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Article Dans Une Revue The Journal of Pediatric Pharmacology and Therapeutics Année : 2022

Pre-formulation and Stability Study of 20-mcg Clonidine Hydrochloride Pediatric Capsules

Maya Wasilewski
  • Fonction : Auteur
Christophe Curti
  • Fonction : Auteur
Camille Panuccio
  • Fonction : Auteur
Cyrielle Bouguergour
  • Fonction : Auteur
Nicolas Primas
  • Fonction : Auteur
Caroline Castera-Ducros
  • Fonction : Auteur
Christophe Jean
  • Fonction : Auteur
Pierre Bertault-Peres
  • Fonction : Auteur
Patrice Vanelle
  • Fonction : Auteur

Résumé

OBJECTIVE Clonidine hydrochloride is an antihypertensive, centrally acting α2 adrenergic agonist with various pediatric indications. For pediatric patients, 20-mcg clonidine hydrochloride capsules can be compounded from commercial tablets or from a pre-compounded titrated powder. These methods should be compared to ensure the best quality for the high-risk patients, and a beyond-use date should be established. METHODS Eight experimental batches were made from commercial tablets and 8 were made from microcrystalline cellulose (MCC)–based titrated powders. Quality controls were performed to determine the best compounding protocol. Stability study was conducted on capsules compounded with the best method. RESULTS Of 8 batches manufactured from commercial tablets, 7 were compliant for both clonidine mean content and content uniformity, whereas 7 of 8 batches manufactured from titrated powders were not. A clonidine loss during compounding was evidenced by surface sampling analyses. Clonidine hydrochloride 20-mcg capsules' mean content remained higher than 90% of initial content for 1 year when stored at 25°C with 60% relative humidity and protected from light. CONCLUSIONS Commercial tablets should be preferred to 1% clonidine hydrochloride and MCC titrated powder made from the active pharmaceutical ingredient. Twenty-microgram clonidine hydrochloride capsules made from commercial tablets are stable for 1 year when stored under managed ambient storage condition.
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Dates et versions

hal-04029261 , version 1 (14-03-2023)

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Maya Wasilewski, Christophe Curti, Camille Panuccio, Cyrielle Bouguergour, Nicolas Primas, et al.. Pre-formulation and Stability Study of 20-mcg Clonidine Hydrochloride Pediatric Capsules. The Journal of Pediatric Pharmacology and Therapeutics, 2022, 27 (7), pp.625-631. ⟨10.5863/1551-6776-27.7.625⟩. ⟨hal-04029261⟩
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