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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00064203:_____/18:10375261

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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).

Název v anglickém jazyce

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

Popis výsledku anglicky

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).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

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Návaznosti

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

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

European Journal of Hospital Pharmacy: Science and Practice

ISSN

2047-9956

e-ISSN

—

Svazek periodika

25

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

6

Strana od-do

144-149

Kód UT WoS článku

000431400800008

EID výsledku v databázi Scopus

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