کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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5547916 | 1556151 | 2017 | 6 صفحه PDF | دانلود رایگان |
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 Abstract138
Journal: European Journal of Pharmaceutical Sciences - Volume 99, 1 March 2017, Pages 279-284