Dose Form Exam III SLides
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Dose Form Exam III SLides
Parentals Suspensions Emulsions Aerosal
What are small volume parentals used for?
Biologicals (vaccines, toxoids, anti-toxins)
What are large volume parentals used for?
IV fluids for maintenance, replacement, replenishment of fluids, electrolytes, vitamins
Irrigation fluid, to bathe body wounds or surgical openings
: used for peritoneal dialysis or hemodialysis for removal of toxic substances from blood
Blood replenishment products
: whole blood red blood cells,serum albumin, plasma protein
What are the facts stated from the slides about IV parentals solutions?
Optimum blood levels
: accuracy and immediacy
Can be adminstered to unconscious or uncooperative patients
For emergiences; rapid action, no absorption
Cant be removed once administered
Absolute sterility requirments
ONly aqueous solutions are used except for fat emulsions in partenal nutrition solutions
What are the main hazards with IVs?
: blood clot formed with a blood vessel, it is from low circulation or to an alteration of the blood or vessel wall
: Circulating clot that can lodge in a blood veseel, can cause obstruction
WHat are te facts stated from the slide about IM parental solutions?
Less rapid and longer duration than IV
Aqueous and oleagenou solutions
: suspensions variable absorption rate
The sites of injection should be rotated if there is a series of injections
Where should IM parental injections be administered?
Into the skelatal muscle
Try to avoid blood vessels and nerves
Slight aspiration before injection
: to make sure the drug is not injected into a vein
Where should adults be administered a IM injections?
Upper outer quadrant of the gluteal maximus is prefered
Where should infants be administered a IM injection?
Best are the upper deltoid muscle of the upper arm or the mid lateral muscles of the thigh
The gluteal area is small without much muscle and is close the sciatic nerve so this area should be avoided
Where should subcutaneous injections be adminstered?
Into the loose intstitial tissue, underneath the surface of the skin
Outer surface of the upper arm, anterior surface of the thigh, lower portion of the abdomEN
What is the max volume administered by subcutaneous route
1.3 ml, anything larger would cause large pressure and pain/irritation
What are the facts stated about intradermal route of administration ?
Administered into the dermis
The usual site is the anterior surface of the forearm
Very little volumes are applied (0.1)
USed as a diagnosed, for TB, diptheria toxin, immuniztions
What are the facts on steam under pressure sterility?
It is the method of choice for thermostable products
the pressure allows for higher temperature that 100
It is the temperature that kill the microbial not the high pressure
The heat denatures the microbes proteins
Standard load it 15 mins art 121oC
What is the steam under pressure sterility not suitable for?
Oil, oleagenous preparations, exposed powders
What is the dry heat method of sterility?
Very high temperatures at long periods of time
160-170 for 2 hours
Kill cells be dehydration followed by burning and oxidative processes
Used for glassware and surgical tools
What is the dry heat method of sterility applicable for?
To all products not penetrated by moisture, glycerin, oils, petrolatum products and heat stable products
What are the facts about filtration sterility?
Microorganism are removed by adsorption to a filter medium of by sieving mechanism
USed for smalll volumes (ophthalmics)
Good for heat sensitive products
What is the pore size filtration sterility to be steril?
0.2 mcm pore size
What are the advantages filtration sterility?
Speed, Cost, complete removal of microbials and particulate matter
What are the disadvantages of filtration sterility?
Effectiveness of filtrate is determined by microbal load
Adsorption of certain materials to the membrane
Long time needed for large volumes
What are the facts about gas sterility of parentals?
The gases used are extremely flammable and are mixed with inert gas (CO2)
The gas interferes with the metabolism of the bacterial cells
Longer exposure is needed 4 to 16 hours
Useful for heat sensitive and moisture sensitive materials
What is the main use of gas sterility?
Sterilization of medical and surgical supplies and appliances
What are the facts on ionizing radiation sterilization?
Rays induce the mricoorganisms to form harmful products that induce destruction of cells and/or destruction of DNA
What are pyrogens?
They are lipopolysaccharides from the outer cell wall of bacteria and endotoxins, fever producing
Relative thermal stable and still remain after regular autoclaving, dry heat sterilization, and filter >0.2 mcm
How are pyrogens destroyed?
High heat and oxidation (POtassium permanganate, peroxides, acid)
250 oC for 30 to 45 minutes
What dose it mean to be particulate free in parental solutions?
to be free of the mobile , undissolved substances unitentionally present in parentals solutions
What is the number of pariculate allowed for LVP?
50 particles/ml less that 10mcm
5 particles/ml greater than 25 mcm
What are the number of particles allowed for SVP
10,000particle/container less than 10mcm
1,000 particles/container greater than 25 mcm
What are the origins of particulate in parentals?
The solution itselft and the chemicals comprising it
The manufacturering process
The devices used for administration
The packaging components
THe manipulations during preparation
Parentals regularly have added substance to maintain stability, what are they?
Buffer to regulate the pH
Prevent oxidative process; citric acid, EDTA, tartaric acid,
Prevent microbial and fungal growth; Benzoyl alcohol, chlorobutanol, benzoates
What are the test for validation of sterility?
To confirm the absence of microorganisms and spores
Because some spores of microorganism are resistant to certain sterility processes
What are the test to validate pyrogen absence?
: the change in the rectal temperature of 0.5 oC or the sum of 1.4 oC in 5 rabbits
: Tests for coagulation of an enzyme-protein complex from red blood cells of the horseshoe crab in the presence of lipopolysaccharides. This test is more sensitive than the rabbit test
How is the detection of particulates measured?
Electronic liquid borne particles counter with a light obscuration sensor
Particulates bring the risk of thrombus and embulus formation
The clarity test can be used, swirling the contents of the solution againsts a light and dark background under light
What are some specific characteristic for parentals?
Buffers, stabilizers, and preservatives are restricted
Coloring agents are prohibited
Sterile, pyrogen free, particulate free
Must be package in completly air tight containers
Volume are slightly larger than what the package says becuase there is no way to get all the solution out
Powders that are used for reconstituted must be lyophilized or spray dried
What are the facts about water for injection (WFI)?
Same as purified water USP
NOT REQUIRED TO BE STERIL
Must be pyrogen free
No antimicrobial agent
What is the main use for water for injection for parentals solutions?
For manufacturing parentals that will go through a final sterilization
What are the facts about sterile water for injection (SWFI)?
Package in single dose containers
No antimicrobial agent
Diluent for reconstituted of powders or in a parental admixture
What are the facts about Sodium Chloride Injection, or Normal Saline Injection?
NS (0.9 %)
No microbial agent
What are the facts about bacteriostatic water for injection
Contains Bacteriostatic agent (inhibits bacterial growth)
Package in containers no greater than 30ml
Bacteriostatic Sodium Chloride Injection, same but with USP NaCl
When are bacteriostatic water for injection used?
When small volumes are administered due to the toxicity of antimicrobial agents
What is Ringer's injection?
A sterile solution of NaCl, KCl, and CaCl2 in concentration similar to body fluids
Used as a vehicle or electrolyte replenisher
Ringers Lactate injection, same with lactate
What are the facts about dextrose 5% (D5W) in water?
Isotonic solution of dextrose
Used to hydrate patients without the addition salts
What are the non-aqueous vehicle used for parentals solutions?
USed for drugs that have limited water solubility or are susceptiple to hydrolysis
Should allow syringability, can be given in a syringe
Vegetable Oil USP, safflower oil, cotton seed oil,
Must remain clear when stored in refrigeration
Must not contain mineral oil, paraffin
What is the main use for parentals containing non-aqueous vehicles?
What are some added substances to parental solutions?
N2 or CO2 to replace the atmospheric gas that can potentially make the solution unstable
Are only added if necessary to increase stability or effectivness
What are the concerns for containers for parental solution?
Leaching of consituents
Adsorption of drugs
Transmission of light
Alteration during storage
Clarity and absence of color
What are the facts about the types of glass containers for parental solution?
NP-type is not allowed
They are heavy, bulky for storage, easy to break
Leaching of alkali from soda-lime glass, types II, III
What are the facts about plastic containers?
Low and medium density polymers of
Allow for larger variety of shapes and size
More resistant for impact
MOre prone to cause binding of drug molecules to polymer material
What type of plastic container can be autoclaved?
What are some single dose containers?
Cannot be resealed
May be packaged as small volume or large volume
What are some multiple dose containers?
Contain antimicrobial preservatives, becuase of multiple penetration
Allow withdrawl of multiple doses
Can be resealed
Packaged only as small volume (max of 30ml to limit the number of penetrations and excess anitmicrobial agent)
What is important about labels on parentals?
There must allow for suficient area free for inspection of particulate matter
What are the storage requirement for pure agents?
What parentals required to be stored in the refrigerator?
Can parentals be freezed?
Some can but check the literature
What are the main uses for small volume parentals?
Preparations for direct injection into vein, muscle, subcutaneous tissue
What are the main uses for large volume parentals?
Solutions for intravenous infusion only, contain no antimicrobial agents, used for replenishment of body fluids and electrolytes,
Single dose containers
What are Maintenance Therapy LVP used for?
For patient that are entering or recovering from surgery
What are Replacement Therapy LVP used for?
Patient with heavy fluid loss and/or eletrolyte
Severe diarrhea, vomiting
What are Fluid Requirment LVP used for?
Water is administered in a solution with dextrose or electrolytes
What are the electrolyte requirments for potassium?
Cardiac and skeletal muscle function
Is used for hypokalemia during severe burns
What are the electrolyte requirments sodium?
Principle extracellular cation
Is used for Hyponatremia during excessive sweating diarrhea,
Use of some diuretics
What are the electrolyte requirments for Chloride?
Principle extracellular anion
Necessary for muscle contraction
To maintain acid-base balance
What are sterile pellets or implants?
Sterile small solids implanted subcutaneously in thigh or abdomen has long lasting effect