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

Publication date: 1 March 2017
Source:European Journal of Pharmaceutical Sciences, Volume 99
Author(s): A.J.P. van Heugten, C.L. Braal, M. Versluijs-Helder, H. Vromans
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.

Graphical abstract

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