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137 Cards in this Set

  • Front
  • Back
Main parenteral routes
intravenous, intramuscular, subcutaneous, intradermal
two main devices for parenteral admin
needles and catheters
Needles are attached to what two containers?
syringes for single inj and IV sets for infusions
Catheters are made from
flexible plastic or silicone.
How are catheters introduced into the vein?
introduced into vein with a needle. Example "over the needle" catheters.
"G"
gauge value. Large the G the smaller the needle. Exmaple-insulin 30 needle very thin.
Two types of IV injection istes
central and peripheral
Central IV sitesfor catheters
superior vena cava or sometimes the right atrium.
catheters insertion sites for central IV
subclavian and jugular veins
Benefits of central IV admin site
rapid diffusion and reduced risk of infection
PICC
peripherally inserted central catheter. Inserted into perip vein but with tip in central IV site.
Peripheral IV admin site
Hand, arm, antecubital fossa, scalp in babies.
Methods of IV admin
continous infusion, intermittent infsion and bolus.
Continous infusion
prolonged drug admin, uses an administration set.
5 parts of the admin set
1.spike
2.drip chamber
3.plastic tubing
4.a clamp
5.y port
y-port function
connects a secondy admin set for secondary admin (piggy back infusion). can allow for one line to flow at a time.
intermittent infusion
IV therapy administered at perecribed intervals. Usually administered through an already existing IV so, it will use a Y-port.
Heparin Lock
a small intermittent infusion device that remains in the vein btwn uses. Keeps the vein ready for next infusion.
Piggyback infusion and what drugs use them
infusion of second IV fluid thru a connection in the primary IV set. Antibiotics.
Bolus
concentrated med given rapidly (1-5min). If given too fast can be dangerous (KCL or teniposide).
time it takes IV drug to reach brain/heart and circulation
heart/brain in 10-20 seconds
circulation 1min
Intramuscular injection sites
striated muscle fibers under the subcut layer at 90 degree angle.
primary IM inj sites
butt(large mass for large inj), deltoid (more pain but better circulation), vastus lateralis (best for kids under 3)
depot inj site
for IM. type of inj that serves as storage reservoir from which the drug is slowly removed into systemic ciculation.
Pro's and Con's of IM
IM can accept diverse formulations like oil and suspensions but can not recieve more than 10ml
Subcut inj site
in fat tissue below dermis. inj at 45 degree. arms, stomach, thigh.
Absorption mechanism of subcut inj
can be absorbed in lymph nodes, interstitial fluid or blood. but slower on set.
Hypodermoclysis
continous sc infusion. normally 2ml is max sc inj.
Intradermal INJ site
inj at artery and it specificlly targets an organ. Chemo drugs.
intraperitoneal inj
peritoneal cavity. provides local therapy. chemo drugs.
epidural inj
epidural (on or over dura mater) which is between dura mater and ct on vertebral canal. anesthetic.
requirements of epidural inj
1.drug must diffuse across meninges
2. much of drugs maybe absorbed in systemic circ
3. arachoid is the primary barrier for drug transport into the CSF
intrathecal inj
within spinal cord. inj in the subarachnoid layer in the lumbar region. Example- Balcofen for cerebral palsy
intraventricular inj
lateral ventricles of the brain. local therapy for CNS infections and cancer.
intra-articular inj
synovial sac of joints. for local action. rhuematoid, pain, inflamm.
intrapleural inj
pleural cavity. local action.
intraosseous inj
with bone marrow cavity. systemic. "noncollapsable vein". example is inj into tibia for emergency meds for children.
intralesional inj
in or around a lesion. local.
intraocular inj
local action in eye. intraviteral injs.
Disadvantages of Parenteral inj
1. nerve or tissue damage
2.phlebitis
3.extravastation
4.infection
5. pyrogenic response
6.cost
drug formulations that could be irritating for inj
1. non-isotonic drugs
2.non-physiological pH
3. cosolvents/surfactants
4. the drug it's self
possible sequelae of phlebitis
thrombus (blood clot), Embolus (can lodge in puml artey), Embolism (blood clot).
contributing factors to phlebitis
1.needle/catheter
2. admin site (small veins less able to dilute prd, leg veins have stagnant flow)
3.technique of inject
4. drug prd can cause endothelial damage or physically irritate endothelium
extravasation and infiltration
escape of fluid into surrounding tissue
sequelae of extravasation
swelling/pain, cell death from chemical irritation, tissue death and infection, nerve damage and loss of a limb.
contributing factors to extravasation
puncture of vein, slippage of catheter out of vein, trauma to venous endothelium, drug prd
Vesicants
any agent that prd blisters
IV agents that cause necrosis
dextrose 10%, TPN solutions. These are hypertonic. Also antibiotics, chemo agents, vasopressin.
types of infections that could occur with parenterals
cellulitis from staphylococcus/streptococcus. septicemia from bacteria. Microbes come from air or skin.
main concern of exogenous pyrogens
bacterial endotoxin such as LPS which is associated with gram neg bacteria.
effects of bacterial endotoxin
pyrogenicity, limulus lysate gelation, shock, fever/
why parenterals cost more
administered by trained personelle. liability. cost of manufacturing and compounding.
ommaya resevior
a is an intraventricular catheter system that can be used for the aspiration of cerebrospinal fluid or for the delivery of drugs (e.g. chemotherapy) into the cerebrospinal fluid.
Purity requirements for parenterals
free from pyrogens, pathogens, and particulates.
Sterilization methods for parenterals
1.thermal (2 types)
2.Filtration (most common)
3.Radiation with gamma
4. Radiation with UV
5.Gas
Thermal Moist sterilization
1.121 degrees for 15 mins
2.High P in autoclave
3.protein denaturation
Pros and Cons for thermal moist steriliatoins
pros- can do large batches
cons- can't do oils, fats, or powders
Thermal dry sterilization
1.170 degrees for 2 hours
2.dehydration then burning
3.best for stuff not able to thermally moist sterilizied
Filtration sterilization
1. removes and kills microorganisms.
2. pore sizes from 5 micrometers to 0.22 micrometers
3. adsorption or sieving
Pro/Cons for filtration sterilization
Pro-sterilizes heat sensitive solutions
Con- possible drug adsorption
Radiation with Gamma, sterilization
1.effects DNA
2.can sterilize in packaging without use of heat
Radiation with UV sterilization
1.Thymine denaturation
2.Does not penetrate well. Limited to sterilizing air and surfces.
Gas sterilization
1.interferes with metabolism
2.great penetration
3.difficult and time comsuming
Gases used for sterilization
ethylene and prolylene oxide
Two USP tests used for sterility
1. direct transfer to sterile culture media
2.Membrane filtration
Membrane filtration test
1. filter concentrates microbes for detection
2. filter is 0.45microm and then tranfered to soybean casein/trypticase for 7 days
Methods for removing pyrogens from parenterals
rinsing, ultrafilatration,distillation
MEthods for inactivating pyrogens from parenterals
dry heat, moist heat, alkylatoin
2 pyrogens test performed for parenterals
1.rabbit test- monitor rectal temps for rabbits.
2.Limulus test- contents clot is presence of endotoxin
Why particulates are dangerous in parenterals
1. particles 8 micrometes in diam can get lodged in arterioles or capillaries
2.Blood vessle collapse
3. Granulomas
4.interaction with reticuloendotheilial system
USP limits for particulates for large volume(100ml) parenterals
No more than 50 particles per ml. No particles larger than 10micrometers and no more than 5 parts/ml
USP limits for particulares for Small Volume (<100ml) parenterals
No more than 10,000 particles per container.
Methods to remove particulates
1.Filters 1-5 micro
2. Air-eliminating, 0.2 micro filters.
Ideal IV tonicity range
240-340 mOsm/L
pH range for IM and SC inj
4-9 but this inc their risk for necrosis
pH range for central IV
3-10.5. Large range because of dilution and blood buffer.
pH range for peripheral IV
5-9
Intrathecal pH range
7-7.6, tissue is sensitve and has slow circulation and low volume.
four types of parenteral products
solutions, suspensions, emulsions, and reconstitutables.
Vehicle for parenterals
water (most common) and oil (usually for insoluble drugs and depots)
Administration of injectables in oil
vegetable type of oil. IM.
Substances added to parenterals
1.solubilizers
2.preservations
3.buffers
4.antioxid
5.tonicity adjusters
Method of enhancing solubility
Organic co solvents, surfactants, cyclodextrins, salt formation and prodrugs.
Most common solubilty enhancers and how they work
Ethanol, propylene gylcol, PEG400. They reduce water polarity.
examples of non-ionic surfactants (preferred)
Tween 80 and polysorbate 80
How do surfactants work?
solubilzes polar and non-polar drugs by dispersing them in micelles. Mostly works with lipophilic drugs.
Example of anti-mircobials and their prescribed limits
Chlorobutanol, cresol, phenol - 0.5%

Benzyl alcohol-1%
Uses for large volume parenterals
hydration, electrolytes, nutrition, TPN, Vehicles, KVO (example- D5W at rate of 10-15ml/hr)
Examples of large volume parenterals and thei uses
1. dextrose- hydration, calories
2.NaCL-ECF replacement
3.Ringer's- fluid and electrolyte replacement
4.Lactated Ringer's- systemic alkalizer and fluid/elec replac
5.Lipid emulsion- cals and fats
Components of Ringer's
Nacl, KCL, CaCl
Components of lactated ringers
Nacl, KCL,CaCL, and sodium lactate
Small volume parenterals uses
drugs, biologics, diagnostic, allergenic, and radiopharmceuticals.
Common DF for small volume parenterals
Solutions(insulin) and suspensions (insulin susp)
rare df for small volume parenterals
Emulsions. Propofol (Diprivan) is an example of one.
Techniques of producing sterile solids
Aseptic crystallization and lyophilization
lyophilization aka freeze dry
is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport.
other convenient SVPs
1. mini-bags
2. ADD-vantage system (2 parts)
3.Disposable pre-fillled syringes
4.double chambered vials
Methods to keep air clean and maintained
1.HEPA (high effic particulate air)
2.Laminar flow
3.Positive pressure
HEPA
removes 99.97% of particles 0.3microns or larger. Reduce chances of contamination but do not elim.
Laminar flow
air moves with uniform velocity along parallel line to minimize turbulence.
positive pressure air flow
air has to be of a higher pressure than air in surrounding areas. Causes air to move out when doors open.
important properties of packaging materials
1. Permeation
2.leaching
3.adsorption
Most common plastics used for packaging
Polyproylene, PVC (polyvinylchloride),polyethylene.
Pros/Cons of packaging with polyproylene
pros- autoclavable,low gas and water perm, and low additives
Cons-translucent not transparent.
PVC pros and cons for packaging use
pros-transparent, flexible
cons-high water perm and oxy perm, leaching is a problem
Polyethylene pros and cons
pros-low additives and leaching is no prob
cons-high or low density
Fours types of glass
type 1- borosilicate glass, best kind low leachable and chemically resistant.
type 2- treated soda-lime glass. surface treated to improve chem resist.
type 3- soda-lime glass
type 4- Non-parenteral glass
Potential leachables in glass
alkaline earth and heavy metal oxides can raise pH in product.
Imp physical properties of rubber used for stoppers
coring-pludding the needle with a piece of rubber
resealability- rubber needs to reseal itself post needle insertion
potential leachable in rubber
heavy metal salts and lubricants
types of containers for parenterals
1.ampules
2.vials
3.plastic bags
4.large volume bottles
Ampules
Heat sealed glass containers for single use. Hermetic but have broken glass particles upon opening.
Vials
closed with rubber stopper or aluminum crimp
plastic bags
Dominant for parenterals. Single use. collapsibleso fluid can drip out.
Large volume bottles
plastic or glass and for single use
admixtures
combination of parenteral df for administration as a single entity. example- when drugs, nutrients, electrolytes are added to LVPs
horizontal vs vertical laminar air flow
H- air flows at worker and does not protect worker

V- downward flow protects the worker from potential hazards. (use for antineoplastic handling).
DOP smoke test
dioctyl phthalate smoke test is used to test for the passage of particles through the HEPA.
Barrier isolator
physical barrier between worker and HEPA. sometimes class glove boxes.
Chemical incompatibilities for mixed parenterals
1. mixture led to suboptimal pH
2. photodegradation
example of pH related chemical incompatibility
ampicillin sodium in D5W
examples of drugs affected by photodegradation
1.metoclopramide
2.adriamycin
3.cisplatin
4.daunomycin
5.amphtericin
6.b-complex vitamins
7.sodium nitroprusside
Physical incompatibilty of mixing parenterals
precipitations, visual incompatibility, layering effect, destabilization, drug-containter interaction.
example of percipitation caused by changes in pH
1.sodium salts of weak acids added to an acidic medium. Cefazolin ppt at pH 4.5
2. HCL salt added to weak base. Metoclopramide and cephalothin.
percipitation caused by formation of poorly soluble salts
Divalent cations in the presence of bicarb, citrate, sulfite, and phosphate salts.
Important example of salt incompatibility
calcium-phosphate incompatibility. This mix can form insoluble salt in LVP or in-line. Causes many pulmoney embolism deaths.
Layering effect
occurs due to diff densities. dangerous. occurs in container or in-line. Imp to mix well!!
destabilization
for colloidal prds (less than 1 microm). occurs bc of incompatibilities and temp extremes.
Example of colloids that show destabilization
IV fat emulsions, liposomes, amphotericin B
parenteral-container interactions
adsorption and leaching
adsorption
drugs can adsorb to PVC, gladd, rubber, or a filter.
drugs that adsorb to PVC
lipophilic drugs like insulin, nitroglycerin, warfarin, sodium diazepam
drugs that adsorb to glass
insulin and denileukin difitox
drugs that adsorb to rubber
methyl paraben
Leaching from plastic components
phthalates from PVC and DEHP from surfactants
Alternatives to PVC when it presents a problem
ethylene vinyl acetate, polyolefin like polyethylene and polypropylene.
alternative to DEHP
non-DHEP PVC.