Extemporaneous sotalol hydrochloride oral solutions for use in paediatric cardiology: formulation and stability study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F16%3A10323765" target="_blank" >RIV/00064203:_____/16:10323765 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11160/16:10323765

Výsledek na webu

<a href="http://ejhp.bmj.com/content/23/1/33.full" target="_blank" >http://ejhp.bmj.com/content/23/1/33.full</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/ejhpharm-2015-000711" target="_blank" >10.1136/ejhpharm-2015-000711</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Extemporaneous sotalol hydrochloride oral solutions for use in paediatric cardiology: formulation and stability study

Popis výsledku v původním jazyce

Objectives Sotalol hydrochloride (SOT) is an antiarrhythmic beta-blocker which is highly effective for the treatment of supraventricular tachycardia in children. However, a licensed paediatric dosage form with sotalol is not currently available in Europe. The aim of this work was to formulate paediatric oral solutions with SOT 5 mg/mL for extemporaneous preparation in a hospital pharmacy with the lowest possible amount of excipients and to determine their stability. Methods Three aqueous solutions were formulated. One preparation without any additives for neonates and two preparations for children from 1 month of age were compounded using citric acid to stabilise the pH value, potassium sorbate 0.1% w/v as a preservative, and simple syrup or sodium saccharin as a sweetener. The samples were stored at room temperature and in a refrigerator, respectively, and the content of SOT and potassium sorbate was determined simultaneously using a validated high performance liquid chromatography method at different time points over 180 days. Results At least 95% of the initial sotalol concentration remained throughout the 180-day study period in all three preparations at both temperatures. The content of potassium sorbate decreased by 17% with sodium saccharin stored at room temperature. Conclusions The three proposed oral aqueous solutions of SOT for neonates and infants were stable for 180 days. Storage in a refrigerator is preferred, particularly with sodium saccharin. The additive-free solution of SOT can be autoclaved to ensure microbiological stability and used particularly for neonates and in emergency situations.

Název v anglickém jazyce

Extemporaneous sotalol hydrochloride oral solutions for use in paediatric cardiology: formulation and stability study

Popis výsledku anglicky

Objectives Sotalol hydrochloride (SOT) is an antiarrhythmic beta-blocker which is highly effective for the treatment of supraventricular tachycardia in children. However, a licensed paediatric dosage form with sotalol is not currently available in Europe. The aim of this work was to formulate paediatric oral solutions with SOT 5 mg/mL for extemporaneous preparation in a hospital pharmacy with the lowest possible amount of excipients and to determine their stability. Methods Three aqueous solutions were formulated. One preparation without any additives for neonates and two preparations for children from 1 month of age were compounded using citric acid to stabilise the pH value, potassium sorbate 0.1% w/v as a preservative, and simple syrup or sodium saccharin as a sweetener. The samples were stored at room temperature and in a refrigerator, respectively, and the content of SOT and potassium sorbate was determined simultaneously using a validated high performance liquid chromatography method at different time points over 180 days. Results At least 95% of the initial sotalol concentration remained throughout the 180-day study period in all three preparations at both temperatures. The content of potassium sorbate decreased by 17% with sodium saccharin stored at room temperature. Conclusions The three proposed oral aqueous solutions of SOT for neonates and infants were stable for 180 days. Storage in a refrigerator is preferred, particularly with sodium saccharin. The additive-free solution of SOT can be autoclaved to ensure microbiological stability and used particularly for neonates and in emergency situations.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FR - Farmakologie a lékárnická chemie

OECD FORD obor

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Projekt

<a href="/cs/project/EE2.3.20.0235" target="_blank" >EE2.3.20.0235: Vybudování výzkumného týmu experimentální a aplikované biofarmacie</a><br>

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2016

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

European Journal of Hospital Pharmacy

ISSN

2047-9956

e-ISSN

—

Svazek periodika

23

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

5

Strana od-do

33-37

Kód UT WoS článku

000367461100007

EID výsledku v databázi Scopus

2-s2.0-84963700692