biologics lecture 2

Question 1

why solution formulation?

Answer 1

simplest and least expensive to manufacture
convenient for patients and hospital personnel since they do not require reconstitution
can be inspected visually prior to administration

Question 2

clinical concerns

Answer 2

efficacy
sterility
side effects
pain on inj
-volume administered
-pH 7.4
-tonicity, ionic strength

Question 3

making aggrevates

Answer 3

IRREVERSIBLE

Question 4

What if soln formulation doesnt work?

Answer 4

store at refigerated temp
freeze
freeze-dry (lyophilize) ot spray-dry to create a dried power for reconstitution
re-engineer the protein molecule
abandon drug molecule

Question 5

biologics can be inj that are suspenisions or emulsions, not soluntions

Answer 5

TRUE

Question 6

suspension

Answer 6

microscopic particles “suspended” in a liquid

Question 7

emulsion

Answer 7

oil and ater like mixture
salad dressing example

Question 8

practical considerations for solution formulations

Answer 8

store at recommended temp
protect from light if recommended
avoid agitation
examine vial for particulates prior to administration
be aware of the potential for adverse immune repsonses

Question 9

summary

Answer 9

soluntions for inj are common for biologics
solution properties desirable for clinical use may not be optimal for stability