Formulation Flashcards
1
Q
Factors that influence the delivery route
A
Solubility
PH sensitive
Bioavailability
Pass cell membrane?
Rheology
Amount of V (SC,IM when only small)
2
Q
Main challenges of Biopharmaceuticaly?
A
ADA, Imunogenicity, CRS
Compliance e.g. if IV
Handeling
Sterility
3
Q
How to increase Ch. stability?
A
AA from R to L
T
Antioxidants
PH to prevent deamination
no Light (if nessecary)
EDTA against metal ions
4
Q
4 Important Specifications
A
ID
Impurities (very difficult)
Microorganisms
Endotoxins
Particles
