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Pediatric Dispersible Tablets: a Modular Approach for Rapid Prototyping
Jonas Buck1,2, Jörg Huwyler2, Peter Kühl3
1Pharmaceutical Research and Development, F. Hoffmann-La Roche, Grenzacherstr. 124, CH-4070, Basel, Switzerland.
Pharmaceutical Research
|June 3, 2016
Summary
Developing pediatric dispersible tablets requires careful selection of viscosity enhancers and superdisintegrants. Optimized formulations achieve rapid disintegration (<30s) and good mouthfeel, meeting children's specific needs.
Area of Science:
- Pharmaceutical Sciences
- Formulation Development
- Pediatric Drug Delivery
Background:
- Designing pediatric solid dosage forms presents unique challenges, including varied dosing requirements.
- A modular formulation strategy enables rapid prototyping for pediatric tablets.
Purpose of the Study:
- To investigate different tablet compositions and characteristics for pediatric dispersible tablets.
- To develop customized analytical methods for evaluating pediatric tablet properties.
Main Methods:
- Fluid bed granules were blended with extragranular components and compressed into tablets.
- Disintegration behavior was assessed using a Texture Analyzer and Tensiometer.
- Methods for determining disintegration time and water uptake were established.
Main Results:
- Twenty-two tablet formulations were analyzed for disintegration time, hardness, friability, and viscosity.
- Multivariate data analysis highlighted the significant impact of viscosity enhancers on tablet disintegration.
- An optimized formulation achieved a disintegration time of 24 seconds.
Conclusions:
- Novel methods provide enhanced insights into dispersible tablet disintegration beyond pharmacopoeia standards.
- Critical factors for pediatric tablet development include selecting appropriate viscosity enhancers and superdisintegrants.
- Achieving rapid disintegration (<30s) and pleasant mouthfeel is key for successful pediatric formulations.
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