Effects of the controlled temperature in the production of high-shear granulated protein-containing granules

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.

Highlights

The effect of cooling on the activity of pepsin.

The application of cooling has a significant effect on the D50 value.

The granules prepared with binder solution has favourable deformation process.

The production of granules prepared with binder solution with cooling is recommended.

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.

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Materials

In the course of the experimental work, purified water (distilled water, pH. Eur. 10th Ed.) and microcrystalline cellulose (MCC; Vivapur 101, J. Rettenmaier & Söhne GmbH + Co., Rosenberg, Germany) (D50 65 μm; bulk density 0.29 g/cm³; data from producer) were used. The active pharmaceutical ingredient was porcine pepsin powder (pH. Eur. 10th Ed., Meditop Ltd., Pilisborosjenő, Hungary) (D50 10 μm). Bovine haemoglobin (Sigma-Aldrich), Folin-Ciocalteu reagent (Sigma-Aldrich), trichloroacetic acid (Molar Chemicals Ltd.), hydrochloric acid (pH. Eur. 10th Ed.) and sodium hydroxide (pH. Eur. 10th Ed.) were used for pepsin activity measurement.

Article information: Katalin Kristó, Elvira Csík, Dániel Sebők, Ákos Kukovecz, Tamás Sovány, Géza Regdon, Ildikó Csóka, Botond Penke, Klára Pintye-Hódi, Effects of the controlled temperature in the production of high-shear granulated protein-containing granules, Powder Technology, 2021. https://doi.org/10.1016/j.powtec.2021.10.003.