Bioavailability study of tablet Bezafibrate 200 mg (Lipocor).
In order to determine the ultimate quality of any formulated dosage form and rationalize the therapeutic plan as well as to individualize the prescription, in vivo measurement of drug is the modem and specialized expertise of the clinical/research area of pharmacy practice, which provides effectiveness and assures the safety of drugs. All pharmacological, therapeutic or toxic responses are subject to reaching of drug at the site of action through connective tissue. Other than physico chemical properties of drug, there are numerous factors from manufacturing process to biochemical behaviour of the individual which resist in the absorption, distribution, metabolism and elimination of drugs in the biological system. Bezafibrate Tablet 200 mg (Lipocor) an oral conventional formulation manufactured by Efroze Chemical Industries (Pvt.) Ltd. was investigated for bioavailability followed by pharmacokinetic studies on adult, male, healthy, human local population. For this purpose, a sensitive, specific and validated method was used for the estimation of bezafibrate in blood. HPLC was performed on a reversed phase C18 column (flow rate 1.5 ml/min, UV = 230 nm) with 0.02 M buffer of KH2PO4 (Adjusted pH 3.5 with Phosphoric Acid) and Methanol (40: 60) whereas extraction of the drug from the plasma was carried out by deproteinization of plasma according to classical method described in previous studies (Obaid A. et al., 1999). Peak level (Tmax) of Bezafibrate Tablet 200 mg (Lipocor) was observed at about 1.42 +/- 0.53 hours after the dose and practically free Bezafibrate Tablet 200 mg (Lipocor) could be detected in blood after 9 hours. Cmax of the investigated formulation of Lipocor register mark or target was 1732 +/- 374.2 ng/ml. Area under curve (AUC) was 5198.65 +/- 1231.8 ng. hr/ml.
Ali
Obaid
O
Ministry of Health, Govt. of Pakistan, Karachi, Pakistan.
Khan
M A S
MA
Obaid
Roohi
R
Ahmed
Syed Waseemuddin
SW