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Evaluation of some water-miscible organic solvents for spray-drying enzymes and carbohydrates.

Drug development and industrial pharmacy (2013-04-20)
Anke Sass, Geoffrey Lee
ABSTRACT

The spray-drying behaviour of 16 water-miscible organic solvents on a bench-scale machine (Büchi B290 with inert loop) was determined under mild-to-moderate process conditions, namely inlet gas temperature of 130 °C and liquid feed flow rate of ≤3 mL/min. The solvents with boiling points below the inlet gas temperature could be fully dried (Group 1 solvents). The two exceptions were DMSO and DMF which despite their higher boiling points could be fully dried. The remaining solvents with boiling points above the inlet gas temperature were not fully dried during passage through the spray-dryer (Group 2 solvents). Trypsin and lysozyme when spray-dried from Group 1 solvent binary mixtures with water showed similar inactivation and residual water content, independent of solvent. The level of residual solvent was, however, strongly dependent on solvent. Trehalose (20%) and mannitol (10%) could be spray-dried from DMSO/water binary mixtures, but the amorphous disaccharide required higher inlet gas temperature. Trehalose/trypsin and mannitol/trypsin formulations showed differing degrees of protection against enzyme inactivation when spray-dried from Group 1 solvent binary mixtures with water. In all solvents the mannitol protected as well, if not better, than the trehalose. This study identifies some suitable organic solvents for spray-drying protein formulations, but also shows the difficulties of remaining organic solvent under the moderate inlet gas temperature used.

MATERIALS
Product Number
Brand
Product Description

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