• From basic to highly advanced formulations
• Complete stability program
The drug product development work at GEA Pharmaceutical A/S encompasses products with a wide variety of dosage forms.
Particular expertise has been accumulated with solid oral dosage forms, and with functional coatings and pellets.
we provide:
• Formulation and process development
• Manufacture of clinical trial batches
• Scale up/tech. transfer to costumer sites
• Development and production support
Our analytical development department is equipped with the most advanced instruments and technologies;
• Chromatography (HPLC, GC, IC)
• Dissolution
• Titration
• Spectrometry (UV, IR)
• All Pharmacopoeia instrumentation in order to enable and establish
specifications (APIs and drug products)
• Method development/validation/transfer
• Stability studies
Thanks to integrated development capabilities between API and finished dosage form development we are specifically
competent in handling problematic API’s where the API’s physico-chemical properties might have an
impact on stability, dissolution and absorption of the API.
We are capable of optimizing your development formulation to a highly advanced formulation with specified targets
absorption and plasma concentration profile. This may be supported by our in vitro in vivo correlation
approach which has proven extremely helpful in a large number of development projects
PHARMACEUTICAL DEVELOPMENT
