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77 Cards in this Set

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What is a pharmaceutical Aerosol?
Pressurized dosage forms containing one or more active ingredients which upon activation emit a fine dispersion of liquid and/or solid materials in a gaseous medium.
What are aerosols used for?
They are used to administer drugs to the lungs especially to treat resp. cond.s. (ex, Asthma). They can also be used for topical application of a drug and for systemic action as the drug can be absorbed through the lungs into the blood supply.
What are the 2 principle ingredients of aerosol?
1. Active ing.

2. Propellant
Aerosols are meds in a ? package.
Meds in a pressurized package.
What forces the contents out of an aerosol?
Pressure
What does the form of aerosol depend upon?
The form depends on the medication, the propellant, and the valve.
What are some of physical forms that can be seen in aerosols?
1. Fine mist. This can travel longer distances than other forms. An example is in the treatment of asthma. 6 micrometers can reach the bronchioles and 2 micrometers can reach the alveoli.

2. Coarse wet form is for dermatological applications.

3. Dry sprays are for dermatological applications.

4. Stable or fast breaking foam is for vaginal or rectal applications
Pharmaceutical aerosols are generally an ? dosage form.
Unstable dosage form.
List 6 advantages of Aerosols as a dosage form.
1. Easy to use and convenient

2. The dose is withdrawn from the package without contaminating other doses

3. Protect unstable drug from light, O2, and moisture sensitive products.

4. Provide medications to areas tough to reach.

5. Target sites do not need to be touched.

6. Sometimes doses are controlled through metered valves
List 6 disadvantages of Aerosols?
1. Expensive

2. Evironmental hazards

3. Dose measurement

4. Dose may change with pressure change inside the aerosol

5. Performance can deteriorate during the life of the product

6. Limited safety hazard. This is due to the fact that they may be flammable and are pressurized.
What is an SAA?
A surface acting agent. It enhances the emulsification of concentrates and propellants and stabilize the foam in an aerosol delivery form.
What are some things involved in the concentration of a drug for an aerosol dosage form?
Requires solubilized or micronized antioxidants (ascorbic acid...), dispersing agents, SAA, etc.
List 3 types of propellants used in aerosol preps?
1. Compressed Gases

2. Fluorinated Hydrocarbons

3. Hydrocarbons
Give 2 examples of compressed gases used in aerosol preps?
1. N2

2. CO2
Give 2 examples of Fluorinated hydrocarbons used in aerosol preps?
1. Chloroflurocarbons (CFC)

2. Hydrofluoroalkanes (HFA)
When would a compressed gas propellant be used?
May be used when dose is not critical. This is due to the fact that pressure falls during use and changes the concentration.
List 5 advantages of using compressed gas propellants?
1. Low toxicity

2. High stability

3. High purity

4. Inexpensive

5. No environmental problems
List 3 disadvantages of compressed gas propellants?
1. Produces coarse mist. This prevents compressed gas from being used in inhalers.

2. Pressure falls during use. This means you lose gas. This effects the drug concentration thus altering the dose.

3. Requires the use on non-volatile solvents.
What is a CFC?
Chlorofluorocarbons : A type of Fluorinated hydrocarbon.
CFCs are ? relative to the ? hydrocarbons.
CFCs are nonflammable relative to the flammable hydrocarbons.
CFCs are ? at room temperature and are ? by cooling.
They are gases at room temperature and liquify upon cooling.
Why have CFCs use been limited?
Use has been limited due to environmental issues. They are destructive to the ozone.
List 4 advantages of CFCs.
1. Low inhalation toxicity

2. High chemical stability

3. High purity

4. Good solvent
List 2 disadvantages of CFCs?
1. Destructive to the ozone. This is why an attempt is being made to gradually withdraw them from the market and replace them with HFAs.

2. High cost
There is an attempt being made to withdraw fluorinated hydrocarbons (CFCs) from the market. What are 3 conditions that permit their use?
1. There is no alternative for chlorofluorocarbon (CFC)

2. The product provides substantial health benefit

3. The use does not involve significant release of CFC
Converning CFCs withdrawal from the market, what is being anticipated?
A gradual replacement of CFCs based MDIs with hydrofluoroalkanes (HFA) propellants. An example is Proventil becoming Proventil HFA
What is an MDI?
Metered Dose Inhaler
What is an HFA?
Hydrofluoroalkanes
What are 4 advantages of HFAs?
1. Low inhalation toxicity

2. High chemical instability

3. High purity

4. Not ozone depleting
What are 2 disadvantages of HFAs?
1. Poor solvents. (However, CFCs are good solvents.)

2. High cost
What is the most commonly used of all the propellants?
Hydrocarbons
What have largely replaced fluorocarbons in topical pharmaceutical aerosols?
The hydrocarbons: n-butane, propane, and iso-butane.
List 4 advantages of hydrocarbons.
1. Inexpensive

2. Minimal ozone depletion

3. Minimal global warming effect

4. Excellent solvents
List 3 disadvantages of hydrocarbons.
1. Flammable

2. Aftertaste

3. Unknown toxicity following inhalation
In aerosol preps what does the gas propellant do?
It exerts pressure in all directions.
Upon ?, the gas will push the ? phase out.
Upon ACTUATION, the gas will push the LIQUID phase out.
What does the propellant of an aerosol prep do once it meets the air?
It expands and leaves the product concentrate in a mist or dry powder.
When is equilibrium able to be reestablished within an aerosol prep once it has been used?
The pressure inside the prep remains constant only if the propellant is a liquefied gas. Compressed gas would be lost. So as long as part of the propellant is available as a liquid.
A liquefied propellant could be composed of what?
CFC, HFA, or Hydrocarbon.
What can a liquefied propellant be used for? Explain.
Inhalers. Because the pressure does not fall and it produces a fine mist.
What could a compresssd gas propellant contain?
N2 or CO2
Compressed gas propellants can not be used for what? Explain.
Can not be used for inhalers. Because drug concentration will increase after use. Also it will be delivered too coarse. However, you can use it for topicals.
List the two different aerosol phase systems available?
1. Two-Phase System

2. Three-Phase System
What are the two-phases in a two-phase system?
1. Liquid phase (containing liquid propellant + product concentrate)

2. Vapor phase
What are the three-phases in a three-phase aerosol system?
1. Water (Immiscible liquid propellant, at the bottom)

2. High aqueous product concentrate

3. Vapor phase
More than one ? may be mixed.
More than one propellant.
In a 3-compressed gas system what is the difference between N2 and CO2?
1. N2 is NOT soluble in the liquid concentrate. The formed spray will be exactly like the concentration in the container. (Inert and protects from oxidation)

2. CO2 is SLIGHTLY SOLUBLE. This is good if a foamy consistency is required.
In a 3-compressed gas system the pressure ? as the product is used so ? ? ? is required.
The pressure decreases so high gas pressure is required.
What must not interact with an aerosol container?
The formulation
What must the container and valve withstand?
Pressure
The container and valve must withstand ? and ?.
Pressure and corrosion.
What must the valve create?
The required product.
Name the 3 types of containers that may be seen with aerosol preps.
1. Glass

2. Metal

3. Plastic
Glass containers may be either ? or ?.
They may be either coated or uncoated.
What are metal aerosol containers composed of?
Tin-plated steel. Stainless steel may be used when chemical resistance is required, very expensive.
What are some risks and limitations of using a plastic aerosol container?
The is a permeabilty risk that needs to be considered and a chance of interactions with drugs.
What are the 7 components of the valve of an aerosol container?
1. Actuator

2. Stem

3. Gasket

4. Spring

5. Mounting cup

6. Housing

7. Dip Tube
What is an acuator?
It is the component of a valve. It is the button that opens and closes the valve. It contributes to the form of the discharged product and the particle size.
What is a stem?
The actuator supporter.
What is the purpose of a valve's gasket?
It prevents leakage.
What is the purpose of a valve's spring?
It pushes back the actuator when closed.
What is the purpose of the valves housing?
It determines the delivery rate.
What kind of medication is a metered dose used for?
It is used for potent medications.
Metered doses involve ? chambers.
Auxiliary chambers.
Give examples of products that utilize metered doses.
Translingual aerosol Nitrolingual spray
What are the two methods of aerosol filling?
1. Cold

2. Pressure
How cold is cold aerosol filling?
-34.5 to -40 C
How are cold aerosol preps prepared?
1. Chilled product concentrate is added

2. Liquefied gas is added to the concentrate

3. Valve is assembled
Are cold aerosol filling preperations suitable for aqueous systems?
No. They would freeze. Cold preps are around -34.5 to -40 C. Due to the cold you also get condensation and can not use for moisture sensitive drugs.
How are Pressure aerosol preps prepared?
1. The product concentrate is added to the can.

2. The valve is fitted

3. Propellant is injected under pressure.

4. Actuator is fitted and tested
Are pressure aerosol preps suitable for aqueous systems? What about moisture sensitive drugs?
Yes, it is suitable for both.
List the 4 methods for testing aerosol containers?
1. Leak testing

2. Valve proper function

3. The spray, amount, particle size

4. Reproducibility of the dosage form
List the 4 types of pharmaceutical aerosols?
1. Respiratory

2. Topical Aerosols

3. Vaginal Aerosols

4. Rectal Aerosols
Give an example of a respiratory aerosol used for bronchospasms?
Albuterol (It is anti-anginal)
Give 2 examples of Topical aerosols?
1. Povidine Iodine : For Anti-infection

2. Benzocaine : Local Anesthetics
Give an example of a Vaginal aerosol?
Estrogenic and contraceptive foam spray
Give an example of a Rectal aerosol?
Pramoxin HCL, Hydrocortisone: For hemorrhoidal treatment.