OSD
Improving stability through science-led OSD reformulation
How do you address a stability failure in an already filed and marketed OSD product while limiting unnecessary disruption to the registered formulation and manufacturing platform?
This case study explores the science behind a complex OSD reformulation, combining formulation and analytical science with particle engineering, excipient evaluation, process optimisation and packaging assessment to target the underlying degradation pathway and enable a move from wet granulation to direct compression.
The reformulated product remained stable through six months under the same accelerated conditions, while reducing the number of manufacturing steps.
Key takeaways:
- Identifying the root cause of a complex stability failure
- Reformulating while limiting changes to an already filed product
- Moving from wet granulation to direct compression
- Achieving six-month accelerated stability
- Simplifying the manufacturing process
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