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

Patrick Thevin1, Christophe Curti1,2, Alexandre Benech1

  • 1Service central de la qualité et de l'information pharmaceutiques (SCQIP), Pharmacy Department, AP-HM, Marseille, France.

Plos One
|February 24, 2023
PubMed

Insights

Compounded 20 mg erythromycin capsules offer a stable, year-long option for premature neonates needing prokinetic therapy. This formulation addresses the lack of adapted oral erythromycin for high-risk infants.

Area of Science:

  • Pharmaceutical Sciences
  • Neonatal Pharmacology

Background:

  • Erythromycin, a macrolide antibiotic, is used off-label as a prokinetic agent in premature neonates.
  • Existing oral formulations lack appropriate dosage and excipients for this vulnerable population.

Purpose of the Study:

  • To develop and assess the stability of a compounded oral erythromycin formulation suitable for premature neonates.
  • To establish a reliable beyond-use date for the compounded medication.

Main Methods:

  • A stability-indicating chromatographic method, as per United States Pharmacopoeia, was employed for analysis.
  • 20 mg erythromycin capsules were compounded using microcrystalline cellulose.
  • Stability was evaluated for capsules stored at room temperature, protected from light, over one year.

Main Results:

  • The compounded 20 mg erythromycin capsules demonstrated stability.
  • A beyond-use date of not less than one year was determined for the capsules.

Conclusions:

  • Hospital pharmacies can compound 20 mg erythromycin capsules in batches of 300 units.
  • These compounded capsules are stable for one year at ambient temperature when protected from light, offering a viable therapeutic option.
Abstract

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