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Is propranolol compounding from tablet safe for pediatric use? Results from an experimental test
A Casiraghi1, U M Musazzi, I Franceschini
1Department of Pharmaceutical Sciences University of Milan, Milan, Italy - antonella.casiraghi@unimi.it.
Minerva Pediatrica
|September 26, 2014
Summary
Manually splitting propranolol 40 mg tablets for infant dosing resulted in many inaccurate doses. A pediatric oral solution is recommended to ensure safe and effective propranolol treatment for infantile hemangiomas.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Pharmaceutical Compounding
Background:
- Propranolol is a common treatment for infantile hemangiomas.
- Standard 40 mg propranolol tablets require fractionation for pediatric dosing.
- Accurate dosing is critical for infant treatment efficacy and safety.
Purpose of the Study:
- To assess the weight and dose uniformity of propranolol tablets split into quarters.
- To determine the suitability of manually split propranolol tablets for infant dosing.
Main Methods:
- Pharmacy students manually split 70 propranolol 40 mg tablets into quarters using a kitchen knife.
- Weight analysis of intact tablets and split quarters.
- High-performance liquid chromatography (HPLC) used to determine propranolol content in 200 quarters.
Main Results:
- Over 23% of split quarters were deemed unsuitable for administration.
- Significant weight loss occurred during splitting, averaging 2.97 mg per tablet.
- 42% of quarters had propranolol content outside the ±10% acceptance range, with concentrations varying from 7.36 to 12.23 mg.
Conclusions:
- Manual splitting of propranolol 40 mg tablets leads to significant variability in weight and active ingredient concentration.
- A substantial proportion of split quarters fall outside acceptable dosing ranges for infants.
- Development and availability of a pediatric oral propranolol solution are crucial to mitigate dosing errors and ensure patient safety.
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