciences
|January 18, 2006
Summary
This study assessed the bioavailability and pharmacokinetics of Bezafibrate Tablet 200 mg (Lipocor) in healthy males. The formulation showed a peak drug concentration at 1.42 hours, with a maximum concentration of 1732 ng/ml.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Clinical Pharmacy and Drug Development
Background:
- In vivo drug measurement is crucial for assessing formulation quality, therapeutic efficacy, and patient safety.
- Drug absorption, distribution, metabolism, and elimination are influenced by numerous factors, including formulation and individual biochemical behavior.
Purpose of the Study:
- To investigate the bioavailability and pharmacokinetic profile of Bezafibrate Tablet 200 mg (Lipocor).
- To establish an individualized prescription and rationalize therapeutic plans through in vivo drug analysis.
Main Methods:
- A sensitive, specific, and validated High-Performance Liquid Chromatography (HPLC) method was employed for bezafibrate estimation in blood.
- Pharmacokinetic parameters were determined in adult, healthy, male subjects following oral administration of Bezafibrate Tablet 200 mg (Lipocor).
Main Results:
- The peak plasma concentration (Cmax) of bezafibrate was 1732 ± 374.2 ng/ml.
- The time to reach peak concentration (Tmax) was observed at 1.42 ± 0.53 hours.
- Bezafibrate was detectable in blood for up to 9 hours post-administration, with an Area Under the Curve (AUC) of 5198.65 ± 1231.8 ng.hr/ml.
Conclusions:
- The study provides essential pharmacokinetic data for Bezafibrate Tablet 200 mg (Lipocor).
- This information supports the quality assessment of the oral formulation and contributes to rational drug therapy.
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