날짜 기록: May 17 2016

Duration: 35 minutes 58 seconds

Demonstrating bioequivalence (BE) for complex generics such as nasal spray suspension drug products is a challenging task. Sponsors not only have to consider device requirements but also understand the properties of the API in the presence of functional excipients. The process of achieving equivalence to the reference listed drug product is therefore complex. In this presentation we explore the requirements for BE and the application of in vitro techniques for API and formulation characteristics. A systematic approach for measuring and assessing the API particle size changes within the formulation will be discussed, alongside the link these measurements have to API solubility and bioavailability. We also explore how the formulation and device interact through considering the force required to actuate during dose delivery. Together, these analytical methods facilitate the determination of critical material and process attributes that may affect drug product quality. As part of the presentation we will reference research carried out during the development of a generic mometasone furoate product.
Table of contents
1. Welcome!
00:47
2. Characterizing Nasal Suspensions for Regulatory and Scientific Purposes
00:32
3. About Nanopharm
01:02
4. Nanopharm Mission Statement
01:57
5. Synopsis of Webinar
01:44
6. Nasal Suspension Drug Products
01:07
7. Weight of Evidence Approach for Demonstrating Bioequivalence of Nasal Suspensions – US
01:49
8. Untitled
01:29
9. FDA-SOL-1120918 : Study to investigate the sensitivity of pharmacokinetics in detecting differences in physicochemical properties of the active in suspension nasal products for local action
01:40
10. FDA FUNDING: HHSF223201310220C: Drug Substance and Formulation Investigations
01:49
11. Morphology Directed Raman Spectroscopy (MDRS) Approach to Characterize Nasal Suspensions
03:36
12. Morphological Analysis of Nasonex and Placebo
01:17
13. Morphological Analysis of Nasonex and Placebo
00:53
14. MDRS Analysis of Nasonex
00:41
15. Raw API Particle Size Distribution of Batches of Mometasone Furoate Monohydrate – Laser Diffraction
00:59
16. As-received and formulated API MDRS PSD – Batch 1
00:21
17. As-received and formulated API MDRS PSD – Batch 2
00:09
18. As-received and formulated API MDRS PSD – Batch 3
00:20
19. As-received and formulated API MDRS PSD – Batch 4
00:30
20. PSD Comparability of Reference and Formulated Drug Substance – MDRS
01:21
21. Dissolution Analysis of Drug Product
00:59
22. Relationship Between MDRS PSD of Formulated API and Dissolution
01:29
23. Force Vs. Displacement Studies of Nasonex
00:55
24. Measuring Viscoelastic Properties of the Different Commercial Formulations
02:21
25. Relationship Between Formulation and Droplet Size
01:04
26. Effect of Avicel Concentration on Formulation Rheology
01:43
27. Summary
01:23
28. Thank you for your attentionAny questions?
01:16
29. Contact Information
00:45