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声悬浮器中的单滴蒸发动力学与颗粒形成。第2部分:甘露醇、海藻糖或过氧化氢酶水溶液微滴的干燥动力学与颗粒形成。

Single-droplet evaporation kinetics and particle formation in an acoustic levitator. Part 2: drying kinetics and particle formation from microdroplets of aqueous mannitol, trehalose, or catalase.

作者信息

Schiffter Heiko, Lee Geoffrey

机构信息

Department of Pharmaceutics, Friedrich-Alexander-University, Erlangen, Germany.

出版信息

J Pharm Sci. 2007 Sep;96(9):2284-95. doi: 10.1002/jps.20858.

Abstract

A single droplet drying acoustic levitator has been used to examine the drying behavior of droplets of pharmaceutically relevant solutes used to produce protein-loaded particles via spray-drying. The drying behavior of solution droplets of mannitol, trehalose, or catalase was determined. Evidence of super-saturation of the solute in the droplet surface up to the critical point of drying was obtained. The trehalose achieves a lower degree of super-saturation than does the mannitol before precipitating at the droplet surface. This results in a shorter duration of the constant-rate period, but protracted further drying of this amorphous material. Mannitol achieved a higher degree of super-saturation, and a later critical point with shorter falling-rate period. Measurements of dried particle radius showed that both solutes form hollow particles. The catalase formed holed, hollow particles with characteristic drying rate profiles that correlated well with developing particle morphology. A strong similarity between the morphologies of dried particles of mannitol, trehalose, or catalase produced either in the levitator or in a spray-dryer was found.

摘要

一种单滴干燥声悬浮器已被用于研究用于通过喷雾干燥生产载蛋白颗粒的药学相关溶质液滴的干燥行为。测定了甘露醇、海藻糖或过氧化氢酶溶液液滴的干燥行为。获得了在干燥临界点之前溶质在液滴表面超饱和的证据。在液滴表面沉淀之前,海藻糖的过饱和度低于甘露醇。这导致恒速期持续时间较短,但这种无定形材料的进一步干燥时间延长。甘露醇达到了更高的过饱和度,并且临界点较晚,降速期较短。干燥颗粒半径的测量表明,两种溶质都形成空心颗粒。过氧化氢酶形成有孔的空心颗粒,其特征干燥速率曲线与颗粒形态的发展密切相关。发现悬浮器或喷雾干燥器中产生的甘露醇、海藻糖或过氧化氢酶干燥颗粒的形态之间有很强的相似性。

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