Although high shear mixers can represent a single-pot process, separate drying equipment is com-monly 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 con-taining 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 mi-gration and crystallization on the granule surface. In conclusion, while DSP offers advantages, careful consideration of the drying technique is essential during product development.

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

Nicola Realdon;
2024-01-01

Abstract

Although high shear mixers can represent a single-pot process, separate drying equipment is com-monly 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 con-taining 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 mi-gration and crystallization on the granule surface. In conclusion, while DSP offers advantages, careful consideration of the drying technique is essential during product development.
2024
Single-pot process
High shear mixer
Effect of drying
Compression properties
API solubility
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/1146893
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