Formulation characterization - small molecules
Oral Dosage Forms:
Bioneer:FARMA can characterize solid dosage forms as described in the European and US Pharmacopeias. This includes studies of disintegration, friability, dissolution and resistance to crushing and other standard methods.
Further Bioneer:FARMA carries out dissolution studies to the specifications of the client.
Dissolution apparatus available:
Basket (Apparatus 1)
Paddle (Apparatus 2)
Reciprocating Cylinder (Apparatus 3, Bio Dis)
Flow through cell (Apparatus 4)
Dissolutions studies can be carried out in standard Pharmacopeial media or in simulated gastric and/or intestinal fluids.
Bioneer:FARMA has a long experience with developing simulated intestinal fluids and using them in dissolution studies.
Dynamic Lipolysis Model
The model simulates digestion in the small intestine, employing crude bile extract and enzymes from porcine pancreatin. Pure lipid or lipid based formulation can be used as substrate. Rate of lipolysis is controlled by calcium addition.
Solubilizatioon of drug in to the micellar phase formed during digestion is determined.
Absorption from a formulation
Dissolution combined with absorption (Caco-2 cells)
Digestion combined with absorption (Caco-2 cells)
Franz cells (topical formulations)
Ussing chamber (intestinal tissue)
For further information, please contact head of Bioneer:FARMA, Anette Müllertz by phone (+45 45160444) or email.