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Pediatric Orally Disintegrating Tablets (ODTs) with Enhanced Palatability Based on Propranolol HCl Coground with
Marzia Cirri1, Paola A Mura1, Francesca Maestrelli1
1Department of Chemistry Ugo Schiff (DICUS), University of Florence, 50019 Sesto Fiorentino, Italy.
Pharmaceutics
|November 27, 2024
Summary
New orally disintegrating tablets (ODTs) mask the bitter taste of propranolol, improving dosing accuracy and palatability for pediatric patients. This development offers a better alternative to current liquid preparations, enhancing medication compliance.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Pediatric Formulations
Background:
- Propranolol, used for hypertension and arrhythmias in children, has a bitter taste and astringent aftertaste.
- Current administration involves crushing tablets, leading to inaccurate dosing, poor palatability, and low patient compliance.
Purpose of the Study:
- To develop orally disintegrating tablets (ODTs) of propranolol using cyclodextrin complexation.
- To enhance dosing accuracy, palatability, safety, and ease of swallowing for pediatric patients.
Main Methods:
- Cyclodextrin complexation via cogrinding was employed to create propranolol ODTs.
- Formulation variables and process parameters were optimized.
- Technological, morphological, and disintegration tests were conducted, including in vitro palatability assessment using an electronic tongue.
Main Results:
- An optimal ODT formulation utilized a Hydroxypropyl-β-cyclodextrin (HPβCD) coground complex with Pearlitol® Flash and Explotab®.
- The selected formulation exhibited high drug dissolution in simulated saliva.
- Electronic tongue assessment confirmed effective taste-masking of propranolol by HPβCD.
Conclusions:
- The developed propranolol ODTs offer a viable alternative to extemporaneous liquid preparations.
- This novel dosage form addresses the need for solid propranolol formulations in pediatric medicine.
- Improved palatability and dosing accuracy are expected to enhance pediatric patient compliance.
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