药物网络研讨会：
药物开发与配方的进展
Pharma e-Symposium: Advancements in Drug Development and Formulation
日程安排
Schedule
September 14, 2022 9月14日
10:00 a.m. – 12:45 a.m. EDT
15:00 p.m. – 17:45 p.m. BST
16:00 p.m. – 18:45 p.m. CEST
10:00 p.m. – 12:45 p.m.中国时间
September 15, 2022 9月15日
10:00 a.m. – 11:45 a.m. EDT
15:00 p.m. – 16:45 p.m. BST
16:00 p.m. – 17:45 p.m. CEST
10:00 p.m. – 11:45 p.m.中国时间
参加此次网络研讨会，了解药物开发和配方的最新研究和创新解决方案。了解如何在整个药物开发过程中缩短上市时间、降低开发成本、提高产量并确保质量和药典符合性。
Attend this e-symposium to gain insights into the latest research and innovative solutions in drug development and formulation. Learn how you can shorten your time-to-market, reduce development costs, increase yield, and assure quality and pharmacopoeia compliance throughout the drug development process.
您将学习关于口服固体制剂(OSD)配方、药物传递系统、植入剂开发以及工艺研发和制造的有用策略。此外，该系列还涵盖了几个关键技术:
You will learn useful strategies regarding oral solid dosage (OSD) formulation, drug delivery systems, and implant development, as well as process R&D and manufacturing. In addition, the series covers several key techniques:
热熔挤出用于口服固体制剂(OSD)和植入剂
Hot-melt extrusion for OSD and implants
双螺杆连续化制粒和制造
Twin-screw granulation and continuous manufacturing
利用PAT进行过程监控和质量保证
Utilizing PAT for process monitoring and quality assurance
显微拉曼光谱用于诊断和最终产品验证
Raman microscopy for diagnosis and final product verificatio
用于质量控制和药典标准的紫外光谱
UV-Visible spectroscopy for quality control and adherence to pharmacopoeial standards
点击阅读原文，报名参加你感兴趣的课程; 如果您注册，您还将收到一个观看录制的网络研讨会的链接。每节课45分钟，包括15分钟的问答。
Register below by clicking on the link(s) to attend the sessions of interest to you; if registered, you will also receive a link to watch the recorded webinar. Each session is 45 minutes including 15 minutes for Q&A.
热熔挤出，过程监控和最终产品验证
Hot melt extrusion, process monitoring and final product verification
热熔挤出(HME)是一种强大的和多功能的现代药物开发技术。HME可以用于许多应用，从提高生物利用度到设计新的药物传递方法。
Hot melt extrusion (HME) is a powerful and versatile technique for modern pharmaceutical formulation development. HME can be used for many applications, from increasing bioavailability to devising novel drug delivery methods.
September 14, 2022 9月14日
10:00 a.m. – 10:45 a.m. EDT
15:00 p.m. – 15:45 p.m. BST
16:00 p.m. – 16:45 p.m. CEST
10:00 p.m. – 10:45 p.m.中国时间
注册链接：点击阅读原文
伊曲康唑的下游加工:HPMC-AS无定型固体分散:利用QbD设计从热熔挤出到压片
Downstream Processing of Itraconazole:
HPMCAS Amorphous Solid Dispersion: from Hot-Melt Extrudate to Tablet Using a Quality by Design Approach
基于热熔挤出(HME)的无定型固体分散体(ASD)在药物开发中具有许多优势，但这些无定型固体分散体的进一步加工可能具有挑战性。本文展示了如何使用质量设计(QbD)方法建立一个健壮的下游加工平台。测试了挤出机挤出终端不同的切割工艺和不同的粉碎条件对关键质量参数(CQAs)的影响。为了帮助成功地工艺放大，将建立从实验室规模的早期配方手工切割加工到工业适用工艺的相关性。
Hot melt extrusion (HME)-based amorphous solid dispersion (ASD) offers many advantages in pharmaceutical development, but further processing of those ASD extrudates can be challenging. The presented work shows how a robust platform for downstream processing was established using a Quality by Design (QbD) approach. Different cutting techniques at the end of the extruder barrel and different milling conditions were tested for their influence on critical quality attributes (CQAs). To assist a successful scale-up, correlations from early-formulation hand-cut processing at the lab scale to industrial-applicable processes will be established.
特别感谢演讲嘉宾
With special guest presenter
Saurabh Mishra
制剂研究员、药剂化验室经理
SE Tylose（信越）美国有限公司
Saurabh Mishra, Formulation Scientist, Manager of Pharmaceutical Laboratory
SE Tylose USA Inc.
September 14, 2022 9月14日
11:00 a.m. – 11:45 a.m. EDT
16:00 p.m. – 16:45 p.m. BST
17:00 p.m. – 17:45 p.m. CEST
11:00 p.m. – 11:45 p.m.中国时间
注册链接：点击阅读原文
制粒及PAT监控下的制粒
Granulation and PAT for monitoring granulation
连续化制粒为克服药片和胶囊传统批次生产的几个挑战提供了机遇。它高效且自身具备工艺可放大性，而且该技术已经发展到具有真正的可靠性和灵活性的程度。它也可以一次生产全部（批次），或者一次只生产一点。
Continuous granulation offers opportunities to overcome several challenges of traditional batch production of tablets and capsules. It is efficient and inherently scalable, and the technique has advanced to a point of true reliability and flexibility. It can also be implemented all at once, or a little at a time.
September 14, 2022 9月15日(中国)
12:00 p.m. – 12:45 p.m. EDT
17:00 p.m. – 17:45 p.m. BST
18:00 p.m. – 18:45 p.m. CEST
00:00 a.m. – 00:45 a.m.中国时间
注册链接：点击阅读原文
植入剂及分子光谱应用
Implants and applications of vibrational spectroscopy
与传统的口服制剂相比，植入式给药系统有许多优点。植入剂允许特定部位的药物管理，将药物输送到最需要的地方。拉曼显微镜可以帮助验证这一过程的有效性。
Implantable drug delivery systems offer several advantages over conventional oral dosage formulations. Implants allow site-specific drug administration that delivers the drug where it is needed most. Raman microscopy can help to verify the effectiveness of the process.
September 15, 2022 9月15日
10:00 a.m. – 10:45 a.m. EST
15:00 p.m. – 15:45 p.m. BST
16:00 p.m. – 16:45 p.m. CEST
10:00 p.m. – 10:45 p.m.中国时间
注册链接：点击阅读原文
根据药典程序对药品中的颜色进行鉴别
Identification of color in pharmaceutical products according to pharmacopeia procedures
药品的颜色对药品开发过程中的各种不同方面都有影响。美国药典（USP）和欧洲药典（EP）都描述了定量确定药品颜色所需的分析方法，这些方法包括获得CIE实验室色度值。为了进行此分析，收集液体或粉末的紫外-可见吸收光谱，并用于确定产品的颜色值。
The color of a pharmaceutical product has implications towards a variety of different aspects in the drug product development process. Both USP and EP describe analysis methods needed to quantitatively determine the color of a drug product, and these methods include acquiring CIE Lab color values. To perform this analysis, the UV-Visible absorption spectra of either liquids or powders are collected and used to determine the color values of the products.
September 15, 2022 9月15日
11:00 a.m. – 11:45 a.m. EDT
16:00 p.m. – 16:45 p.m. BST
17:00 p.m. – 17:45 p.m. CEST
11:00 p.m. – 11:45 p.m.中国时间
注册链接：点击阅读原文
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