Review of the article "Stability Assessment Approaches for Amoxicillin Nano-suspension as Promising Tool for Drug Delivery System", verified by Publons, Web of Science

Abstract

While nano-suspension amoxicillin is one of the approaches for improving dissolution rate of amoxicillin that is widely used as antibiotic. Stabilizing these nano. dosage forms is always a challenge. The present study utilizes Nanoprecipitation solvent evaporation technique for preparation of amoxicillin nanoparticles and proposed stability study approach of the same. The methodology based on investigating stability of amoxicillin Nano suspension based on the in vitro dissolution and particle size, the optimized drug: Polymer ratio re-formulated into nano-suspensions and compared with marketed suspensions. Samples initially characterized and then subjected to stability testing at ambient temperature and relative humidity up to 6 months assayed using a validated HPLC method. During initial characterization, increase in saturation solubility and dissolution rate observed in all samples. During stability testing, there was gradual decrease in saturation solubility and dissolution rate of the samples, over the period of 3 months. This study considers long-term isothermal measurements, consistent with short-term non-isothermal (accelerating) measurements, providing predictive model to calculate the isothermal degradation periods. While nonisothermal method ignores the effect of the storage conditions. While isothermal and nonisothermal treatments would allow accurate and fast prediction of the drug-loaded nanoparticle shelf life correlating parameters obtained using a single mathematical model. The isoconversional method does not consider crystalline state of the sample, the accuracy of the prediction would be assessed by comparison of estimated shelf life versus data coming from traditional stability studies.