Based off of Dr. Miroshnyk's Study Guide
USP <_____> provides the minimum practice and quality standards for compounded sterile preparations.
<797>
USP <____> sets the standards for safe handling of hazardous drugs.
<800>
Injections definition:
liquid preparations that are drug substances or solutions of APIs
Injectable emulsions/suspensions definition:
liquid preparations of drug substance dissolved or dispersed or suspended in a suitable medium
If something says “for injections” is that substance a dry solid or liquid?
dry solid
Small-volume parenterals (SVP) definition:
an injection packaged in containers up to 100 ml
Large-volume parenterals (LVP) definition:
a single dose injection intended for IV use and is packaged in a container larger than 100 mL.
If I administered a 35 mL injection to a patient, would that be considered a small or large volume parenteral?
small
What are the different categories of sterile parenterals?
parenteral injections
ophthalmic preparations
irrigation fluids
dialysis solutions
biologics
What are the advantages of parenteral injections?
when rapid action is needed
when pt is unconscious/uncooperative
when pt is unable to have oral meds
when the drug is not effective by other routes
What are the disadvantages of parenteral injections?
must be administered by trained personnel
the effects are difficult to reverse (overdose/hypersensitivity)
aseptic procedure required
contamination is possible
invasive
more expensive
True or False: All parenteral routes of administration are sterility-demanding.
FALSE
Is Water for Injections (WFI) sterile?
no
Water for Injections (WFI) is the vehicle of choice for…
freely soluble APIs (injections)
poorly water soluble APIs (suspensions)
the external phase for injectable emulsions
Describe Sterile Water for Injection:
package in single-dose containers
no antimicrobials or anything else added
pyrogen-free
not used for IV administration
used as a vehicle
Bacteriostatic Water for Injections is ____________ + _____________.
Sterile WFI + one or more antimicrobial agent
When using bacteriostatic Water for injections (BWFI) _______________ of the antimicrobial agents and APIs has to be considered.
compatibility
BWFI is only used for _________ volume parenterals. (small/large)
small
Examples of aqueous vehicles used for parenteral products:
Water for Injections (WFI)
Sterile Water for Injections
Bacteriostatic Water for Injections (BWFI)
Ringer’s Injection
Large volume parenterals must NOT contain what?
bacteriostatic agents or other additives
Vegetable oils are used as non-aqueous vehicles ONLY FOR _____ injection.
IM
Examples of non-aqueous vehicles for parenteral products:
vegetable oils
corn, sesame, peanut, etc.
glycerin
polyethylene/propylene glycol
alcohol
What are the drawbacks of non-aqueous solvents?
pain/irritation on injection
patients can be sensitive to the oils
Differentiate IV/IM/SQ injections in terms of onset of action.
IV injection- fastest onset, directly introduced into bloodstream
IM injection- in the middle- longer than IV, shorter onset than SQ
SQ injection- slowest onset, introduced into loose interstitial tissues
What are the different methods of sterilization?
moist-heat (steam)
dry heat
filtration
gas
ionizing radiation
Definition of Sterilization:
in pharm terms, sterilization means destruction of ALL living organisms and their spores or their complete removal from the preparation.
Describe steam sterilization:
conducted in autoclaves
temp is responsible for sterilization
method of choice
Describe Dry Heat sterilization
carried out in ovens
higher temps and longer sterilization times
used for sterilizing equipment (glassware, instruments, oils, etc.)
Describe filtration sterilization:
removal of bacteria and spores by filtration using 0.22 um filter
advantage: speed, inexpensive
disadvantage: inspection needed, faulty assembly
Describe gas sterilization
utilizes mixtures of ethylene oxide or propylene oxide gas w/ inert gases
mechanism: ethylene oxide is thought to sterilize by interfering w/ metabolism of the bacterial cell
Describe ionizing radiation sterilization:
uses gamma and cathode rays
very reliable
limited applications
Validation of sterility includes:
tests to confirm the absence of microorganisms
The USP methods
use biological indicators
Describe pyrogenicity tests:
pyrogens are any fever-inducing agents like bacteria, virus, etc.
USP injection monographs state a bacterial Endotoxin Unit Limit (USP EU)
basically we inject bunnies and see if the drug raises the bunnies temps
List the categories of pharmaceutical excipients for parenteral products
What are the special requirements for multiple-dose containers?
MUST CONTAIN one or more preservatives no matter what
Why is the use of benzyl alcohol as an antimicrobial agent limited in parenteral injections?
NOT FOR USE IN NEONATES!!!!!!!
can cause Benzyl alcohol poisoning
Packaging requirements of parenterals:
containers, including closures, must be inert
should allow visual inspection of the solution
should protect the product from contamination during the entire shelf-life