In this webinar, the importance of an integrated development of both the spray dried intermediate (SDI) and the formulation, is highlighted.

1. Formulating Amorphous Solid Dispersions:
Bridging Particle Engineering and Formulation
João Henriques & Pedro Valente
06/04/2017

2. Confidential Hovione © 2017Formulating ASDs: Bridging Particle Engineering and Formulation 06/04/2017
Integrated Spray Drying and Final Dosage development
Two approaches for downstream processing
Direct compression
• Spray dried dispersion is
blended with excipients
• Blend is compressed into
tablets
• SDD properties are
critical
Dry granulation
• SDD is granulated by
roller compaction
• Intra/extra granular
blends
• SDD impact is mitigated
in downstream process

3. Confidential Hovione © 2017Formulating ASDs: Bridging Particle Engineering and Formulation 06/04/2017
Integrated Spray Drying and Final Dosage development
Case study 1 - Direct compression
• Direct compression of
an SDD
• Compactability and flow
are SDD driven
• Particle size
• Bulk density
• Water content
• Temperature
• Atomization ratio
• Feed rate
• Weight uniformity
• Compactability
The challenge
How to optimize/
establish SD CPPs?

4. Confidential Hovione © 2017Formulating ASDs: Bridging Particle Engineering and Formulation 06/04/2017
Integrated Spray Drying and Final Dosage development
Case study 1 - Direct compression
CQAs and CPPs
Feed rate
Outlettemperature
RSDw < 2.0%
Hardness > 160N
CPPs CQAsSpray drying Compression
Establish design space
Identify CPPs

5. Confidential Hovione © 2017Formulating ASDs: Bridging Particle Engineering and Formulation 06/04/2017
Integrated Spray Drying and Final Dosage development
Case study 1 - Direct compression

6. Confidential Hovione © 2017Formulating ASDs: Bridging Particle Engineering and Formulation 06/04/2017
Integrated Spray Drying and Final Dosage development
Case study 1 - Direct compression
Spray drying
Feed rate
Outlettemperature

7. Confidential Hovione © 2017Formulating ASDs: Bridging Particle Engineering and Formulation 06/04/2017
Integrated Spray Drying and Final Dosage development
Case study 1 - Direct compression

8. Confidential Hovione © 2017Formulating ASDs: Bridging Particle Engineering and Formulation 06/04/2017
Integrated Spray Drying and Final Dosage development
Case study 1 - Direct compression
Tableting
Feed rate
Outlettemperature

9. Confidential Hovione © 2017Formulating ASDs: Bridging Particle Engineering and Formulation 06/04/2017
Integrated Spray Drying and Final Dosage development
Case study 1 - Direct compression
Design space
SD design space
• Fine tuning SD parameters
yields optimal material for
downstream
• SD yield is compromised in
favor of material properties
Tableting design space
• Compromise between
adequate compactability and
flowability must be met
• Optimal processing
conditions are achieved with
particle engineering of ASD
Low
compactability
Poor
flowability
Small
particles
Low bulk
density

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