Effects of water content, particle size and density on the dissolution profile of mannitol

Abstract

In this study the reason for fluctuation of assay test results during in process quality control of injectable mannitol solution production was investigated. Particle size distribution, water content, thermographic behavior, Fourier-transform infrared spectroscopy (FTIR) and dissolution profile were evaluated using differential light scattering, Loss on drying method, differential scanning calorimetry (DSC), FTIR and intrinsic dissolution rate respectively. Results showed that change in water content of mannitol powder could result in particle size distribution and dissolution profile change. Based on the results of this study, we recommend that water content of mannitol must be measured before adding it to the any formulation. Manufacturers could be able to justify mixing time, temperature and rate based on water content test results. It will be helpful for pharmaceutical industries if mannitol producers add some extra tests to their current Certificate of Analysis (CoA) including particle size distribution, polymorphism, and dissolution profile based on intrinsic dissolution rate (IDR) which are not pharmacopoeia tests for this material.