lec 12 Flashcards
Components of parenteral formulations: vehicles
medium in which formulation is prepared
water for injection:
pyrogen-free, purified water
sterile water for injection:
water that has been sterilized
Bacteriostatic water for injection:
sterile water containing one or more antimicrobial agents
Sodium chloride injection:
sterile isotonic solution of NaCl in water
Bacteriostatic Sodium chloride injection:
sterile isotonic solution of NaCl in water which contains antimicrobial agents
5% Dextrose Injection, USP (D5W):
isotonic with blood and uses water as vehicle
Ringer’s Injection:
sterile solution of NaCl, KCl, and CaCl in water for electrolyte replenishment
Hypotonic solutions are used to?
dilute excess serum electrolytes as in hyperglycemia
Hypertonic solutions are used to?
correct electrolyte imbalances as in losses from excess vomiting/diarrhea
T/F fixed oils must never be administered IV and are mostly administered IM
true
T/F co-solvents should be diluted with water before administrated
false, should not be diluted with water
T/F there are limits to concentrations of preservatives due to risk of toxicity
true
T/F newborns can tolerate very low concentrations of preservatives
false, no preservatives given to newborns
T/F buffering agents are used to adjust and maintain the pH of solutions in order to increase drug stability, solubility and absorption.
true
what is the acceptable pH range of parenteral i.v. products?
3 to 10.5
what are antioxidants used for in parenteral products?
protect them from oxidative degradation
define what a chelating agent is:
compound that forms complexes with metal ions and inactivate their catalytic activity
what is the name of the chelating agent used?
EDTA
what are tonicity agents used for?
to achieve isotonicity in a parenteral formulation
how is dry heat sterilization conducted?
in an oven at 150 to 170 degrees C for 2 to 4 hours
steam sterilization is performed in?
an autoclave
filtration relies on what to sterilize?
removal of bacteria by trapping it in filter
a large volume parenteral is defined as containing more than?
100 mL
a small volume parenteral is defined as containing ____ mL or less
100
define Physical incompatibility
interaction of two or more substances causing changes in solubility, precipitation, color, odor, viscosity, and morphology
define Chemical incompatibility
decomposition of drug substance resulting from combination of dosage forms
