Parenterals Part 1 Flashcards
define parenteral drug delivery systems
STERILE dosage forms to be administered by injections
**what are the 4 S’s of parenteral drug delivery systems
safety
sterility
stability
solubility
parenteral drug delivery systems are free from what 3 things
microbes
pyrogens
particulates
3 common formulations that are parenteral drug delivery systems
solutions
suspensions
emulsions
there are small volume parenterals (SVPs) and large volume parenterals (LVPs)
what is the volume of each?
small volume parenterals is 100mL or less and large volume parenterals is over 100 mL
true or false
parenterals have the most direct access possible to the vascular system
true
true or false
parenterals have unpredictable drug levels in the blood
FALSE - highly predictable
do parenterals go through the GI route?
no
true or false
a disadvantage of parenterals is that they are a relatively high cost
true
“#1 component” of parenteral products
WATER (aqueous vehicle)
true or false
parenteral products can NOT have aqueous vehicles
false - they can - as cosolvents
name 4 potential “solutes” that may be added into a parenteral product
drug
antimicrobial agent (if multi dose)
tonicity adjuster
antioxidants and buffers (for stability)
**name the 5 types of aqueous vehicles for parenteral products
water for injection
sterile water for injection
bacteriostatic water for injection
sodium chloride injection
bacteriostatic sodium chloride injection
*true or false
water for injection is NOT required to be sterile
TRUE – but it MUST be pyrogen free
because it isn’t sterile, the final parenteral PRODUCT MUST be sterilized
water for injection must be used within ____ after collection
24 hours
*true or false
sterile water for injection is both sterile and free from pyrogens
true
*what is bacteriostatic water for injection
sterile water for injection that has antimicrobial agent(s)!!!!
*SPECIAL CONSIDERATION for bacteriostatic water for injection as well as bacteriostatic sodium chloride injection
USP labeling – must state NOT FOR USE IN NEONATES!!!!
due to gasping syndrome from benzyl alcohol poisoning
*explain what sodium chloride injection, USP is
STERILE and ISOTONIC solution of sodium chloride in “water for injection”
true or false
sodium chloride injection has no antimicrobial agents
TRUE
sodium chloride injection has no antimicrobial agents but……
has around 154 mEq each of Na and chloride ions/Liter
true or false
sodium chloride injection, USP is sterile
true
sterile and isotonic
*explain what bacteriostatic sodium chloride injection is
sterile and isotonic (like sodium chloride injection)
BUT also has 1 or more antimicrobial agents – must be specified on the label not for use in neonates!!!!!
*****true or false
water for injection is isotonic
FALSE
**true or false
water for injection is not sterile
true
it’s not sterile – END PRODUCT MUST BE STERILIZED!!!
*when adding a non-aqueous vehicle to a parenteral product, it must be both physically and chemically stable at…..
VARIOUS pH levels
*when adding a non-aqueous vehicle to a parenteral product, it is important that ___ is maintained over ____
fluidity is maintained over a fairly WIDE temperature range