Open AccessComparative in vitro-in vivo correlation analysis with pioglitazone tablets
Author(s) -
Sajal Kumar Saha,
Ahsan Raja Chowdhury,
Sitesh Chandra Bachar,
Sreedam Chandra Das,
Ruhul Kuddus,
Md. Aftab Uddin
Publication year - 2013
Publication title -
asian pacific journal of tropical disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.208
H-Index - 33
ISSN - 2222-1808
DOI - 10.1016/s2222-1808(13)60105-x
Subject(s) - pioglitazone , in vivo , chromatography , chemistry , dissolution testing , hydrochloric acid , dissolution , dosage form , medicine , biopharmaceutics classification system , inorganic chemistry , microbiology and biotechnology , type 2 diabetes , biology , diabetes mellitus , endocrinology
Objective: To assess the in vitro-in vivo correlation of immediate release formulation of\udpioglitazone 30 mg film coated tablet.\udMethods: In vitro release data were obtained for test and reference formulation using the USP\udpaddle method (Apparatus 2) at 50 r/min and with the temperature of 37 °C in the dissolution\udmedium of 0.1 mol/L hydrochloric acid of pH 1.2. Twelve healthy volunteers were administered\udboth test and reference pioglitazone 30 mg tablet orally and blood samples were collected over 24\udh period. In vivo drug concentrations were analyzed by a simple, fast and precise reverse phase\udbinary HPLC method with UV detection to establish a correlation between in vitro release and in\udvivo absorption data.\udResults: Similarity factor (f2) and dissimilarity factor (f1) were determined for the time intervals\udof 5, 10, 15, 30, 45, 60, 75, 90, 105 and 120 min and the obtained values were 65.17%, 59.37%, 63.62%,\ud66.61%, 68.89%, 70.73%, 72.27%, 73.59%, 74.65% and 75.67% for f2 and 9.43%, 9.00%, 5.42%, 3.86%,\ud3.07%, 2.56%, 2.20%, 1.94%, 1.82% and 1.65% for f1 at respective time intervals. Mean dissolution\udtime for test and reference products were obtained at 3.06 and 3.40 min respectively. f2 and f1\udvalues obtained were within the acceptable range f2 (50%-100%) and f1 (<15%).\udConclusions: Comparison of dissolution profiles corroborate that the test and reference\udformulations are similar and there is no linear in vitro-in vivo correlation