Pharmaceutics Ii (Test 1): Aerosols

Front 1

What is a pharmaceutical Aerosol?

Back 1

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.

Front 2

What are aerosols used for?

Back 2

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.

Front 3

What are the 2 principle ingredients of aerosol?

Back 3

1. Active ing.

2. Propellant

Front 4

Aerosols are meds in a ? package.

Back 4

Meds in a pressurized package.

Front 5

What forces the contents out of an aerosol?

Back 5

Pressure

Front 6

What does the form of aerosol depend upon?

Back 6

The form depends on the medication, the propellant, and the valve.

Front 7

What are some of physical forms that can be seen in aerosols?

Back 7

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

Front 8

Pharmaceutical aerosols are generally an ? dosage form.

Back 8

Unstable dosage form.

Front 9

List 6 advantages of Aerosols as a dosage form.

Back 9

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 The dose is withdrawn from the package without contaminating other doses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

Front 10

List 6 disadvantages of Aerosols?

Back 10

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.

Front 11

What is an SAA?

Back 11

A surface acting agent. It enhances the emulsification of concentrates and propellants and stabilize the foam in an aerosol delivery form.

Front 12

What are some things involved in the concentration of a drug for an aerosol dosage form?

Back 12

Requires solubilized or micronized antioxidants (ascorbic acid...), dispersing agents, SAA, etc.

Front 13

List 3 types of propellants used in aerosol preps?

Back 13

1. Compressed Gases

2. Fluorinated Hydrocarbons

3. Hydrocarbons

Front 14

Give 2 examples of compressed gases used in aerosol preps?

Back 14

1. N2

2. CO2

Front 15

Give 2 examples of Fluorinated hydrocarbons used in aerosol preps?

Back 15

1. Chloroflurocarbons (CFC)

2. Hydrofluoroalkanes (HFA)

Front 16

When would a compressed gas propellant be used?

Back 16

May be used when dose is not critical. This is due to the fact that pressure falls during use and changes the concentration.

Front 17

List 5 advantages of using compressed gas propellants?

Back 17

1. Low toxicity

2. High stability

3. High purity

4. Inexpensive

5. No environmental problems

Front 18

List 3 disadvantages of compressed gas propellants?

Back 18

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.

Front 19

What is a CFC?

Back 19

Chlorofluorocarbons : A type of Fluorinated hydrocarbon.

Front 20

CFCs are ? relative to the ? hydrocarbons.

Back 20

CFCs are nonflammable relative to the flammable hydrocarbons.

Front 21

CFCs are ? at room temperature and are ? by cooling.

Back 21

They are gases at room temperature and liquify upon cooling.

Front 22

Why have CFCs use been limited?

Back 22

Use has been limited due to environmental issues. They are destructive to the ozone.

Front 23

List 4 advantages of CFCs.

Back 23

1. Low inhalation toxicity

2. High chemical stability

3. High purity

4. Good solvent

Front 24

List 2 disadvantages of CFCs?

Back 24

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

Front 25

There is an attempt being made to withdraw fluorinated hydrocarbons (CFCs) from the market. What are 3 conditions that permit their use?

Back 25

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

Front 26

Converning CFCs withdrawal from the market, what is being anticipated?

Back 26

A gradual replacement of CFCs based MDIs with hydrofluoroalkanes (HFA) propellants. An example is Proventil becoming Proventil HFA

Front 27

What is an MDI?

Back 27

Metered Dose Inhaler

Front 28

What is an HFA?

Back 28

Hydrofluoroalkanes

Front 29

What are 4 advantages of HFAs?

Back 29

1. Low inhalation toxicity

2. High chemical instability

3. High purity

4. Not ozone depleting

Front 30

What are 2 disadvantages of HFAs?

Back 30

1. Poor solvents. (However, CFCs are good solvents.)

2. High cost

Front 31

What is the most commonly used of all the propellants?

Back 31

Hydrocarbons

Front 32

What have largely replaced fluorocarbons in topical pharmaceutical aerosols?

Back 32

The hydrocarbons: n-butane, propane, and iso-butane.

Front 33

List 4 advantages of hydrocarbons.

Back 33

1. Inexpensive

2. Minimal ozone depletion

3. Minimal global warming effect

4. Excellent solvents

Front 34

List 3 disadvantages of hydrocarbons.

Back 34

1. Flammable

2. Aftertaste

3. Unknown toxicity following inhalation

Front 35

In aerosol preps what does the gas propellant do?

Back 35

It exerts pressure in all directions.

Front 36

Upon ?, the gas will push the ? phase out.

Back 36

Upon ACTUATION, the gas will push the LIQUID phase out.

Front 37

What does the propellant of an aerosol prep do once it meets the air?

Back 37

It expands and leaves the product concentrate in a mist or dry powder.

Front 38

When is equilibrium able to be reestablished within an aerosol prep once it has been used?

Back 38

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.

Front 39

A liquefied propellant could be composed of what?

Back 39

CFC, HFA, or Hydrocarbon.

Front 40

What can a liquefied propellant be used for? Explain.

Back 40

Inhalers. Because the pressure does not fall and it produces a fine mist.

Front 41

What could a compresssd gas propellant contain?

Back 41

N2 or CO2

Front 42

Compressed gas propellants can not be used for what? Explain.

Back 42

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.

Front 43

List the two different aerosol phase systems available?

Back 43

1. Two-Phase System

2. Three-Phase System

Front 44

What are the two-phases in a two-phase system?

Back 44

1. Liquid phase (containing liquid propellant + product concentrate)

2. Vapor phase

Front 45

What are the three-phases in a three-phase aerosol system?

Back 45

1. Water (Immiscible liquid propellant, at the bottom)

2. High aqueous product concentrate

3. Vapor phase

Front 46

More than one ? may be mixed.

Back 46

More than one propellant.

Front 47

In a 3-compressed gas system what is the difference between N2 and CO2?

Back 47

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.

Front 48

In a 3-compressed gas system the pressure ? as the product is used so ? ? ? is required.

Back 48

The pressure decreases so high gas pressure is required.

Front 49

What must not interact with an aerosol container?

Back 49

The formulation

Front 50

What must the container and valve withstand?

Back 50

Pressure

Front 51

The container and valve must withstand ? and ?.

Back 51

Pressure and corrosion.

Front 52

What must the valve create?

Back 52

The required product.

Front 53

Name the 3 types of containers that may be seen with aerosol preps.

Back 53

1. Glass

2. Metal

3. Plastic

Front 54

Glass containers may be either ? or ?.

Back 54

They may be either coated or uncoated.

Front 55

What are metal aerosol containers composed of?

Back 55

Tin-plated steel. Stainless steel may be used when chemical resistance is required, very expensive.

Front 56

What are some risks and limitations of using a plastic aerosol container?

Back 56

The is a permeabilty risk that needs to be considered and a chance of interactions with drugs.

Front 57

What are the 7 components of the valve of an aerosol container?

Back 57

1. Actuator

2. Stem

3. Gasket

4. Spring

5. Mounting cup

6. Housing

7. Dip Tube

Front 58

What is an acuator?

Back 58

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.

Front 59

What is a stem?

Back 59

The actuator supporter.

Front 60

What is the purpose of a valve's gasket?

Back 60

It prevents leakage.

Front 61

What is the purpose of a valve's spring?

Back 61

It pushes back the actuator when closed.

Front 62

What is the purpose of the valves housing?

Back 62

It determines the delivery rate.

Front 63

What kind of medication is a metered dose used for?

Back 63

It is used for potent medications.

Front 64

Metered doses involve ? chambers.

Back 64

Auxiliary chambers.

Front 65

Give examples of products that utilize metered doses.

Back 65

Translingual aerosol Nitrolingual spray

Front 66

What are the two methods of aerosol filling?

Back 66

1. Cold

2. Pressure

Front 67

How cold is cold aerosol filling?

Back 67

-34.5 to -40 C

Front 68

How are cold aerosol preps prepared?

Back 68

1. Chilled product concentrate is added

2. Liquefied gas is added to the concentrate

3. Valve is assembled

Front 69

Are cold aerosol filling preperations suitable for aqueous systems?

Back 69

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.

Front 70

How are Pressure aerosol preps prepared?

Back 70

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

Front 71

Are pressure aerosol preps suitable for aqueous systems? What about moisture sensitive drugs?

Back 71

Yes, it is suitable for both.

Front 72

List the 4 methods for testing aerosol containers?

Back 72

1. Leak testing

2. Valve proper function

3. The spray, amount, particle size

4. Reproducibility of the dosage form

Front 73

List the 4 types of pharmaceutical aerosols?

Back 73

1. Respiratory

2. Topical Aerosols

3. Vaginal Aerosols

4. Rectal Aerosols

Front 74

Give an example of a respiratory aerosol used for bronchospasms?

Back 74

Albuterol (It is anti-anginal)

Front 75

Give 2 examples of Topical aerosols?

Back 75

1. Povidine Iodine : For Anti-infection

2. Benzocaine : Local Anesthetics

Front 76

Give an example of a Vaginal aerosol?

Back 76

Estrogenic and contraceptive foam spray

Front 77

Give an example of a Rectal aerosol?

Back 77

Pramoxin HCL, Hydrocortisone: For hemorrhoidal treatment.