Relevant phenomena and process parameters in granulation for manufacturing of pharmaceutical, nutraceutical and zootechnical products

Abstract

Wet granulation is a size enlargement process used in many fields, such as pharmaceutical, nutraceutical, zootecnichal, etc., due its ability to improve technological properties of the final product, compared to the powder form, and/or to realize suitable delivery systems for drug/functional molecules for oral administrations/food preparations and/or to produce intermediate processing products. In spite of its widespread use, economic importance and almost 50 years of research, granulates manufacture is still based on empirical approach. Moreover, phenomena involved in powders aggregation are not well understood, and thus it is difficult to successfully obtain a product with tailored features without extensive experimental tests. In the scientific literature the approach to the granulation study is based on experimental tests, to investigate the impact of formulation and process variables on granules properties, or on modeling activities, to mathematically describe the involved phenomena. The two approaches, experimental and theoretical, are rarely applied together. In this study a novel integrate strategy of investigation was applied to elucidate the role of the phenomenological aspects, and their connection with the main operating parameters in granulation process, on the granules final properties, in order to develop physical-mathematical descriptions of the size enlargement unit operation, which can indubitably constitute a starting point for scale up purposes. ... [edited by Author]