Коллоидный журнал

After more than two decades of development, particulate formulations have gradually entered the industrialization stage, and their quality control is important. In the manufacturing process, many particles are originated from hydrophobic materials, they might be prepared as a suspension, and then filled. The physical stability of the particles in the suspension is an important aspect of the industrial production, because it influences the filling accuracy of the dose. Due to the tiny size, it is hard to determinate the particle status under the suspension stage. In this work, aiming at developing a method for characterizing the physical stability of particulate suspensions, the particle counting method was developed to establish a unique characterization technique for determining sedimentation of particulate drug delivery system. The methodology was validated, and particle sedimentation was test using poly (D,L-lactic acid)(PLA)micro suspensions, the dispersion coefficient of variation (MCV) was calculated to furthering express the stability of the suspension system. The methodological validation results showed that the RSD values of each validation term of the method were less than 10%, the sedimentation of the PLA particle suspension system could be determinated through the method, and the dispersion coefficient of variation (MCV) could distinguish subtle difference between the components. This method could effectively monitor the stability of opaque hydrophobic particles, improving the efficiency and accuracy of the conventional method. It was feasible and has potency to be applied for industrial scale, due to its high efficacy.