Abstract
Precipitation with compressed antisolvent (PCA) process was used to produce fine particles of Ibuprofen Sodium with the ultimate goal of obtaining controlled particle size and size distribution of this non-steroidal anti-inflammatory drug. This systematic investigation shows that particle size and size distribution of the final product can be controlled reproducibly by varying a number operating parameters such as antisolvent addition rate, temperature, concentration, and solution addition rate. The mechanisms that control particle size and particle size distribution were explained by invoking the differences in the relative weight of primary, secondary nucleation and growth kinetic phenomena. A number of techniques were used for the characterization of the generated particles. In addition to scanning electron microscope (SEM), dynamic light scattering measurements were conducted to determine the size of the particles in terms of number-weighted size distribution. The influence of process parameters on the Ibuprofen Sodium crystallinity was investigated using X-ray diffraction (XRD). Moreover, the ‘‘in vitro’’ drug performance was tested. The results showed an improvement of the PCA processed Ibuprofen Sodium ‘‘in vitro’’ drug activity. In addition, dissolution investigations demonstrated that the flow rate, in combination with the particle size distribution, substantially influence the drug “in vitro” dissolution.