对共处理赋形剂F-MELTS®的综合研究:流量,粘弹性和紧凑型性能

本文旨在比较三种商用的共同处理赋形剂(CPE),即F-Melts®类型C,米和F1。所有三种cpe都进行了物理性能评估,然后使用三种压缩压力制备了紧缩剂。在压缩期间测试了粘弹性特性和弹射力,并根据欧洲药典评估了压坯,并进行了其他相关测试(AFM成像、润湿性等)。

根据得到的结果,可以说CM有非常相似的性质根据它们相似的组成。一般来说,很难选择最好的CPE,因为它们具有不同的性能,适合制造商的多种需求。然而,得到的结果表明,M和F1是否比?更适合加入对水分敏感的成分C

作品简介:

口服分散的片剂(ODTS)在其给予口腔后迅速崩解,形成易吞咽的分散体,对吞咽困难的患者有利(儿童,老年人,精神病患者)是有利的。随着ODTS在口中液化,它们将液体和常规固体剂型的益处结合在一起,例如良好的稳定性,易于给药,吞咽与给药药物的高生物利用度连接。用于生产ODTS的广泛使用方法之一是直接压缩(DC)[1,2]。原理仅在于称重,混合和压缩适当的组件。从而获得了有限数量的制造步骤的优点,减少了制造时间和较低的能量需求。这导致成本降低,生产的可变性降低,改善活性物质(API)的稳定性,较短的崩解和制造片剂的溶解,更容易验证生产和较低的微生物污染风险较低[3]。另一方面,通过省略造粒工艺,具有高含量的活性成分(API)的片剂的制造受到限制,因为API颗粒经常在混合过程中隔离,这可能对含有粉末的含量均匀性产生负面影响。共混物通常具有更差的流量,重量变异性也可能增加[4]。此外,粉末共混物的较高表面积需要添加较大量的润滑剂。片剂还可以具有低功耗,可以在应力测试期间观察到这一点[5]。 To address these limitations and disadvantages, producers decided to refine direct compression excipients. Firstly, mono-excipients with improved flow properties and compressibility were introduced. Secondly, co-processed excipients (CPEs) were put in practice. CPEs are blends containing mostly fillers, binders, and disintegrants and sometimes also surfactants or lubricants. These blends are processed by various technologies, such asmelt granulation, dry granulation, wet granulation, fluid bed granulation and cocrystallisation, but mainly spray drying (SpD) [6]. The SpD leads to the formation of highly porous particles with good flowability and tabletability, while ensuring short-time disintegration in the physiological fluids, particularly in saliva. Usually the spherical shape of the newly formed particles improves the flow properties and provides a better rearrangement of the particles in the die during tableting, resulting in better compaction characteristics [7]. However, although the composition of these CPEs may be virtually similar, the small changes in the components’ characteristics can make them behave differently after compression [8].点击这里下载整篇文章的PDF格式

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文章信息:PetraSvačinováa,巴尔切拉vraníkováa,martin dominik b,jan elbl,SylviePavloková,罗马kubalák,帕夫利纳Kopecká,Alešfranc。粉末技术355(2019)675-687


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