التفاصيل البيبلوغرافية
| العنوان: |
Preparation of tofacitinib sustained-release tablets using hot melt extrusion technology. |
| المؤلفون: |
Kim, Sung-Yeop1 (AUTHOR), Pena, Ike de la2 (AUTHOR), Weon, Kwon Yeon3 (AUTHOR) weonky@cu.ac.kr, Park, Jun-Bom1 (AUTHOR) junji4@gmail.com |
| المصدر: |
Pharmaceutical Development & Technology. Mar2024, Vol. 29 Issue 3, p248-257. 10p. |
| مصطلحات موضوعية: |
*EXTRUSION process, MELT spinning, CONTROLLED release preparations, PUNCHING machinery, COATING processes |
| مستخلص: |
This study aimed to develop a tablet that shows a drug release profile similar to the tofacitinib sustained-release tablet (Xeljanz XR®; OROS™) using hot melt extrusion technology. Tofacitinib citrate was selected as the drug. HPMCAS, HPMCP, and Kollidon VA64 were used as thermoplastic polymers to prepare a hot-melt extrudate. The extrudate was obtained from a twin screw extruder and pelletizer. The granules were compressed using a single punch press machine and then coated. TGA, DSC, XRD, FT-IR, and SEM were performed on the hot melt extrudate to understand its physicochemical properties. Dissolution tests were performed using the paddle method (USP Apparatus II). The results showed that the crystallinity state of tofacitinib changed to amorphous after the hot melt extrusion process; however, no chemical change was observed. The drug release profile was similar to that of Xeljanz XR®, which has an initial lag time owing to its OROS™ formulation; a coating process was performed to obtain a similar drug release profile. The lag time was controlled by adjusting the thickness of the coating layer. Moreover, the extrudate size and compression force during tableting did not significantly affect drug release. In conclusion, the new tofacitinib sustained-release tablet prepared using hot melt extrusion showed a drug release behavior similar to that of Xeljanz XR®. [ABSTRACT FROM AUTHOR] |
|
Copyright of Pharmaceutical Development & Technology is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Business Source Index |
