Fecha registrada: October 24 2019

Duration: 50 minutes 56 seconds

Developing generic versions of complex drug products presents a number of challenges as a result of the nature of their formulation or their route of delivery. In response to this, regulators, including the US FDA, have released product-specific guidance aimed at advising generics manufacturers on the approaches which may be applied to prove bioequivalence in vitro through the measurement of a complex drug product’s physicochemical properties.

In this webinar, we considered the regulatory guidance available for nano drug delivery systems such as liposomes, parenteral emulsions and iron sucrose complexes. These products are considered complex formulations due to the importance of the drug delivery system’s structure and stability in determining the post-delivery fate of the drug product, along with its bioavailability at the site of action. Product-specific guidance documents from the US FDA, along with general guidance from the EMA and Japanese regulators, highlight the importance of physicochemical properties such as particle size and particle charge, along with the formulation structure, phase behavior and rheology, in assessing drug product bioequivalence. We considered how this guidance can be followed and will also consider the additional insight which can be obtained through the application of physicochemical analysis techniques in order to aid prototype formulation development and optimization.

Table of contents
1. Focus on Pharma: Assessing in vitro bioequivalence: Nano drug delivery systems
02:43
2. Complex Generics
00:53
3. Complex Generics
00:44
4. Complex Generics
02:04
5. Malvern Panalytical solutions
00:37
6. Liposomes
01:10
7. Characterization of Liposomes by Several Complementary Techniques
00:15
8. Review of liposome structures
01:07
9. Liposome preparation
01:09
10. Liposome extrusion
00:47
11. Liposome formulations
00:40
12. Liposome characterization solutions for thisparticular study
00:53
13. Zetasizer and NanoSight results
00:05
14. DOPC, 2mg/mL, checking size by extrusion pass # with various pore-sizes
00:33
15. Effect of varying lipid concentration on extrusion sizing by pass # through 100nm pore size
00:29
16. Effect of Freeze / Thaw cycles (5x) on particle size and concentration as extruded through 100 nm pores
00:41
17. Effect of Freeze / Thaw cycles (5x) on particle size and concentration as extruded through 100 nm pores
00:29
18. Effect of both Freeze / Thaw cycles (5x) and Step-Down extrusion on particle size and concentration (11x passes/pore size)
00:50
19. Effect of both Freeze / Thaw cycles (5x) and Step-Down extrusion on particle size and concentration (11x passes/pore size)
00:52
20. Effect of % Cholesterol on size, concentration, and zeta potential (1mM NaCl + 0.1mM MOPS) with diffusion barrier method
01:41
21. Effect of % Cholesterol on size, concentration, and zeta potential (1mM NaCl + 0.1mM MOPS) with diffusion barrier method
00:16
22. Zeta potential: anionic liposomes
00:30
23. Zeta potential: STEALTH liposomes
00:36
24. Zeta potential affected by PEG concentration
00:20
25. 2 mg/mL DOPC with varying mol% Rh-DPPE Fluorescence-mode concentration efficiency of Rhodamine labeled liposomes as a function of increasing dye loadings.
00:42
26. SAXS / WAXS and DSC Results
00:15
27. Investigated samples
00:51
28. DPPC @ 20°CBefore extrusion - multilamellar vesicles
01:01
29. DPPC at different temperaturesBefore extrusion
00:29
30. DPPC at differenttemperatures Before extrusion
01:32
31. DPPC at different temperaturesBefore extrusion
01:20
32. Phase transition temperature assessment by DSC
00:21
33. DPPC vs. DOPC @ T = 20°CBefore extrusion
00:43
34. DPPC @ T = 20°Cbefore and after extrusion
00:41
35. Summary and conclusions
01:00
36. Applying IVBE approaches to nano-drug delivery formulationsCharacterizing iron colloid complexes
00:20
37. Introduction
01:20
38. Untitled
01:13
39. Physicochemical Characterization
00:43
40. Untitled
01:12
41. Effective volume fraction
00:43
42. Untitled
00:33
43. The Kuhn–Mark–Houwink–Sakurada equation
00:43
44. Nanoparticle sizing using DLS
00:18
45. Physicochemical Equivalence Assessment of Reference and Generic Sodium Ferric Gluconate Complex
01:10
46. Physicochemical Equivalence Assessment of Reference and Generic Sodium Ferric Gluconate Complex
00:47
47. Case study : Iron complexes
01:14
48. Case study : Iron Complexes
00:18
49. Case Study: Iron Complexes
01:15
50. Case study: Iron Complexes
00:36
51. Summary
02:15
52. Predictive or Simulation Modeling
00:40
53. References
00:20
54. Question & Answers
04:44
55. Thank you for attention
01:13