ORAL SUSPENSION OF ABEXOL AND ITS ANALYTICAL METHOD

Abstract

A new formulation with the active ingredient (AI) of Abexol® is presented. This formulation consists on an oral aqueous suspension with gastroprotective effects greater than that of the current commercialized tablet, which was demonstrated through pharmacological and clinical studies. This suspension was formulated for containing 10 mg fatty alcohols per milliliter, so that 5 ml contain a doses equivalent to one tablet. In this formulation, the particle size of the AI was reduced to 0,52μm by change of temperature at high stirring speed in aqueous medium with Cremophor RH40 as surfactant, and later the following excipients were added: refined glicerine as moisturizer, microcrystalline cellulose and carboxymethylcellulose sodium as suspending agents, methyl and propylparabene in ethanol, as preservatives, extract with banana flavor and purified water. The obtained suspension, after shaking, was a homogeneous, white, and opaque liquid with a light banana flavor, pH from 6.5 to 8.0, viscosity of 380 cPs, phases separation time > 1 h and also fulfilled the other quality parameters of the pharmaceutical industry, such as the deliverable volume and the microbiological content. For determining the concentration of fatty alcohols (chemical markers) in this suspension, it was developed a method by Gas Chromatography. Validation process of this method demonstrated that it is linear from 50 to 150 % of the nominal doses, accurate from 80 to 120 % of the nominal doses (recoveries not significantly different from 100 %), precise (CV of repeatability and intermediate precision < 4%) and specific (even for samples submitted to degradation conditions).