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Development of Rectodispersible Tablets and Granulate Capsules for the Treatment of Serious Neonatal Sepsis in

Tina Kauss1, Marie-Hélène Langlois1, Alice Guyonnet-Dupérat1

  • 1Faculty of Pharmacy, University Bordeaux, EA 4575 Analytical and Pharmaceutical Developments Applied to Neglected Diseases and Counterfeits, Bordeaux, France.

Journal of Pharmaceutical Sciences
|March 18, 2019
PubMed

Insights

Researchers developed novel rectal formulations of ceftriaxone (a third-generation cephalosporin) for critically ill neonates. This offers a promising alternative when oral or intravenous routes are not feasible, especially in resource-limited settings.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Drug Delivery Systems

Background:

  • Current pediatric antibiotic administration methods, including oral and parenteral routes, present challenges for critically ill neonates.
  • Neonates in developing countries may lack access to hospital care, necessitating alternative drug delivery methods.
  • Ceftriaxone is a vital third-generation cephalosporin antibiotic used in pediatric care.

Purpose of the Study:

  • To develop and evaluate rectal formulations of ceftriaxone for pediatric use.
  • To assess the stability and bioavailability of novel rectal antibiotic delivery systems.
  • To provide a viable therapeutic option for critically ill neonates in resource-limited settings.

Main Methods:

  • Development of rectodispersible tablets and hard capsules containing ceftriaxone.
  • Accelerated stability testing of the developed rectal formulations.
  • Assessment of rectal ceftriaxone bioavailability in rabbit models.

Main Results:

  • Rectodispersible tablets and capsules demonstrated successful passage of 6-month accelerated stability tests.
  • Rabbit bioavailability studies showed plasma concentrations exceeding minimal inhibitory concentrations for multiple rectal formulations.
  • Three rectodispersible tablet formulations and two hard capsule formulations exhibited favorable pharmacokinetic profiles.

Conclusions:

  • Rectal administration of ceftriaxone is a feasible and effective alternative for treating critically ill neonates.
  • This development offers a crucial noninvasive drug delivery option for pediatric patients, particularly in resource-limited environments.
  • The successful proof of concept may pave the way for developing other rectal antibiotic treatments.

Keywords:
antiinfective(s)bioavailabilityformulationpediatricsolid dosage form(s)

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