SOLID DISPERSION AND IONOTROPIC GELATION TECHNIQUE FOR OBTAINING CONTROLLED DRUG DELIVERY SYSTEM CONTAINING DICLOFENAC AND PANTOPRAZOLE

E.E. Zien El-Deen*, M.M. Ghorab, S. Gad, H.A. Yassin

ABSTRACT

Non-steroidal anti-inflammatory drugs (NSAID) are among the most commonly prescribed agents for rheumatic disorders such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. One of the best choices to improve the GI safety is the co-medication of proton pump inhibitors (PPIs) with NSAID in one formula to suppress gastric acid. A fixed NSAID/PPI combination ensures expected protective effects by improving patients’ PPI adherence and physicians’ PPI prescription persistence. A fixed combination of enteric-coated diclofenac/pantoprazole formula was been studied. An accurate simple and précised method was adopted for simultaneous determination of diclofenac and pantoprazole in a physical mixture form. The method is based on measuring the first derivative amplitudes at 285.20 nm and 272.60 nm for diclofenac and pantoprazole respectively in 0.1N HCl using 0.1N HCl as a blank. The first derivative values of absorbance at 288.90 nm and 275.60 nm were measured for diclofenac and pantoprazole respectively in phosphate buffer (pH7.4) using phosphate buffer (pH7.4) as a blank. The obtained results were validated for accuracy, precision, LOD, LOQ and were found to be satisfactory. The proposed method is sample, rapid and suitable for the assay of such combinations.

Keywords: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.