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Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution

Author(s):  Zaid Abdel-Naser, Zaaror Yara Abu, Qaddumi Aiman, Ratrout Ala, Ahmad Ayda, Hamad Emad, Kittana Naim

Issue:  Nov/Dec 2021 - Volume 25, Number 6
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Page(s):  523-527

Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution Page 1
Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution Page 2
Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution Page 3
Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution Page 4
Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution Page 5

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Abstract:  Ivermectin is a gamma amino butyric acid (GABA)-gated-Cl-channels modulator, which has been used orally in the treatment of numerous parasitic infections. The study target was to set up a stable, efficient 0.2% w/v ivermectin solution, which would be achieved from pure ivermectin powder as a source of the active pharmaceutical ingredient. Several trial solutions were prepared. The most fitting solution, with respect to its organoleptic properties, was chosen for additional investigation, including the solution’s physical stability. Two storage conditions, room temperature (25°C, 60% relative humidity) and accelerated stability chambers (40°C, 75% relative humidity) were subjected to guarantee the physical stability of the solution through the 3-month study period. Furthermore, other quality tests were assessed, (e.g., pH, assay, organoleptic properties, microbial contamination) for the same latter period. Quantification of ivermectin was validated utilizing a high-performance liquid chromatography analytical method. The adopted solution showed accepted organoleptic properties. The pH of the solutions was approximately 5 and remained unchanged during the stability study. The mean percent of remained ivermectin solution was close to 97% ± 0.2 at room temperature. Ivermectin solution was additionally tested for microbial contamination, and it was free from any microbial contamination (E. coli bacteria: Negative/mL, yeast and molds count: <10 cfu/mL and aerobic microbial count results in <10 cfu/mL). The adopted formula showed the best physical stability within at least the three months of storage at both room and accelerated conditions. Ivermectin solution was successfully prepared from its pure powder. This formula provides a stable, efficient oral solution for those who suffer from swallowing difficulties or patients in the intensive care unit who cannot receive the medication in a solid dosage form. Using the suggested formula, community and hospital pharmacists could prepare an effective, high quality ivermectin oral solution using pure ivermectin powder. 

Related Keywords: Abdel-Naser Zaid, PhD, Yara Abu Zaaror, BSc, Aiman Qaddumi, BSc, Ala Ratrout, BSc, Ayda Ahmad, BSc, Emad Hamad, BSc, Naim Kittana, PhD, ivermectin, oral solution, formulation, GABA-gated chloride channels modulator, parasitic infection, physical stability, swallowing disorder, dysphagia

Related Categories: FORMULATIONS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS, INFECTIOUS DISEASE, STORAGE

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