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83 Cards in this Set
- Front
- Back
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what removed sterile from all injections other than water
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USP 23 1995
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possesses same osmolarity as serum or body fluid
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isotonic (stays in blood vessels)
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higher osmolarity than serum
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hypertonic
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lower osmolarity than serum
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hypotonic
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isotonic substances
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D5W, .9% NaCl (normal saline), lactated ringers, ringers
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what are the solvents and vehicles for injections
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water for injection
sterile water for injection bacteriostatic water for injection sodium chloride injection bacteriostatic sodium chloride ringers injection lactated ringer's injection |
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water for injection USP
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most frequently used solvent in large scale production
may not contain added substances pyrogen free but doesn't have to be sterile |
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sterile water injection USP
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packaged in single dose containers (no larger than 1 L)
pyrogen free can't contain antimicrobrial agent or added substances |
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what is the intended use for sterile water for injection USP
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as a solvent, vehicle or diluent
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what is the intended use for water for injection USP
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manufacturing of injectible products
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how is water for injection USP purified
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distilation
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bacteriostatic water for injection USP
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sterile water for injection
contains one or more suitable antimicrobrial agents contains no more than 30 ml water |
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what is the intended use for bacteriostatic water for injection
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solvent, vehicle or diluent
used to prepr small volumes of injectable product |
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how does bacteriostatic water for injection give flexibility for a multidose vial
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can use diff amounts at diff times, not one use only
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what reads "Not for Use in Newbors" and why
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bacteriostatic water for injections says this because it contains anitmicrobial agent Benzoyl alcohol which babies liver can't detoxify
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Sodium Chloride Injection (normal saline)
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sterile isotonic solution of NaCl in water for injection
contains no antimicrobial agents may be used as a vehicle in preparing solutions or suspensions of drugs, catheter or line flush |
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bacteriostatic Sodium Chloride Injection
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sterile isotonic solution of NaCl in water for injection
contains antimicrobial agents not packaged in containers larger than 30 ml |
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what are the uses of bacteriostatic Sodium Chloride Injection
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vehicle (dilueting)
flush catheter/lines |
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what two lables states Not for Use in Newborns
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bacteriostatic NaCl and water
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ringers injection
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sterile solution of NaCl, KCl, CaCl in water for injection (in concentrations similar to physiological fluids)
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what are the uses for ringers injection
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vehicle
replenish electrolytes |
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lactated ringers injection
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ringer + sodium lactate
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what are the uses of lactated ringers injection
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replenish fluids/electrolytes
system alkanizer (if patient body in acidic state) |
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what is an example of a non-aqueous vehicle
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progesterone in oil, alcohol, vegetable oil, glycerin, PEG
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what are the characteristics of non-aqueous vehicles
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non irritating
non toxic can't exert any pharmacological activity vehicle can't effect activity of the drug itself |
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what are the added substances for parenterals
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buffers
antibacterial preservatives antioxidants |
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what happens when pH > 9
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necrosis of tissue
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what happens when pH < 3
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extreme pain and phlebitis
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what are examples of buffers
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weak acid/base and their salts (citrates, acetates)
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what are antibacterial preservatives added to and why
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multi dose vial so it can be used more than once
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what are common antibacterial preservatives
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benzyl alcohol
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what do antioxidants do
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they have lower oxidation potential than drug so they will be preferentially oxidized
added either seperately or w/ chelating agent |
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what is an example of an antioxidant
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ascorbic acid, sulfur dioxide
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extent to which drug retains the same properties throughout storage
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stability
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what is the prime consideration in development of sterile dosage form
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stability
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what are the types of stability
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chemical
physical microbiologic therapeutic toxicologic |
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microbiologic
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ability for drug to resist microbial growth
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therapeutic
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ability for drug to maintain therapeutic effect
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toxicologic
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ability of drug to maintain original level of toxicity
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process of rapidly freezing and drying frozen sterile solid solution of drug under high vacuum
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lyophilization (frozen IV can maintain stability)
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factors affecting stability
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light
humidity container (plastic vs glass) opening of drug container (expiring) compatability of each drug w/ container |
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phenomenon that occurs when one drug is mixed with others to produce a product unsuitable for administration to the patient
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incompatibility
causes physical, chemical, or therapeutic change in the drug |
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this results from a chemical rx between 2 or more components of a mixture affecting the activity or molecular structure of the other drugs
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chemical incompatibilities
changes may not cause physical phenomenon |
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factors affecting chemical rxs resulting in incompatibility
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photolysis
reduction oxidation complexation |
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what is photolysis
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decomposition caused by light
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what does photolysis lead to
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hydrolysis or discoloration
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what occurs in reduction
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one drug gains electrons from another
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what occurs in oxidation
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loss of electrons occurs when reduction takes place
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what happens in complexation
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rxn between drugs that inactivates them (tetracyclin and calcium)
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what are some examples of physical incompatibilities
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change in color, precipitation, seperation of mixture, bubbles
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what are most physical incompatibilities a result of
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chemical reactions
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these are manifested by physical changes seen or felt by observer
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physical incompatibilities
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this occurs when two drugs are given together decreasing the effectiveness of either or both agents
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therapeutic incompatibilities (EX penicilin and tetracycline)
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factors affecting IV incompatibilities
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pH
temperature length of time in solution order of mixing |
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what happens to IV that are incompatible for pH
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occurs when components have significantly different pH
acids + base = salt |
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what happens to IV that are incompatible for temperature
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increase or decrease storage temp
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what happens to IV that are incompatible for length of time in solution
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greater length of contact time the greater chance of reaction resulting in incompatibility
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what are the references for incompatibilities
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handbook on injectable drugs (trissel)
guide to parenteral admixtures AHFS drug information |
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what happens to IV that are incompatible for order of mixing
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calcium and phosphate should not be added consecutively when making a IV
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complete destruction or removal of all living organisms and their spores from the preparation
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sterilization
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methods of sterilization
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steam
dry heat filtration gas ionizing radiation |
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factors determining method of sterilization
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compatibility
acceptability of packaging penetration of agent to remote areas containing microorganisms lowest expense time required for process highest safety and lowest toxicity simplicity |
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why is penetration of agent to remote areas containing microorganisms a factor for determining the method of sterilization
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the agent must penetrate the entire container
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what is the method of choice in product can withstand water, heat, steam, pressure
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steam sterilization
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what can't undergo steam sterilization
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oils and fats
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what causes destruction of organisms in steam sterilization
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temperature
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what does steam sterilization use to employ steam under pressure
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autoclave
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what denatures or causes coagulation of bacteria in steam sterilization
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steam
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this method of sterilization uses no pressure, just heat
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dry heat sterilization
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how does dry heat sterilization kill bacteria
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by dehydrating them
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what does dry heat sterilization use
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sterilizing oven
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is dry heat sterilization more or less effective than steam sterilization and why?
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it is less effective and requires higher temps and longer periods of exposure
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where is dry heat sterilization used
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space crafts
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what are some things dry heat sterilization is used on
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instruments, glass wear, oils, glycerin
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how does filtration kill bacteria
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by removing them through a filter
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what method is used for heat sensitive solutions
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filtration
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what is an advantage of filtration
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speed in filtering small quantities
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what method is used for heat sensitive and moisture sensitives products
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gas sterilization
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how does gas sterilization work
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sterilizes by interfering with the metabolism of the bacterial cell
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what are some of the things gas sterilization is used for
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catheters, needles, medical/surgical supplies
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what method uses gamma rays and cathode rays
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ionizing radiation sterilization
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what method may cause accelerated drug decomposition
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ionizing radiation sterilization
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how does ionizing radiation sterilization sterilize
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by altering chemicals within the bacteria
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