Objectives: Sotalol hydrochloride (SOT) is an antiarrhythmic β-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.
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http://dx.doi.org/10.1136/ejhpharm-2015-000711 | DOI Listing |
Food Chem X
January 2025
School of Life Sciences, Yunnan Normal University, Kunming 650500, PR China.
Food spoilage causes significant economic losses and endangers human health. Developing novel antimicrobial agents and preservatives is urgently needed for anti-foodborne diseases and improving food storage. Zhen Zhu Cai () species are well-known edible plants among the East Asian populace that clear heat and anti-aging.
View Article and Find Full Text PDFInt J Biol Macromol
January 2025
Technology Innovation Center of Natural Fragrances and Flavors, State Administration for Market Regulation, People's Republic of China.
Cinnamon essential oil has gained widespread attention in the food industry as a safe and effective preservative. However, its low water solubility and high volatility limit its application in food, making the use of natural emulsifiers for its emulsification an increasingly popular focus of research. This study focuses on the extraction of galactomannan-rich aqueous extracts from Gleditsia sinensis seeds using a low-energy, low-pollution microwave-assisted method.
View Article and Find Full Text PDFFoods
November 2024
Laboratory of Physiology of Nutrition and Food Safety, Department of Biology, Faculty of Natural and Life Sciences, University Oran 1 Ahmed Ben Bella, Oran 31000, Algeria.
Sodium benzoate (E211) and potassium sorbate (E202) are two preservatives widely used alone or in combination in the food industry in Algeria. This study aims to estimate the dietary exposure of children and adolescents to these substances in Oran Province (Algeria) and to assess the risks incurred in consuming these two preservatives. For this, a total of 116 commercial food samples were analyzed for potassium sorbate and sodium benzoate content by HPLC, and a survey was carried out on 250 children and 765 adolescents using a consumption frequency questionnaire as the method.
View Article and Find Full Text PDFNanophotonics
August 2024
School of Opto-Electronic Engineering, Zaozhuang University, Zaozhuang 277160, China.
Sci Rep
November 2024
Department of Pharmacology and Toxicology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
Advanced glycation end products (AGEs) are obtained intermediate from nonenzymatic reactions between reducing sugars and proteins, lipids, or nucleic acids and it's associated with diabetic complications. Today, potassium sorbate (PS), sodium citrate (CIT) and sodium benzoate (SB) were widespread used as food preservatives that can easily enter biological matrices. Here, the interaction between glycosylation Bovine Serum Albumin (BSA) and food preservatives individually and combination of two and three was studied by biochemical and simulation analysis.
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