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48 Cards in this Set

  • Front
  • Back
inhalation therapy
any procedure or device by means of which a drug can be administered by inhalation to a region of the respiratory tract
inhalations
drugs or drug solutions administered via nasal route for local or systemic effect
insufflatlons
group of products which consist of finely powdered or liquid drugs that are carried into the respiratory tract by the use of special devices
aerosols
products packaged under pressure and the active ingredient is released upon activation of an appropriate valve system
Advantages of inhalation therapy(6)
1. self-medication possible
2. inhalation therapy may replace injectable products and thereby the dangers of giving drugs by injection are avoided
3. a dose can be dispensed from the container without affecting its stability and sterility
4. medication can be delivered directly to the affected area in a desired form
5. irritation during mechanical application of topical preparation is reduced
6. onset of drug response is faster in case of inhalation therapy as compared to drugs given orally
components of aerosol package (4)
1. propellant
2. container
3. valve and actuator
4. product concentrate
propellant
responsible for developing the proper pressure necessary to expel the contents of an aerosol when the valve is open
-serves as solvent for certain active ingredients
what can propellants be classified as?
1. liquified gases
2. compressed gases
liquified gases (2 types)
a. fluorinated hydrocarbons: used in most aerosols for oral and inhalation use
b. hydrocarbons: used in topical pharmaceutical aerosols
examples of fluorinated hydrocarbons(liquified gases)
-trichloromonofloromethane (propellant 11)
-dichlorodifioromethane (propellant 12)
-dichlorortetrafluoroethane (propellant 114)
examples of hydrocarbons (liquified gas)
propane, butane and isobutant
compressed gases examples
nitrogen, carbondioxide, nitrous oxide
dalton's law
the total pressure of a system is equal to the sum of the individual or partial pressures of the various components
raoult's law
depression of vapor pressure of a solvent by the addition of a solute is proportional to the mole fraction of the solute molecules in the solution
containers
must withstand pressures as high as 140-180 psig at 103F are used for aerosol packaging
types of containers
1. metal
2. glass
3. synthetic resins and plastics
types of metal containers
-tin-plated
-aluminum
-stainless steel
types of glass containers
uncoated or plastic coated glass
aerosol valve function (3)
1. capable of being easily opened and closed
2. dispense the product in the correct physical form
3. should deliver desired amount of product
two types of valves
-metered valves: dispenses a pre-determined quantity of material
-non-metered valve
actuators
attached to valve and allows for easy opening and closing of valve
types of actuators producing different forms of product discharge
1. spray
2. foam
3. solid stream
4. special application: designed to deliver medications to appropriate site of action- throat, nose, eye, etc
formulation of pharmaceutical aerosols (two parts)
1. product concentrate
2. propellant
product concentrate
consists of active ingredients and other adjuncts (solvents, antioxidents, surfactants)
propellant
single or blend of more propellants
types of formulation systems
1. solution system
2. water-based system
3. suspension or dispersion system
4. foam system
processes used to manufacture aerosol products
1. cold process
2. pressure process
cold process
active ingredients are chilled and weighed into a container - the cold propellant is metered into the container - crimping the valve in place seals the container
pressure process
-the product concentrate is placed into the container at room temperature
-valve is crimped into place
-trapped air is evacuated from container by vacuum system
-propellant is added through the valve using vapor pressure of propellant to force it through valve
selection of propellant
-before 1978 fluorinated hydrocarbons were used
-now hydrocarbons, compressed gases, and mechanical devices and pumps
selection of containers
both glass and metal containers are used
-glass is used when total pressure is less than 25 psig and less than 15% propellant in system
selection of valves
selected depending on materials of construction, size of orifice and specific applications
selection of applicators
selected depending on specific use of aerosol product
stability testing of aerosols (3 areas)
1. concentrate and propellant
2. container
3. valve
stability of concentrate/propellant
-vapor pressure
-pH
-density
-refractive index
-viscosity
-total weight
-assay of active ingredient, color, odor
stability of container
examined for signs of corrosion during storage
stability of valve
examined to confirm that it is functioning, dispensing the product satisfactorily and dosing immediately after use
testing of aerosols
1. flammability and combustibility
2. physico-chemical characteristics
3. performance
flammability and combustibility
1. flash point: aerosol chilled to -25 C, then temperature raised; point when vapor ignites is flash point
2. flame projection: measures effect of aerosol formulation on extension of open flame
physico-chemical characteristics
1. vapor pressure: measured with pressure gauze, etc
2. density: determined by use of hydrometer or pycnometer
3. moisture: karl fischer or gas chromatographic method used
4. identification of propellants: gas chromatography and infrared spectrophotometry used
performance
1. aerosol valve discharge rate
2. spray pattern
3. dosage with metered valves
4. foam stability
5. particle size determination
aerosol valve discharge rate
change in weight per time dispensed
spray patterns
impingemnet of spray on piece of paper that has been treated with dyd-talc mixture
dosage with metered valves
-reproducibility of dosage each time valve is depressed is determined by analysis of active ingredient
foam stability
visual evaluation by measure the required time for a given mass to penetrate the foam or by use of rotational viscometer
particle size determination
cascade impactor and light scatter decay methods are used for measuring particle size
-cascade impactor a stream of particles are projected through series of nozzles and glass slides at high velocity
biologic testing
limited number of tests are used to evaluate efficiency of an aerosol product
biologic tests (2)
1. consideration of therapeutic activity
2. toxicity (should include both topical and inhalation toxicities)