Module 1 Part 1

100問 • 5ヶ月前

問題一覧

An agent intended for use in the diagnosis, mitigation, treatment, cure, and prevention of disease in humans or in other animal.

Drug

Used to diagnose or determine a disease by assaying the percentage of antibodies present.

Drug

Alleviate, lessen, and ease; for comfort

Mitigation

Something that deals with a disease, injury, etc., in order to make someone feel better or become healthy again.

Treatment

Indudes vaccines, vitamins and minerals, contraceptives, and maintenance drug

Prevention

Dosage forms are also known as ____

pharmaceuticals

Preparations designed to contain a specified quantity of medication for ease and accuracy of dosage administration.

Dosage forms

Give the formulation its unique composition and characteristic physical appearance.

Non-active ingredients

API / pharmacologically active / therapeutic ingredients

Active ingredients

Inert / inactive ingredients / additive / excipients

Non-active ingredients

According to USP, it holds the article and is or maybe in direct contact with the article.

container

The one that is in direct contact with the article at all times

immediate container

Closure is an example of ____

immediate container

Container types according to their ability to protect their contents from external conditions

well closed, tightly-closed, hermetic container, light-resistant, child-resistant, tamper-proof container

Container types according to content or capacity

Single dose, Multiple doses

It protects the content from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage, and distribution

well-closed container

It protects the contents from contamination by extraneous liquids, solids or vapors, from loss of the article and from efflorescence, deliquescence or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution and is capable of tight re-closure

tighly-closed container

It is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution.

hermetic container

Intended for injection or parenteral preparation

hermetic container

Examples are vials and ampules / ampoules

hermetic container

It provides protection from the degradative effects of light by reducing light transmission

light-resistant container

Light-resistant container is also known as _____ bottle

amber

Plastic that reduce light transmission sufficiently to protect a light sensitive pharmaceutical

Light-resistant opaque plastic

Added to decrease the transmission of hort ultraviolet rays

ultraviolet absorbers

USP standard on limit for light transmission

290-450nm

A container that is significantly difficult for children to open or to obtain a harmful amount of its contents within a measurable time and that is not difficult for normal adults to use properly

Child-resistant container

Child-resistant containers are specially for children ___ old and below

5 years

What child-resistant container design is this?

latch top

What child-resistant container design is this?

press down and turn

What child-resistant container design is this?

squeeze and turn

What child-resistant container design is this?

align the arrows

A packaging that has one or more indicators or barriers to entry which if breached or missing, can reasonably be expected to provide visible evidence that tampering has occured.

Tamper-evident container

A kid of tamper-evident packaging sealed around the product and/or product container: must be cut or storm to remove the product.

Film wrapper

Tamper-evident packaging where individually sealed dose units; removal requires tearing or breaking individual compartment.

Blister/strip pack

Tamper-evident packaging where product and container is sealed in plastic, usually mounted on display card; plastic must be cut or broken open to remove the product.

Bubble pack

Tamper-evident packaging where wrapper is shrunk by heat or drying to conform to cap; must be torn or broken to reach the product.

Shrink seal/band

Tamper-evident packaging where sealed individual packet must be torn to reach the product; can be foil, plastic, or paper

Pouch

Tamper-evident packaging where paper or foil is sealed to the mouth of the container, under the cap; must be torn or broken to reach the product

Bottle seal

Tamper-evident packaging where paper or foil is sealed over carton flap or bottle cap; must be torn or broken to reach the product.

Tape seal

Tamper-evident packaging where a plastic or metal tear-away cap is over the container; must be broken to remove.

Breakable cap

Tamper-evident packaging sealed over the mouth; must be punctured to reach the product.

Sealed tubes

Tamper-evident packaging where carton flaps are sealed; carton cannot be opened without damage.

Sealed cartoon

Usually in spray bottles or conatiners

Aerosol container

One that holds a quantity of drug intended as a single dose and when opened, cannot be resealed with assurance that sterility has been maintained.

Singe dose container

Examples of single dose containers

ampules, prefilled syringes / cartridges

One that contains more than a single dose of the medication and permits the withdrawal of successive portions without changing the strength or endangering the quality or purity of the remaining portion

Multiple dose container

Example of multiple dose container

vials

Type I glass

highly-resistant borosilicate glass

Type II glass

treated soda-lime glass

Type III glass

soda lime glass

Type IV glass

general purpose soda-lime glass

Rigid and has good clarity; useful in blister packaging of tablets and capsules

polyvinyl chloride (PVC)

Not suitable when gamma sterilization is required

polyvinyl chloride (PVC)

Have excellent transparency and luster and can be sterilized with gamma radiation

APET & PETG

Light weight and resistant to impact

plastic

Versalitle in container design and consumer acceptance

plastic

Consumer preference for squeeze bottles

plastic

Popular in blister packaging and unit-dose dispensing

plastic

Permeable to atmospheric oxygen and to moisture vapos

plastic

Leaching of constituent of the container to the internal contents and absorption of drugs from the contents to the container

plastic

Prone to transmission of light through the container and to alteration of the container (deformity)

plastic

Any temperature not exceeding 8 degrees Celcius

cold temperature

Refrigerator temp.

2 to 8 degrees Celcius

Freezer temp

-25 to -10 degrees Celcius

Any temperature between 8 to 15 degrees Celcius

cool temperature

Temperature prevailing in a working area

room temperature

Temperature between 20 to 25 degrees Celcius or sometimes 15 to 30 degrees Celcius

controlled room temperature

Any temp between 30 to 40 degrees Celcius

warm temperature

Any temp above 40 degrees Celcius

excessive heat

To protect drug substance from the destructive influences of atmospheric oxygen or humidity

coated tablets & sealed tablets

To protect drug substance from the destructive influences of gastric acid after oral administration

enteric coated tablets

To conceal bitter, offensive, or salty taste or odor of a drug substance

capsule, coated tablets, & syrups

To provide rate or controlled drug action

capsule, controlled release tablet, & suspension

To provide liquid preparation of substances that are either insoluble or unstable in the desired vehicle

suspension or clear preparation solution

To provide drug action form topical administration sites

ointments, creams, transdermal patch, & ophthalmic, ear, and nasal preparations

To provide for insertion into one of the body's orifices

rectal & vaginal suppositories

To provide placement of drug directly in the bloodstream or body tissues

injections

To provide optimal drug action through inhalation therapy

inhalants & inhalation aerosols

The formulation that best meets the goals for the product selected

master formula

Considers the purity of the chemical substance which is essential for its identification and for evaluation of its hemical, physical, and biological properties

physical description

Considers the structure, form, and reactivity of the substance

chemical property

Considers the physical description, particle size, crystalline structure, melting point, and solubility of the substance

physical property

Considers the ability to get to a site of action and elicit response

biological property

Gives an indication of particle size and size range of the raw material along with the crystal structure

microscope examination

Which flows more easily?

spherical and oval powders

The amount of het absorbed when 1g of liquid vaporizes

heat vaporzation

Affects the operation of implantable pumps delivering medicine, aerosol dosage, and nasal inhalants for treating nasal decongestion

heat vaporization

Particle size affects vapor pressure, the ____ the particle size, the greater the vapor pressure

smaller

Used to determine the purity of the substance

melting point depression

Change in _____ means the products is not pure

melting point

A useful fevice for relating the effect of the least number of independent variables upon the various phases that can exist in an equilibrium system containing a number of components.

phase rule

Temperature, pressure, and concentration acts as ____ in phase rule

independent variable

Certain physical and chemical properties of drug substance, including dissolution rate, bioavailablity, content uniformity, taste, texture, color, and stability which are affected by its distribution

particle size

It influences oral absorption, flow characteristics, and sedimentation rates

particle size

Indicates if a substance is crystal or amorphous; affects the melting point and solubility

polymorphism

Should possess aqueous _____ for therapeutic effect

solubility

Frequently added to increase solubility

salt and ester

Adjustment in particle size and pH can _____ solubility

increase

Rate-limiting step in the absorption process

dissolution

100

The time it take for the drug to dissolve in the fluid at the absorption site.

dissolution rate

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問題一覧

An agent intended for use in the diagnosis, mitigation, treatment, cure, and prevention of disease in humans or in other animal.

Drug

Used to diagnose or determine a disease by assaying the percentage of antibodies present.

Drug

Alleviate, lessen, and ease; for comfort

Mitigation

Something that deals with a disease, injury, etc., in order to make someone feel better or become healthy again.

Treatment

Indudes vaccines, vitamins and minerals, contraceptives, and maintenance drug

Prevention

Dosage forms are also known as ____

pharmaceuticals

Preparations designed to contain a specified quantity of medication for ease and accuracy of dosage administration.

Dosage forms

Give the formulation its unique composition and characteristic physical appearance.

Non-active ingredients

API / pharmacologically active / therapeutic ingredients

Active ingredients

Inert / inactive ingredients / additive / excipients

Non-active ingredients

According to USP, it holds the article and is or maybe in direct contact with the article.

container

The one that is in direct contact with the article at all times

immediate container

Closure is an example of ____

immediate container

Container types according to their ability to protect their contents from external conditions

well closed, tightly-closed, hermetic container, light-resistant, child-resistant, tamper-proof container

Container types according to content or capacity

Single dose, Multiple doses

It protects the content from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage, and distribution

well-closed container

tighly-closed container

It is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution.

hermetic container

Intended for injection or parenteral preparation

hermetic container

Examples are vials and ampules / ampoules

hermetic container

It provides protection from the degradative effects of light by reducing light transmission

light-resistant container

Light-resistant container is also known as _____ bottle

amber

Plastic that reduce light transmission sufficiently to protect a light sensitive pharmaceutical

Light-resistant opaque plastic

Added to decrease the transmission of hort ultraviolet rays

ultraviolet absorbers

USP standard on limit for light transmission

290-450nm

A container that is significantly difficult for children to open or to obtain a harmful amount of its contents within a measurable time and that is not difficult for normal adults to use properly

Child-resistant container

Child-resistant containers are specially for children ___ old and below

5 years

What child-resistant container design is this?

latch top

What child-resistant container design is this?

press down and turn

What child-resistant container design is this?

squeeze and turn

What child-resistant container design is this?

align the arrows

A packaging that has one or more indicators or barriers to entry which if breached or missing, can reasonably be expected to provide visible evidence that tampering has occured.

Tamper-evident container

A kid of tamper-evident packaging sealed around the product and/or product container: must be cut or storm to remove the product.

Film wrapper

Tamper-evident packaging where individually sealed dose units; removal requires tearing or breaking individual compartment.

Blister/strip pack

Tamper-evident packaging where product and container is sealed in plastic, usually mounted on display card; plastic must be cut or broken open to remove the product.

Bubble pack

Tamper-evident packaging where wrapper is shrunk by heat or drying to conform to cap; must be torn or broken to reach the product.

Shrink seal/band

Tamper-evident packaging where sealed individual packet must be torn to reach the product; can be foil, plastic, or paper

Pouch

Tamper-evident packaging where paper or foil is sealed to the mouth of the container, under the cap; must be torn or broken to reach the product

Bottle seal

Tamper-evident packaging where paper or foil is sealed over carton flap or bottle cap; must be torn or broken to reach the product.

Tape seal

Tamper-evident packaging where a plastic or metal tear-away cap is over the container; must be broken to remove.

Breakable cap

Tamper-evident packaging sealed over the mouth; must be punctured to reach the product.

Sealed tubes

Tamper-evident packaging where carton flaps are sealed; carton cannot be opened without damage.

Sealed cartoon

Usually in spray bottles or conatiners

Aerosol container

One that holds a quantity of drug intended as a single dose and when opened, cannot be resealed with assurance that sterility has been maintained.

Singe dose container

Examples of single dose containers

ampules, prefilled syringes / cartridges

Multiple dose container

Example of multiple dose container

vials

Type I glass

highly-resistant borosilicate glass

Type II glass

treated soda-lime glass

Type III glass

soda lime glass

Type IV glass

general purpose soda-lime glass

Rigid and has good clarity; useful in blister packaging of tablets and capsules

polyvinyl chloride (PVC)

Not suitable when gamma sterilization is required

polyvinyl chloride (PVC)

Have excellent transparency and luster and can be sterilized with gamma radiation

APET & PETG

Light weight and resistant to impact

plastic

Versalitle in container design and consumer acceptance

plastic

Consumer preference for squeeze bottles

plastic

Popular in blister packaging and unit-dose dispensing

plastic

Permeable to atmospheric oxygen and to moisture vapos

plastic

Leaching of constituent of the container to the internal contents and absorption of drugs from the contents to the container

plastic

Prone to transmission of light through the container and to alteration of the container (deformity)

plastic

Any temperature not exceeding 8 degrees Celcius

cold temperature

Refrigerator temp.

2 to 8 degrees Celcius

Freezer temp

-25 to -10 degrees Celcius

Any temperature between 8 to 15 degrees Celcius

cool temperature

Temperature prevailing in a working area

room temperature

Temperature between 20 to 25 degrees Celcius or sometimes 15 to 30 degrees Celcius

controlled room temperature

Any temp between 30 to 40 degrees Celcius

warm temperature

Any temp above 40 degrees Celcius

excessive heat

To protect drug substance from the destructive influences of atmospheric oxygen or humidity

coated tablets & sealed tablets

To protect drug substance from the destructive influences of gastric acid after oral administration

enteric coated tablets

To conceal bitter, offensive, or salty taste or odor of a drug substance

capsule, coated tablets, & syrups

To provide rate or controlled drug action

capsule, controlled release tablet, & suspension

To provide liquid preparation of substances that are either insoluble or unstable in the desired vehicle

suspension or clear preparation solution

To provide drug action form topical administration sites

ointments, creams, transdermal patch, & ophthalmic, ear, and nasal preparations

To provide for insertion into one of the body's orifices

rectal & vaginal suppositories

To provide placement of drug directly in the bloodstream or body tissues

injections

To provide optimal drug action through inhalation therapy

inhalants & inhalation aerosols

The formulation that best meets the goals for the product selected

master formula

Considers the purity of the chemical substance which is essential for its identification and for evaluation of its hemical, physical, and biological properties

physical description

Considers the structure, form, and reactivity of the substance

chemical property

Considers the physical description, particle size, crystalline structure, melting point, and solubility of the substance

physical property

Considers the ability to get to a site of action and elicit response

biological property

Gives an indication of particle size and size range of the raw material along with the crystal structure

microscope examination

Which flows more easily?

spherical and oval powders

The amount of het absorbed when 1g of liquid vaporizes

heat vaporzation

Affects the operation of implantable pumps delivering medicine, aerosol dosage, and nasal inhalants for treating nasal decongestion

heat vaporization

Particle size affects vapor pressure, the ____ the particle size, the greater the vapor pressure

smaller

Used to determine the purity of the substance

melting point depression

Change in _____ means the products is not pure

melting point

A useful fevice for relating the effect of the least number of independent variables upon the various phases that can exist in an equilibrium system containing a number of components.

phase rule

Temperature, pressure, and concentration acts as ____ in phase rule

independent variable

Certain physical and chemical properties of drug substance, including dissolution rate, bioavailablity, content uniformity, taste, texture, color, and stability which are affected by its distribution

particle size

It influences oral absorption, flow characteristics, and sedimentation rates

particle size

Indicates if a substance is crystal or amorphous; affects the melting point and solubility

polymorphism

Should possess aqueous _____ for therapeutic effect

solubility

Frequently added to increase solubility

salt and ester

Adjustment in particle size and pH can _____ solubility

increase

Rate-limiting step in the absorption process

dissolution

100

The time it take for the drug to dissolve in the fluid at the absorption site.

dissolution rate