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首页> 外文期刊>Drug development and industrial pharmacy >Solid dispersion adsorbate technique for improved dissolution and flow properties of lurasidone hydrochloride: characterization using 32 factorial design
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Solid dispersion adsorbate technique for improved dissolution and flow properties of lurasidone hydrochloride: characterization using 32 factorial design

机译：静态分散吸附性技术改善盐酸盐酮溶出和流动性能：表征32因子设计

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摘要

The aim of the present study was to improve the dissolution and flow properties of lurasidone hydrochloride (LH) by solid dispersion adsorbate (SDA) technique. Solid dispersions (SDs) of LH were prepared by fusion method using Poloxamer P188. The melt dispersion was adsorbed onto the porous carrier Florite (calcium silicate). A 32 factorial design was employed to quantify the effect of two independent variables, namely ratio of carrier (Poloxamer 188) and LH in SD and ratio of adsorbent (Florite) to SD. SDA granules of LH were studied for flow properties and characterized using differential scanning calorimetry, scanning electron microscopy, and X-ray diffraction. Tablets of optimized composition of SDA granules (equivalent to 20 mg of drug) and plain tablets were prepared by direct compression method. The dissolution studies were carried out in Mcllvaine buffer (pH 3.8) as per USFDA guidelines and characterized for parameters such as percent dissolution efficiency, t50, and Q30. Tablets prepared from SDA granules showed almost four-fold increase in cumulative percentage drug release as compared to tablets prepared from plain LH. The value of dissolution efficiency was enhanced from 49.60% for plain tablets to 94.15% for SDA tablets. SDA granules did not show any change in drug release and X-ray diffraction pattern after storage at 40 °C/75% of RH for 3 months, which confirms that Florite prevented conversion of drug from amorphous form to crystalline form improving physical stability of the amorphous state of LH.
机译：本研究的目的是通过固体分散吸附（SDA）技术改善盐酸盐酮盐酸盐（LH）的溶出度和流动性能。通过使用泊洛沙姆P188通过融合方法制备LH的固体分散体（SDS）。将熔体分散体吸附在多孔载体佛罗矾（硅酸钙）上。采用32个因素设计来量化两个独立变量的效果，即载体（Poloxamer 188）和LH中的SD和吸附剂（佛罗里酯）与SD的比例。研究了LH的SDA颗粒，用于流动性能，并使用差示扫描量热法，扫描电子显微镜和X射线衍射表征。通过直接压缩方法制备了SDA颗粒的优化组合物（相当于20mg药物）和普通片剂的片剂。根据USFDA指南，在Mcllvaine缓冲液（pH3.8）中进行溶出性研究，其特征在于溶出效率百分比百分比，T50和Q30。与由Plain LH制备的片剂相比，由SDA颗粒制备的片剂显示出累积百分比药物释放的几乎增加。溶解效率的值从普通片剂的49.60％提高至SDA片剂的94.15％。 SDA颗粒未显示在40°C / 75％RH下储存3个月后的药物释放和X射线衍射图案的任何变化，这证实佛罗里特将药物从无定形形式转化为结晶形式改善物理稳定性无定形状态为lh。

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