Effect of the drying type on the properties of granules and tablets produced by high shear wet granulation

Although high shear mixers can represent a single-pot process, separate drying equipment is commonly employed. Limited literature exists on the use of a heating jacket coupled with a vacuum pump typically used in a single-pot setup, so this study compares the drying effects of a single-pot setup (DSP) and ventilated oven (DVO) on the properties of granules and tablets. Granules containing three actives of varying water solubility were produced and characterised. The results showed that DSP reduced the drying time and produced smaller, irregular, and weaker granules with different compression mechanisms. The tablets were produced and characterised. All tablets passed the uniformity test. Compression differences had no impact on tablet properties for poorly water-soluble actives, but altered properties for highly soluble actives due to increased active migration and crystallization on the granule surface. In conclusion, while DSP offers advantages, careful consideration of the drying technique is essential during product development.

Materials

Microcrystalline cellulose (MCC, Vivapur 101) was kindly donated by JRS Pharma (JRS Pharma, Germany). Caffeine anhydrous FU-BP-USP, Paracetamol FU-BP-Ph.Eu, Monohydrate Lactose (GranuLac® 70), Polyvinylpyrrolidone K30 (Luviskol K30), Sodium starch glycolate EP, colloidal silica (Aerosil), and Magnesium stearate were all purchased by Acef (Acef SpA, Italy); Brilliant green was purchased by Sigma Aldrich (Sigma Aldrich, Italy) and finally Citric acid anhydrous was purchased by Faravelli.

Erica Franceschinis, Valentina Bressan, Elena Fontanel, Nicola Realdon, Silvia Volpato, Andrea C. Santomaso,
Effect of the drying type on the properties of granules and tablets produced by high shear wet granulation,
Powder Technology, Volume 434,2024, 119316, ISSN 0032-5910,
https://doi.org/10.1016/j.powtec.2023.119316.

excipients formulation