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Process Modelling, Scale-Up and Characterization of Acetaminophen Spray Dried Milk Powder as Novel Pediatric Dosage
Harsh S Shah1,2, Urmilasri Syamala3, Khushbu Chaudhari4
1J-Star Research Inc., 6 Cedarbrook Drive, Cranbury, NJ, 08512, USA. harsh.shah@jstar-research.com.
Insights
A novel amorphous acetaminophen spray-dried milk powder (ASDM) was developed for children, improving drug delivery and overcoming swallowing difficulties. This reconstitutable formulation offers a safer alternative to solid dosage forms for pediatric patients.
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.
Purpose:
Successful drug therapy in children is contingent upon hassle-free administration of pediatric dosage forms. Pediatric patients suffer from difficulty in swallowing due to weak esophagus muscles in their early age. Considering this challenge liquid formulations are preferred over solid dosage form among pediatric patients to avoid the possibility of choking which can be a serious life-threatening condition in children. The main aim of the present research work was to develop a reconstitutable amorphous acetaminophen spray-dried milk powder (ASDM) as novel pediatric formulation.
Methods:
ASDM was prepared by spray drying process and the spray drying process was optimized using Box-Behnken design to study the effect of spray drying process parameters at X1 [inlet temperature], X2 [aspiration rate] and X3 [feed rate] to Y1 [% yield], Y2 [angle of repose], Y3 [Hausner's Ratio] and Y4 [Carr's Index] as dependent variables of ASDM. In addition, each batch was characterized for particle size by polarized light microscopy and drug entrapment.
Results:
Predicted parameters from optimized spray drying process model were successfully employed to manufacture a scale up cum validation batch of ASDM, which showed notably improved yield and desirable flow properties. The scale-up validation batch was further characterized using thermal analysis, diffraction studies, spectroscopic analysis, dispersion studies, stability APAP in dispersion formulation and formulation stability studies to confirm the physico-chemical stability of ASDM.
Conclusions:
Thus, ASDM for oral use can serve as a promising pediatric formulation and the developed prototype formulation can be further extended to future newly discovered drugs with similar characteristics.
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