記録された日時: June 10 2015

Duration: 01 hours 01 minutes 35 seconds

The development of generic products involves the use of a variety of particle characterization techniques including traditional approaches such as laser diffraction and novel technologies such as Morphology Directed Raman Spectroscopy (MDRS). In this webinar, we will discuss how to maximize the value provided by these techniques to effectively approach formulation challenges and achieve product bioequivalence while saving time, energy and resources. We will discuss the basic principles of MDRS for the characterization of particle size, shape and chemical identity of active pharmaceutical ingredients (APIs) and excipients in a variety of sample types including solid dose and suspension products.
Table of contents
1. Welcome
02:18
2. Achieving Bioequivalence in Pharmaceutical Generic Formulations by Characterizing Particle Size, Shape & Chemical Identity
00:53
3. Generic Product Formulation
01:21
4. The main target for the development of generic formulation…
01:32
5. Deformulation Workflow
02:17
6. Beyond Traditional Analytical Technology
01:48
7. Analytical Techniques
00:41
8. Laser Diffraction – Particle Size
02:27
9. Laser Diffraction – Particle Size (Bulk Material)Particle Size Distribution of a Topical Formulation
01:28
10. In Vitro Bioequivalence Studies for Nasal Sprays
00:59
11. Laser Diffraction – Droplet SizeUnderstanding the delivery of the drug product
02:05
12. Microscopy – Particle Size & Shape
01:34
13. Automated Image Analysis- Particle Morphology- Understanding Agglomeration for a Meter Dose Inhaler (MDI)
03:53
14. Automated Image Analysis –Particle MorphologyDecoding Manufacturing Process for a Tablet Formulation
02:11
15. Automated Image Analysis –API Characterization pre- and post- actuation
01:31
16. Automated Image Analysis –API Characterization pre- and post- actuation
01:09
17. Morphologically Directed Raman Spectroscopy (MDRS) Advanced technique for product deformulation
01:24
18. MDRS – Size, Shape & Chemical ID
03:12
19. MDRS – Size, Shape & Chemical ID
01:17
20. MDRS- Analysis Flexibility
01:42
21. MDRS for Spray Suspensions
02:01
22. MDRS for Spray Suspensions
01:47
23. MDRS for Spray SuspensionsChemical Classification of Particulates
01:51
24. MDRS for Dry Powder Inhalers (DPI)2-component DPI: component classification
00:52
25. MDRS for DPIs2-component DPI: relative API concentration
00:41
26. MDRS for Solid BlendsGeneric vs. Innovator – Cold Remedy
01:00
27. MDRS for Solid Blends
01:20
28. MDRS for Solid BlendsAPI size Distribution
00:45
29. MDRS for Solid Blends – Polymorphism
01:31
30. MDRS for Topical FormulationsComponent-Specific Characterization - Complementing Laser Diffraction
02:18
31. Conclusions
01:20
32. Thank you for your attention
09:57
33. Contact Information
00:30