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 药物剂型科学与技术 307条(本栏目收费,不能显示细节,电话15274084725)
3.7 Fill Formulation 59 59
3.8 Product Development 62 62
3.8.1 Fill Formulation Development Processes 62 62
3.8.2 Shell Compatibility 63 63
3.8.3 Prototype Manufacture 64 64
3.8.4 Process Development 65 65
3.9 Clinical Supply 66 66
3.10 Analytical Considerations 67 67
3.11 Excipient Considerations 67 67
3.11.1 Gelatin 68 68
3.11.2 Plasticizers 68 68
3.11.3 Water 69 69
3.11.4 Colors, Opacifiers etc. 69 69
3.11.5 Ingredient Specifications 69 69
3.12 Packaging and Stability Considerations 69 69
3.13 Manufacturing Process 70 70
3.14 Key Process and Product Parameters 72 72
3.14.1 In-process Testing 72 72
3.14.2 Set up (Pre-start) 73 73
3.14.3 During Encapsulation 73 73
3.14.4 During Drying 74 74
3.14.5 Finished Product 74 74
3.15 Recent Technology Advances 75 75
3.15.1 Film Coating 75 75
3.15.2 Non-gelatin Shell and Controlled Release Fill 75 75
3.15.3 Vaginal Dosage Forms 75 75
3.16 Trends in Patent Activity 75 75
3.17 Conclusions 76 76
References 76 76
Chapter 4 Tablet Formulation 78 K. G. Pitt 78
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