Beca nacional Edna Teresa Alcantara Fierro
PEI 2015/220172All raw materials used for solid oral drugs manufacturing must be evaluated according
to the pharmacopoeial monographs, which consist in a verification of critical quality attributes related
to the identity and purity of the molecule. However, active pharmaceutical ingredients may present
differences in non-pharmacopoeial tests, such as particle size and shape or flow. Although these
differences are not evaluated routinely by Quality Control area, they can alter the technological
performance during production, as well the stability and ultimately the efficacy of a pharmaceutical
product. In this study, 10 production batches of magnesium valproate were evaluated, characterizing
flow index, fusion enthalpy and particle shape and size distribution. An analysis of variance was
carried out, finding statistically-significant differences in the flow index, particle shape and fusion
enthalpy tests for two batches. These differences may be due to small variations in the crystalline
configurations. The study showed differences in the characterization of fundamental and functional
properties of the particles of the active pharmaceutical ingredient evaluated, which could have an
impact on the manufacturing processes and affect therapeutic efficacy.CONACY