Dose Form Exam III SLides
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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
- Dialysis solutions: 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?
- Thrombus: blood clot formed with a blood vessel, it is from low circulation or to an alteration of the blood or vessel wall
- Embolus: 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?
- Rabbit test: the change in the rectal temperature of 0.5 oC or the sum of 1.4 oC in 5 rabbits
- LAL test: 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 STERILe
- 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)?
- Pyrogen free
- 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 %)
- Pyrogen free
- No microbial agent
What are the facts about bacteriostatic water for injection
- Pyrogen free
- 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?
- Propylene glycol
- 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?
- Types I,II,III
- 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 polyethylene (PE)
- 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?
- Prefilled syringes
- 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?
- Biological products
- Some antibiotics
- Biotechnology products
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
- Or unconcious
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
- Avoid hemolysis
What are the electrolyte requirments for potassium?
- Cardiac and skeletal muscle function
- Is used for hypokalemia during severe burns
- GI diseases
- Acute Alcoholism
- Poor Nutrition
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
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