Protein And Peptide Formulation And Delivery

Question 1

What are the goals?

Answer 1

Clinically effective
Physically, chemically, biologically stable
Industrially productive
User friendly
Acceptable unit cost

Question 2

What are the different administration options?

Answer 2

Traditional/parenteral (solution, lyophilized powder, medical implant, emulsion, liposomes, polymeric dispersion)
Novel (pulmonary, nasal, ophthalmic, buccal/sublingual, rectal, transdermal, oral)

Question 3

What can affect stability (13)?

Answer 3

The pH
Temperature
Ionic strength
Freeze/thaw effects
Organic solvents
Light
Oxygen
Surfactants
Radiation
Residual moisture
Shear forces
Interfacial adsorption
Heavy metal ions

Question 4

How do we analyze peptides/proteins?

Answer 4

Chromatography (HPLC, GPC, TLC)
Immunoassay
Optical method
Mass spectrometry
Nuclear magnetic resonance
Electrophoresis

Question 5

What are some structure modifications?

Answer 5

Conjugates
Prodrugs
The pH resistant structure
Enzyme resistant structure
Balance between hydrophilic and lipophilic properties

Question 6

What are the different factors that can affect protein/peptide formulation and delivery?

Answer 6

Physical factors (temperature, moisture, excipients, processing)
Chemical factors (pH, salts, solvents, additives)
Biological factors (in vivo pH, enzyme activity, metabolism, absorption barrier)
Other factors (shelf life, administration)