Ceutics II Quiz 9

Sterile Water for Injection, USP, must have a lower pyrogen content than Sodium Chloride Injection, USP.

True/False

False

1 multiple choice option

Potassium chloride is used as ____ .

tonicity-adjusting agent

3 multiple choice options

Tartaric acid is used as ____ .

buffer component

3 multiple choice options

Chlorobutanol is used as ____ .

antibacterial agent

3 multiple choice options

Sterility Assurance Level of heat terminal sterilization is typically ____ .

10⁶

3 multiple choice options

Oils cannot be sterilized by moist heat.

True/False

False

1 multiple choice option

The decimal reduction time (DT) ____ the temperature.

depends in a nonlinear way on

3 multiple choice options

Select all particle properties that determine the aerodynamic particle size.

a) mass

b) porosity

c) size
d) density

c) size

d) density

3 multiple choice options

Select all particle properties that govern the deposition in alveolar region of lungs after the inhalation of an aerosol.

a) size

b) mass

c) density

d) porosity

a) size

c) density

3 multiple choice options

The pressure above a mixture of propellants is calculated using the ____ Law.

Raoult's

3 multiple choice options

Citric acid is used as ____ .

buffer component

3 multiple choice options

Dextrose is used as ____ .

tonicity-adjusting agent

3 multiple choice options

Select the injection that can be used to administer oleaginous solutions.

intramuscular

3 multiple choice options

Mannitol is used as ____ .

tonicity-adjusting agent

3 multiple choice options

The acronym HEPA in the phrase 'HEPA filter' means ____ .

High Efficiency Particulate Air

3 multiple choice options

The main purpose of a spacer is to ____ .

allow evaporation of aerosol droplets to a size maximizing the deposition in the alveolar region

3 multiple choice options

Select all materials that are used in production of aerosol containers.

a) uncoated glass

b) polymer-coated aluminum

c) zinc-plated steel

d) stainless steel

e) aluminum

f) plastic

g) titanium steel

h) tin-plated steel

i) polymer-coated glass

a) uncoated glass

b) polymer-coated aluminum

d) stainless steel

e) aluminum

f) plastic

h) tin-plated steel

i) polymer-coated glass

3 multiple choice options

The dose from an aerosol drug product can have the form of ____ . Select all applicable options.

a) stream

b) foam

c) spray

d) powder

all of the above

Butylated hydroxyanisole is used as ____ .

antioxidant

3 multiple choice options

Select the processes that are used in pyrogen removal.

a) the treatment with ionizing radiation

b) the treatment with ethylene oxide

c) distillation

d) oxidation

c) distillation

d) oxidation

3 multiple choice options

Phenylmercuric nitrate is used as ____ .

antibacterial agent

3 multiple choice options

The killing rate constant (kT) ____ the temperature.

depends in a nonlinear way on

3 multiple choice options

Sterility of the product can be verified by ____ the product.

microbiological cultivation of a portion of

3 multiple choice options

In an industrial setting, endotoxins are detected by ____ .

Limulus amebocyte lysate test

3 multiple choice options

Select all propellants that are liquids under the pressures used in aerosols.

a) propane

b) CCl₂F₂

c) CF₃CFHCF₃

d) n-butane

e) compressed N₂

a) propane

b) CCl₂F₂

c) CF₃CFHCF₃

d) n-butane

3 multiple choice options

Cresol is used as ____ .

antibacterial agent

3 multiple choice options

Select the intravascular injections.

a) intra-arterial

b) intradermal

c) intra-articular

d) intrathecal

e) intrasynovial

f) intramuscular

g) intravenous

h) subcutaneous

a) intra-arterial

g) intravenous

3 multiple choice options

Syringes and sutures are sterilized by ____ .

irradiation

3 multiple choice options

The typical pore size of sterilizing filter is ____ .

0.22 micrometers

3 multiple choice options

Endotoxins are ____ from the cell walls of Gram-negative bacteria.

lipopolysaccharides

3 multiple choice options

Select all types of dry powder inhalers.

a) unit-dose inhaler

b) multi-dose pre-metered inhaler

c) multi-dose reservoir inhaler

d) reservoir pre-metered inhaler

a) unit-dose inhaler

b) multi-dose pre-metered inhaler

c) multi-dose reservoir inhaler

3 multiple choice options

Andersen Cascade Impactor is to simulate the behavior of aerosols in topical applications.

True/False

False

1 multiple choice option

Purified Water, USP, contains ____- times less total solids than drinking water.

100

3 multiple choice options

Select the injection with the needle entering the skin at the largest angle.

intramuscular

3 multiple choice options

Nitrogen is used as ____ .

antioxidant

3 multiple choice options

Select the radiation source for gamma irradiation.

cobalt 60

3 multiple choice options

The control of particle size, both before and after filling the canister, is a key issue in inhalation aerosol products.

True/False

True

1 multiple choice option

Match the aerodynamic particle diameter with the behavior of the inhaled particles in the lung.

Column A:

daer > 3 micrometers

daer ~ 3 micrometers

daer < 3 micrometers

Column B:

deposited in the alveolar region of the lung

exhaled

deposited in the upper airways

daer > 3 micrometers ---- deposited in the upper airways

daer ~ 3 micrometers ---- deposited in the alveolar region of the lung

daer < 3 micrometers ---- exhaled

3 multiple choice options

Aerosols are used for ____ .

a) topical application

b) inhalation

c) subcutaneous delivery

d) introduction to body orifices

a) topical application

b) inhalation

d) introduction to body orifices

3 multiple choice options

Phenol is used as ____ .

antibacterial agent

3 multiple choice options

Sodium bisulfite is used as ____ .

antioxidant

3 multiple choice options

Select the injection that is often used for prolonged action of the administered dose.

intramuscular

3 multiple choice options

Select all attributes that make the moist heat in an autoclave an effective method of sterilization.

a) saturated steam directly kills microorganisms

b) the pressure directly kills microorganisms

c) saturated steam provides heat transfer

d) the heat directly kills microorganisms

c) saturated steam provides heat transfer

d) the heat directly kills microorganisms

3 multiple choice options

Select the sterilization method for dry and thermolabile pharmaceutical products.

irradiation

3 multiple choice options

Select all flammable propellants. (alkanes are flammable)

a) n-butane

b) CF₃CFHCF₃

c) compressed N₂

d) propane

e) CCl₂F₂

a) n-butane

d) propane

3 multiple choice options

Drugs can be present in aerosols as ____ .

a) liposomes

b) micelles

c) particulate matter

d) liquids

c) particulate matter

d) liquids

3 multiple choice options

Select all drawbacks of aerosols.

a) specialized manufacturing equipment

b) complex construction

c) performance deterioration when propellant is depleted

d) high cost

all of the above

Select the processes that are used for sterilization.

a) the treatment with ionizing radiation

b) distillation

c) oxidation

d) the treatment with ethylene oxide

a) the treatment with ionizing radiation

d) the treatment with ethylene oxide

3 multiple choice options

Select the injections leading to immediate and complete bioavailability.

a) intramuscular

b) intrasynovial

c) intra-articular

d) subcutaneous

e) intravenous

f) intradermal

g) intra-arterial

h) intrathecal

e) intravenous

g) intra-arterial

3 multiple choice options

The thermal death time (FT) ____ the decimal reduction time (DT).

is proportional to

3 multiple choice options

A fast killing of microorganisms means that the killing rate constant (kT) is ____ and the decimal reduction time (DT) is ____ .

high; low

3 multiple choice options

In aerosols, if a drug is dispersed in liquefied gas, the dispersion can be a ____ . Select all applicable options.

a) suspension

b) foam

c) solution

d) emulsion

a) suspension

c) solution

d) emulsion

3 multiple choice options

Select all propellants with low Ozone Depletion Potential / Global Warming Potential relative to CFC-11.

a) CCl₂F₂

b) CF₃CFHCF₃

c) n-butane

d) propane

e) compressed N₂

b) CF₃CFHCF₃

c) n-butane

d) propane

e) compressed N₂

3 multiple choice options

Ethylenediamino tetraacetate is used to increase ___ .

a) safety

b) sterility

c) drug solubility

d) physical and chemical stability

e) patient comfort

c) drug solubility

d) physical and chemical stability

3 multiple choice options

Select the injections into joints.

a) intra-articular

b) intra-arterial

c) intrasynovial

d) subcutaneous

e) intradermal

f) intrathecal

g) intramuscular

h) intravenous

a) intra-articular

c) intrasynovial

3 multiple choice options

Sodium acetate is used as ____ .

buffer component

3 multiple choice options

Lactose is used as ____ .

tonicity-adjusting agent

3 multiple choice options

Select all advantages of aerosol drug products.

a) no mechanical irritation for topical applications

b) protection of the content from moisture and oxygen

c) enhanced safety of the product as compared to other drug products

d) no contamination upon administration of a dose

a) no mechanical irritation for topical applications

b) protection of the content from moisture and oxygen

d) no contamination upon administration of a dose

3 multiple choice options

In aerosols, the drug can be dispersed in ____ . Select all applicable options.

a) propellant

b) gas phase

c) solvent

a) propellant

c) solvent

3 multiple choice options

Select the solvents that can be used in parenteral products.

a) ethyl alcohol

b) propylene glycol

c) dimethyl sulfoxide

d) polyethylene glycols with MW 300

e) polyethylene glycols with MW 900

f) glycerin

g) acetone

h) polyethylene glycols with MW 600

a) ethyl alcohol

b) propylene glycol

c) dimethyl sulfoxide

d) polyethylene glycols with MW 300

f) glycerin

3 multiple choice options

Select all methods that can be used for sterilization of dry pharmaceutical formulations.

a) irradiation

b) dry heat

c) sterile filtration

d) moist heat

a) irradiation

b) dry heat

3 multiple choice options

Thimerosal is used as ____ .

antibacterial agent

3 multiple choice options

Sodium tartarate is used as ____ .

buffer component

3 multiple choice options

Standard topical aerosols have a lower propellant content than foams.

True/False

False

1 multiple choice option

A needle gauge 20 is thinner than a needle gauge 25.

True/False

False

1 multiple choice option

Match the valve types with the way how the aerosol products fitted with them are used.

Continuous Valve: ____

Metered Valve: _____

continuous valve ---- spray 'valve up'

metered valve ---- spray 'valve down'

1 multiple choice option

Select the injection with the needle entering the skin at the smallest angle.

intradermal

3 multiple choice options

Sterile Water for Injection, USP, must have a lower pyrogen content than Water for Injection, USP.

True/False

False

1 multiple choice option

Select the preferred method of sterilization of pharmaceutical products containing water.

moist heat

3 multiple choice options

To increase the Sterility Assurance Level of aseptic processing, sterile filtration is usually combined with ____ .

moist heat with reduced temperature or time

3 multiple choice options

Select all possible functions of liquefied gas(es) in the aerosol drug product.

a) conserving agent

b) dispersion medium for the drug

c) glidant

d) propellant

b) dispersion medium for the drug

d) propellant

3 multiple choice options

Sodium chloride is used as ____ .

tonicity-adjusting agent

3 multiple choice options

Moist heat sterilization uses the temperatures ____ °C.

100-120

3 multiple choice options

Some inhalation aerosol formulations are excipient free.

True/False

True

1 multiple choice option

Sorbitol is used as ____ .

tonicity-adjusting agent

3 multiple choice options

In the endotoxin research, LAL stands for ____ .

Limulus Amebocyte Lysate

3 multiple choice options

To degrade endotoxins from aseptic vials, dry heat at the temperature ____ °C is applied for at least ____ hour(s).

250; 0.5

3 multiple choice options

Topical aerosol formulations have less controlled particle size than inhalation formulations.

True/False

True

1 multiple choice option

The dose from an aerosol drug product can have the form of ____ . Select all applicable options.

a) powder

b) stream

c) spray

d) foam

all of the above

Butylated hydroxytoluene is used as ____ .

antioxidant

3 multiple choice options

Dibasic sodium phosphate is used as ____ .

buffer component

3 multiple choice options

In the clean room terminology, the acronym RABS stands for ____ .

Restricted Access Barrier System

3 multiple choice options

Gas sterilization is typically performed using ____ .

ethylene oxide

3 multiple choice options

Select the injections that are typically given into the upper arm.

a) intravenous

b) intrasynovial

c) intradermal

d) intra-arterial

e) intramuscular

f) intrathecal

g) subcutaneous

h) intra-articular

e) intramuscular

g) subcutaneous

3 multiple choice options

Select the injections that are typically given into the forearm.

a) subcutaneous

b) intramuscular

c) intra-arterial

d) intrathecal

e) intrasynovial

f) intravenous

g) intra-articular

h) intradermal

f) intravenous

h) intradermal

3 multiple choice options

Dry heat sterilization at 150-170 °C must last at least ____ hour(s).

2

3 multiple choice options

Monobasic sodium phosphate is used as ____ .

buffer component

3 multiple choice options

Select all propellants that are used in dry powder inhalers.

no propellant - breath activated

3 multiple choice options

Select the most frequently used method of sterilization of pharmaceutical products.

moist heat

3 multiple choice options

Ascorbic acid is used as ____ .

antioxidant

3 multiple choice options

The Biological Indicator in sterilization ____ .

is a sample of resistant microorganisms that is sterilized with the product and characterizes the effectiveness of sterilization

3 multiple choice options

Select all product that can be sterilized by moist heat.

a) lyophilized product in plastic bags

b) aqueous solutions in vials

c) oleaginous base in jars

d) powder in bottles

e) oil solutions in vials

b) aqueous solutions in vials

e) oil solutions in vials

3 multiple choice options

Benzalkonium chloride is used as ____ .

antibacterial agent

3 multiple choice options

The Z-value is the ____ change that leads to the change of ____ by the factor of 10.

temperature; DT

3 multiple choice options

Select all methods used for sterilization of thermolabile pharmaceutical formulations.

a) sterile filtration

b) irradiation

c) dry heat

d) moist heat

a) sterile filtration

b) irradiation

3 multiple choice options

Select the preferred method of sterilization of thermolabile, liquid pharmaceutical products.

sterilizing filtration

3 multiple choice options

Water for Hemodialysis, USP, has a higher pyrogen content than Water for Injection, USP.

True/False

True

1 multiple choice option

The decimal reduction time (DT) ____ the killing rate constant (kT).

is inversely proportional to

3 multiple choice options

Select the method of sterilization for thermally stable pharmaceutical products that do not contain water.

dry heat

3 multiple choice options