Process Modelling, Scale-Up and Characterization of Acetaminophen Spray Dried Milk Powder as Novel Pediatric Dosage...

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Pediatric drug administration faces challenges due to difficulty swallowing, necessitating alternative dosage forms.
• Liquid formulations are preferred for children to mitigate choking risks associated with solid dosage forms.

Purpose of the Study:

• To develop a novel reconstitutable amorphous acetaminophen spray-dried milk powder (ASDM) for pediatric use.
• To create a pediatric formulation that is easy to administer and safe.

Main Methods:

• Spray drying was employed to create ASDM, with parameters optimized using Box-Behnken design.
• Process variables (inlet temperature, aspiration rate, feed rate) were studied against yield and flow properties.
• Batches were characterized for particle size, drug entrapment, and physico-chemical stability.

Main Results:

• Optimization of the spray drying process yielded improved drug product yield and flow characteristics.
• A scale-up validation batch confirmed the successful manufacturing of ASDM.
• Comprehensive characterization confirmed the physico-chemical stability of the amorphous acetaminophen formulation.

Conclusions:

• The developed amorphous acetaminophen spray-dried milk powder (ASDM) shows promise as a safe and effective pediatric formulation.
• This formulation approach can be adapted for other drugs with similar properties for pediatric use.