The influence of cetomacrogol ointment processing on structure: A definitive screening design

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• 作者：A.J.P. van Heugten^a ; ^b ; ^{tvheugten@tiofarma.nl} ; C.L. Braal^a ; ^b ; M. Versluijs-Helder^c ; H. Vromans^a ; ^b ; ^d
• 关键词：Quality by design (QbD) ; Ointment ; Design of experiments (DoE) ; Definitive screening design (DSD) ; Rheology ; Critical process parameters (CPPs)
• 刊名：European Journal of Pharmaceutical Sciences
• 出版年：2017
• 出版时间：1 March 2017
• 年：2017
• 卷：99
• 期：Complete
• 页码：279-284
• 全文大小：926 K
• 卷排序：99

文摘

Batch-to-batch variability is a challenge for the industrial scale production of ointments. Therefore the current investigation focussed on identifying and understanding critical process parameters (CPPs) for cetomacrogol ointment. This was evaluated using a definitive screening design (DSD) approach in which fourteen batches were produced under predefined and controlled conditions using the following variables: addition of SiO2 nanoparticles, mixing speed, cooling rate, heating temperature, container filling temperature and isothermal mixing at the filling temperature.Ointment structure was evaluated using a number of rheological parameters. One of these parameters, yield stress was found to be strongly influenced by filling temperature and mixing speed (p = 0.0065 and p = 0.0013 respectively). Both significantly affect ointment structure and they also have a significant interaction (p < 0.05). Understanding the ointment production process can help in defining a processing window to produce ointment of constant quality.