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137 Cards in this Set
- Front
- Back
Main parenteral routes
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intravenous, intramuscular, subcutaneous, intradermal
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two main devices for parenteral admin
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needles and catheters
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Needles are attached to what two containers?
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syringes for single inj and IV sets for infusions
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Catheters are made from
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flexible plastic or silicone.
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How are catheters introduced into the vein?
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introduced into vein with a needle. Example "over the needle" catheters.
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"G"
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gauge value. Large the G the smaller the needle. Exmaple-insulin 30 needle very thin.
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Two types of IV injection istes
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central and peripheral
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Central IV sitesfor catheters
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superior vena cava or sometimes the right atrium.
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catheters insertion sites for central IV
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subclavian and jugular veins
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Benefits of central IV admin site
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rapid diffusion and reduced risk of infection
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PICC
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peripherally inserted central catheter. Inserted into perip vein but with tip in central IV site.
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Peripheral IV admin site
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Hand, arm, antecubital fossa, scalp in babies.
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Methods of IV admin
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continous infusion, intermittent infsion and bolus.
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Continous infusion
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prolonged drug admin, uses an administration set.
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5 parts of the admin set
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1.spike
2.drip chamber 3.plastic tubing 4.a clamp 5.y port |
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y-port function
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connects a secondy admin set for secondary admin (piggy back infusion). can allow for one line to flow at a time.
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intermittent infusion
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IV therapy administered at perecribed intervals. Usually administered through an already existing IV so, it will use a Y-port.
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Heparin Lock
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a small intermittent infusion device that remains in the vein btwn uses. Keeps the vein ready for next infusion.
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Piggyback infusion and what drugs use them
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infusion of second IV fluid thru a connection in the primary IV set. Antibiotics.
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Bolus
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concentrated med given rapidly (1-5min). If given too fast can be dangerous (KCL or teniposide).
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time it takes IV drug to reach brain/heart and circulation
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heart/brain in 10-20 seconds
circulation 1min |
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Intramuscular injection sites
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striated muscle fibers under the subcut layer at 90 degree angle.
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primary IM inj sites
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butt(large mass for large inj), deltoid (more pain but better circulation), vastus lateralis (best for kids under 3)
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depot inj site
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for IM. type of inj that serves as storage reservoir from which the drug is slowly removed into systemic ciculation.
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Pro's and Con's of IM
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IM can accept diverse formulations like oil and suspensions but can not recieve more than 10ml
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Subcut inj site
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in fat tissue below dermis. inj at 45 degree. arms, stomach, thigh.
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Absorption mechanism of subcut inj
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can be absorbed in lymph nodes, interstitial fluid or blood. but slower on set.
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Hypodermoclysis
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continous sc infusion. normally 2ml is max sc inj.
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Intradermal INJ site
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inj at artery and it specificlly targets an organ. Chemo drugs.
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intraperitoneal inj
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peritoneal cavity. provides local therapy. chemo drugs.
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epidural inj
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epidural (on or over dura mater) which is between dura mater and ct on vertebral canal. anesthetic.
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requirements of epidural inj
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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 |
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intrathecal inj
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within spinal cord. inj in the subarachnoid layer in the lumbar region. Example- Balcofen for cerebral palsy
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intraventricular inj
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lateral ventricles of the brain. local therapy for CNS infections and cancer.
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intra-articular inj
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synovial sac of joints. for local action. rhuematoid, pain, inflamm.
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intrapleural inj
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pleural cavity. local action.
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intraosseous inj
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with bone marrow cavity. systemic. "noncollapsable vein". example is inj into tibia for emergency meds for children.
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intralesional inj
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in or around a lesion. local.
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intraocular inj
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local action in eye. intraviteral injs.
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Disadvantages of Parenteral inj
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1. nerve or tissue damage
2.phlebitis 3.extravastation 4.infection 5. pyrogenic response 6.cost |
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drug formulations that could be irritating for inj
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1. non-isotonic drugs
2.non-physiological pH 3. cosolvents/surfactants 4. the drug it's self |
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possible sequelae of phlebitis
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thrombus (blood clot), Embolus (can lodge in puml artey), Embolism (blood clot).
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contributing factors to phlebitis
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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 |
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extravasation and infiltration
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escape of fluid into surrounding tissue
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sequelae of extravasation
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swelling/pain, cell death from chemical irritation, tissue death and infection, nerve damage and loss of a limb.
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contributing factors to extravasation
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puncture of vein, slippage of catheter out of vein, trauma to venous endothelium, drug prd
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Vesicants
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any agent that prd blisters
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IV agents that cause necrosis
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dextrose 10%, TPN solutions. These are hypertonic. Also antibiotics, chemo agents, vasopressin.
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types of infections that could occur with parenterals
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cellulitis from staphylococcus/streptococcus. septicemia from bacteria. Microbes come from air or skin.
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main concern of exogenous pyrogens
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bacterial endotoxin such as LPS which is associated with gram neg bacteria.
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effects of bacterial endotoxin
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pyrogenicity, limulus lysate gelation, shock, fever/
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why parenterals cost more
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administered by trained personelle. liability. cost of manufacturing and compounding.
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ommaya resevior
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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.
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Purity requirements for parenterals
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free from pyrogens, pathogens, and particulates.
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Sterilization methods for parenterals
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1.thermal (2 types)
2.Filtration (most common) 3.Radiation with gamma 4. Radiation with UV 5.Gas |
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Thermal Moist sterilization
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1.121 degrees for 15 mins
2.High P in autoclave 3.protein denaturation |
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Pros and Cons for thermal moist steriliatoins
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pros- can do large batches
cons- can't do oils, fats, or powders |
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Thermal dry sterilization
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1.170 degrees for 2 hours
2.dehydration then burning 3.best for stuff not able to thermally moist sterilizied |
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Filtration sterilization
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1. removes and kills microorganisms.
2. pore sizes from 5 micrometers to 0.22 micrometers 3. adsorption or sieving |
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Pro/Cons for filtration sterilization
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Pro-sterilizes heat sensitive solutions
Con- possible drug adsorption |
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Radiation with Gamma, sterilization
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1.effects DNA
2.can sterilize in packaging without use of heat |
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Radiation with UV sterilization
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1.Thymine denaturation
2.Does not penetrate well. Limited to sterilizing air and surfces. |
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Gas sterilization
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1.interferes with metabolism
2.great penetration 3.difficult and time comsuming |
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Gases used for sterilization
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ethylene and prolylene oxide
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Two USP tests used for sterility
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1. direct transfer to sterile culture media
2.Membrane filtration |
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Membrane filtration test
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1. filter concentrates microbes for detection
2. filter is 0.45microm and then tranfered to soybean casein/trypticase for 7 days |
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Methods for removing pyrogens from parenterals
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rinsing, ultrafilatration,distillation
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MEthods for inactivating pyrogens from parenterals
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dry heat, moist heat, alkylatoin
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2 pyrogens test performed for parenterals
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1.rabbit test- monitor rectal temps for rabbits.
2.Limulus test- contents clot is presence of endotoxin |
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Why particulates are dangerous in parenterals
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1. particles 8 micrometes in diam can get lodged in arterioles or capillaries
2.Blood vessle collapse 3. Granulomas 4.interaction with reticuloendotheilial system |
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USP limits for particulates for large volume(100ml) parenterals
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No more than 50 particles per ml. No particles larger than 10micrometers and no more than 5 parts/ml
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USP limits for particulares for Small Volume (<100ml) parenterals
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No more than 10,000 particles per container.
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Methods to remove particulates
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1.Filters 1-5 micro
2. Air-eliminating, 0.2 micro filters. |
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Ideal IV tonicity range
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240-340 mOsm/L
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pH range for IM and SC inj
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4-9 but this inc their risk for necrosis
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pH range for central IV
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3-10.5. Large range because of dilution and blood buffer.
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pH range for peripheral IV
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5-9
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Intrathecal pH range
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7-7.6, tissue is sensitve and has slow circulation and low volume.
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four types of parenteral products
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solutions, suspensions, emulsions, and reconstitutables.
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Vehicle for parenterals
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water (most common) and oil (usually for insoluble drugs and depots)
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Administration of injectables in oil
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vegetable type of oil. IM.
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Substances added to parenterals
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1.solubilizers
2.preservations 3.buffers 4.antioxid 5.tonicity adjusters |
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Method of enhancing solubility
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Organic co solvents, surfactants, cyclodextrins, salt formation and prodrugs.
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Most common solubilty enhancers and how they work
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Ethanol, propylene gylcol, PEG400. They reduce water polarity.
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examples of non-ionic surfactants (preferred)
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Tween 80 and polysorbate 80
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How do surfactants work?
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solubilzes polar and non-polar drugs by dispersing them in micelles. Mostly works with lipophilic drugs.
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Example of anti-mircobials and their prescribed limits
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Chlorobutanol, cresol, phenol - 0.5%
Benzyl alcohol-1% |
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Uses for large volume parenterals
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hydration, electrolytes, nutrition, TPN, Vehicles, KVO (example- D5W at rate of 10-15ml/hr)
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Examples of large volume parenterals and thei uses
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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 |
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Components of Ringer's
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Nacl, KCL, CaCl
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Components of lactated ringers
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Nacl, KCL,CaCL, and sodium lactate
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Small volume parenterals uses
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drugs, biologics, diagnostic, allergenic, and radiopharmceuticals.
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Common DF for small volume parenterals
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Solutions(insulin) and suspensions (insulin susp)
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rare df for small volume parenterals
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Emulsions. Propofol (Diprivan) is an example of one.
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Techniques of producing sterile solids
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Aseptic crystallization and lyophilization
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lyophilization aka freeze dry
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is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport.
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other convenient SVPs
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1. mini-bags
2. ADD-vantage system (2 parts) 3.Disposable pre-fillled syringes 4.double chambered vials |
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Methods to keep air clean and maintained
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1.HEPA (high effic particulate air)
2.Laminar flow 3.Positive pressure |
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HEPA
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removes 99.97% of particles 0.3microns or larger. Reduce chances of contamination but do not elim.
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Laminar flow
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air moves with uniform velocity along parallel line to minimize turbulence.
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positive pressure air flow
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air has to be of a higher pressure than air in surrounding areas. Causes air to move out when doors open.
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important properties of packaging materials
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1. Permeation
2.leaching 3.adsorption |
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Most common plastics used for packaging
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Polyproylene, PVC (polyvinylchloride),polyethylene.
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Pros/Cons of packaging with polyproylene
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pros- autoclavable,low gas and water perm, and low additives
Cons-translucent not transparent. |
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PVC pros and cons for packaging use
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pros-transparent, flexible
cons-high water perm and oxy perm, leaching is a problem |
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Polyethylene pros and cons
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pros-low additives and leaching is no prob
cons-high or low density |
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Fours types of glass
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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 |
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Potential leachables in glass
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alkaline earth and heavy metal oxides can raise pH in product.
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Imp physical properties of rubber used for stoppers
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coring-pludding the needle with a piece of rubber
resealability- rubber needs to reseal itself post needle insertion |
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potential leachable in rubber
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heavy metal salts and lubricants
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types of containers for parenterals
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1.ampules
2.vials 3.plastic bags 4.large volume bottles |
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Ampules
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Heat sealed glass containers for single use. Hermetic but have broken glass particles upon opening.
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Vials
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closed with rubber stopper or aluminum crimp
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plastic bags
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Dominant for parenterals. Single use. collapsibleso fluid can drip out.
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Large volume bottles
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plastic or glass and for single use
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admixtures
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combination of parenteral df for administration as a single entity. example- when drugs, nutrients, electrolytes are added to LVPs
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horizontal vs vertical laminar air flow
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H- air flows at worker and does not protect worker
V- downward flow protects the worker from potential hazards. (use for antineoplastic handling). |
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DOP smoke test
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dioctyl phthalate smoke test is used to test for the passage of particles through the HEPA.
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Barrier isolator
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physical barrier between worker and HEPA. sometimes class glove boxes.
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Chemical incompatibilities for mixed parenterals
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1. mixture led to suboptimal pH
2. photodegradation |
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example of pH related chemical incompatibility
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ampicillin sodium in D5W
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examples of drugs affected by photodegradation
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1.metoclopramide
2.adriamycin 3.cisplatin 4.daunomycin 5.amphtericin 6.b-complex vitamins 7.sodium nitroprusside |
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Physical incompatibilty of mixing parenterals
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precipitations, visual incompatibility, layering effect, destabilization, drug-containter interaction.
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example of percipitation caused by changes in pH
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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. |
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percipitation caused by formation of poorly soluble salts
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Divalent cations in the presence of bicarb, citrate, sulfite, and phosphate salts.
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Important example of salt incompatibility
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calcium-phosphate incompatibility. This mix can form insoluble salt in LVP or in-line. Causes many pulmoney embolism deaths.
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Layering effect
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occurs due to diff densities. dangerous. occurs in container or in-line. Imp to mix well!!
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destabilization
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for colloidal prds (less than 1 microm). occurs bc of incompatibilities and temp extremes.
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Example of colloids that show destabilization
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IV fat emulsions, liposomes, amphotericin B
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parenteral-container interactions
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adsorption and leaching
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adsorption
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drugs can adsorb to PVC, gladd, rubber, or a filter.
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drugs that adsorb to PVC
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lipophilic drugs like insulin, nitroglycerin, warfarin, sodium diazepam
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drugs that adsorb to glass
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insulin and denileukin difitox
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drugs that adsorb to rubber
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methyl paraben
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Leaching from plastic components
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phthalates from PVC and DEHP from surfactants
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Alternatives to PVC when it presents a problem
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ethylene vinyl acetate, polyolefin like polyethylene and polypropylene.
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alternative to DEHP
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non-DHEP PVC.
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