An assessment of the interactions between diclofenac sodium and ammonio methacrylate copolymer using thermal analysis and Raman spectroscopy.

The objective of the work was to assess the possible interactions between the model drug diclofenac sodium (DS) and the water-insoluble ammonio methacrylate copolymer (AMC). Films with different drug/polymer ratios were therefore prepared by the solvent casting method and investigated as a preformulation study towards sustained release microparticles. Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) were used to investigate the dispersed/dissolved state of the DS in the preparation, the thermal stability and the properties of DS-containing AMC films; and Raman spectroscopy was used to confirm the possible interactions between DS and AMC. Thermoanalytical studies confirmed that the DS could behave as a plasticizer, which was indicated by decreasing glass transition temperature (Tg) of the AMC, depending on its dispersity level in the AMC matrix. Partially solid solutions were formed at DS/AMC ratios of 1:12, 1:8 and 1:6. The DS was mainly crystalline at DS/AMC ratio of 1:4, while it remained crystalline at a ratio of 1:2. The Raman spectra confirmed that none of the major structural changes revealed any significant difference, which can indicate a strong ionic interaction between the DS and the AMC. The investigations provided good facilities for the selection of a DS/AMC ratio, in the preformulation study of the microsphere preparation process, in conformity with the therapeutic aim.