Parenteral Formulations

Question 1

What are some advantages of injection into the circulation?

Answer 1

fast action, 100%bioaailable, prolonged release can be achieved

Question 2

What are some disadvantages of injection into the circulation?

Answer 2

risk overdose, hard to self administer, risk infection or embolization, more costly

Question 3

Which endotoxin contributes to the most septic events in humans?

Answer 3

Lipopolysaccharide from gram negative bacteria. 1microgram per kg induces shock

Question 4

Antimicrobials are added to injectable water to reduce the formation of microbes after vial is opened to enviornment. What are a few antimicrobials that are added?

Answer 4

Methyl and Propyl parabens, Benzyl alcohol, Benzalkonium choloride

Question 5

Which agents can be used to prevent oxidation?

Answer 5

ANtioxidants, ascorbic acid, sodium bisulfite, EDTA,

Question 6

What processes are used to serilize parenterals?

Answer 6

Autoclaving (steam under pressure, filtration via 0.2micron filter (doesn’t filter out viruses or endotoxins), gamma radiation

Question 7

What factors affect stability of parenterals?

Answer 7

temp, pH, trace metal, buffers, light, oxygen, agitation, debirs, chemicals

Question 8

What are the two tests to measure sterility?

Answer 8

injection into rabbits and note presence of hypothermia, or LAL limulus Amebocyte Lysate- direct endotoxin test for IV 5EU/kg or less
VIsible particles- anything over 50 micrometers, Filters of varying size

Question 9

What are the benefits of lyophilization?

Answer 9

no water, no oxidation

Question 10

What are the hurdles of lyophilization?

Answer 10

harder to prepart