New molecular entities (NMEs) are becoming larger and more lipophilic and, as a result, less soluble.市场目前约40%活性药素显示溶解性,估计60%至90%开发中的复合物有溶解性挑战1 2口服配方,API溶解性和渗透性s
New molecular entities (NMEs) are becoming larger and more lipophilic and, as a result, less soluble.市场目前约40%活性药素显示溶性差,估计60%至90%开发中的复合物有溶性挑战。 12口服配方中,API溶性和渗透性是肠道吸收的关键因素。结果,提高溶性技术已成为药用配方器的焦点领域如果不能成功解决可溶性限制问题,NME不太可能推进开发管道,因为GI道吸收量有限。转而减少分子整体效果,因为吸收是LADME关键组件(解放、吸收、分布、新陈代谢消除Figure 1) model of drug pharmacokinetics.
Expanding upon the LADME model, one can identify strategies to improve the oral absorption of a poorly soluble molecule.具体地说,可以通过提高溶性/渗透性以及其他方法增加吸收量,包括通过P-gp传输器减少消除提高溶性,盐法和药法编组等化学方法通常只在开发初期才可行,因为它们根本改变API的化学性质。实现化学基质强活动与良好的物理特性之间有微平衡,后者往往优先处理。物理(或后合成)法开发时高度相关,并包括:
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Authors: Daniel Joseph Price and Thomas Kipping
Der Beitrag Improving the Bioavailability of Challenging APIs using Hot Melt Extrusion with Polyvinyl Alcohol erschien zuerst auf Pharma Excipients.
The incorporation of 3D printing technologies in the pharmaceutical industry can revolutionize its R&D, by providing a simple and rapid method to produce tailored one-off batches, each with customized dosages, different compounds, shapes, sizes, and adjusted release rates.具体地说,这类技术可有利于开发热点和跨面药提供系统,包括 [.]
Der Beitrag The incorporation of 3D printing technologies in the pharmaceutical industry can revolutionize its R&D, by providing a simple and rapid method to produce tailored one-off batches, each with customized dosages, different compounds, shapes, sizes, and adjusted release rates.具体地说,这类技术可有利于开发专题和跨式药物提供系统,包括补丁和微软码片。
最近数项研究被选择支持本文所探讨主题的相关性并讨论这些打印技术的局限性,包括规范、质量和安全问题。
This work explored 3D bioplotting to mimic the intrinsic hierarchical structure of natural articular cartilage.Alginatedimede-GEL使用水凝墨创建层次排序脚架与先前报告的ADA-GEL组成法相比,我们引入一种配方修改法,配方加热修改Gelatine量增加高亮度悬浮-Ghydate-Gelatin演示 [.]
Der Betrag
This work explored 3D bioplotting to mimic the intrinsic hierarchical structure of natural articular cartilage.Alginatedimede-GEL使用水凝墨创建层次排序脚架In comparison to previously reported ADA-GEL compositions, we introduce a modified formulation featuring increased amounts of thermally modified gelatine.
Highlights
Bioprinting of alginate dialdehyde-gelatine demonstrated for cartilage tissue engineering.
Thermal pre-treatment of gelatine affects hydrogel mechanical and rheological characteristics.
Thermal pre-treatment of gelatine enables 3D printing of hierarchical complex structures.
Gelatine was degraded by hydrolysis which resulted in tailorable printability characteristics further substantiated by rheological analysis.ADA(3.75%w/v)-GEL(7.5%w/v)与Gelatine修改80°C3H脚架层次结构通过m-C分析确认测试机械性能和水凝合适性作为细胞播种和封装的适当矩阵时,进行了纳米缩进5千帕测距弹性模Gelatine heat pre-treatment resulted in modifiable mechanical and rheological characteristics of ADA-GEL.
In summary, this study demonstrates the possibility to enhance the printability of ADA-GEL hydrogels to fabricate hierarchical scaffold structures with shape stability and fidelity, without the necessity to change the initial hydrogel chemistry by the use of additives or crosslinkers, providing a valuable approach for fabrication of designed scaffolds for cartilage tissue engineering.
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Materials: Covalently crosslinked ADA-GEL hydrogel was synthesised as described by Sarker et al [20].简言之,ADA(ginate-di-althyde )由 alginiate氧化编译(,德国)使用钠代用法(naio 4 ,Sigma-Aldrich,德国)作为乙醇-诱杀水混合体中的氧化剂(1:1)。悬浮22摄氏6H(室温,RT)完全缺光氧化反应通过添加ene-glycol(VWR化学国际)解析并再搅30分钟生成悬浮转入数个透析多膜管管(MWCO:6-8kDa,spectrum Laborates,USA)和对超纯水拨号(UPW,Milli-QQQs,
The oral route is the most common form of drug administration, being a safe and convenient, particularly for solid oral dosage forms.当前大规模制造技术大都产生固定剂量单元并允许有限选择用量强在某些情况下,需要用药强度个性化化,包括髓治法理学
The oral route is the most common form of drug administration, being a safe and convenient, particularly for solid oral dosage forms.当前大规模制造技术大都产生固定剂量单元并允许有限选择用量强在某些情况下,需要用药强度个性化化,包括髓治疗指数药或伴生药药药-药性/药效药-药性交互作用、酶或运输器药性变异性,以及特殊人群,包括老年人、儿童和肾功能缺陷/肝功能缺陷患者a类='btnbn-defaultbn-md'hrefs.com/wp-content/uploads/2021/06/this-print-a-aproach-to-Dose个性化可以通过复合或使用其他管理路径实现(例如侧接式),但这些路径缺少与标准制造相同的质量控制水平,不便/可接受性差不等。自动制造个性化固口化强力可解决这一需求开发三维打印自动逐层生成自定义平板三维打印片片子除单点使用外,还有可能用于早期临床试验期间的剂量升级、制片点药短期和制作复杂多药片片件并配有个人化配方图解特别是阻塞沉积建模(FDM),它涉及通过窄热喷嘴并随后沉积准备固态物体而分解热塑丝,似乎对临床现场生产有帮助,因为制造过程没有松散粉末,后处理可以避免。FDM应用需要FDM处理线程由热熔扩展制造。
IR是口服量表最常用发布剖面图,并同时产生来自通过热熔流程制造三维打印片片的固有特性的重大挑战 工作旨在为从FDM-和直接粉打印中产生的独特值建议创建选项,这些方面与标准制造过程基本不同(即分散化制作和定制平板结构)。临界质量属性(CQAs)集成为3D打印片片片的成功标准,包括内容一致性提供剂量精度(相对标准一致性数据偏差)、权重一致性(以确保内容一致性)、分解剖面貌(目标快速释放)和物理化学稳定性此外,还考虑了开发三维打印剂量表的可接受外观和大小。
关键目标之一是开发一个工业化配方工具箱,适合不同的API开发可缩热熔挤出配方并装有多种药量首项研究探索选定前接收者组合实现快速或极快从FDM打印片状带水益模型复合所选水溶聚合物和水分分解/处理辅助工具对FDM兼容性的影响,并结合填充密度对配方质量属性的影响(即重量和内容一致性、分解率)进行了研究。Hypray-Cellose SSL选择为水益聚合物和咖啡因,药载量5-20%热稳定模型药Poly-Serveridone-vilenegletate聚合物(在第三次研究中开发出易溶性模型复合立即释放FDM表,并使用非损性精确形态分析检测出分解关键结构参数基本methacrylate共聚物( 虽然FDM打印可能有利于临床现场制造,因为打印过程没有粉末或溶剂参与,但一大挑战是如何实现丝状所需机械性能允许FDM处理第四次研究探索直接粉色3D打印平板片,省略了简化引信沉积建模的丝片步骤直接三维打印时,粉状混合装入像盒头并成功打印出蜂窝设计跨步DPP内装孔度高表面积证明概念制作快速释放用量表水溶性HPCSSL选择矩阵前和咖啡因模拟药PEG4000增塑原型和KollidonQVA64快速分解聚合物对DPP可处理性和解析率的影响得到了调查3D打印低密度(30%)显示快速分解与配方无关,而高填密度(80%)则需要PEG4000和KollidonVA64组合实现快速释放所得平板显示药含量百分比完全一致,但有可变权重咖啡因以晶状状态和稳定多态形式出现直接粉末打印可行性即时释放用量表制作这种方法可创造避免热熔溢出的机会,允许三维打印独立于线性机械特性并有可能通过减热延长产品架存存存存期。
开发表板时对成人和儿童的尺寸都满足一致性内容需求,以提供精度剂量(相对标准一致性数据偏差)、权重一致性、分解目标(快速释放)和物理化学稳定性运算学研究表明,未来开发IR3D打印剂量表,除适当聚合矩阵选择外,还可以减少闭口孔量,增加开孔量,优化形状/大小和分解之间的平衡水益聚合矩阵与CAD设计相结合,通过FDM或DPP制造,对未来3D打印药产品开发大有希望然而,仍应克服的挑战包括直径整齐化丝状物、精度和可复制沉积质量、设计密度和实际密度差异、可预测最终形态学和丝状机械性能In addition, there might be a need in a real-time monitoring of flow and viscosity of the molten mass during the 3D-printing process.
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Author: Marina Fanous, Basel University.
Der Beitrag Three-dimensional printing of tablets – a potential approach to on-clinical-site extemporaneous formulation and personalized medicine erschien zuerst auf Pharma Excipients.
Protein delivery systems have been extensively applied in controlled releasing of protein or polypeptides for therapeutic treatment or tissue regeneration.三维打印技术显示新用量格式大有希望,配有裁剪剂量大小和药物释放剖面图,三维可打印蛋白传递系统必须面对许多难点挑战研究中,我们开发 [.]
Der Beitrag Protein delivery systems have been extensively applied in controlled releasing of protein or polypeptides for therapeutic treatment or tissue regeneration.3D打印技术显示新用量表大有希望并配有剂量大小和药物释放剖面图,3D可打印蛋白提供系统必须面对许多难点.
To improve patient compliance and personalised drug delivery, long-acting drug delivery devices (LADDDs), such as implants and inserts, greatly benefit from a customisation in their shape through the emerging 3D-printing technology, since their production usually follows a one-size-fits-most approach.三维打印LADDs使用受限制,但主要受三维可打印应用不足的限制 [.]
Der Beitrag To improve patient compliance and personalised drug delivery, long-acting drug delivery devices (LADDDs), such as implants and inserts, greatly benefit from a customisation in their shape through the emerging 3D-printing technology, since their production usually follows a one-size-fits-most approach.The use of 3D-printing for LADDDs, however, is mainly limited by the shortage of flawlessly 3D-printable, yet biocompatible materials. A novel 3D-printing excipient for long-acting drug delivery devices is introduced. A mechanistic understanding of material requirements for 3D-printing is presented. A novel progesterone immersion strategy for 3D-printed devices is developed. The novel excipient shows comparable drug permeability to ethylene-vinyl acetate. The present study tackles this issue by introducing a novel, non-biodegradable material, namely a polyester-based thermoplastic elastomer (TPC) – a multi-block copolymer containing alternating semi-crystalline polybutylene terephthalate hard segments and poly-ether-terephthalate amorphous soft segments.下一步详细描述材料3D可打印性,通过机械、风学和热学分析发现优于传统聚合物(ene-evenyacates),本研究首次建立对progeTPC展示了广选移植尺寸和复杂地理特征的3D可打印性。
Highlights
Der Beitrag Novel polyester-based thermoplastic elastomers for 3D-printed long-acting drug delivery applications erschien zuerst auf Pharma Excipients.
The development of printable filaments has been identified as a critical aspect for the processing of pharmaceutical grade polymers and the fabrication of oral solid dosage forms.在这次研究中,对一系列平面聚合物和装药聚合物进行了调查和评估,以确定它们的可打印性与商业丝状比较聚合物物理化学描述 [.]
Der Betrag
The development of printable filaments has been identified as a critical aspect for the processing of pharmaceutical grade polymers and the fabrication of oral solid dosage forms.在这次研究中,对一系列平面聚合物和装药聚合物进行了调查和评估,以确定它们的可打印性与商业丝状比较聚合物物理化学特征包括差分扫描量解热分析和Rhelog学研究纹理分析器用于研究丝状机械性能,以获取最大抗拉强度、Young的模变和断裂时延展主构件分析用于比较聚合物可打印性并识别每项机械属性的贡献分析显示最大抗拉强度15-20兆帕是预测可打印性最关键属性此外,可打印分页使用聚合沉积建模技术处理,并确定了最优打印参数。研究表明,通过评价机械性能预测可打印性是可行的More on HME and prediction on 3D printability of polymers
Der Beitrag Investigation on Hot Melt Extrusion and Prediction on 3D Printability of Pharmaceutical Grade Polymers erschien zuerst auf Pharma Excipients.
Binder jetting is an additive manufacturing technique that creates three-dimensional constructs from a powder feedstock.数行使用,包括制药添加式制造法提供数项功能效益,使用传统制造法不容易实现。公有有限知识详解ss/www.pharmaexbenses.com3d-printing/binder3d-jetting-presters/
Binder jetting is an additive manufacturing technique that creates three-dimensional constructs from a powder feedstock.数行使用,包括制药添加式制造法提供数项功能效益,使用传统制造法不容易实现。目前只有有限的公开知识详解有效绑定反射粉末的要求自2015年发布Spritam-l-topu-margin-xs-字量: 400文本转换方式:初始化;++++span样式=font-size:187px字量: 400文本转换方式:初始化;'>提取药前受体粉片用于Binder喷射过程. 我们的目标是提高我们对粉流、粉湿和粉绑定知识,将粒子与过程连通并建设能力以创建更多范围适合绑定式喷射新产品粉末的能力初步筛选数个标准药前受体粉末相关属性后,两位候选人显示最合宜潜力用于绑定喷射,具体指微晶素纤维素(Pharmacel101和102)和晶体素(Lactohale200)。使用这些药前火药简单配方模型,我们用数位参数分析可打印性与火药性能,参数范围包括维精度、构建硬性性性、易碎性、易渗透性及表面完成总的来说,这些粉状的配方显示可打印性良好,但某些粉状混合生成构造,制造不完全性更显眼数条提高这些药粉可打印性路线拟供未来工程使用归根结底,这项工作为开始量化评估标准药前端粉末使用粉分化技巧和打印质量结果Continue reading Table 1.Candidate powders evaluated for binder jetting in a Projet CJP 460Plus printer. by A.Antic J张南阿米尼D.A.V莫顿K.PHapgood筛选药前接受者粉末用于商业三维反射打印机,高级粉末技术2021,ISSN0921-8831,https://doi.org/10.1016/j.apt.2021.0014(https://www.sciencedirect.com/science/article/pii/S0921883121002387) Der Beitrag Screening pharmaceutical excipient powders for use in commercial 3D binder jetting printers erschien zuerst auf Pharma Excipients.
Powder Trade Name Powder Generic Name Manufacturer Batch d10 d50 d90 Calcium sulfate dihydrate Set gypsum Sigma Aldrich BCBV1390 7 18 46 Calcium sulfate anhydrous – Sigma Aldrich MKBW9429V 3 9 23 Calcium sulfate hemihydrate Plaster of Paris Sigma Aldrich BCBV7581 5 17 62 Hydroxyapatite – Sigma Aldrich BCBZ3280 3 7 15 β-tricalcium phosphate – Sigma Aldrich BCBS4390V 3 7 17 Methocel E5 HPMC E5 Dow Chemical VJ27012N23 24 51 107 Methocel E6 HPMC E6 Dow Chemical QC27012402 24 49 127 Methocel K100 HPMC K100 Dow Chemical TK06012N21 20 51 119 Methocel K4M HPMC K4M Dow Chemical TD02012N12 23 62 186 Methocel K3 HPMC K3 Dow Chemical TE18012N22 19 56 160 Salicylic Acid – Merck KGaA F1591335 9 18 36 Croscarmellose sodium – DFE Pharma Not available* 19 31 47 Sigmacell Cellulose Cellulose Sigma Aldrich SLBN4490V 10 20 36 Avicel PH101 MCC 101 FMC Corp BCBQ8403V 24 55 103 Pharmacel 101 MCC 101 DFE Pharma 765 25 60 120 Pharmacel 102 MCC 102 DFE Pharma 772 31 86 172 Lactopress anhydrous lactose Lactose DFE Pharma 956 3 20 70 Lactochem extra fine lactose Lactose DFE Pharma 974 3 20 50 Lactochem fine lactose Lactose DFE Pharma 752 3 15 40 Pharmatose 350 M Lactose DFE Pharma 689 4 30 80 Pharmatose 450 M Lactose DFE Pharma 105 3 20 50 Lactohale 200 Lactose DFE Pharma 395 18 65 114 Pharmatose 130 M Lactose DFE Pharma Not available* 16 85 196 20:80 VA64-Pharmacel 102 – BASF-DFE Pharma Not applicable** 27 73 150 20:80 VA64-Pharmacel 101 – BASF-DFE Pharma Not applicable** 21 54 105 20:80 VA64-Lactohale 200 – BASF-DFE Pharma Not applicable** 27 71 119 0.5:9.0:90.5 MgSt-VA64-Lactohale 200 – Honeywell-BASF-DFE Pharma Not applicable** 24 70 119
Biodegradable polymeric microneedle arrays (BPMNAs) could be explored as potential devices for transdermal drug delivery, which can provide a painless and safe drug delivery method.BPMNA还可能提供高药载量和长期提供药后与药库合并s/www.pharmaexccepties.com/news/3d-pl-micledle-estradiol/
Biodegradable polymeric microneedle arrays (BPMNAs) could be explored as potential devices for transdermal drug delivery, which can provide a painless and safe drug delivery method.BPMNA还可能提供高药载量和长期提供药后与药库合并mNA编译药库费用昂贵并需要复杂程序 。
本项研究是为了描述编译水库bpnana使用多维酸并结合FDM3D打印和注入容量填充技术3D打印针小尺寸使用化学蚀刻过程减为173m3D印制PLAMNA内容为29.79+0.03 mg,释放时间长达7天机械测试结果显示3D印制PLAMNAs骨折(900N)所需强度比皮肤渗透(4N)所需强度高得多3D打印PLAMNAs通过直角成功渗透通过渗透测试、甲型蓝染色和语义检验得到确认。
结果显示3D印制PLAMNAs可穿透皮肤而不触摸皮肤神经并穿插血管在当前研究中,我们探索用FDM三维打印和注入体积填法组合无痛持久转用药的可行性。
/ahrefs/link.sprianger.com/article/10.10.10/s1137/s133401-0106-4'目标='blank'rel=noper'translRes. (2021).https://doi.org/10.1007/s133401-0106-4Der Beltrag
Three-dimensional (3D) printing is a revolutionary technology that is disrupting pharmaceutical development by enabling the production of personalised printlets (3D printed drug products) on demand.多功能技术通过创建小批量剂量软药,为临床实践和药开发提供重要优势,即个人化药满足个人病人需求的能力, uncts
Der Betragts Three-dimensional (3D) printing is a revolutionary technology that is disrupting pharmaceutical development by enabling the production of personalised printlets (3D printed drug products) on demand.多功能技术通过生成小批量剂量弹性药为临床实践和药开发提供巨大优势,即能将药个化满足患者个人需求,并加速临床前科研究内药开发时间推向人类优先级和第一/二阶段临床试验。 尽管三维打印药大有益处,但该技术的临床潜力尚未实现。即时评审中,我们概述医学前和临床领域三维打印药品最新前沿调查,并用前瞻性方法制定战略,以进一步帮助三维打印转至诊所。
Der Beitrag Translating 3D printed pharmaceuticals: From hype to real-world clinical applications erschien zuerst auf Pharma Excipients.
The pulsatile-release Chronotopic™ system was conceived of as a drug-containing core surrounded by a coat made of swellable/soluble hydrophilic polymers, the latter being able to provide a programmable lag phase prior to drug liberation.系统目标化配置中也建议使用此系统,包括防毒膜预防内部大衣的早期交互性 [.]
Der Beitrag The pulsatile-release Chronotopic The printing parameters identified as suitable during the set-up phase were then used to fabricate prototypes either in a single step for the pulsatile configuration or following two different fabrication approaches for the colon-targeting one. Download the full article as a PDF here or read it here Materials: Hydroxypropyl cellulose, HPC (Klucel® LF, Ashland, Kearny, NJ, USA)!低粘性液化纤维素,HPCSSLmethacrylic acid copolymer, EDR (Eudragit® L 100-55, Evonik, Essen, Germany)!多维尼醇PVA(GohsenolsupQQ/supEG03P,三菱化工公司,日本东京)glycerol,Glylpolyethylene glycol 400, PEG (Clariant Masterbatches, Milan, Italy)!三乙二联网TEC咖啡因CFFsodium starch glycolate, EXP (Explotab® CLV, JRS Pharma, Rosenberg, Germany)!high-amylose maize starch, AMY (Amylo® N-460, Roquette Pharma, Lestrem, France)!和多效酸丝化(TreeDfilaments,Milan,意大利)。 formation信息:MelocchiAUbordi MBriatio-Vangosa,F.穆塔哈里克切拉M福波里州马龙尼A帕鲁甘 L泽马 L加扎尼加The Chronotopic
system was independently investigated starting from in-house made filaments, characterizing the resulting specimens for physico-technological and performance characteristics.系统活性模类交付精密医学时代:3D通过FDM打印可行性https://doi.org/10.3390/pharmatutics1300559
It is key to understand powder blend characteristics in relation to tablet characteristics when using pharmaceutical 3D printing, in order to obtain 3D powder bed printed tablets that comply with the pharmaceutical specifications.3D打印前端选择文献有限,即使唯一3D打印药片由ss/ps/eced/DerBeitrag
It is key to understand powder blend characteristics in relation to tablet characteristics when using pharmaceutical 3D printing, in order to obtain 3D powder bed printed tablets that comply with the pharmaceutical specifications.There is limited literature available on excipient selection for 3D printing, even though the only marketed 3D printed drug is prepared with powder bed printing.
Highlights
• A lactose monohydrate binder blend is preferred for 3D powder bed printing.• Wettability is related to the particle size distribution of the blend.
• A hydrophilic and hydrophobic API was successfully formulated into a printed tablet.
• The impact of pre-blend/print settings on tablet hardness and dissolution was studied.
• Optimizing the pre-blend and print settings have to be in conjunction for 3D printing.
In this study, the impact of different particle size distributions of lactose-starch base formulations on key critical material attributes such as wettability, consolidation and flowability was studied.发现微粒积分较少有助于墨水快速渗透火药床使用Acetaminophen或DiclofenacSodium配方研究印刷设置或绑定器类型对初级平面属性的影响,如硬性分解发现优化基础配制和打印设置必须并发,因为它们密切相关。本研究详细显示水益/水分API可成功编译为3D打印平板子,并计及描述的写法因素 。
Materials
The materials used are sieved lactose monohydrate, milled and classified lactose monohydrate, fully pregelatinized potato starch, partly pregelatinized maize starch and sodium starch glycolate (Primojel®, DFE Pharma, Germany), Povidone (Duchefa Farma, The Netherlands), Diclofenac Sodium as hydrophobic model compound with a particle size of x10 = 1.8, x50 = 17.4 and x90 = 76.8 μm (Fagron, The Netherlands) and Acetaminophen fine powder as hydrophilic model compound with a particle size of x10 = 4.3, x50 = 22.1 and x90 = 82.3 μm (Mallinckrodt, Raleigh, NC, USA).液化单水合物与适当的绑定器合并时,适合3D粉状平板打印功能填充器晶体 stark配方的罚款(按x10测量)对每种配方都要求混合优化的湿易流性有重大影响火药混合物1和2均适合三维打印,然而一级则更适合有挑战流的API,而另一级则为API低湿性提供解法。
类型和量绑定器显示清晰与平板制作所用打印液量相关并给配方设计空间 找到硬性与分解最优平衡硬性分解平衡受像打印液和小滴大小等参数影响因此,这将是未来研究的一个重要题目。
a成功配制疏水模型复合局部凝固星体使用平板硬度和分解三维打印平板块优于使用全前位星体未来工作将优化此功能,修改绑定层并添加解脱药产品表单
DerBeitrag
Artificial intelligence (AI) is redefining how we exist in the world.几乎社会的每一部分都使用超人速度和智能执行任务从预测股市趋势到无司机车辆,诊断疾病和机器人外科药业尚未真正控制AI[.]
Der Beitrag
Artificial intelligence (AI) is redefining how we exist in the world.几乎社会的每一部分都使用超人速度和智能执行任务从预测股市趋势到无司机车辆,诊断疾病和机器人外科药业尚未真正使用AI.s/p>
开发与制造药大都保留在一刀切范式中,最近三维打印点播全定制药药方3DP由于其灵活性,在开发配方时提出了数不胜数的选择,通常需要专家导航。药方3DP内运用AI消除人际知识需求,因为机器学习可精确预测最优过程参数AI也可以融入药用3DP'物联网',将个性化药品编译成智能精简自主管道。
支持性基础设施,如云链和块链,也将发挥关键作用关键地说,这些技术将加速在临床环境使用药方3DP并驱动全球实现个人化医学4.0.
/ahref='https/www.sciencedent.com/science/article/abs/pi/S0169409X21001794'mcoubrey,FrancescaK.HGavins、Jun Jie Ong、Alvaro Goyanes、Simon Gaisford、Abdul W贝西特利用人工智能下一代三维印刷药品,高级药品提供评审,2021年https://doi.org/10.1016/j.ddr.2021.015.
Der Betrag
Hot-melt extrusion (HME) has emerged as a pioneering manufacturing technology for pharmaceutical industries, and the utilization is overgrowing due to its unit operation, cost-effectiveness, solvent-free nature, and continuous manufacturing as compared to conventional techniques.首要重心应放在研究配方和过程参数上,以满足需求。修改设备 [.]
Der Beitrag
Hot-melt extrusion (HME) has emerged as a pioneering manufacturing technology for pharmaceutical industries, and the utilization is overgrowing due to its unit operation, cost-effectiveness, solvent-free nature, and continuous manufacturing as compared to conventional techniques.首要重心应放在研究配方和过程参数上,以满足需求。By modifying the equipment design and varying a few processing conditions, a myriad of different dosage forms for various applications can be developed.
Highlights
This paper describes the Hot-melt extrusion (HME) equipment, process and materials.
Recent advancements in the applications of HME are reviewed.
Opportunities for HME technology in the veterinary field are discussed.
Recent patents of last five years in field of HME are presented.
An insight on pharmaceutical HME market globally is elucidated.
In-depth pre-formulation research is required for the rational selection of an active pharmaceutical ingredient, carrier, and additives for the smooth and continuous functioning of the HME process to achieve the desired product.近些年来,审查渠道从全局角度分析几种设备组件、处理需求、HME使用的材料和各种药送系统使用HME综合论文介绍数大新契机和创新方法,如三维打印剂量表、滥用确定式配方、共发药、时代药交付、联播器、纳米技术、半固片、双片粒子和多项应用。
文章还简要洞察2016至2024年间HME制药市场的全球状况Latterst,本审查汇总了最近四年HME数项应用,用表格方式提供药物,方便阅读文章试图为在这一领域工作的公式论者打下书目基础并推广这一领域的深入调查。 s/www.sciencedent.com/science/article/abs/pii/S1773224721001325热熔溢出:强调药方应用的最新进展,《药品科技杂志》,第63卷,2021年https://doi.org/10.1016/j.jddst.2021.102452.Der Beitrag Hot-melt extrusion: Highlighting recent advances in pharmaceutical applications erschien zuerst auf Pharma Excipients.
The utilization of 3DP as manufacturing process might provide some potential benefits for the pharmaceutical industry as well as for patients.关于药用量表定制化问题,3DP似有很大潜力点播制造过程与传统制造流程相比,3DP技术似乎快速适配 和 [.]
Der Beitrag The utilization of 3DP as manufacturing process might provide some potential benefits for the pharmaceutical industry as well as for patients.关于药用量表定制化问题,3DP似有很大潜力点播制造过程与传统制造流程相比,3DP技术似乎快速适应并灵活化。除打印定制复杂结构的可能性外,3DP还可用于按需调整剂量表的药物释放特征。 3DP的实现可能大大缩短整体制造链,因为像粒子化、研磨、筛分化、分片化和 除提供优势和机会外,3DP必须克服重大挑战[109]这些挑战可划分为三大类:1技术挑战二叉调控挑战3级良好制造实践挑战。 1技术挑战: 取决于应用打印技术,印刷对象可能不完全机械性能并拥有高易碎性,这使得进一步处理这些用量表相当困难。特别是在打包印刷片片时可能发生缺陷,可能导致批量批量拒绝BJ或SLA等3DP技术中,许多未打印材料在打印过程后积聚一方面,必须找到技术解决办法避免多印未印材料,另一方面,需要澄清非处理材料是否可以重新使用以进一步打印与成熟制药流程相比,3DP缺少流程控制策略传统片段制作期间,过程内控制是为了密切监控制作3DP进程目前不常用IPC技术,即打印平板片打印后评估分析3DP过程耗时多,而传统平面设备每小时可制造数十万片片片(视平面按键规模而定)。 2规程: 从规程角度讲,三维打印用量表必须满足与传统制造用量表相同的要求管治框架目前大有漏洞既定流程指南得到很好实施和标准化,3DP流程缺少监管当局的任何指南。世界各地的卫生当局确认缺乏指导并启动制定标准和定义实用指南进程林业局指定2个内部实验室-固态机械实验室和FD科学工程实验室功能性能设备使用实验室-探索3DP药理学未来潜力[110]这两单元的工作应帮助第一步获取知识,帮助制定标准并识别影响产品安全的关键方面。卫生主管部门必须多加努力定义标准流程和为药厂提供指南。 3DP社区药店和医院药店可点制过程,则供应链有可能出现不同场景。关于FFF技术,装药丝必须由外部化学或制药公司提供,印刷过程由药店本身执行假设情况提出了如何用药店设备测试进货问题,由谁负责发布制造起始材料[111]. 3GMP挑战 更多时,3D打印器制造商的资格标准必须定义以满足GMP的要求特别是清洁验证专题应处理以避免交叉污染只要清洗概念不到位和验证,制药厂家就有义务使用三维打印器专用设备The mentioned regulatory and GMP challenges must be tackled together by health authorities and pharmaceutical manufacturers to establish 3DP as manufacturing process for pharmaceutical dosage forms. Download the full dissertation about 3D printing here! See Part 1: "Introduction to 3D-printing" here and Part 2: "Technologies in 3D-printing" here! Article information: Ilias El Aita.启动分解:用压力辅助微波3D打印制作固态用量表,2021年Heinrich-Heine-University Düsseldorf. See the references in the PDF document! Der Beitrag Advantages and challenges of pharmaceutical 3D printing erschien zuerst auf Pharma Excipients.