Achieving Bioequivalence in Generic Formulations by Characterizing Particle Size, Shape & Chemical Identity

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00:00:00 Welcome
00:02:18 Achieving Bioequivalence in Pharmaceutical Generic Formulations by Characterizing Particle Size, Shape & Chemical Identity
00:03:11 Generic Product Formulation
00:04:32 The main target for the development of generic formulation…
00:06:04 Deformulation Workflow
00:08:21 Beyond Traditional Analytical Technology
00:10:09 Analytical Techniques
00:10:50 Laser Diffraction – Particle Size
00:13:17 Laser Diffraction – Particle Size (Bulk Material)Particle Size Distribution of a Topical Formulation
00:14:45 In Vitro Bioequivalence Studies for Nasal Sprays
00:15:44 Laser Diffraction – Droplet SizeUnderstanding the delivery of the drug product
00:17:49 Microscopy – Particle Size & Shape
00:19:23 Automated Image Analysis- Particle Morphology- Understanding Agglomeration for a Meter Dose Inhaler (MDI)
00:23:16 Automated Image Analysis –Particle MorphologyDecoding Manufacturing Process for a Tablet Formulation
00:25:27 Automated Image Analysis –API Characterization pre- and post- actuation
00:26:58 Automated Image Analysis –API Characterization pre- and post- actuation
00:28:07 Morphologically Directed Raman Spectroscopy (MDRS) Advanced technique for product deformulation
00:29:31 MDRS – Size, Shape & Chemical ID
00:32:43 MDRS – Size, Shape & Chemical ID
00:34:00 MDRS- Analysis Flexibility
00:35:42 MDRS for Spray Suspensions
00:37:43 MDRS for Spray Suspensions
00:39:30 MDRS for Spray SuspensionsChemical Classification of Particulates
00:41:21 MDRS for Dry Powder Inhalers (DPI)2-component DPI: component classification
00:42:13 MDRS for DPIs2-component DPI: relative API concentration
00:42:54 MDRS for Solid BlendsGeneric vs. Innovator – Cold Remedy
00:43:54 MDRS for Solid Blends
00:45:14 MDRS for Solid BlendsAPI size Distribution
00:45:59 MDRS for Solid Blends – Polymorphism
00:47:30 MDRS for Topical FormulationsComponent-Specific Characterization - Complementing Laser Diffraction
00:49:48 Conclusions
00:51:08 Thank you for your attention
01:01:05 Contact Information
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.