Modified Release Tablet Transfer and Dissolution Fix
Western India · Generic Pharma Companies
Overview
Transfer of a modified release tablet that failed dissolution f2 similarity on the receiving equipment train, resolved by granulation change rather than coating change.
The challenge
On our roller compactor the transferred blend produced a dissolution profile that failed f2 similarity against the reference at the 2 and 4 hour points, despite identical formula and coating weight gain.
What we did
Investigation traced the difference to ribbon density and the resulting granule size distribution, not the film coat. Compaction force and roll gap were re-established against a target ribbon solid fraction, restoring granule distribution and f2 similarity of 68 before any coating parameter was touched.
Project data
| Root cause | Ribbon solid fraction, not coating |
|---|---|
| f2 similarity | 41 (fail) → 68 (pass) |
| Batch size | 300 kg blend |
| Trial batches | 4 before PPQ |
| Stability | Zone IVb long-term and accelerated in progress |
| Transfer duration | 16 weeks |
Standards applied
- WHO-GMP
- Schedule M
- ICH Q1A(R2)
Scope supplied
- Oral Solids & Liquids
- Technology Transfer
Related
- Oral Solids & Liquids
- Technology Transfer