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Drug Delivery II > Exam 2 Packaging > Flashcards

Exam 2 Packaging Flashcards

1
Q

A _______ holds the article or may be in direct contact with the article. The _______ _____ is that which is in direct contact with the article at all times.

A

Container

Immediate container

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2
Q

T or F: The closure is part of the container

A

True

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3
Q

Special precautions and cleaning procedures may be necessary to ensure that each container is clean and that extraneous matter is not introduced into or onto the _____.

A

article

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4
Q

T or F: No physical or chemical interactions between the container and the contents that might result in altering the strength, quality, or purity of the stored article beyond official requirements

A

True

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5
Q

Tamper resistant packaging is used for what type of products?

A

Opthalmic, otic, or OTC

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6
Q

Light resistant containers are used for compounds prone to ______. A container may be made light resistant by means of _____ coloring.

A

Oxidation

Opaque

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7
Q

Well closed containers protect from extraneous ______ (solids, liquids, and/or gas) and from loss of the drug under the ordinary or customary conditions of handling, shipment, storage, and distribution

A

Solids

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8
Q

Well closed containers are used for solid dosage forms not prone to ______ or _____

A

Oxidation or hydrolysis

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9
Q

Tight container protect the contents form contamination by extraneous _____ (solids, liquids, and/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

A

solids, liquids, and vapors

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10
Q

T or F: Tight containers are not capable of tight re-closure

A

False: tight containers are capable of tight reclosure

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11
Q

The loss of water of hydration in hydrates

A

Efflorescence

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12
Q

The absorption of water vapor

A

Deliquescence

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13
Q

Which containers are impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution

A

Hermetic

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14
Q

T or F: Each single unit container shall be labeled to indicate the identity, quantity, and/or strength, name of the manufacturer, lot number, and expiration date of the article

A

True

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15
Q

Packaging designed to hold a quantity of drug product intended for administration as a single dose or a single finished device intended for use promptly after the container is opened

A

Single-unit

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16
Q

Single-dose containers are a single-unit container for articles intended for ______ administration, with no antimicrobial preservation required. The maximum volume is ___L

A

Parenteral administration

1 L

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17
Q

A single-unit container for articles intended for administration by other than the parenteral route as a single dose, direct from the container

A

Unit-dose

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18
Q

Multiple-dose includes multiple-unit containers for articles intended for ______ administration only. Antimicrobial preservation ____ (is / is not) required. The maximum volume is ____mL

A

30mL

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19
Q

Container that contains a specific quantity of a drug product that is intended to be dispensed as such without further modification except for the addition of appropriate labeling

A

Unit-of-use containers

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20
Q

T or F: The container must protect against adverse effects of the environments and must prevent loss of drug product components

A

True

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21
Q

T or F: The materials selected for the container do not need to be FDA approved

A

False; they need to be FDA approved

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22
Q

T or F: Glass is a liquid of a high degree of viscosity that it appears to exist as a solid

A

True

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23
Q

In the composition of glass, a structural network is formed by ______ ______

A

Silicon oxide

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24
Q

____ oxide can enter the structural network, but most other oxides cannot

A

Boric oxide

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25
Q

Most common cations in pharmaceutical glassware include (8)

A 
Silicon
Boron
Aluminum
Sodium
Potassium
Calcium
Magnesium
Barium
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26
Q

T or F: In glass, many useful properties are affected by the kind of elements presents, such as lead in small traces can give clarity and brilliance

A

True

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27
Q

T or F: The USP provides chemical resistance tests for glass containers, which are designed to determine the resistance of new glass containers to water attack

A

True

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28
Q

T or F: The degree of attack in chemical resistance testing is determined by the amount of acid released from the glass under the influence of the attacking medium under specific conditions

A

False; alkali released

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29
Q

T or F: The volume of 0.02 N sulfuric acid required to neutralize the alkalinity leached from the test material should not exceed certain value specified for each type of glass

A

True

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30
Q

Type I glass

A

Borosilicate (6% boron)

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31
Q

Type I glass is ____ (highly/ not highly) resistant, with ____ (high or low) leachability. A substantial part of the alkali and earth cations are replaced by boron and/or aluminum and zinc

A

Highly

Low leachability

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32
Q

The level of the non-network forming oxides is known as

A

Leachability

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33
Q

T or F: Type I glass is suitable for all products, but because of cost, one of the other less expensive types may be acceptable

A

True

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34
Q

Type II glass

A

Treated soda-lime glass

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35
Q

Type II glass undergoes _____ treatment with _____ _____, which neutralizes the alkali oxides on the interior surface of the container, making the glass more resistant and prevents “weathering”

A

Sulfur treatment with sulfur dioxide

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36
Q

T or F: Type II may be suitable for a solution that is buffered, has a pH above 7, or is not reactive with the glass

A

False; has a pH below 7

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37
Q

T or F: Type II usually has a lower concentration of migratory oxides than Type III

A

True

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38
Q

Type III glass

A

Soda-lime glass

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39
Q

T or F: Type III soda lime glass will be suitable principally for anhydrous liquids or dry powders

A

True

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40
Q

T or F: NP Soda-lime glass is also suitable for containers for parenterals

A

False; not suitable for parenterals

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41
Q

Which types of glass undergo a powdered glass test?

A

Types I, III, and NP

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42
Q

What type of glass undergoes a water attack test?

A

Treated soda-lime glass

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43
Q

What is the limit in mL of 0.020 N Acid for Type I glass?

A

1.0

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44
Q

What is the limit in mL of 0.02 N Acid for Type II glass that is 100mL or less?

A

0.7

45
Q

What is the limit in mL of 0.02 N Acid for Type II glass that is over 100mL?

A

0.2

46
Q

What is the limit in mL of 0.02 N Acid for Type III glass?

A

8.5

47
Q

What is the limit in mL of 0.02 N Acid for NP glass?

A

15

48
Q

Advantage of glass include ______, _______, and _____.

A

Inertness, visibility, and stability

49
Q

T or F: Any other material proposed by a manufacturer is tested agains glass as the standard before use for drug packaging

A

True

50
Q

A material that contains as an essential ingredient one or more polymeric organic substances of large molecular weight

A

Plastic

51
Q

T or F: There are over 100 different polymers available for use in packaging

A

True

52
Q

Material that assists in processing of plastic during the molding or extrusion operation. A commonly used substance for polyethylene is zinc stearate

A

Lubricant

53
Q

Material that retards or prevents degradation of the polymer by heat and light, during manufacturing, as well as improves its aging characteristics

A

Stabilizers

54
Q

Classes of common stabilizers (2)

A

Fatty acids, inorganic oxides

55
Q

Common lubricant for PE

A

Zinc oxide

56
Q

Material that achieves softness and flexibility and are used commonly in vinyls and cellulosics

A

Plasticizers

57
Q

Material that assists in retarding oxidation

A

Antioxidants

58
Q

Material that prevents the buildup of static charges on the plastic surface

A

Antistatic agents

59
Q

Material added primarily to polyolefins (polyethylene and polypropylene) to reduce the coefficient of friction of the material

A

Slip agents

60
Q

Material added to impart color

A

Dyes and pigments

61
Q

Most widely used plastic that is a good barrier against water, but relatively poor against oxygen

A

Polyethylene

62
Q

What are the two types of polyethylene?

A

Low density or branched: LDPE

High density or linear: HDPE

63
Q

_____ (LDPE/HDPE) is more crystalline, better moisture barrier, more heat-resistant, and stiffer than _____ (LDPE/HDPE)

A

HDPE; LDPE

64
Q

T or F: Polyethylenes have a high resistance to most solvents and chemicals, are unaffected by strong acids and alkalis, and are tasteless and odorless.

A

True

65
Q

T or F: Polyethylenes lack clarity and have a relatively low rate of permeation of essential odor, flavor, and oxygen

A

False; have a relatively high rate of permeation

66
Q

_____ (LDPE/HDPE) is used widely where rigidity and barrier properties are preferred, such as in bottles of solid dosage formes

A

HDPE

67
Q

_____ (LDPE/HDPE) is used where flexibility is required, such as in squeeze bottles of sprays and drops

A

LDPE

68
Q

T or F: HDPE can be sterilized with ethylene oxide only, while LDPE can be sterilized with steam and ethylene oxide

A

False: HDPE sterilized with steam and ethylene oxide

LDPE sterilized with only ethylene oxide

69
Q

______ is lighter than PE but much stiffer and more heat resistant. It _____ (has / lacks) clarity, is a _______ (poor/excellent) moisture barrier, and is ________ (susceptible/resistant) to solvents

A

Polypropylene
Lacks clarity
Excellent moisture barrier
Resistant to solvents

70
Q

Polypropylene is used widely for ____ (solid/liquid) dosage products and can be sterilized with (steam and/or ethylene oxide)

A

Solid dosage products

Steam and ethylene oxide

71
Q

Plastic that has glass-like clarity, and is used in the manufacture of blood bags, examination gloves, IV solution containers and pump tubing

A

Polyvinyl chloride (PVC)

72
Q

What is the most commonly used plasticizer in PVC to add flexibility

A

DEHP

73
Q

T or F: DEHP is toxic

A

True

74
Q

Widely used for fabrication of containers and syringes, but lacks impact strength i.e. used for solid dosage forms and not liquid products

A

Polystyrene (PS)

75
Q

T or F: PS is rigid and non-transparent

A

False; PS is rigid and transparent

76
Q

Nylon is a ______ with a ______ (high/low) water transmission rate, and a (high/low) oxygen transmission

A

Polyamide
High water transmission
Low oxygen transmission

77
Q

T or F: Laminates of PE and nylon are resistant to both water and oxygen

A

True

78
Q

Class of plastics that includes polymethacrtylates, polyacrylates, and copolymers of acrylonitrile

A

Acrylics

79
Q

Acrylics have a ____ (high/low) water transmission rate and are used in adapters of IV solution administration sets and blood collection sets

A

Low water transmission rate

80
Q

Cellulose alcohol groups are esterified with which three types of acids?

A

Acetic, butyric and/or propionic acid

81
Q

T or F: Cellulosics are used in articles such as tubing and membranes in dialyzers for sterile filtration

A

True

82
Q

The transmission of gases, vapors, or liquids through the plastic material that can adversely affect the stability of a drug

A

Permeation

83
Q

Permeation rate is influenced by both _____ and relative ______

A

Temperature and relative humidity

84
Q

T or F: Molecules do not permeate through crystalline zones

A

True

85
Q

T or F: Nylon is hydrophobic while Polyethylene is hydrophilic

A

False: Nylon = hydrophilic

PE = hydrophobic

86
Q

When plasticizers, colorants, and other additives are removed by contents and can have a toxic effect in parenterals

A

Leaching

87
Q

The removal of constituents from contents by the container that can result in adverse effects such as a decrease in potent drugs and preservative concentration which can cause low doses or no protection

A

Sorption

88
Q

When chemical reactions between plastic and drug in contact result in changes in color, viscosity, or potency, as well as haze or precipitate

A

Chemical attack

89
Q

Increasing temperature and humidity (increases/decreases) the rate of chemical attack

A

Increases

90
Q

The physical and chemical alteration of the container by the drug product, in which permeation, leaching, and sorption are also factors.

A

Modification

91
Q

T or F: PE containers are deformed due to permeation of gases and vapors or loss of contents through the walls i.e. oils soften PE

A

True

92
Q

T or F: Flexibility of a container can be affected by extraction of plasticizers

A

True

93
Q

Biological tests for plastics are designed to test the suitability of plastic material intended for use in fabricating containers and accessories for use in ______ preparations and for use in _____ devices, implants, and other systems

A

Parenteral preparations and medical devices and implants

94
Q

Biological tests the reaction of living animal tissue and animals to the presence of the _____ or extracts of it is determined

A

plastics or extracts

95
Q

Biological reactivity test to evaluate systemic response; tested in albino mice

A

Systemic injection test

96
Q

Biological reactivity test to evaluate local response; tested in albino mice

A

Intracutaneous test

97
Q

Biological reactivity test in direct contact with living tissue where strips of plastic are implanted into rabbits

A

Implantation

98
Q

Four types of physiochemical tests (4)

A
  1. Nonvolatile residue
  2. Residue on ignition
  3. Heavy metals
  4. Buffering capacity
99
Q

Determines the moisture permeability when packaging and storage in a tight container or a well-closed container is specified

A

Moisture permeation test

100
Q

Classification of a tight moisture permeation test

A

Exceeds 100mg/day/liter in not more than 1 of the 10 test containers. Exceeds 200 mg/day/liter in none of them

101
Q

Classification of a well-closed permeation test

A

Exceeds 2000 mg/day/liter in not more than 1 of the 10 test containers, and exceeds 3000mg/day/liter in none of them

102
Q

In a light transmission test for plastic containers, the products intended for oral or topical administration does not exceed 10% at any wave length in the range of ____ to ____ nm

A

290-450 nm

103
Q

Category one of recycling plastics

A

PETE

104
Q

Category two of recycling plastics

A

HDPE

105
Q

Category three of recycling plastics

A

V

106
Q

Category four of recycling plastics

A

LDPE

107
Q

Category five of recycling plastics

A

PP

108
Q

Category six of recycling plastics

A

PS

109
Q

_____ can leach bisphenol A, a potential hormone disruptor, into liquids, which is controversial in baby bottles

A

Polycarbonate

Drug Delivery II (10 decks)

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