Pharmaceutics Final: Q9-10, P8-10

t or f: sterile water for injection must have a lower pyrogen content than sodium chloride injection

false

chlorobutanol is used as

antibacterial agent

all solvents that can be used in parenteral products

• propylene glycol

• ethyl alcohol

• dimethyl sulfoxide

• polyethylene glycols with MW 300

• glycerin

dibasic sodium phosphate is used as

buffer component

sterility assurance level of heat terminal sterilization is typically

10⁶

radiation source for gamma irradiation

cobalt 60

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

• dry heat

• irradiation

all flammable propellants

• propane

• n-butane

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

• size

• density

all propellants with low ozone depletion potential/global warming potential relative to CFC-11

• CF₃CFHCF₃

• n-butane

• compressed N₂

• propane

benzalkonium chloride is used as

antibacterial agent

dextrose is used as

tonicity-adjusting agent

t or f: sterile water for injection must have a lower pyrogen content than water for injection

false

select the method for depyrogenating glassware

dry heat

preferred method of sterilization of thermolabile liquid pharmaceutical products

sterilizing filtration

t or f: oils can be sterilized by moist heat

true

drugs can be present in aerosols as

• particulate matter

• liquids

processes involved in “priming” a metered dose inhaler

• shaking

• spraying in the air

t or f: standard topical aerosols have a lower propellant content than foams

false

sodium tartarate is used as

buffer component

ascorbic acid is used as

antioxidant

dibasic sodium phosphate is used as

buffer component

intravascular injections

• intra-arterial

• intravenous

syringes and sutures are sterilized by

irradiation

t or f: anderson cascade impactor is to stimulate the behavior of aerosols in topical applications

false

the main purpose of a spacer is to

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

all propellants that are liquids under the pressures used in aerosols

• propane

• CCl₂F₂

• n-butane

• CF₃CFHCF₃

mannitol is used as

tonicity-adjusting agent

citric acid is used as

buffer component

the decimal reduction time (D_T) ___ the temperature

depends in a nonlinear way on

the killing rate constant (k_T) ___ the temperature

depends in a nonlinear way on

all methods used for sterilization of thermolabile pharmaceutical formulations

• irradiation

• sterile filtration

all flammable propellants

• n-butane

• propane

ethylenediamino tetraacetate is used to increase

• drug solubility

• physical and chemical stability

butylated hydroxytoluene is used as

antioxidant

sterilization method for dry and thermolabile pharmaceutical products

irradiation

in an industrial setting, endotoxins are detected by

limulus amebocyte lysate test

any substance that causes a febrile response is called

pyrogen

in aerosols, if a drug is dispersed in liquefied gas the dispersion can be a

• solution

• emulsion

• suspension

if an aerodynamic particle diameter (d_aer) is > 3 micrometers, the particles are

deposited in the upper airways

if an aerodynamic particle diameter (d_aer) is = 3 micrometers, the particles are

deposited in the alveolar region of the lung

if an aerodynamic particle diameter (d_aer) is < 3 micrometers, the particles are

exhaled

in aerosol products, if there is a continuous valve

spray “valve up”

in aerosol products, if there is a metered valve

spray “valve down”

phenylmercuric nitrate is used as

antibacterial agent

tartaric acid is used as

buffer component

injections leading to immediate and complete bioavailability

• intra-arterial

• intravenous

moist heat sterilization uses the temperature

100 - 120 C

gas sterilization is typically performed using

ethylene oxide

all types of dry powder inhalers

• unit-dose inhaler

• multi-dose pre-metered inhaler

• multi-dose reservoir inhaler

nitrogen is used as

antioxidant

sodium chloride is used as

tonicity-adjusting agent

phenol is used as

antibacterial agent

HEPA stands for

high efficiency particulate air

the pressure above a mixture of propellants is calculated using what law

Raoult’s

t or f: the control of particle size, both before and after filling the canister, is a key issue in inhalation aerosol products

true

an aerosol drug product can have the form of

• stream

• spray

• foam

• powder

tartaric acid is used as

buffer component

sodium bisulfite is used as

antioxidant

the typical pore size of sterilizing filter is

0.22 micrometers

a fast killing of microorganisms means that the killing rate constant (k_T) is ___ and the decimal reduction time (D_T) is ___

high; low

t or f: some inhalation aerosol formulations are excipient free

true

in aerosols, the drug can be dispersed in

• propellant

• solvent

sodium acetate is used as

buffer component

butylated hydroxyanisole is used as

antioxidant

preferred method of sterilization of pharmaceutical products containing water

moist heat

preferred method of sterilization of thermolabile liquid pharmaceutical products

sterilizing filtration

sterility assurance level of aseptically filled products is typically

10³

all materials used in production of aerosol containers

• plastic

• polymer-coated aluminum

• stainless steel

• tin-plated steel

• aluminum

• polymer-coated glass

• uncoated glass

purified water contains ___- times less total solids than drinking water

100

the drug molecules need to cross ___ cell layers on the way from the alveolar air into the bloodstream

2

the aerosol dose delivered to the lung consists of ___ phases

2

capillaries cover about ___ of the alveolar surface

70%

olfactory receptors are localized in the ___ part of the nasal cavity

upper

t or f: optimal deposition of aerosols in alveoli is achieved when a fast and deep inhalation to total lung capacity is followed by breath-holding before exhalation

false

the decay constant depends on

• the time of measurement

• the rate constant

diagnostic radiopharmaceuticals are ideally

gamma emitters

all transport mechanisms that are involved in transport of radiopharmaceuticals in the body

• phagocytosis

• ion exchange and transport

• passive diffusion

all radioisotopes producing positrons and used in positron emission tomography

• rubidium-82

• oxygen-15

• fluorine-18

• nitrogen-13

characteristics of samarium-153

• half-life of 46.3 hrs

• beta emitter

• used for bone pain palliation in cancers

all clearance mechanisms for drugs after a nasal delivery

• enzymatic degradation

• sneeze

• mucociliary movement

nasal absorption is limited for molecules with the molecular weight larger than ___ Da

1000

surface area of nasal cavity is ___ cm²

200

there are about ___ million alveoli in a standard adult

300

the decay constant depends on

• the time of measurement

• the rate constant

all characteristics of strontium-89 chloride

• beta emitter

• half-life of 51 days

• used for bone pain palliation in cancers

• harmful to skeletal tissue

the decay constant ___ the rate constant

depends in a nonlinear way on

characteristics of Technetium-99m

• used as a radiolabel for various compounds because of flexible chemistry

• gamma emitter

• half-life of 6 hours

gravitational sedimentation in small airways and alveoli affects particles with the size

0.5 - 3 micrometers

t or f: nasal drops should be taken in a way that the nasal cavity is inversed

true

typical acidity of nasal mucous

5.5 - 6.5

all parts of the transitional and respiratory zones of the lung

• alveolar ducts

• Alveolar sacks

• respiratory bronchioles

all characteristics of samarium-153

• used for bone pain palliation in cancers

• beta emitter

• half-life of 46.3 hours

all routes used for administration of radiopharmaceuticals

• IV injection

• inhalation

• oral

all characteristics of sodium iodide-131

• beta and gamma emitter

• used in therapeutic treatment of carcinoma and ablation after surgery

• available as oral capsule or (volatile) solution

• used for thyroid function tests

all radioisotopes producing positrons and used in positron emission tomography

• fluorine-18

• nitrogen-13

• rubidium-82

• oxygen-15

how many bilayers must drug molecules cross to get from the nasal cavity to the bloodstream

10

volume of the nasal cavity

20 mL

all advantages of pulmonary delivery

• a fast onset of systemic effect

• local delivery possible

• noninvasive delivery

• some absorption for macromolecules

the particle ___ is the best characteristic of particle deposition in the regions of the lungs

aerodynamic diameter