A study of the stability of solid dispersions of albendazole obtained by mechanochemical solid-phase synthesis

Introduction. Pharmacological treatment of opisthorchiasis remains the relevant challenge due to the limited choice of drugs against opisthorchiasis and their unsatisfactory biopharmaceutical properties. The use of the mechanochemical method for obtaining solid dispersions (SDs) of albendazole (ALB) with excipients allows to increase its water-solubility and decrease toxicity. Investigation of the stability of SDs of ALB during long-term storage is a relevant objective of the further development of SDs of ALB-based dosage forms. Aim. A study of the stability of SDs of ALB obtained by mechanochemical solid-phase synthesis. Materials and methods. The objects of the study were SDs of ALB with arabinogalactan (AG) and licorice extract (LE) as complexing agents in various mass ratios and at different machining duration. The stability of SDs of ALB was studied by the method of accelerated ageing at 40°C for 6 months. Stability control was carried out at 3 time points (0, 3 and 6 months, respectively) based on the description parameter and the ALB content that was measured using high-performance liquid chromatography. Results. The qualitative and quantitative parameters of the stability of SDs of ALB during storage were studied. The content of the main active substance at the end point for all studied samples is not less than 97% relative to the parent composition. Based on the van’t Hoff’s rule, the concordance coefficient, the expected shelf life for SDs of ALB and the storage temperature allowing to ensure the estimated shelf life were calculated. Conclusion. SDs of ALB with AG and SDs of ALB with LE obtained by mechanochemical solid-phase synthesis are stable for 182 days of experimental storage, which corresponds to 728 days under natural conditions. The data obtained indicate high stability of the studied SDs of ALB and can be used in further development of dosage forms based on them.