| 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.