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

Current pediatric antibiotic therapies often use oral and parenteral routes of administration. Neither are suitable for treating very sick neonates who cannot take oral medication and may be several hours away from hospital in developing countries. Here, we report on the development of rectal forms...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2019-08, Vol.108 (8), p.2805-2813
Main Authors: Kauss, Tina, Langlois, Marie-Hélène, Guyonnet-Dupérat, Alice, Phoeung, Thida, Xie, Xiao Yu, Cartwright, Anthony, White, Nicholas, Gomes, Melba, Gaudin, Karen
Format: Article
Language:English
Subjects:
Animals
Anti-Bacterial Agents - administration & dosage
Anti-Bacterial Agents - blood
antiinfective(s)
bioavailability
Biological Availability
Capsules
Ceftriaxone - administration & dosage
Ceftriaxone - blood
Drug Compounding
formulation
Humans
Infant
Infant, Newborn
Life Sciences
Male
Neonatal Sepsis - drug therapy
pediatric
Rabbits
solid dosage form(s)
Suppositories
Tablets
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Summary:Current pediatric antibiotic therapies often use oral and parenteral routes of administration. Neither are suitable for treating very sick neonates who cannot take oral medication and may be several hours away from hospital in developing countries. Here, we report on the development of rectal forms of ceftriaxone, a third-generation cephalosporin. Rectodispersible tablets and capsules were developed and successfully passed 6-month accelerated stability tests. Rabbit bioavailability showed plasma concentrations above the minimal inhibitory concentrations for 3 formulations of rectodispersible tablets and 2 formulations of hard capsules. Clinical batches are currently being prepared for human evaluation with the prospect of offering therapeutic alternatives for treating critically ill neonates. This proof of concept for efficient rectal delivery of antibiotics could help the development of other rectal antibiotic treatments and increase options for noninvasive drug development for pediatric patients.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2019.03.004