金属氧化物-制药辅料

表征和评价不同钙镁盐作为直接压缩辅料的性能

菲利普 — 星期一，2019年6月24日05:30:04 +0000

系统地评估了一系列无机盐的性能作为直接压缩赋形剂。

不同盐的物理化学和技术特性在结晶/非晶态，形态，粒度，表观/触发密度，比表面积，流动性，可压缩性，稀释和分配系数方面研究。为了实现对不同盐的性能的综合评估，通过各种分析获得的数据归一化，为每个评估属性/参数的每个赋形剂进行分数。

统计阐述（JMP软件）完整数据集根据其作为直接压缩赋形剂的有效性提供了最终排名。盐作为最佳燃料用于制备直接压缩片剂，通过修饰营销片剂的组成，使用Cefixime作为模型药物。观察到新片剂的机械性能的显着改善，与市场上的崩溃强度增加超过30％，没有药物溶解谱的变化。即使由此产生的排名也是如此不能具有绝对值，是不同赋形剂的行为易受这种药物和其他配方赋形剂的影响，所提出的方法可以提供有用的模型，用于系统评估和潜在相似赋形剂的比较。 More on calcium and magnesium excipients

Der Beitrag Characterization and evaluation of the performance of different calcium and magnesium salts as excipients for direct compression erschien zuerst auf Pharma Excipients.

通过对压实和压片工艺参数的建模，预测布洛芬片的关键质量属性

菲利普 — 星期二，2019年5月14日12:10:36 +0000

< div风格= " margin-bottom: 20 px;src="//www.novoestroim.com/www2/wp-content/uploads/2019/05/predicting-the-critical-quality-attributes-of-ibuprofen-tablets-.jpg" class="attachment-post-thumbnail size-post- image wp-post-image" alt="process-parameters-for-roller-compaction" loading="lazy"srcset="//www.novoestroim.com/wp-content/uploads/2019/05/predicting-the-critical-quality-attributes-of-ibuprofen-tablets-.jpg 659w, //www.novoestroim.com/wp-content/uploads/2019/05/predicting-the-critical-quality-attributes-of-ibuprofen-tablets--150x121.jpg 150w， "//www.novoestroim.com/wp content/uploads/2019/05/predicting - -关键质量属性-的-布洛芬-平板电脑- 300 x242.jpg 300 w "大小= " (max-width:滚轮压实是一种低成本的造粒工艺，其应用有时受到压实性颗粒损失和药物溶出率降低的限制。因此，设计一个健全的生产流程是确保片剂质量的关键。

本研究采用实验设计(DoE)方法，对布洛芬片(赋形剂含量为7%)的两个关键工艺参数(CPPs)，即造粒时的辊压力和压片时的压实压力，以及几个关键质量属性(cqa)之间的相关性进行了研究。以200和600 mg布洛芬片的崩解度、溶出度、质量均匀度、硬度、孔隙度和抗拉强度为指标，采用多因素分析(MVA)确定最佳回归模型。

压片压实压力对上述cqa的影响大于压片辊力。主成分分析(PCA)相关负荷图显示，压实压力与崩解时间、抗拉强度、硬度直接相关，与药物溶解率、孔隙率均呈负相关。在干燥造粒过程中，观察到辊力的反相关关系。 Amongst all the regression models constructed, multiple linear regression (MLR) showed the best correlation between CPPs and CQAs. More on Ibuprofen tablets by roller compaction

Der Beitrag Predicting the critical quality attributes of ibuprofen tablets via modelling of process parameters for roller compaction and tabletting erschien zuerst auf Pharma Excipients.

药物和赋形剂对水合地位的影响

菲利普 — Sun, 24 Mar 2019 09:00:12 +0000

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然而，到目前为止，关于水化状态与药物/辅料相互作用的研究还很少。药物可通过腹泻、尿或出汗增加水分排出，从而触发水合不足的出现;口渴感或食欲下降;或者中枢体温调节的改变。 On the other hand, pharmaceutical excipients induce alterations in hydration status by decreasing the gastrointestinal transit time or increasing the gastrointestinal tract rate or intestinal permeability. In the present review, we evaluate studies that focus on the effects of drugs/excipients on hydration status.

These studies support the aim of monitoring the hydration status in patients, mainly in those population segments with a higher risk, to avoid complications and associated pathologies, which are key axes in both pharmaceutical care and the field of nutrition. Download the full MDPI article here: Effects of Drugs and Excipients on Hydration Status

Der Beitrag Effects of Drugs and Excipients on Hydration Status erschien zuerst auf Pharma Excipients.

润滑剂硬脂酸颗粒的形态及其在片剂中的分布的多维可视化

菲利普 — Sun, 10 Mar 2019 04:10:01 +0000

< div风格= " margin-bottom: 20 px;" > < img宽度= " 2636 "高度= " 1170 " src = " //www.novoestroim.com/wp-content/uploads/2019/03/Multi-dimensional-visualization-for-the-morphology-of-lubricant-stearicacid-particles-and-their-distribution-in-tablets.png "类=“attachment-post-thumbnail size-post-thumbnail wp-post-image“alt = "可视化润滑剂硬脂的形态" loading="lazy" srcset="//www.novoestroim.com/wp-content/uploads/2019/03/Multi-dimensional-visualization-for-the-morphology-of-lubricant-stearicacid-particles-and-their-distribution-in-tablets.png 2636w，//www.novoestroim.com/wp content/uploads/2019/03/multi -维可视化- - -形态-润滑油- stearicacid粒子-和-他们分布在平板电脑- 150 x67.png 150 w,//www.novoestroim.com/wp content/uploads/2019/03/multi -维可视化- - -形态-润滑油- stearicacid粒子-和-他们分布在平板电脑- 300 x133.png 300 w,//www.novoestroim.com/wp content/uploads/2019/03/multi -维可视化- - -形态-润滑油- stearicacid粒子-和-他们分布在平板电脑- 768 x341.png 768 w,//www.novoestroim.com/wp content/uploads/2019/03/multi -维可视化- - -形态-润滑油- stearicacid粒子-和-他们分布在平板电脑- 1024 x455.png 1024 w "大小= " (max-width:通过前处理和压片工艺控制颗粒形状及其在片剂中的分布，决定了类辅料润滑剂的药用性能。本研究旨在深入了解硬脂酸(SA)的形态和空间分布与润滑效率的关系，以及由此产生的片剂性能。

首先将未改性的片状SA粒子在热水中进行乳化，得到形貌为球形的再处理SA粒子。采用同步辐射x射线微计算机断层扫描(SR-μCT)技术，定量、无创的三维结构解析技术检测片剂中SA颗粒的三维信息。 SA particles in glipizide tablets prepared by using unmodified SA (GUT), reprocessed SA (GRT), as well as reference listed drug (RLD) of glipizide tablets were analyzed by SR-μCT. The results showed that the reprocessed SA with better flowability contributed to similarity of breaking forces between that of GRT and RLD. SA particles in GRT were very similar to those in RLD with uniform morphology and particle size, while SA particles in GUT were not evenly distributed.

These findings not only demonstrated the feasibility of SR-μCT as a new method in revealing the morphology and spatial distribution of excipient in drug delivery system, but also deepened insights of solid dosage form design into a new scale by powder engineering.

Download full article here: Multi-dimensional visualization for the morphology of lubricant stearic acid particles and their distribution in tablets

Der Beitrag Multi-dimensional visualization for the morphology of lubricant stearic acid particles and their distribution in tablets erschien zuerst auf Pharma Excipients.

潜在使用氧化镁作为赋形剂，以保持臭氧的硬度

菲利普 — 星期六，2019年3月9日06:30:55 +0000

< div风格= " margin-bottom: 20 px;" > < img宽度= " 1920 "高度= " 1080 " src = " //www.novoestroim.com/wp content/uploads/2019/03/excipients - 2. png”类=“attachment-post-thumbnail size-post-thumbnail wp-post-image“alt =“氧化镁作为赋形剂的使用”加载= "懒惰" srcset = " //www.novoestroim.com/wp content/uploads/2019/03/excipients - 2. png 1920 w,//www.novoestroim.com/wp-content/uploads/2019/03/Excipients-2-150x84.png 150w, //www.novoestroim.com/wp-content/uploads/2019/03/Excipients-2-300x169.png 300w, //www.novoestroim.com/wp-content/uploads/2019/03/Excipients-2-768x432.png 768w，本研究旨在阐明氧化镁(MgO)对口腔崩解片(ODTs)贮存过程中硬度的影响。通过粉末直接压缩制备了一系列MgO浓度的ODTs，并在40°C、相对湿度75%的未包装条件下存储长达4周。不含MgO的片剂贮存1周后硬度显著降低，而含MgO质量分数≥4%的片剂贮存4周后硬度仍保持不变。不论MgO水平如何，储存后的崩解时间与储存前观察到的时间相当(约30秒)。此外，模型药物对乙酰氨基酚的溶出行为不受MgO水平的影响。这些结果表明，MgO的加入抑制了在未包装状态下储存过程中ODT硬度的降低，没有延迟片剂的崩解或抑制药物的释放。口腔崩解片(ODTs)是固体口腔制剂，在口腔唾液或少量水中迅速崩解，由美国食品和药物管理局(FDA)定义为30秒内。这种剂型对婴儿、老年人或吞咽困难的患者和饮水量有限的患者非常有用。
初始ODT配方相对较软，操作时需要小心。 However, recently developed ODTs have good disintegration properties and a higher level of hardness.However, ODTs contain strongly hydrophilic materials that absorb water and swell; therefore, exposure to moisture decreases tablet hardness, increasing the risk of cracking or chipping during handling. Therefore, it is important to ensure the quality of the preparation to minimize any reduction in tablet hardness due to moisture absorption. Several solutions to this problem using additives have been reported to date, but elaborate processing of the additives is required before tablet preparation. Further research is required to develop a convenient method of preparing an ODT that exhibits rapid disintegration while maintaining its hardness during storage under high humidity.
Magnesium oxide (MgO) is widely used as an effective and safe laxative and antacid. Previous studies have shown that the hardness of tableted MgO increases during storage under high humidity in the unpackaged state. We have previously investigated the inhibitory effect of MgO on the decrease in hardness during storage of tablets, and the mechanism underlying this effect. Download full article here: Potential Use of Magnesium Oxide as an Excipient to Maintain the Hardness of Orally Disintegrating Tablets during Unpackaged Storage

Article from Chem. Pharm. Bull. 67, 284–288 (2019) – Link to Paper

Der Beitrag Potential Use of Magnesium Oxide as an Excipient to Maintain the Hardness of ODTs erschien zuerst auf Pharma Excipients.

辅料科学的最新发展——产品开发中每种辅料的定量选择的意义

菲利普 — 2019年1月24日星期四13:43:16 +0000

< div风格= " margin-bottom: 20 px;"> < / div > < h2 >暗示量化各赋形剂的选择产品开发< / h2 > < p >赋形剂的作用,设计不同的剂型不需要任何介绍。这些是添加到配方中的添加剂以及药理活性物质。添加它们的主要目的是增加配方的体积并赋予所需的性能。辅料与原料药一样，需要经过验证和标准化;下一章简要介绍了不同剂型的辅料，包括固体剂型、液体剂型和半固体剂型。考虑到药物先进配方领域的持续发展，我们也涵盖了用于纳米配方的赋形剂。

除此之外，还提供了关于多矿物赋形剂、共加工赋形剂和赋形剂不相容的特别说明，以及赋形剂在制药行业的简要使用历史。 Continue the book chapter on excipients or check excipients basics.

Der Beitrag Current Developments in Excipient Science – Implication of Quantitative Selection of Each Excipient in Product Development erschien zuerst auf Pharma Excipients.

氧化镁抑制片剂贮存过程中硬度降低的机理

菲利普 — 星期三，2016年9月14日13:33:16 +0000

< p>摘要

Takatoshi Sakamoto,*,a Shigeto Kachi,b Shohei Nakamura,a Shinsuke Miki,b Hideaki Kitajima,b and Hiroshi Yuasaa
a Department of Pharmaceutical Technology, School of Clinical Pharmacy, College of Pharmaceutical Sciences, Matsuyama University; 4–2 Bunkyo-cho, Matsuyama, Ehime 790–8578, Japan: and b Pharmaceuticals Division, Kyowa Chemical Industry Co., Ltd.; 2876–2 Inoue, Miki-cho, Kita-gun, Kagawa 761–0705, Japan.
Received January 7, 2016; accepted May 26, 2016

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Der Beitrag Mechanism by Which Magnesium Oxide Suppresses Tablet Hardness Reduction during Storage erschien zuerst auf Pharma Excipients.

以氢氧化镁为赋形剂的药物制剂，提高了有效成分的释放-专利

菲利普 — 太阳，2015年11月29日15:46:52 +0000

2015年11月< / span > < / div > < h1类=“j-blog-header j-blog-headline j-blog-post——标题" > < / h1 > < / div > < div class = " post j-blog-content”> < div id = " cc -矩阵2726819498”> < div id =“cc - m - 10212865298”class =“j-module n j-text”> < p >本发明涉及制药配方的有效成分在水溶解度较低具有提高有效成分释放度的溶液，以及其制备工艺。特别是，这些是以氢氧化镁碳酸盐作为赋形剂的药物制剂。< / p > < p > <标题= " http://www.freepatentsonline.com/y2015/0328316.html " href = " http://www.freepatentsonline.com/y2015/0328316.html " target = "平等" rel = " noopener " >更多< / > < / p > < / div > < div id =“cc - m - 10212865898”class =“j-module n j-sharebuttons”> < div class = " cc-sharebuttons-element cc-sharebuttons-size-32 cc-sharebuttons-style-coloredcc-sharebuttons-design-round cc-sharebuttons-align-left " > < / div > < / div > < / div > < / div > < div id = " flexsocialbuttons " class = " n " > < div class = " cc-sharebuttons-element cc-sharebuttons-size-32 cc-sharebuttons-style-colored cc-sharebuttons-design-round cc-sharebuttons-align-left " > < / div > < / div > < /文章> < p >, < / p > < p > Der Beitrag < rel =“nofollow”href="//www.novoestroim.com/www2/news/magnesium-hydroxide-carbonate-as-excipient-in-pharmaceutical-preparations-having-improved-release-of-active-ingredient-patent/">氢氧化镁作为赋形剂在药物制剂中具有改善有效成分释放的作用–专利 erschien zuerst auf Pharma辅料.

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