14: Protein Formulation and Delivery Flashcards
polypeptides with ____ amino acids are called proteins
> 40
what determines the function of a protein
- covalent interactions
- primary structure
- affinity to binding proteins
- noncovalent 3D structure
4
where can you find out more about protein drugs
drugbank
classes of protein pharmaceuticals
vaccines
peptides
blood products
recombinant therapeutic proteins
which of the following is not a therapeutic protein
- vaccines
- factor X
- interferon beta
- secretagogues
4
T or F: proteins are very large but are stable as they are held together by strong covalent forces
F- weak noncovalent forces
T or F: proteins are very large but are stable as they are held together by strong covalent forces
F- weak noncovalent forces
which of the following is a problem with proteins in vivo
- elimination by dendritic cells
- small proteins filtered out by kidneys very fast
- tends to stay in the body for too long
- can’t be injected SQ
2
which of the following is not a noncovalent in vitro problem for protein drugs
- denaturation
- oxidation
- aggregation
- precipitation
oxidation (covalent change)
list some covalent problems for protein drugs in vitro
deamination
oxidation
disulfide exchange
proteolysis
what method of storage is best for long term storage
freeze drying
what is a problem with freezing proteins
freeze/ thawing process can denature proteins
why do low temps prolong storage times
reduces microbial growth and metabolism
reduces thermal or spontaneous denaturation
reduces adsorption
what is the best packaging for proteins
smooth glass walls to reduce adsorption or precipitation
which of the following is true
- protein drugs should be packed in polystyrene or containers with silanyl or plasticizer coatings to prevent adsorption
- stabilizing salts or ions actually cause proteins to aggregate
- argon atmosphere reduces protein drug oxidation
- freeze drying requires sugars or dextran to displace water/ reduce microbe growth
3
how to avoid light oxidation
dark, opaque walled containers
what do polyols do
help protein drug solubilize
T or F: in the process of freeze drying, some proteins will become deactivated as water is removed
Tt
how to deal with protein stability problems by changing the formulation
modify protein sequency PEGylation proteinylation microsphere/ nanosphere encapsulation formulating with permeabilizers