Low-dose erythromycin in pediatrics: Formulation and stability of 20 mg hard gelatin capsules.

OBJECTIVE: Erythromycin is a macrolide antibiotic that is also prescribed off-label in premature neonates as a prokinetic agent. There is no oral formulation with dosage and/or excipients adapted for these high-risk patients. METHODS: Clinical studies of erythromycin as a prokinetic agent were reviewed. Capsules of 20 milligrams of erythromycin were compounded with microcrystalline cellulose. Erythromycin capsules were analyzed using the chromatographic method described in the United States Pharmacopoeia which was found to be stability-indicating. The stability of 20 mg erythromycin capsules stored protected from light at room temperature was studied for one year. RESULTS: 20 mg erythromycin capsules have a beyond use date not lower than one year. CONCLUSION: 20 milligrams erythromycin capsules can be compounded in batches of 300 unities in hospital pharmacy with a beyond-use-date of one year at ambient temperature protected from light.

Paediatric capsule compounding in hospital practices: by weight or by volume?

OBJECTIVE: Capsule compounding is common for paediatric patients. In Europe, pharmacists often use a volume-based method whereas, in the USA, the weight-based method prevails. These two methods should be compared in order to help hospital pharmacists to make their choice. METHODS: We evaluated the difference between the volume-based method and the weight-based method with 10 mg spironolactone capsules. Six independent batches were made with each technique and their conformity was evaluated with a high-performance liquid chromatography assay. RESULTS: The weight-based method showed superiority over the volume-based method for the following parameters: spironolactone content homogeneity, total weight content homogeneity, batch reproducibility and batch conformity. No differences were seen in spironolactone content between the two methods, but an overall trend towards underweighing the excipient was found with the volume-based method. CONCLUSIONS: Capsule compounding with the weight-based method increases the quality of the resulting formulation. The weight-based method requires knowledge of the galenic parameters of the active pharmaceutical ingredient and excipients, but should be preferred to the volume-based method.