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

Result code in 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>

Alternative codes found

RIV/00216208:11160/16:10323765

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FR - Pharmacology and apothecary chemistry

OECD FORD branch

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Project

<a href="/en/project/EE2.3.20.0235" target="_blank" >EE2.3.20.0235: Establishment of Research Team Focused on Experimental and Applied Biopharmacy</a><br>

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2016

Confidentiality

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

Name of the periodical

European Journal of Hospital Pharmacy

ISSN

2047-9956

e-ISSN

—

Volume of the periodical

23

Issue of the periodical within the volume

1

Country of publishing house

GB - UNITED KINGDOM

Number of pages

5

Pages from-to

33-37

UT code for WoS article

000367461100007

EID of the result in the Scopus database

2-s2.0-84963700692