EVALUATION OF THE GRANULOMETRY IMPACT OF THE COMPRESSION MIXTURE IN THE FORMULATION DEVELOPMENT OF TABLETS

The aim of this research was the preformulation and preliminary formulation studies of oral gastro-resistant tablets containing 500 mg mesalazine. Increased compliance of the patients, superior chemical stability and modified release modulation, enhanced by the local effect on the mucosa were elected as arguments for choosing this type of formulation. The impact and dependence relationship between the sizes of the obtained granules were evaluated through technical parameters, together with dissolution studies. Wet granulation of mesalazine and starch showed that the third formulation (F3) generates the highest amount (64.19%) of granules in the range 1000 - 300 mu m. Oblong tablets (pilot batches) were obtained and the cores were coated with an enteric acrylic agent. The results of the dissolution studies for the F2.2 formulation demonstrate the importance and the impact of the pre-compression phase on the dissolution process of the active substance.