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. Copyright. Pediatric Pharmacy Association. All rights reserved. For permissions, email: membership@pediatricpharmacy.org 2022.
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. Copyright. Pediatric Pharmacy Association. All rights reserved. For permissions, email: membership@pediatricpharmacy.org 2022.
Entities:
Keywords:
capsules; chromatography; clonidine; drug compounding; high-pressure liquid; quality control
Authors: Matthias D'Hondt; Evelien Wynendaele; Kirsten Vandercruyssen; Tiene Bauters; Johan Vandenbroucke; Steven Mullens; Chris Vervaet; Jean Paul Remon; Bart De Spiegeleer Journal: J Pharm Biomed Anal Date: 2014-03-25 Impact factor: 3.935
Authors: Hudson Polonini; Sharlene Loures da Silva; Carolina Neves Cunha; Anderson de Oliveira Ferreira; Korina Anagnostou; Eli Dijkers Journal: Int J Pharm Compd Date: 2020 May-Jun
Authors: V Merino-Bohórquez; M Delgado-Valverde; M García-Palomo; M C Dávila-Pousa; C Cañete; M Villaronga; B Rodriguez-Marrodán; R López-Rojas; M Cameán-Fernández Journal: Pharm Dev Technol Date: 2018-11-19 Impact factor: 3.133