期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 530, 期 1-2, 页码 79-88出版社
ELSEVIER
DOI: 10.1016/j.ijpharm.2017.07.047
关键词
Nanomilling; Design of experiments; Dual centrifugation; Nanosuspension; Wet ball milling; Nanocrystalline suspension; Nanoparticles
The development of nanosuspensions of poorly soluble APIs takes a lot of time and high amount of active material is needed. In this publication the use of dual centrifugation (DC) for an effective and rapid API-nanomilling is described for the first time. DC differs from normal centrifugation by an additional rotation of the samples during centrifugation, resulting in a very fast and powerful movement of the samples inside the vials, which - in combination with milling beads - result in effective milling. DC-nanomilling was compared to conventional wet ball milling and results in same or even smaller particle sizes. Also drug concentrations up to 40% can be processed. The process is fast (typical 90 min) and the temperature can be controlled. DC-nanomilling appears to be very gentle, experiments showed no change of the crystal structure during milling. Since batch sizes are very small (100-1000 mg) and since 40 sample vials can be processed in parallel, DC is ideal for the screening of suitable polymer/surfactant combinations. Fenofibrate was used to investigate DC-nanomilling for formulation screening by applying a DoE-approach. The presented data also show that the results of DC-nanomilling experiments are highly comparable to the results obtained by common agitator mills. (C) 2017 Elsevier B.V. All rights reserved.
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