Dose Form Exam III SLides

• Injections
• Biologicals (vaccines, toxoids, anti-toxins)

• 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

• 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

• 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

• 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

• 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

Upper outer quadrant of the gluteal maximus is prefered

• 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

• 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

1.3 ml, anything larger would cause large pressure and pain/irritation

• 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

• 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

Oil, oleagenous preparations, exposed powders

• OVEN
• 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

To all products not penetrated by moisture, glycerin, oils, petrolatum products and heat stable products

• Microorganism are removed by adsorption to a filter medium of by sieving mechanism
• USed for smalll volumes (ophthalmics)
• Good for heat sensitive products

0.2 mcm pore size

Speed, Cost, complete removal of microbials and particulate matter

• Effectiveness of filtrate is determined by microbal load
• Adsorption of certain materials to the membrane
• Long time needed for large volumes

• 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

Sterilization of medical and surgical supplies and appliances

Rays induce the mricoorganisms to form harmful products that induce destruction of cells and/or destruction of DNA

• 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

• High heat and oxidation (POtassium permanganate, peroxides, acid)
• 250 oC for 30 to 45 minutes

to be free of the mobile , undissolved substances unitentionally present in parentals solutions

• 50 particles/ml less that 10mcm
• 5 particles/ml greater than 25 mcm

• 10,000particle/container less than 10mcm
• 1,000 particles/container greater than 25 mcm

• The solution itselft and the chemicals comprising it
• The manufacturering process
• The devices used for administration
• The packaging components
• THe manipulations during preparation

• Buffer to regulate the pH
• Prevent oxidative process; citric acid, EDTA, tartaric acid,
• Prevent microbial and fungal growth; Benzoyl alcohol, chlorobutanol, benzoates

• To confirm the absence of microorganisms and spores
• Because some spores of microorganism are resistant to certain sterility processes

• 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

• 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

• 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

• Same as purified water USP
• NOT REQUIRED TO BE STERILe
• Must be pyrogen free
• No antimicrobial agent

For manufacturing parentals that will go through a final sterilization

• STERILE
• Pyrogen free
• Package in single dose containers
• No antimicrobial agent
• Diluent for reconstituted of powders or in a parental admixture

• NS (0.9 %)
• Sterile
• Pyrogen free
• Isotonic
• No microbial agent

• Pyrogen free
• Sterile
• Contains Bacteriostatic agent (inhibits bacterial growth)
• Package in containers no greater than 30ml
• Bacteriostatic Sodium Chloride Injection, same but with USP NaCl

When small volumes are administered due to the toxicity of antimicrobial agents

• 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

• Sterile
• Isotonic solution of dextrose
• Used to hydrate patients without the addition salts

• Glycerin
• Propylene glycol
• Alcohol
• 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

IM injections

• 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
• Co-solvent
• Buffers
• Preservatives
• Solubilizers
• Antioxidants

• Permeability
• Leaching of consituents
• Adsorption of drugs
• Transmission of light
• Alteration during storage
• Closures
• Clarity and absence of color

• 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

• 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

Polypropylene (PP)

• Ampuls
• Bottles
• Prefilled syringes
• Cannot be resealed
• May be packaged as small volume or large volume

• Bottles
• Bags
• 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)

There must allow for suficient area free for inspection of particulate matter

Room temperature

• Biological products
• Vaccines
• Insulin
• Some antibiotics
• Cytoxic
• Biotechnology products

Some can but check the literature

Preparations for direct injection into vein, muscle, subcutaneous tissue

• Solutions for intravenous infusion only, contain no antimicrobial agents, used for replenishment of body fluids and electrolytes,
• Single dose containers

• For patient that are entering or recovering from surgery
• Or unconcious

• Patient with heavy fluid loss and/or eletrolyte
• Severe diarrhea, vomiting

• Water is administered in a solution with dextrose or electrolytes
• Avoid hemolysis

• Cardiac and skeletal muscle function
• Is used for hypokalemia during severe burns
• GI diseases
• Acute Alcoholism
• Poor Nutrition

• Principle extracellular cation
• Is used for Hyponatremia during excessive sweating diarrhea,
• Use of some diuretics

• Principle extracellular anion
• Necessary for muscle contraction
• To maintain acid-base balance

• Sterile small solids implanted subcutaneously in thigh or abdomen has long lasting effect
• Hormones