| 00:00:00 | Focus on Pharma: Assessing in vitro bioequivalence: Nano drug delivery systems |
| 00:02:43 | Complex Generics |
| 00:03:36 | Complex Generics |
| 00:04:20 | Complex Generics |
| 00:06:24 | Malvern Panalytical solutions |
| 00:07:01 | Liposomes |
| 00:08:11 | Characterization of Liposomes by Several Complementary Techniques |
| 00:08:26 | Review of liposome structures |
| 00:09:33 | Liposome preparation |
| 00:10:42 | Liposome extrusion |
| 00:11:29 | Liposome formulations |
| 00:12:09 | Liposome characterization solutions for thisparticular study |
| 00:13:02 | Zetasizer and NanoSight results |
| 00:13:07 | DOPC, 2mg/mL, checking size by extrusion pass # with various pore-sizes |
| 00:13:40 | Effect of varying lipid concentration on extrusion sizing by pass # through 100nm pore size |
| 00:14:09 | Effect of Freeze / Thaw cycles (5x) on particle size and concentration as extruded through 100 nm pores |
| 00:14:50 | Effect of Freeze / Thaw cycles (5x) on particle size and concentration as extruded through 100 nm pores |
| 00:15:19 | Effect of both Freeze / Thaw cycles (5x) and Step-Down extrusion on particle size and concentration (11x passes/pore size) |
| 00:16:09 | Effect of both Freeze / Thaw cycles (5x) and Step-Down extrusion on particle size and concentration (11x passes/pore size) |
| 00:17:01 | Effect of % Cholesterol on size, concentration, and zeta potential (1mM NaCl + 0.1mM MOPS) with diffusion barrier method |
| 00:18:42 | Effect of % Cholesterol on size, concentration, and zeta potential (1mM NaCl + 0.1mM MOPS) with diffusion barrier method |
| 00:18:58 | Zeta potential: anionic liposomes |
| 00:19:28 | Zeta potential: STEALTH liposomes |
| 00:20:04 | Zeta potential affected by PEG concentration |
| 00:20:24 | 2 mg/mL DOPC with varying mol% Rh-DPPE Fluorescence-mode concentration efficiency of Rhodamine labeled liposomes as a function of increasing dye loadings. |
| 00:21:06 | SAXS / WAXS and DSC Results |
| 00:21:21 | Investigated samples |
| 00:22:12 | DPPC @ 20°CBefore extrusion - multilamellar vesicles |
| 00:23:13 | DPPC at different temperaturesBefore extrusion |
| 00:23:42 | DPPC at differenttemperatures Before extrusion |
| 00:25:14 | DPPC at different temperaturesBefore extrusion |
| 00:26:34 | Phase transition temperature assessment by DSC |
| 00:26:55 | DPPC vs. DOPC @ T = 20°CBefore extrusion |
| 00:27:38 | DPPC @ T = 20°Cbefore and after extrusion |
| 00:28:19 | Summary and conclusions |
| 00:29:19 | Applying IVBE approaches to nano-drug delivery formulationsCharacterizing iron colloid complexes |
| 00:29:39 | Introduction |
| 00:30:59 | Untitled |
| 00:32:12 | Physicochemical Characterization |
| 00:32:55 | Untitled |
| 00:34:07 | Effective volume fraction |
| 00:34:50 | Untitled |
| 00:35:23 | The Kuhn–Mark–Houwink–Sakurada equation |
| 00:36:06 | Nanoparticle sizing using DLS |
| 00:36:24 | Physicochemical Equivalence Assessment of Reference and Generic Sodium Ferric Gluconate Complex |
| 00:37:34 | Physicochemical Equivalence Assessment of Reference and Generic Sodium Ferric Gluconate Complex |
| 00:38:21 | Case study : Iron complexes |
| 00:39:35 | Case study : Iron Complexes |
| 00:39:53 | Case Study: Iron Complexes |
| 00:41:08 | Case study: Iron Complexes |
| 00:41:44 | Summary |
| 00:43:59 | Predictive or Simulation Modeling |
| 00:44:39 | References |
| 00:44:59 | Question & Answers |
| 00:49:43 | Thank you for attention |
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.
演講者
Ragy Ragheb Ph.D. - Technical Specialist - Field Application Scientist - Advanced Materials
Anand Tadas Ph.D. - Product Specialist Pharmaceutical Sector
更多資訊
- Who should attend?
- Researchers considering the requirements for the deformulation of a reference listed drug product
- Formulation scientists engaged in developing candidate generic drug product formulations
- Analytical scientists engaged in supporting in vitro bioequivalence studies
- Laboratory managers looking to understand the techniques required to support deformulation and in vitro bioequivalence assessments
- What will you learn?
- The physicochemical properties which are currently highlighted as important for in vitro bioequivalence studies for nano drug delivery systems
- What Q3 microstructural equivalence is, and how this is important in showing bioequivalence in vitro
- The range of analytical measurement methods available from Malvern Panalytical for assessing bioequivalence in vitro for nano drug delivery systems
- How techniques such as DLS, NTA, ELS, SEC and SAXS and rheological analysis can aid formulation development and bioequivalence assessments