Protein/Peptide Formulation & Delivery

Question 1

Define a peptide.

Answer 1

Complex macromolecules consisting of one or more chains of amino acids (C, H, O, N,S)
Natural compounds containing to or more amino acids linked between alpha-carboxyl and alpha-amino group

Question 2

What are some examples of peptides?

Answer 2

Insulin, interferons, growth hormones

Question 3

What are the factors that can affect denaturation?

Answer 3

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

Question 4

List the characteristics of proteins that we need to be aware of

Answer 4

• low dose
• Specific selectivity
• Biocompatibility
• Biodegradability
• Minimal adverse effects
• Instability
• Special in vivo profile
• Targeting difficulty
• Low overall therapeutic outcomes

Question 5

What are the goals of peptide use in pharmaceutics?

Answer 5

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

Question 6

What are the traditional administration options for peptides?

Answer 6

Parenterals (solution, lyophilized powder, medical implants, emulsions, liposomes, polymeric dispersions)
Novel options include pulmonary, nasal, ophthalmic, etc.

Question 7

What effects the stability of peptides?

Answer 7

Temperature, ionic strength, organic solvents, light, pH, oxygen, radiation, residual moisture, shear forces, interfacial absorption, surfactants