Pharmaceutical applications for automated particle image analysis

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00:00:00 Particle characterisation using Morphological imaging: Pharmaceutical applications
00:02:19 Overview
00:03:31 What is Morphological Imaging?
00:04:34 Why is particle size and shape important ?
00:05:45 Malvern Instrumentation
00:07:27 Morphological Imaging in the Pharmaceutical Development Cycle
00:09:55 Value of imaging to pharmaceutical industry
00:11:31 Application data Trouble shooting / manufacturing support - identifying batch differences
00:11:42 Difference in behaviour between Tap Milled vs Micronised excipient
00:12:28 Difference in Behavior
00:13:25 API Dissolution behaviour - Batch-to-batch
00:14:00 API Dissolution behaviour - Batch-to-batch
00:14:50 Identify Parameters that differentiate between Good and Bad Batches
00:16:34 Application data Research and Development
00:16:45 Assess Effect of dispersion pressure
00:17:39 Assess Effect of Dispersion Pressure
00:18:33 Assess Effect of dispersion pressure
00:19:19 Assess Effect of dispersion pressure
00:20:05 Assess Effect of dispersion pressure
00:20:34 Effect of Dispersion Conditions – Fragile APIs
00:21:23 Application data Regulation and Quality Control
00:21:27 Foreign Particulate Matter (FPM)
00:22:47 Parenterals USP 788 – Standard Report
00:23:24 QC - Identify Oversized API particles in Drug Suspension
00:24:26 QC - Identify Oversized API particles in Drug Suspension
00:24:52 QC – Biotherapeutics suspension
00:26:00 Application data Measuring individual components with in a formulation
00:26:06 Crystalline and Amorphous API
00:26:54 Crystalline and Amorphous API
00:27:50 Mixture of API and Starch
00:28:49 Application data Measuring PSD of the API in a formulation for Bioequivalence Comparisons
00:29:01 Nasal Spray – API Particle Size Distribution
00:30:21 Nasal Spray – API Particle Size Distribution
00:31:43 Nasal spray – Additional Verification by Morphologically Directed Raman Spectroscopy
00:33:27 Nasal Spray Formulation – API Size Distribution
00:33:38 Assess Bioequivalence Anti-inflammatory cream
00:34:20 Assess Bioequivalence: Injectable formulation
00:35:19 Application data Validating other sizing techniques
00:35:26 Validating other sizing techniques
00:36:49 Validating other sizing techniques
00:38:02 Validating other sizing techniques
00:38:42 Validating other sizing techniques
00:39:14 Validating other sizing techniques
00:39:46 Validating other sizing techniques
00:40:57 Summary
00:41:54 Contact Information
This presentation will provide an overview of the different applications of automated particle imaging within the pharmaceutical research, development and production environments. This will be illustrated with a wide range of application examples.