Furosemide ethanol-free oral solutions for paediatric use: formulation, HPLC method and stability study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11160%2F18%3A10375261" target="_blank" >RIV/00216208:11160/18:10375261 - isvavai.cz</a>

Alternative codes found

RIV/00064203:_____/18:10375261

Result on the web

<a href="http://ejhp.bmj.com/content/25/3/144" target="_blank" >http://ejhp.bmj.com/content/25/3/144</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/ejhpharm-2017-001264" target="_blank" >10.1136/ejhpharm-2017-001264</a>

Result language

angličtina

Original language name

Furosemide ethanol-free oral solutions for paediatric use: formulation, HPLC method and stability study

Original language description

Background Oral liquid solutions of the diuretic active ingredient furosemide (FUR) marketed across Europe do not comply with recent requirements for paediatric preparation owing to their ethanol content and, moreover, in some countries only tablet or injection dosage forms of furosemide are available. Objectives To formulate extemporaneous paediatric ethanol-free solutions of FUR (2mg/mL) with suitable solubility in the aqueous vehicle and an acceptable taste and to evaluate their stability under two different storage conditions during a 9-month study period. Methods Our work presents two developed formulations of FUR ethanol-free paediatric oral solutions 2mg/mL for easy extemporaneous compounding in a pharmacy. FUR solubility avoiding the use of ethanol was achieved using sodium hydroxide (formulation F1) or disodium hydrogen phosphate dodecahydrate (formulation F2). The preparations were stored at 25 degrees C +/- 3 degrees C or at 40 degrees C +/- 0.5 degrees C and protected from light. For FUR and preservative, methylparaben (MP), a stability assay was conducted by a high-performance liquid chromatography validated method and determination of pH stability. Results The remaining FUR concentration was &gt;90% of the initial concentration after 270 days in both formulations at both storage conditions, 25 degrees C and 40 degrees C. The concentration of MP decreased significantly in the formulation F2 stored at 40 degrees C. Conclusions Both formulations were stable when stored at room temperature for up to 9 months; formulation F1 was stable even at 40 degrees C. MP used as an antimicrobial agent fully satisfied the recommended criteria for preservative efficacy in oral preparations according to the European Pharmacopoeia 9.0 (5.1.3).

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30104 - Pharmacology and pharmacy

Project

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Continuities

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2018

Confidentiality

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

Name of the periodical

European Journal of Hospital Pharmacy: Science and Practice

ISSN

2047-9956

e-ISSN

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Volume of the periodical

25

Issue of the periodical within the volume

3

Country of publishing house

GB - UNITED KINGDOM

Number of pages

6

Pages from-to

144-149

UT code for WoS article

000431400800008

EID of the result in the Scopus database

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