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原料药粒径对配方成功的重要性

按需网络研讨会记录 - 现在可用

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原料药的粉末特性和原料药的表征在药品开发中起着至关重要的作用。 它影响药物的关键质量属性,如溶出度、生物利用度、含量均匀性和可制造性。 设计正确的流程、设备和选择合适的表征技术是实现理想粒径的关键。

本次网络研讨会将以现实世界的案例研究作为补充,我们将在此研究客户在原料药属性方面面临配方挑战的例子,以及我们的专家团队如何使用正确的粒子工程方法和最先进的基础设施成功解决这些问题。

What you
will learn:

Application of various particle engineering techniques to tailor API powder properties

Application of various particle engineering techniques to tailor API powder properties

The structured problem solving approach in achieving the right particle for your formulation needs

The structured problem solving approach in achieving the right particle for your formulation needs

Dr. Reddy's capabilities involved in particle engineering and characterization

Dr. Reddy's capabilities involved in particle engineering and characterization

Speakers

Srividya Ramakrishnan

Srividya Ramakrishnan

Head - Process Engineering, API R&D

Srividya Ramakrishnan earned her B.Tech from Indian Institute of Technology, Madras, and a Ph.D. from Princeton University in Chemical Engineering. With 20+ years of experience, she currently heads Process Engineering (Drug substance) at Dr. Reddy's Laboratories. She has presented her research at international conferences and has several publications and patents to her credit. She is also an ASQ-certified Six Sigma Black Belt.

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Suhas Jawlekar

Suhas Jawlekar

Process Engineering Expert, API R&D

Suhas Jawlekar is a chemical engineer from ICT, Mumbai and has 17 years of experience in the process development and scale-up of APIs. He has worked closely on crystallization, polymorph development and particle engineering aspects of APIs. He currently leadsa teamfocused on particle engineering, scale-up and flow manufacturing technologies.

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Amuthan Ramar

Amuthan Ramar

Characterisation Expert, Analytical R&D

Amuthan graduated with a master's degree from Anna University, followed by a doctorate degree in material science from EPFL (Swiss Federal Institute of Technology) from Lausanne, Switzerland. Amuthan is now working as a solid-state characterisation expert focused onthe area of structure property correlation and leads a team of engineers. He has more than 14 years of experience in the field of solid-state characterisation. His microscopy and scattering-based analytical skills are well-known through his scientific publication and presentation.

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Summary of the Webinar

In the webinar, experts from Dr. Reddy's - Srividya Ramakrishnan head - process engineering, API R&D, Suhas Jawlekar, process engineering expert, API R&D, and Amuthan Ramar, characterization expert, analytical R&D address the importance of API particle size on formulation success that includes application of various particle engineering techniques and API powder properties, The structured problem-solving approach in achieving the right particle for formulations and Dr. Reddy's capabilities in particle engineering and characterization.

The first section of the webinar covers the relation between pharma API powder properties and drug product attributes – particle size distribution, API formulation, mechanical properties, morphology (drug product attributes), solid form, surface properties, followed by crystal morphology, size, and surface properties.

The next section of the webinar emphasizes particle engineering technologies spectrum, PAT tools to understand crystallization (PVM, FBRM, Raman, FTIR), and particle engineering capabilities – powder processing, API formulation process, control of PSD in slurry and downstream processing.

The concluding section of the webinar showcases the case studies and success stories related to API formulation – Flowability improvement, the outcome of crystallization design, dissolution performances, and case studies on customer requirements regarding the particle size, followed by orthogonal verification for robust and faster PSD methods and image analysis.

Want to learn more about our capabilities in particle engineering and characterization? Then feel free to contact our product experts by filling the form here https://api.drreddys.com/contact-us (Or) at api@drreddys.com.

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