Next Article in Journal
Protective Effects of Polyphenol Enriched Complex Plants Extract on Metabolic Dysfunctions Associated with Obesity and Related Nonalcoholic Fatty Liver Diseases in High Fat Diet-Induced C57BL/6 Mice
Previous Article in Journal
Artificial Caries Lesion Characteristics after Secondary Demineralization with Theobromine-Containing Protocol
Previous Article in Special Issue
A Drug Content, Stability Analysis, and Qualitative Assessment of Pharmacists’ Opinions of Two Exemplar Extemporaneous Formulations
Open AccessArticle

Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension

1
School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, 111 St. Stephen’s Green, Dublin 2, Ireland
2
Department of Chemistry, RCSI University of Medicine and Health Sciences, 123 St. Stephen’s Green, Dublin 2, Ireland
3
Pharmacy Department, Children’s Health Ireland (CHI) at Crumlin, Dublin 12, Ireland
4
Department of Clinical Microbiology, Education and Research Centre, Beaumont Hospital, RCSI University of Medicine and Health Sciences, Dublin 9, Ireland
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editors: Eneko Larrañeta, Aaron J. Courtenay and Dimitrios A. Lamprou
Molecules 2021, 26(2), 301; https://doi.org/10.3390/molecules26020301
Received: 10 December 2020 / Revised: 4 January 2021 / Accepted: 5 January 2021 / Published: 8 January 2021
Extemporaneous oral liquid preparations are commonly used when there is no commercially available dosage form for adjustable dosing. In most cases, there is a lack of stability data to allow for an accurately assigned shelf life and storage conditions to give greater confidence of product safety and efficacy over its shelf life. The aim of this study was to evaluate the physical, chemical and microbiological stability of an extemporaneous oral liquid suspension of losartan potassium, 5 mg/mL, used to treat paediatric hypertension in Our Lady’s Children’s Hospital Crumlin, Ireland. The losartan content of extemporaneous oral suspensions, prepared with and without addition of water, was measured by UV and confirmed by HPLC analysis. Suspensions were stored at 4 °C and room temperature (RT) and were monitored for changes in; pH, colour, odour, re-dispersibility, Total Aerobic Microbial Count, Total Yeast and Mould Count and absence of E. coli. Results showed that suspensions prepared by both methods, stored at 4 °C and RT, were physically and microbiologically stable over 28 days. Initial losartan content of all suspensions was lower than expected at 80–81% and did not change significantly over the 28 days. HPLC and NMR did not detect degradation of losartan in the samples. Suspensions prepared in water showed 100% losartan content. The reduced initial losartan content was confirmed by HPLC and was related to the acidic pH of the suspension vehicle. Physiochemical properties of the drug are important factors for consideration in the selection of suspension vehicle for extemporaneous compounding of oral suspensions as they can influence the quality, homogeneity and efficacy of these preparations. View Full-Text
Keywords: losartan; extemporaneous compounding; oral suspension; stability; solubility losartan; extemporaneous compounding; oral suspension; stability; solubility
Show Figures

Figure 1

MDPI and ACS Style

Foley, L.; Toney, J.; Barlow, J.W.; O’Connor, M.; Fitzgerald-Hughes, D.; Ramtoola, Z. Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension. Molecules 2021, 26, 301. https://doi.org/10.3390/molecules26020301

AMA Style

Foley L, Toney J, Barlow JW, O’Connor M, Fitzgerald-Hughes D, Ramtoola Z. Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension. Molecules. 2021; 26(2):301. https://doi.org/10.3390/molecules26020301

Chicago/Turabian Style

Foley, Lisa; Toney, Jennifer; Barlow, James W.; O’Connor, Maura; Fitzgerald-Hughes, Deirdre; Ramtoola, Zebunnissa. 2021. "Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension" Molecules 26, no. 2: 301. https://doi.org/10.3390/molecules26020301

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Search more from Scilit
 
Search
Back to TopTop