Parenterals Part 1 Flashcards by amanda kastel

define parenteral drug delivery systems

STERILE dosage forms to be administered by injections

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**what are the 4 S’s of parenteral drug delivery systems

safety
sterility
stability
solubility

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parenteral drug delivery systems are free from what 3 things

microbes
pyrogens
particulates

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3 common formulations that are parenteral drug delivery systems

solutions
suspensions
emulsions

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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

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true or false

parenterals have the most direct access possible to the vascular system

true

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true or false

parenterals have unpredictable drug levels in the blood

FALSE - highly predictable

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do parenterals go through the GI route?

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true or false

a disadvantage of parenterals is that they are a relatively high cost

true

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“#1 component” of parenteral products

WATER (aqueous vehicle)

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true or false

parenteral products can NOT have aqueous vehicles

false - they can - as cosolvents

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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)

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**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

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*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

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water for injection must be used within ____ after collection

24 hours

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*true or false

sterile water for injection is both sterile and free from pyrogens

true

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*what is bacteriostatic water for injection

sterile water for injection that has antimicrobial agent(s)!!!!

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*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

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*explain what sodium chloride injection, USP is

STERILE and ISOTONIC solution of sodium chloride in “water for injection”

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true or false

sodium chloride injection has no antimicrobial agents

TRUE

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sodium chloride injection has no antimicrobial agents but……

has around 154 mEq each of Na and chloride ions/Liter

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true or false

sodium chloride injection, USP is sterile

true

sterile and isotonic

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*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!!!!!

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*****true or false

water for injection is isotonic

FALSE

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****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

*when adding a non-aqueous vehicle to a parenteral product, how is boiling point a consideration?

must be high enough to allow for heat sterilization *****HIGHER THAN 170 degrees celsius!!!!

*true or false when adding a non-aqueous vehicle to a parenteral product, it must be miscible with the body fluids

true

*when adding a non-aqueous vehicle to a parenteral product, how is vapor pressure a consideration?

MUST BE LOW!!!! to avoid problems during heat sterilization (LOW tendency to evaporate when heated)

cosolvents are added to parenteral products to increase _____ and perhaps ____

drug solubility and perhaps stability

water IMMISCIBLE vehicles are generally NOT used in parenteral products when would they be used and what might be used?

for TPN emulsions or IM depots only fixed oils and their derivatives

**true or false a nonaqueous solvent turns viscous when the temperature decreases is this good or bad

BAD should maintain fluidity over a WIDE temperature range

*when adding a non-aqueous solvent to a parenteral product, the boiling point must be...

GREATER THAN 170 DEGREES CELSIUS

* "(DRUG) INJECTION)

LIQUID -- drug solution

* "(DRUG) FOR INJECTION

DRY SOLID when you add a suitable vehicle, it will make a solution, meeting all the requirements for an injection

* (drug) injectable emulsion vs (drug) injectable suspension

drug injectable emulsion - LIQUID. drug is dissolved or dispersed in EMULSION medium drug injectable suspension - LIQUID. solid is suspended in liquid medium

** "(drug) for injectable suspension)"

DRY SOLID will become an INJECTABLE SUSPENSION when a vehicle is added

*true or false (drug a) for injection is supplied as a vial of injectable solution

FALSE - dry powder when you add diluent it will form solution

***** relationship between gauge number and lumen diameter

as the gauge number increases, the lumen diameter DECREASES IE - 18 gauge is LARGER than 22 gauge

rank the following according to the volume of their injection: sub Q IM IV ID

largest - IV IM SUBQ smallest - ID (intradermal)

intravenous preparations can be ___ or ____

aqueous solutions OR O/W emulsions (ie - TPN)

max volume for a SUBQ injection

1mL over 2mL can cause a painful pressure

where is SUBQ injected

under the skin - between the dermis and the muscle

****rate the following according to onset time IM SUBQ IV

slowest - SUBQ IM fastest - IV

*WHY is SUBQ injection the slowest onset what can be done to increase the absorption rate?

bc blood flow is SLOW onset of action and absorption rate are slower can use heat or massage the site, or administer vasodilators

administering epinephrine near the time of a SUBQ injection will increase or decrease the absorption rate of the SUBQ drug?

decrease -- bc blood flow decreased

explain the onset and length of duration for an IM injection

SLOW onset but longer lasting ie - emulsion depot -- bolus forms a depot and drug slowly releases

common syringe and gauge needle for IM injections

3mL syringe 18-25 gauge needle

the limit on the amount of IV fluid you can give to a patient in one day is determined by what?

the amount of fluid that the person's body can take every day 35-50mL/kg/day

2 risks of IV injections

thrombus and embolus

IV administration can be divided into .... (based on time)

continuous infusion intermittent bolus or IV push

needle size for IV

20-22 gauge

for continuous IV infusions, the drug is added to.... and then administered how?

added to a large volume parenteral solution slowly and continuously dripped into a vein

true or false continuous IV infusions have an advantage over IV push/bolus because they are less irritating to the vein

TRUE -- bc they are in dilute solutions, and IV push is highly concentrated in a small volume of solution

IV continuous infusions are beneficial because ------- can be administered at the same time

drug therapy AND fluid

which is usually cheaper - IV bolus/push or continuous infusion?

continuous infusion bc less units needed -- and less staff

true or false giving drugs via continuous IV infusion can be dangerous because blood levels are unpredictable

FALSE --- advantage that the blood levels are continuous and constant

3 disadvantages of continuous IV infusions

-more monitoring bc runs continuously -CANNOT BE USED on fluid-restricted patients -certain unstable drugs cannot be given via continuous infusion -- bc of the extended running times. ex - drug unstable in water must be given quickly

explain how IV intermittent preparations are administered

given an intermediate volume in spaced intervals (ie for 15 mins - every 6 hours)

true or false an advantage of INTERMITTENT IV is that is requires LESS monitoring than continuous infusion

true

advantage of intermittent IV over bolus/push

many drugs are more stable at moderate concentrations than concentrated also, less chance of bolus toxicity

true or false drug levels are LESS CONSTANT with intermittent IV than for continuous IV

true - this is a disadvantage

which IV administration is really the only one suitable for emergencies

IV bolus/push

true or false IV bolus/push requires monitoring

false - it does not

a disadvantage of IV bolus/push is that some drugs are ____ in concentrated solutions

less stable

IV bolus/push can be given as one time administration or.....

may be repeated in spaced intervals disadvantage when given again bc requires more staff --- 2-10 mins at bedside for each dose given