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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmaceutical-manufacturing-granulation/
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本课程《制药工业工艺开发：制粒：GMP》旨在深入探讨制药行业中用于片剂或胶囊生产的粉末制备技术。课程涵盖了制药过程中的关键要素，包括： 1. **引言**：介绍粉末制备在制药中的重要性。 2. **药用辅料**：详细介绍稀释剂、粘合剂、崩解剂和润滑剂等关键辅料。 3. **制备可压性粉末的制药制造方法** 4. **直接压片（干法混合）**：讨论直接压片的定义、优点和缺点。 5. **直接压片的QTPP、CMA、CPP和CQA**：阐述与直接压片相关的质量目标产品特性、关键物料属性、关键工艺参数和关键质量属性。 6. **制粒**：定义制粒，并阐述其优势和劣势。 7. **湿法制粒**：详细介绍湿法制粒的定义、理论、设备设计和工艺步骤。 8. **湿法制粒的QTPP、CMA、CPP和CQA**：分析湿法制粒的质量目标产品特性、关键物料属性、关键工艺参数和关键质量属性。 9. **喷雾制粒（流化床制粒）**：介绍喷雾制粒（流化床制粒）的定义、理论、设备设计和工艺步骤。 10. **喷雾制粒（FBD制粒）的QTPP、CMA、CPP和CQA**：评估喷雾制粒（FBD制粒）的质量目标产品特性、关键物料属性、关键工艺参数和关键质量属性。 11. **干法制粒（辊压压实）**：阐释干法制粒（辊压压实）的定义、理论、设备设计和工艺步骤。 12. **干法制粒（辊压压实）的QTPP、CMA、CPP和CQA**：探讨干法制粒（辊压压实）的质量目标产品特性、关键物料属性、关键工艺参数和关键质量属性。 本课程强调了制粒技术在获得所需粉末流动性、内聚性、可压性和润滑性方面的作用，超越了材料本身的固有特性。课程全面覆盖了混合、湿法制粒、喷雾制粒（流化床制粒）和干法制粒（辊压压实）等关键制造技术，并深入阐述了不同工艺的质量目标产品特性（QTPP）、关键物料属性（CMAs）、关键工艺参数（CPPs）和关键质量属性（CQAs）。
In pharmaceutical industry, powder mixture included active product ingredient (API) and other ingredients, can be compressed into a tablet or filled into a capsule. The powder must possess a number of physical characteristics including flowability, cohesiveness, compressibility, and lubrication. Some of the pharmaceutical materials already have these required physical characteristics, the all ingredients are mixed for tablet compression or capsule filling directly. Since most pharmaceutical materials do not possess all of these required properties, granulation methods are commonly used to impart the required characteristics. Wet granulation and dry granulation are the two most common methods of preparing granules for tablet compression or capsule manufacture. This course provides informations, evaluations, and explanations on the contents of mixing, wet granulation, spray granulation (fluid bed granulation) and dry granulation (roller compaction) manufacturing technologies in the scope of pharmaceutical industry. Besides defining of these powder technologies used for tablet / film coated tablet / capsule manufacturing, Quality Target Product Profile (QTPP), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs) and Critrical Quality Attributes (CQAs) of these manufacturing technologies have been also described in this course. COURSE CONTENT1 INTRODUCTION 2 PHARMACEUTICAL EXCIPIENTS 2_1 Diluent 2_2 Binder 2_3 Disintegrants 2_4 Lubricants 3 PHARMACEUTICAL MANUFACTURING METHODS FOR PREPARATION OF COMPRESSIBLE POWDERS 4 DIRECT COMPRESSION (DRY MIXING) 4_1 General Definition of Direct Compression 4_2 Advantageous of Direct Compression 4_3 Disadvantageous of Direct Compression 5 QTPP, CMA, CPP AND CQA FOR DIRECT COMPRESSION (DRY MIXING) 5_1 Quality Target Product Profile for Direct Compression 5_2 Critical Material Attributes (CMAs) of Direct Compression 5_3 Critical Process Parameters (CPPs) of Direct Compression 5_4 Critical Quality Attributes (CQAs) of Direct Compression 6 GRANULATION 6_1 General Definition of Granulation 6_2 Advantageous of Granulation 6_3 Disadvantageous of Granulation 7 WET GRANULATION 7_1 General Definition of Wet Granulation 7_2 Wet Granulation Theory 7_3 Wet Granulator Equipment Design 7_4 Wet Granulation Process Steps 8 QTPP, CMA, CPP AND CQA FOR WET GRANULATION 8_1 Quality Target Product Profile for Wet Granulation 8_2 Critical Material Attributes (CMAs) of Wet Granulation 8_3 Critical Process Parameters (CPPs) of Wet Granulation 8_4 Critical Quality Attributes (CQAs) of Wet Granulation 9 SPRAY GRANULATION (FLUID BED GRANULATION)9_1 General Definition of Spray Granulation (Fluid Bed Granulation) 9_2 Spray Granulation (Fluid Bed Granulation) Theory 9_3 Spray Granulation (Fluid Bed Granulation) Equipment Design 9_4 Spray Granulation (Fluid Bed Granulation) Process Steps 10 QTPP, CMA, CPP AND CQA FOR SPRAY GRANULATION (FBD GRANULATION) 10_1 Quality Target Product Profile for Spray Granulation (FBD Granulation) 10_2 Critical Material Attributes (CMAs) of Spray Granulation (FBD Granulation) 10_3 Critical Process Parameters (CPPs) of Spray Granulation (FBD Granulation) 10_4 Critical Quality Attributes (CQAs) of Spray Granulation (FBD Granulation) 11 DRY GRANULATION (ROLLER COMPACTION) 11_1 General Definition of Dry Granulation (Roller Compaction) 11_2 Dry Granulation (Roller Compaction) Theory, Equipment Design and Process Steps 12 QTPP, CMA, CPP AND CQA FOR DRY GRANULATION (ROLLER COMPACTION) 12_1 Quality Target Product Profile for Dry Granulation (Roller Compaction) 12_2 Critical Material Attributes (CMAs) of Dry Granulation (Roller Compaction) 12_3 Critical Process Parameters (CPPs) of Dry Granulation (Roller Compaction) 12_4 Critical Quality Attributes (CQAs) of Dry Granulation (Roller Compaction)
