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所在平台: Udemy |
课程主页: https://www.udemy.com/course/film-coating-applications-in-the-pharmaceutical-industry/
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课程名称：制药行业的工艺开发：涂层：GMP 课程概述：制药剂型开发通常包括预配方研究、分析方法开发及验证、配方和制造工艺的设计、开发、放大及优化，以及体内生物利用度和稳定性研究。在制药剂型的开发过程中，高质量制造工艺的设计、开发和优化扮演着重要角色。理解这些制造工艺可以为解决制造问题、提高生产力和支持商业目标提供合理和科学的视角。制药工艺与制造策略的设计、开发和优化对于制药行业剂型的发展至关重要。涂层工艺作为一种古老而重要的制药过程，至今仍在广泛应用。本课程将帮助您理解膜涂层过程的基本概念及其在研发阶段和商业制造期间的技术与实践应用。 课程内容包括： - **膜涂层与基本信息**：膜涂层的定义、应用原因、主要组成部分及理论，以及制药行业中膜涂层过程的执行方式。 - **膜涂层与膜涂层溶液**：膜涂层悬浮液的制备方法、有效设备、制备要点及理想浓度。 - **膜涂层材料的配方**：玻璃化转变温度的理论及其在膜涂层操作中的重要性，膜涂层材料的主要组成成分（聚合物、增塑剂、色素和溶剂）及其角色。 - **膜涂层与膜涂层工艺**：选择膜涂层过程所需设备、涂层量的决定标准、膜涂层过程的基本原则及步骤。 - **膜涂层与涂层设备**：膜涂层设备的一般设计，包括处理空气单元、不同类型的锅和喷枪。 - **膜涂层与基材要求**：化学稳定性、相容性、硬度、脆化、重量变化、形状和商标设计等要求。 - **膜涂层应用中的故障排除**：处理过湿、喷雾干燥、平板磨损/侵蚀、涂层均匀性差和商标定义丧失等问题的解决策略。 本课程为您提供了制药行业膜涂层过程的全面理解，适用于相关领域的研究和实际应用。
A pharmaceutical dosage form development typically includes preformulation studies, analytical method development and validation, design, development, scale-up and optimization of formulation and manufacturing process, invivo bioavailability and stability studies.Especially, designing, developing and optimizing of manufacturing process at a high quality play an essential role in pharmaceutical dosage form development process. To understand this manufacturing processes provides us rational and scientific view to solve manufacturing problems, increase our productivity and support our commercial aims. Design, development and optimization of pharmaceutical process and manufacturing strategies are very important for the development of a pharmaceutical dosage forms in the pharmaceutical industry. Coating is one of the oldest and important pharmaceutical process that is still practiced today. This course will help you to understand film coating process with basic concepts of technical and practical applications of pharmaceutical manufacturing in the research and development phase and commercial manufacturing period.COURSE CONTENT FILM COATING & GENERAL INFORMATION What is film coating? Why do we prefer to apply film coating? What is the main components of film coating operations? What is the theory of film coating? How is the film coating process performed in pharmaceutical industry? FILM COATING & FILM COATING SOLUTION How is the film coating suspension prepared in pharmaceutical industry?What is the effective equipments for preparation of film coating solution?What is the important points of preparation of film coating solution?What is the ideal film coating concentration for film coating suspensions?FILM COATING & FORMULATION OF FILM COATING MATERIALWhat is glass transition temperature? What is the theory of film coating? What is the importance of glass transition temperature for film coating operation? What is the main components of film coating material? Polymers and their role in formulation of film coating material Plasticizers and their role in formulation of film coating material Colorants and their role in formulation of film coating material Solvents and their role in preperation of film coating suspension FILM COATING & FILM COATING PROCESS Which equipment I have to prefer for film coating process? How can we decide film coating amount? What are the main principles of film coating process? What is the process steps of film coating process?FILM COATING & FILM COATING EQUIPMENT General Design of Film Coating Equipment Process Air Unit Pan Units Pan Units-Solid Pan / Partially Perforated Pan / Fully Perforated Pan Spray Gun (Spray Nozzle)FILM COATING & SUBSTRATE REQUIREMENTS FOR FILM COATING Chemical Stability Compatibility Hardness Friability Weight VariationShape Logo designFILM COATING & TROUBLESHOOTING IN FILM COATING APPLICATIONS Troubleshooting Overwetting / Picking Spray Drying Tablet Attrition / Erosion Poor Coating Uniformity Loss of Logo Definition
