Very-Rapidly Dissolving Printlets of Isoniazid Manufactured by SLS 3D Printing: In Vitro and In Vivo Characterization.
Very-Rapidly Dissolving Printlets of Isoniazid Manufactured by SLS 3D Printing: In Vitro and In Vivo Characterization.
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DOI：
10.1021/acs.molpharmaceut.2c00306
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发表时间：
2022-08-01
影响因子：
4.9
通讯作者：
Khan, Mansoor A.
中科院分区：
文献类型：
--
作者：
Khuroo, Tahir;Mohamed, Eman M.;Dharani, Sathish;Kayalar, Canberk;Ozkan, Tanil;Kuttolamadom, Mathew A.;Rahman, Ziyaur;Khan, Mansoor A.
本研究的重点是了解配方和工艺变量对选择性激光烧结（SLS）三维（3D）打印方法制造的异烟肼（INH）快速溶解打印片的影响，并表征其理化性质，稳定性和药代动力学。通过改变激光扫描速度（400 - 500 mm/s，X1）、表面温度（100 - 110 °C，X2）和交联羧甲基纤维素钠（CCS，%，X3）制备了15种打印片制剂，测量的响应为重量（Y1）、硬度（Y2）、崩解时间（DT，Y3）和溶出度（Y 4）。激光扫描是影响响应的最重要的加工因素。DT非常快速（≥3 s），溶出度（>99%）在3 min内完成。研究响应的均方根误差较低，方差分析（ANOVA）具有统计学显著性（p < 0.05）。X射线显微计算机断层扫描（micro-CT）图像显示非常多孔的结构，孔隙率为24.6 - 34.4%。X-射线粉末衍射和差示扫描量热法数据表明结晶药物部分转化为无定形形式。印片在40 °C/75%RH下是稳定的，在测定和溶解方面没有显著变化。印片和压片的药代动力学特征可重叠。总之，INH的快速溶解印片是稳定的，口服生物利用度与组成相同的压缩片剂相似。
The focus of this research was to understand the effects of formulation and processing variables on the very-rapidly dissolving printlets of isoniazid (INH) manufactured by the selective laser sintering (SLS) three-dimensional (3D) printing method, and to characterize their physicochemical properties, stability, and pharmacokinetics. Fifteen printlet formulations were manufactured by varying the laser scanning speed (400−500 mm/s, X1), surface temperature (100−110 °C, X2), and croscarmellose sodium (CCS, %, X3), and the responses measured were weight (Y1), hardness (Y2), disintegration time (DT, Y3), and dissolution (Y4). Laser scanning was the most important processing factor affecting the responses. DT was very rapid (≥3 s), and dissolution (>99%) was completed within 3 min. The root-mean-square error in the studied responses was low and analysis of variance (ANOVA) was statistically significant (p < 0.05). X-ray micro-computed tomography (micro-CT) images showed very porous structures with 24.6−34.4% porosity. X-ray powder diffraction and differential scanning calorimetry data indicated partial conversion of the crystalline drug into an amorphous form. The printlets were stable at 40 °C/75% RH with no significant changes in assay and dissolution. Pharmacokinetic profiles of the printlets and compressed tablets were superimposable. In conclusion, the rapidly dissolving printlets of the INH were stable, and oral bioavailability was similar to that of compositionally identical compressed tablets.
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DOI：
10.3889/oamjms.2018.161
发表时间：
2018-04-15
影响因子：
--
作者：
Ilievska-Poposka B;Metodieva M;Zakoska M;Vragoterova C;Trajkov D
通讯作者：
Trajkov D
影响因子：
2.9
作者：
Lee SH
通讯作者：
Lee SH
影响因子：
4.6
作者：
Janssens, Sandrien;de Armas, Hector Nouoa;Van den Mooter, Guy
通讯作者：
Van den Mooter, Guy
影响因子：
5.8
作者：
Hamed, Rania;Mohamed, Eman M.;Khan, Mansoor A.
通讯作者：
Khan, Mansoor A.
影响因子：
3
作者：
Gudeman J;Jozwiakowski M;Chollet J;Randell M
通讯作者：
Randell M