Oral solid-dose development work begins
Ergopharm has established a formulation development group for oral solid-dose products, beginning the work that would later justify a dedicated tablet facility.
Injectables and tablets are different manufacturing disciplines, and a company good at one does not automatically become good at the other. Blend uniformity, compression behaviour, disintegration and dissolution are problems with no counterpart in a filling line, and they are solved at development scale long before anyone specifies a press.
“You do not learn to make tablets by buying a tablet press.”
The group works at laboratory and pilot scale on granulation approaches, excipient selection and tablet coating, with analytical support developing the dissolution and content-uniformity methods that any eventual commercial product would need. Formulations are assessed against ICH Q1A(R2) stability conditions from the beginning rather than after the process is fixed.
No commercial oral products are supplied at this stage; the work is development, and the facility to manufacture at scale would follow later.
Key facts
- Scope
- Laboratory and pilot-scale formulation development
- Focus
- Granulation, compression, coating, dissolution
- Stability
- ICH Q1A(R2) conditions from the outset
- Status
- Development only; no commercial supply at this stage