Complex Generics: Orthogonal Characterization of Microemulsions | Malvern Panalytical

Date recorded: May 25 2017

Duration: 46 minutes 15 seconds

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.

Table of contents

1. Welcome

00:11

2. Introduction

00:25

3. Complex Generics: Orthogonal Characterization of Microemulsions

00:22

4. Agenda:

00:20

5. Untitled

02:13

6. Complex Generics

00:41

7. Untitled

02:10

8. Untitled

01:01

9. Microemulsions

01:48

10. Microemulsions: Ophthalmics

01:38

11. Ophthalmics: Characterization for Generics - Deformulation and IVBE

01:43

12. Particle size characterization of microemulsions

02:22

13. Microemulsions : Processing

00:05

14. Technique: Dynamic Light Scattering (DLS)

01:16

15. Microemulsions : Processing

00:15

16. Technique: Dynamic Light Scattering (DLS)

00:10

17. Untitled

00:57

18. Untitled

01:08

19. Untitled

00:43

20. Technique: Laser Diffraction (cont.)

01:09

21. Microemulsions for Ophthalmics: Cyclosporine globule size distribution

00:37

22. Measuring Zeta Potential

00:38

23. Measuring Zeta Potential

01:13

24. Measuring Electrophoretic Mobility – Zeta Potential

01:45

25. Ophthalmic microemulsions: Cyclosporine zeta potential

00:51

26. Rheology

03:01

27. Rheology of Microemulsions

01:50

28. Reason for Shear Rate Dependency

01:15

29. More ‘Rheology’ from increase in fluid structure

02:21

30. Ophthalmics: Cyclosporine viscosity vs. shear rate

00:35

31. Reason for Shear Rate Dependency

00:19

32. Ophthalmics: Cyclosporine viscosity vs. shear rate

00:56

33. Ophthalmics: Cyclosporine viscosity vs. shear rate

00:36

34. Dilution effects:

00:57

35. Ophthalmics: modified cellulose (HEC)

00:50

36. Ophthalmics: Cyclosporine viscoelasticity

03:22

37. Summary: Orthogonal Characterization- Microemulsions

00:05

38. Thank You for Your Time

00:08

39. Thank you for your attentionAny questions?

04:02

40. Contact Information

00:17

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