Impact of Vehicle Composition on Solubility, Autoclave Sterilization Stability, and Antibacterial Activity of Ciprofloxacin Hydrochloride Ear Drops.

IF 5.6 2区生物学

International Journal of Molecular Sciences Pub Date : 2025-05-07 DOI:10.3390/ijms26094458

Weerasak Samee, Sarin Tadtong, Wanna Eiamart, Pattaraporn Singwiset, Sirivimon Yingyomsarn, Patcharawee Nunthanavanit

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Abstract

This research focused on the formulation of ciprofloxacin hydrochloride ear drops for the treatment of acute otitis externa, caused by pathogens such as Staphylococcus aureus and Pseudomonas aeruginosa. The study aimed to enhance the solubility of ciprofloxacin at physiological pH and improve its stability during autoclave sterilization by employing polyalcohol vehicle systems composed of deionized water, glycerin, and propylene glycol. Formulations containing 0.33% w/v ciprofloxacin HCl were evaluated for solubility within a pH range of 4.0 to 7.0 and underwent autoclave sterilization to assess their chemical stability and antibacterial efficacy. Following sterilization, the formulations were stored at 25 °C in amber containers for a duration of 180 days. High-performance liquid chromatography (HPLC) was utilized to evaluate chemical stability, while antibacterial activity was determined using the disk diffusion method. The results demonstrated that glycerin and propylene glycol effectively inhibited ciprofloxacin precipitation at physiological pH. The ciprofloxacin content decreased by less than 3.58% while preserving antimicrobial efficacy against S. aureus and P. aeruginosa. Both formulations retained over 90% of their labeled drug content, indicating a minimum shelf life of 180 days under the specified storage conditions.

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载体组成对盐酸环丙沙星滴耳液溶解度、灭菌稳定性及抗菌活性的影响。

本研究主要研究盐酸环丙沙星滴耳液的配方，用于治疗由金黄色葡萄球菌和铜绿假单胞菌等病原体引起的急性外耳炎。本研究旨在通过采用由去离子水、甘油和丙二醇组成的多醇载体体系，提高环丙沙星在生理pH下的溶解度，并提高其在高压灭菌器灭菌过程中的稳定性。含0.33% w/v盐酸环丙沙星的配方在pH为4.0 ~ 7.0的范围内进行溶解度评价，并进行高压灭菌以评估其化学稳定性和抗菌效果。灭菌后，在25°C的琥珀容器中保存180天。采用高效液相色谱法评价其化学稳定性，采用纸片扩散法测定其抑菌活性。结果表明，在生理ph下，甘油和丙二醇能有效抑制环丙沙星沉淀，环丙沙星含量降低不超过3.58%，同时保持了对金黄色葡萄球菌和铜绿假单胞菌的抑菌效果。这两种制剂保留了90%以上的标签药物含量，表明在规定的储存条件下，最低保质期为180天。

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来源期刊

International Journal of Molecular Sciences 化学-化学综合

自引率

10.70%

发文量

13472

审稿时长

1.7 months

期刊介绍： The International Journal of Molecular Sciences (ISSN 1422-0067) provides an advanced forum for chemistry, molecular physics (chemical physics and physical chemistry) and molecular biology. It publishes research articles, reviews, communications and short notes. Our aim is to encourage scientists to publish their theoretical and experimental results in as much detail as possible. Therefore, there is no restriction on the length of the papers or the number of electronics supplementary files. For articles with computational results, the full experimental details must be provided so that the results can be reproduced. Electronic files regarding the full details of the calculation and experimental procedure, if unable to be published in a normal way, can be deposited as supplementary material (including animated pictures, videos, interactive Excel sheets, software executables and others).