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

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Industrial scale production of ointments faces challenges with batch-to-batch variability.
• Ensuring consistent ointment quality is crucial for pharmaceutical applications.

Purpose of the Study:

• To identify and understand critical process parameters (CPPs) affecting cetomacrogol ointment production.
• To investigate the influence of CPPs on ointment rheological properties.

Main Methods:

• Utilized a definitive screening design (DSD) approach for process optimization.
• Produced fourteen batches of cetomacrogol ointment under controlled conditions.
• Varied parameters including SiO2 nanoparticle addition, mixing speed, cooling rate, heating temperature, and filling temperature.

Main Results:

• Yield stress, a key rheological parameter, was significantly influenced by filling temperature and mixing speed.
• A significant interaction between filling temperature and mixing speed was observed (p<0.05).
• These parameters were identified as critical for controlling ointment structure.

Conclusions:

• Understanding the impact of CPPs like filling temperature and mixing speed is essential for controlling ointment quality.
• Defining a specific processing window can lead to consistent ointment production.
• This research aids in mitigating batch-to-batch variability in industrial ointment manufacturing.