Complex Generics: Orthogonal Characterization of Microemulsions

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00:00:00 Welcome
00:00:11 Introduction
00:00:36 Complex Generics: Orthogonal Characterization of Microemulsions
00:00:58 Agenda:
00:01:18 Untitled
00:03:31 Complex Generics
00:04:12 Untitled
00:06:22 Untitled
00:07:23 Microemulsions
00:09:11 Microemulsions: Ophthalmics
00:10:49 Ophthalmics: Characterization for Generics - Deformulation and IVBE
00:12:32 Particle size characterization of microemulsions
00:14:54 Microemulsions : Processing
00:14:59 Technique: Dynamic Light Scattering (DLS)
00:16:15 Microemulsions : Processing
00:16:30 Technique: Dynamic Light Scattering (DLS)
00:16:40 Untitled
00:17:37 Untitled
00:18:45 Untitled
00:19:28 Technique: Laser Diffraction (cont.)
00:20:37 Microemulsions for Ophthalmics: Cyclosporine globule size distribution
00:21:14 Measuring Zeta Potential
00:21:52 Measuring Zeta Potential
00:23:05 Measuring Electrophoretic Mobility – Zeta Potential
00:24:50 Ophthalmic microemulsions: Cyclosporine zeta potential
00:25:41 Rheology
00:28:42 Rheology of Microemulsions
00:30:32 Reason for Shear Rate Dependency
00:31:47 More ‘Rheology’ from increase in fluid structure
00:34:08 Ophthalmics: Cyclosporine viscosity vs. shear rate
00:34:43 Reason for Shear Rate Dependency
00:35:02 Ophthalmics: Cyclosporine viscosity vs. shear rate
00:35:58 Ophthalmics: Cyclosporine viscosity vs. shear rate
00:36:34 Dilution effects:
00:37:31 Ophthalmics: modified cellulose (HEC)
00:38:21 Ophthalmics: Cyclosporine viscoelasticity
00:41:43 Summary: Orthogonal Characterization- Microemulsions
00:41:48 Thank You for Your Time
00:41:56 Thank you for your attentionAny questions?
00:45:58 Contact Information
Ophthalmic microemulsion drugs such as Restasis, indicated for dry eye syndrome, are speciality pharmaceuticals, and are considered complex generics because of their route of delivery and localized activity. Complex generics are challenging to produce, particularly so when it comes to proving bioequivalence with the corresponding Reference Listed Drug.

This webinar aims to provide a guide for proper physical characterization of microemulsions, specifically considering some of the issues with the complexity of such formulations.


Anand Tadas holds a Masters degree in Physical Chemistry and a Doctorate in Colloidal Physics from the University of Mumbai. He has been awarded 4 US patents. Anand has worked for Malvern Aimil as a Technical Specialist for our nanometrics & rheology product ranges for the past 7 years.

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Who should attend?
Anyone working within the Pharmaceutical and Biopharmaceutical industries who has an interest in formulation/analytical development.  Also, those who are interested in bioequivalence, deformulation, and the development of complex generic drugs.