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DOI: 10.48087/BJMS.2026.130201
Authors: Sarah BOUAMEUR1, Meriem DADOUCH2, Yamina SEFFIH2, Amani MEDJAHED2
Affiliations: 1- Département de pharmacie, Faculté de Médecine, Université Oran1. Oran. 2- Département de pharmacie, Faculté de Médecine, Université Djillali Liabes, Sidi Bel-Abbès – Algérie
Keywords: antidiarrheal, citric acid, extemporaneous preparation, loperamide, syrup, tincture.
Abstract
Loperamide hydrochloride is the most commonly indicated molecule for the symptomatic treatment of acute and chronic diarrhea. However, its presentation in solid forms (tablets and capsules) limits its use in children and patients with dysphagia, while the oral solution remains unavailable due to supply shortages and discontinuation of marketing. In response to this situation, a 0.02% loperamide hydrochloride extemporaneous syrup was developed as an alternative to existing formulations. Materials and Methods. Four syrups containing 0.02% loperamide hydrochloride were formulated. Different solubilization media for the active ingredient were investigated: 2% citric acid solution, lemon tincture, distilled water, and glycerol. The simple syrup used as a vehicle was prepared by cold method with sucrose at a concentration of 65% ± 1%. The formulations underwent quality control testing for macroscopic appearance, pH, density, viscosity, and assay content over a 20-day storage period at room temperature and protected from light. Results and Discussion. Under experimental conditions, the density of the syrups and their loperamide hydrochloride content remained within acceptable limits for 14 days. The pH and macroscopic appearance showed notable changes, with the exception of the syrup containing 2% citric acid solution, which demonstrated relatively satisfactory stability. Conclusion. The formulation of 0.02% loperamide hydrochloride in syrup form is an innovative approach aimed at meeting the specific needs of patients with dysphagia and the pediatric population. The stability of this extemporaneous preparation is adequate for the duration of treatment of an acute episode of non-infectious diarrhea.