Parenterals Flashcards
Exam 1 content
USP chapter numbers > 1000
Recommendations (nice to have)
USP chapter numbers < 1000
ENFORCEABLE (must follow)
USP 797
Pharmaceutical compounding, law of compounding sterile preparations
USP 800
Hazardous drugs- handling in healthcare settings
What does parenteral mean?
Products administered by injection and involves all injectable products
Parenteral Route
Introducing drugs into the body outside the GI tract and can be used to administer drugs to a specific body/organ
Considerations about Parenteral Products
-requires an injury to the body
-bypasses the body’s natural defense
-makes the body vulnerable
-must meet certain requirements
What requirements do parenterals must meet?
-right potency
-properly labeled
-sterile
-pyrogen free
-particle free
What does sterile mean?
parenteral formulations must be FREE of microbial organisms
What ways is sterilization achieved?
-steam (autoclave)
-filtration (bacteria retentive membrane)
-dry heat (oven)
-gas (ethylene oxide)
-irradiation (gamma rays)
What are pyrogens?
bacterial endotoxins and “produce” fever and sometimes septic shock and are remnants from microorganisms
What do particles do?
-can trigger immune response, produce damage to the lungs, kidneys and can kill people
Types of parenteral products
-Solutions ready for injection
-Suspensions ready for injection
-Emulsions
Solutions ready for injection
Dry, soluble preparations ready to be combined with a solvent before use
Suspensions ready for injection
Dry, insoluble preparations ready to be combined with a vehicle before use
Emulsion Parenterals
Liquid concentrates ready for dilution prior to administration
“for”
Don’t use it as is; you have to do something to it before injecting
LVP
“Large Volume Parenteral”, single dose injections packaged in a container containing MORE 100mL
Small Volume Parenterals
100 mL or less
Vehicles
Solvents/mediums for the administration of therapeutic agents (water is preferred vehicle)
Water for injection (WFI)
Pyrogen free, non-sterile, single use sealed container
Sterile Water for injection (SWFI)
Pyrogen free, sterile, and in containers not larger than 1000 mL
NEVER INJECT DIRECTLY INTO THE BLOODSTREAM (can cause lysis of the cells)
Bacteriostatic Water for Injection (BWFI)
Pyrogen free sterile with antimicrobial agent added