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Development of a safe and versatile suspension vehicle for pediatric use: Formulation development
Hugo Alarie1, V Gaëlle Roullin1, Grégoire Leclair1
1Platform of Biopharmacy, Faculty of Pharmacy, Université de Montréal, Montréal, Canada.
International Journal of Pharmaceutics
|August 4, 2019
Summary
A new pediatric oral suspension vehicle was developed using safe excipients. The acidic pH formulation with propionic acid demonstrated effective antimicrobial preservation, ensuring stability for six months.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Formulations
Background:
- Developing safe and effective oral suspension vehicles for pediatric use is crucial.
- Existing commercial vehicles may have limitations in terms of safety or efficacy for children.
Purpose of the Study:
- To develop and characterize a novel, safe, and stable oral suspension vehicle for pediatric patients.
- To evaluate the antimicrobial effectiveness and physicochemical properties of the developed vehicle.
Main Methods:
- Formulation of two suspension vehicles at neutral and acidic pH using pediatric-safe excipients.
- Assessment of physicochemical properties including pH, viscosity, and shear-thinning behavior.
- Antimicrobial effectiveness testing using United States Pharmacopeia (USP) standards against various microbial strains over 28 days.
Main Results:
- Propionic acid demonstrated effective antimicrobial preservation at pH 4.5, while preservatives failed at pH 7.5.
- The optimized vehicle exhibited a pH of 4.5, viscosity of 85 cP at 25°C, and shear-thinning properties.
- The formulation showed adequate physical stability and resuspendability with common pediatric drugs and remained stable for 180 days under various storage conditions.
Conclusions:
- An acidic pH (4.5) is essential for effective antimicrobial preservation in pediatric oral suspensions.
- The developed novel vehicle is safe, stable, and ready-to-use for pediatric compounding, offering a shelf-life of six months.
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