lec 12

Question 1

Components of parenteral formulations: vehicles

Answer 1

medium in which formulation is prepared

Question 2

water for injection:

Answer 2

pyrogen-free, purified water

Question 3

sterile water for injection:

Answer 3

water that has been sterilized

Question 4

Bacteriostatic water for injection:

Answer 4

sterile water containing one or more antimicrobial agents

Question 5

Sodium chloride injection:

Answer 5

sterile isotonic solution of NaCl in water

Question 6

Bacteriostatic Sodium chloride injection:

Answer 6

sterile isotonic solution of NaCl in water which contains antimicrobial agents

Question 7

5% Dextrose Injection, USP (D5W):

Answer 7

isotonic with blood and uses water as vehicle

Question 8

Ringer’s Injection:

Answer 8

sterile solution of NaCl, KCl, and CaCl in water for electrolyte replenishment

Question 9

Hypotonic solutions are used to?

Answer 9

dilute excess serum electrolytes as in hyperglycemia

Question 10

Hypertonic solutions are used to?

Answer 10

correct electrolyte imbalances as in losses from excess vomiting/diarrhea

Question 11

T/F fixed oils must never be administered IV and are mostly administered IM

Answer 11

true

Question 12

T/F co-solvents should be diluted with water before administrated

Answer 12

false, should not be diluted with water

Question 13

T/F there are limits to concentrations of preservatives due to risk of toxicity

Answer 13

true

Question 14

T/F newborns can tolerate very low concentrations of preservatives

Answer 14

false, no preservatives given to newborns

Question 15

T/F buffering agents are used to adjust and maintain the pH of solutions in order to increase drug stability, solubility and absorption.

Answer 15

true

Question 16

what is the acceptable pH range of parenteral i.v. products?

Answer 16

3 to 10.5

Question 17

what are antioxidants used for in parenteral products?

Answer 17

protect them from oxidative degradation

Question 18

define what a chelating agent is:

Answer 18

compound that forms complexes with metal ions and inactivate their catalytic activity

Question 19

what is the name of the chelating agent used?

Answer 19

EDTA

Question 20

what are tonicity agents used for?

Answer 20

to achieve isotonicity in a parenteral formulation

Question 21

how is dry heat sterilization conducted?

Answer 21

in an oven at 150 to 170 degrees C for 2 to 4 hours

Question 22

steam sterilization is performed in?

Answer 22

an autoclave

Question 23

filtration relies on what to sterilize?

Answer 23

removal of bacteria by trapping it in filter

Question 24

a large volume parenteral is defined as containing more than?

Answer 24

100 mL

Question 25

a small volume parenteral is defined as containing ____ mL or less

Answer 25

100

Question 26

define Physical incompatibility

Answer 26

interaction of two or more substances causing changes in solubility, precipitation, color, odor, viscosity, and morphology

Question 27

define Chemical incompatibility

Answer 27

decomposition of drug substance resulting from combination of dosage forms