{"title":"Mucoadhesion and rheology characterization in topical semisolid formulations: An AQbD-driven case study.","authors":"Lucas Chiarentin, Vera Moura, Carla Vitorino","doi":"10.1016/j.ijpharm.2025.125389","DOIUrl":null,"url":null,"abstract":"<p><p>This study outlines a framework for developing a texture analyzer-based mucoadhesion method integrated with rheology analysis for evaluating ointment formulations. Using an Analytical Quality by Design (AQbD) approach, key sources of variability affecting critical method variables (CMVs) were identified. A Box-Behnken design evaluated applied force, contact time, and trigger force, with optimal conditions selected via response surface methodology (RSM) within the method operable design region (MODR). The final conditions-2 N applied force, 60 s contact time, and 0.05 N trigger force-ensured compliance with the analytical target profile (ATP). Incorporating mucin dispersion revealed significant rheological synergism, validating the optimized method. The framework adheres to ICH guidelines, demonstrating robust and reproducible performance.</p>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":" ","pages":"125389"},"PeriodicalIF":5.3000,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmaceutics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ijpharm.2025.125389","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
This study outlines a framework for developing a texture analyzer-based mucoadhesion method integrated with rheology analysis for evaluating ointment formulations. Using an Analytical Quality by Design (AQbD) approach, key sources of variability affecting critical method variables (CMVs) were identified. A Box-Behnken design evaluated applied force, contact time, and trigger force, with optimal conditions selected via response surface methodology (RSM) within the method operable design region (MODR). The final conditions-2 N applied force, 60 s contact time, and 0.05 N trigger force-ensured compliance with the analytical target profile (ATP). Incorporating mucin dispersion revealed significant rheological synergism, validating the optimized method. The framework adheres to ICH guidelines, demonstrating robust and reproducible performance.
期刊介绍：
The International Journal of Pharmaceutics is the third most cited journal in the "Pharmacy & Pharmacology" category out of 366 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.
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