Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics

The availability of liquid oral preparations compounded by pharmacists is essential to meet paediatric needs which remain unanswered by the pharmaceutical industry. Unfortunately, compendial monographs are often not available and, in many cases, pre-formulation studies (e.g., compatibility with othe...

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Autores principales:	Antonella Casiraghi, Giorgio Centin, Francesca Selmin, Claudia Picozzi, Paola Minghetti, Davide Zanon
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	off-label age-related dose extemporaneous preparation oral delivery solubility compatibility Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/cde52094620d4cccae2eca2d6096490c
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spelling	oai:doaj.org-article:cde52094620d4cccae2eca2d6096490c2021-11-25T18:42:25ZCritical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics10.3390/pharmaceutics131119631999-4923https://doaj.org/article/cde52094620d4cccae2eca2d6096490c2021-11-01T00:00:00Zhttps://www.mdpi.com/1999-4923/13/11/1963https://doaj.org/toc/1999-4923The availability of liquid oral preparations compounded by pharmacists is essential to meet paediatric needs which remain unanswered by the pharmaceutical industry. Unfortunately, compendial monographs are often not available and, in many cases, pre-formulation studies (e.g., compatibility with other excipients and solubility evaluations) are not performed in-depth, leading, in some rare cases, to the inadvertent administration of a toxic dose. In this study, the preparation of an oral liquid formulation for paediatric use, containing flecainide acetate at different strengths, was considered, taking into account the possible effects of conventionally used excipients. First, the optimal vehicle was selected based on a solubility study, evidencing some unexpected formations of precipitates. As a matter of fact, the buffers commonly used for oral solutions significantly reduced flecainide solubility, and the concomitant presence of citrate buffer and methylparaben even caused the formation of non-resuspendable crystals. Then, chemical, physical, and microbiological stability were assessed. Solutions at strengths of 10 and 20 mg/mL flecainide acetate were stable up to 8 weeks when compounded by using a 40% sucrose solution as a vehicle. Microbiological data showed that the use of methylparaben was not necessary over this time period.Antonella CasiraghiGiorgio CentinFrancesca SelminClaudia PicozziPaola MinghettiDavide ZanonMDPI AGarticleoff-labelage-related doseextemporaneous preparationoral deliverysolubilitycompatibilityPharmacy and materia medicaRS1-441ENPharmaceutics, Vol 13, Iss 1963, p 1963 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	off-label age-related dose extemporaneous preparation oral delivery solubility compatibility Pharmacy and materia medica RS1-441
spellingShingle	off-label age-related dose extemporaneous preparation oral delivery solubility compatibility Pharmacy and materia medica RS1-441 Antonella Casiraghi Giorgio Centin Francesca Selmin Claudia Picozzi Paola Minghetti Davide Zanon Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics
description	The availability of liquid oral preparations compounded by pharmacists is essential to meet paediatric needs which remain unanswered by the pharmaceutical industry. Unfortunately, compendial monographs are often not available and, in many cases, pre-formulation studies (e.g., compatibility with other excipients and solubility evaluations) are not performed in-depth, leading, in some rare cases, to the inadvertent administration of a toxic dose. In this study, the preparation of an oral liquid formulation for paediatric use, containing flecainide acetate at different strengths, was considered, taking into account the possible effects of conventionally used excipients. First, the optimal vehicle was selected based on a solubility study, evidencing some unexpected formations of precipitates. As a matter of fact, the buffers commonly used for oral solutions significantly reduced flecainide solubility, and the concomitant presence of citrate buffer and methylparaben even caused the formation of non-resuspendable crystals. Then, chemical, physical, and microbiological stability were assessed. Solutions at strengths of 10 and 20 mg/mL flecainide acetate were stable up to 8 weeks when compounded by using a 40% sucrose solution as a vehicle. Microbiological data showed that the use of methylparaben was not necessary over this time period.
format	article
author	Antonella Casiraghi Giorgio Centin Francesca Selmin Claudia Picozzi Paola Minghetti Davide Zanon
author_facet	Antonella Casiraghi Giorgio Centin Francesca Selmin Claudia Picozzi Paola Minghetti Davide Zanon
author_sort	Antonella Casiraghi
title	Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics
title_short	Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics
title_full	Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics
title_fullStr	Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics
title_full_unstemmed	Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics
title_sort	critical aspects in the preparation of extemporaneous flecainide acetate oral solution for paediatrics
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/cde52094620d4cccae2eca2d6096490c
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Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics

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