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

• Published in: PloS one Vol. 18; no. 2; p. e0282164
• Main Authors: Thevin, Patrick, Curti, Christophe, Benech, Alexandre, Jean, Christophe, Lamy, Edouard, Castera Ducros, Caroline, Primas, Nicolas, Bertault-Peres, Pierre, Vanelle, Patrice
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 24.02.2023; Public Library of Science (PLoS)
• Subjects: Ambient temperature; Anti-Bacterial Agents; Antibiotics; Biology and Life Sciences; Capsules - chemistry; Cellulose; Child; Chromatography; Complications and side effects; Conformity; Crystalline cellulose; Cytokines; Erythromycin; Gelatin; Health aspects; Human health and pathology; Humans; Hépatology and Gastroenterology; Infant, Newborn; Infants (Premature); Life Sciences; Medicine and Health Sciences; Neonates; Newborn babies; Nutrition; Parenteral nutrition; Patient outcomes; Pediatrics; People and Places; Pharmaceutical sciences; Pharmacology; Physical Sciences; Research and Analysis Methods; Risk groups; Room temperature; Stability; France; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0282164

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. 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. 20 mg erythromycin capsules have a beyond use date not lower than one year. 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.