-
Je něco špatně v tomto záznamu ?
Furosemide ethanol-free oral solutions for paediatric use: formulation, HPLC method and stability study
L. Zahálka, S. Klovrzová, L. Matysová, Z. Šklubalová, P. Solich,
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články
NLK
PubMed Central
od 2016
Europe PubMed Central
od 2016 do Před 1 rokem
ProQuest Central
od 2012-02-01 do Před 6 měsíci
Health & Medicine (ProQuest)
od 2012-02-01 do Před 6 měsíci
- Publikační typ
- časopisecké články MeSH
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 (2 mg/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 2 mg/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°C±3°C or at 40°C±0.5°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 >90% of the initial concentration after 270 days in both formulations at both storage conditions, 25°C and 40°C. The concentration of MP decreased significantly in the formulation F2 stored at 40°C. Conclusions: Both formulations were stable when stored at room temperature for up to 9 months; formulation F1 was stable even at 40°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).
Department of Analytical Chemistry Charles University Hradec Kralove Czech Republic
Department of Pharmaceutical Technology Charles University Hradec Kralove Czech Republic
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc19028937
- 003
- CZ-PrNML
- 005
- 20190913105109.0
- 007
- ta
- 008
- 190813s2018 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1136/ejhpharm-2017-001264 $2 doi
- 035 __
- $a (PubMed)31157009
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Zahálka, Lukáš $u Department of Analytical Chemistry, Charles University, Hradec Kralove, Czech Republic.
- 245 10
- $a Furosemide ethanol-free oral solutions for paediatric use: formulation, HPLC method and stability study / $c L. Zahálka, S. Klovrzová, L. Matysová, Z. Šklubalová, P. Solich,
- 520 9_
- $a 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 (2 mg/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 2 mg/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°C±3°C or at 40°C±0.5°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 >90% of the initial concentration after 270 days in both formulations at both storage conditions, 25°C and 40°C. The concentration of MP decreased significantly in the formulation F2 stored at 40°C. Conclusions: Both formulations were stable when stored at room temperature for up to 9 months; formulation F1 was stable even at 40°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).
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Klovrzová, Sylva $u Department of Pharmaceutical Technology, Charles University, Hradec Kralove, Czech Republic. Hospital Pharmacy, University Hospital Motol, Prague, Czech Republic.
- 700 1_
- $a Matysová, Ludmila $u Department of Analytical Chemistry, Charles University, Hradec Kralove, Czech Republic.
- 700 1_
- $a Šklubalová, Zdenka $u Department of Pharmaceutical Technology, Charles University, Hradec Kralove, Czech Republic.
- 700 1_
- $a Solich, Petr $u Department of Analytical Chemistry, Charles University, Hradec Kralove, Czech Republic.
- 773 0_
- $w MED00200143 $t European journal of hospital pharmacy : science and practice $x 2047-9964 $g Roč. 25, č. 3 (2018), s. 144-149
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/31157009 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20190813 $b ABA008
- 991 __
- $a 20190913105451 $b ABA008
- 999 __
- $a ind $b bmc $g 1434086 $s 1067397
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2018 $b 25 $c 3 $d 144-149 $e 20170802 $i 2047-9964 $m European journal of hospital pharmacy $n Eur J Hosp Pharm $x MED00200143
- LZP __
- $a Pubmed-20190813
