Abstract
During wet granulation, the sample can be exposed to considerable mechanical effects, moisture content and elevated temperatures, and during high-shear granulation the impeller and chopper speeds can induce elevated temperatures and influence the parameters of the products. In our work, we therefore aimed to investigate the effect of cooling and process parameters on product parameters by factorial design in accordance with QbD guidelines. Our other goal was to study the effect of the type of granulation, therefore two series were used to prepare granules in a high-shear granulator, with water and binder solution as granulating fluid, at different chopper and impeller speeds with application of factorial design. The particle size was higher when cooling in the case of granules prepared with binder solution. The pepsin solution had a good granulating effect, the granules displayed a larger particle size, a higher breaking hardness and a favourable deformation process.
Highlights
Active peptides and proteins are increasingly becoming a very important class of therapeutic agents because of their highly specific activity and very well tolerability by the human body [1,2]
The sample can be exposed to considerable mechanical effects, moisture content and elevated temperatures, and during high-shear granulation the impeller and chopper speeds can induce elevated temperatures and influence the parameters of the products [39,40,41,42]
We found that due to friction, a significant temperature rise should be expected with the use of high impeller speeds [40,42]
Summary
Active peptides and proteins are increasingly becoming a very important class of therapeutic agents because of their highly specific activity and very well tolerability by the human body [1,2]. This may allow the direct application of these materials [3,4,5]. The major digestive enzyme of gastric juice, is responsible for the most digestive activity in the stomach [6]. The stability of enzymes is one of the most important parameter during formulation of dosage forms, in consequence of the great number of factors involved [11]
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