Setting pharmaceutical product specifications for particle size analysis

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00:00:00 Setting pharmaceutical product specifications for particle size analysis
00:00:55 Setting pharmaceutical product specifications for particle size analysis
00:02:17 What should be the first stage in setting a specification?
00:03:36 The first stage in QbD is definition of the target product profile and its associated quality attributes
00:04:54 When should particle size be considered as a critical quality attribute?
00:05:53 Where should I measure my product?
00:07:47 When should I measure my product?
00:10:10 What product form is most relevant?
00:12:11 Dissolution dynamics: what should I measure?
00:13:43 Content uniformity: what should I measure?
00:15:04 Dispersion stability: what should I measure?
00:17:18 Suspension properties : what should I measure?
00:18:10 Case study: setting specifications for solid dosage forms
00:19:17 Selecting appropriate control parameters
00:22:23 Setting specification tolerances
00:22:28 Controlling the dispersion properties of powders
00:23:53 Controlling the dispersion properties of powders
00:25:44 Optimising atomisation processes
00:27:24 Optimising atomisation processes
00:28:34 Optimising atomisation processes
00:29:28 Optimising atomisation processes
00:31:09 Setting specifications for specific components within pharmaceutical blends
00:33:06 Setting specifications for specific components within pharmaceutical blends
00:34:07 Linking measurements specifications and product manufacturing specification
00:35:34 Setting specifications: tablets
00:36:57 Conclusions
00:38:16 Contact Information
The end point of any particle size measurement is to provide improved product or process understanding and/or control. It order to achieve this, it is important that the size specifications selected are relevant to those products or processes. In this webinar, we will look at the size distribution data generated by technqiues such as laser diffraction and image analysis, and will consider how these can be used to generate realistic product specifications.