Complex generics: Understanding and optimizing the performance of Oral Solid Dose (OSD) Drug Products

Application of physicochemical characterization methods in OSD product development

Date recorded: March 30 2017

Duration: 44 minutes 08 seconds

In this webinar, we explain how Malvern and PANalytical’s unique range of physicochemical analysis techniques can be used to accelerate the development of oral solid dose products, reducing the time to market for new complex generics.

Oral solid dose (OSD) drug products represent the largest class of products sold by the pharmaceutical industry, and as a result represent a significant opportunity for generic companies. Within this, products which have a modified or sustained release profile represent a significant challenge, as deformulation of these requires specific knowledge of the physicochemical properties of the active pharmaceutical ingredient (API) and any functional excipients present within the formulation.

We’ll explain how the range of measurement solutions from Malvern and PANalytical enable critical material attributes such as particle size, shape, structure and composition to be measured, aiding deformulation and rapid formulation development for complex oral solid dose products.

Table of contents

1. Welcome

00:13

2. Introduction

00:50

3. Complex generics: Understanding and optimising the performance of Oral Solid Dose Drug ProductsApplication of physicochemical characterisation methods in OSD product development

01:22

4. Complex generics: Understanding and optimising the performance of Oral Solid Dose Drug ProductsApplication of physicochemical characterisation methods in OSD product development

01:22

5. Proposed OSD deformulation workflow

03:41

6. Critical material properties for OSD

01:12

7. Possible development timeframe

01:53

8. Complex Generic Products

01:39

9. The FDA sets different equivalence requirements dependant on the RLD product complexity

01:42

10. Malvern PANalytical measurement solutions

01:23

11. Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data

01:15

12. Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data

00:25

13. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies

00:18

14. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies

00:18

15. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies

00:30

16. Oral solid dose: deformulation and IVBE

01:41

17. Bioavailability relates to particle size and solid form

02:20

18. Complex product deformulation using MDRS

01:01

19. Complex product deformulation using MDRS

00:59

20. Complex product deformulation using MDRS

00:49

21. Detecting the presence of different API polymorphs

01:06

22. Linking dissolution rate to particle shape measurements

00:30

23. Linking dissolution rate to particle shape measurements

01:10

24. Understanding the manufacturing process used for the active pharmaceutical ingredient

00:16

25. Understanding the manufacturing process used for the active pharmaceutical ingredient

01:00

26. HPMCAS excipient screening using SEC

02:44

27. Hydroxy ethyl cellulose excipient selection

02:02

28. Excipient grade selection

00:56

29. Conclusion: the OSD deformulation workflow

00:55

30. Thank you for your attentionAny questions?

07:57

31. Contact Information

00:39

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