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 药物剂型-胶囊 409条(本栏目收费,不能显示细节,电话15274084725)
Drug Release Mechanisms and Hard Shell Encapsulation... 58 58
Matrix Capsular Systems.... 58 58
Reservoir Capsular Systems... 59 59
Osmotic Systems..... 59 59
Pulsatile Release Systems...60 60
QbD Approach and Encapsulation for Clinical Trials.... 61 61
Overview..... 61 61
Elements of QbD in Development of Capsules for Clinical Trial... 61 61
Drug and Excipient Characteristics.... 62 62
Manufacturing Process and Process Control.....63 63
Powder Blending...63 63
Capsule Filling...64 64
CQA and Risk Assessment....65 65
Finished Capsule Attributes...66 66
Implementation of QbD in Hard Shell Capsule Formulation for Clinical Trials....66 66
In Vitro and In Vivo Performance of Hard Shell: Regulatory Perspectives... 67 67
In Vitro–In Vivo Performance.... 67 67
Capsules versus Tablets..... 67 67
Capsule versus Granules...68 68
Capsules versus Suspensions...68 68
Regulatory Perspectives on Dissolution and In Vivo Release from Hard Shells.....68 68
Conclusions...69 69
References.....69 69
Introduction... 75 75
Hard Capsules..... 76 76
Early Development of Process and Machines... 76 76
Capsule Shell Design....77 77
Manufacture of Hard Gelatin Capsule Shells.... 78 78
Preparation of the Manufacturing Solutions... 78 78
Formation of Hard Capsule Shells... 79 79
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