دورية أكاديمية
Development and In Vitro–In Vivo Correlation Evaluation of IMM-H014 Extended-Release Tablets for the Treatment of Fatty Liver Disease
العنوان: | Development and In Vitro–In Vivo Correlation Evaluation of IMM-H014 Extended-Release Tablets for the Treatment of Fatty Liver Disease |
---|---|
المؤلفون: | Chi Zhang, Huihui Shao, Zunsheng Han, Bo Liu, Jing Feng, Jie Zhang, Wenxuan Zhang, Kun Zhang, Qingyun Yang, Song Wu |
المصدر: | International Journal of Molecular Sciences, Vol 24, Iss 15, p 12328 (2023) |
بيانات النشر: | MDPI AG, 2023. |
سنة النشر: | 2023 |
المجموعة: | LCC:Biology (General) LCC:Chemistry |
مصطلحات موضوعية: | IMM-H014, extended-release tablet, hydrophilic polymers, in vitro–in vivo correlation, non-alcoholic fatty liver disease, Biology (General), QH301-705.5, Chemistry, QD1-999 |
الوصف: | This study aimed to develop extended-release tablets containing 25 mg IMM-H014, an original drug formulated by a direct powder pressing method based on pharmaceutical-grade hydrophilic matrix polymers such as hydroxypropyl methylcellulose, to establish an in vitro–in vivo correlation (IVIVC) to predict bioavailability. The tablets’ mechanical properties and in vitro and in vivo performance were studied. The formulation was optimized using a single-factor experiment and the reproducibility was confirmed. The in vitro dissolution profiles of the tablet were determined in five dissolution media, in which the drug released from the hydrophilic tablets followed the Ritger–Peppas model kinetics in 0.01 N HCl medium for the first 2 h, and in phosphate-buffered saline medium (pH 7.5) for a further 24 h. Accelerated stability studies (40 °C, 75% relative humidity) proved that the optimal formulation was stable for 6 months. The in vivo pharmacokinetics study in beagle dogs showed that compared to the IMM-H014 immediate release preparation, the maximum plasma concentration of the extended-release (ER) preparation was significantly decreased, while the maximum time to peak and mean residence time were significantly prolonged. The relative bioavailability was 97.9% based on the area under curve, indicating that the optimal formulation has an obvious ER profile, and a good IVIVC was established, which could be used to predict in vivo pharmacokinetics based on the formulation composition. |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 1422-0067 1661-6596 |
Relation: | https://www.mdpi.com/1422-0067/24/15/12328; https://doaj.org/toc/1661-6596; https://doaj.org/toc/1422-0067 |
DOI: | 10.3390/ijms241512328 |
URL الوصول: | https://doaj.org/article/de6ab70bb89f4fb0bbed5f06b7721cd7 |
رقم الأكسشن: | edsdoj.6ab70bb89f4fb0bbed5f06b7721cd7 |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 14220067 16616596 |
---|---|
DOI: | 10.3390/ijms241512328 |