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ph 107 - pharmaceutical dosage forms, drug delivery systems, and medical devices (lec.) > Dosage Form Design > Flashcards

Dosage Form Design Flashcards

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USMLE® Step 1 flashcards
1
Q

Study on the formulation, manufacturing, stability, and effectiveness of pharmaceutical dosage forms

A

Pharmaceutics

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2
Q

Other term for pharmaceutical ingredients

A

Excipients

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3
Q

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

A

Coated tablets

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4
Q

Used to protect the drug substance from the destructive influence of gastric acid after oral administration

A

Enteric-coated

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5
Q

Used to conceal the bitter, salty, or offensive taste or odor of a drug substance

A

Capsules, Flavored syrups

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6
Q

Used to provide liquid preparations of substances that are either insoluble or unstable in the desired vehicle

A

Suspension

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7
Q

Used to provide clear liquid dosage forms of substances

A

Syrups, Solutions

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8
Q

Used to provide rate-controlled drug action

A

Controlled-release tablets

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9
Q

Used to provide optimal drug action from topical administration sites

A

Ointment, Creams, Transdermal patches

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10
Q

Used to provide for insertion of a drug into one of the body’s orfices

A

Suppositories

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11
Q

Used to provide placement of drugs directly in the bloodstream or body tissues

A

Injections

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12
Q

Used to provide for optimal drug action through inhalation therapy

A

Inhalants, Inhalation aerosols

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13
Q

Formulation that best meets the goals of the product

A

Master formula

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14
Q

Defines the nature of the drug substance

A

Preformulation studies

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15
Q

Includes physical description, chemical properties, and purity of the chemical substance

A

Physical description

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16
Q

Done for the indication of particle size and size range of the raw material along with the crystal structure

A

Microscopic examination

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17
Q

Determines the purity of the substance

A

Melting point depression

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18
Q

Determines existence and extent of the presence of solid and liquid phases in binary, ternary, and other mixtures

A

Phase rule

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19
Q

Affects physical-chemical properties of drug susbtances

A

Particle size

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20
Q

Where substances can exist in more than one crystalline form

A

Polymorphism

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21
Q

Is determined by the equilibrium solubility method

A

Solubility

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22
Q

Time for the drug to dissolve in the fluids at the absorption site

A

Dissolution rate

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23
Q

Determines degree and rate of passage of drug through the membrane sac

A

Membrane permeability

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24
Q

Is a measure of a molecule’s lipophilic character; that is the preference for the hydrophilic or lipophilic phase

A

Partition coefficient

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25
Q

Extent of ionization of drug (strong effect on formulation and pharmacokinetic parameters of the drug)

A

pKa/Dissociation constants

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26
Q

Extent that a product retains within specified limits and through its period of storage and use

A

Stability

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27
Q

Destructive process where drug molecules interact with water molecule to yield breakdown product

A

Hydrolysis/Solvolysis

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28
Q

Destructive process which involves the loss of electrons from an atom or molecule

A

Oxidation

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29
Q

Stability in which the active ingredient retains chemical integrity and labeled potency within the specified limits

A

Chemical stability

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30
Q

Stability in which the original physical properties, appearance, palatability, uniformity, dissolution, and suspendability are retained

A

Physical stability

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31
Q

Stability which involves the sterility/resistance to microbial growth

A

Microbiologic stability

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32
Q

Stability where the therapeutic effect remains unchanged

A

Therapeutic stability

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33
Q

Stability where no significant increase in toxicity occurs

A

Toxicologic

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34
Q

Description of the drug concentration with respect to time

A

Rate reactions

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35
Q

Estimate the shelf life of a product that has been stored or to be stored under a different set of conditions

A

Q10 method

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36
Q

Catalyst to oxidation reactions

A

Light

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37
Q

Use of exaggerated conditions of temperature, humidity, light, and others

A

Accelerated stability testing

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38
Q

Determines the most stable of the proposed formulations for a drug product

A

Short term accelerated studies

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39
Q

Testing where temperature elevations in 10° increments higher than used in accelerated studies

A

Stress testing

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40
Q

The product is subjected to different climatic zones nationally and internationally

A

Long term stability studies

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41
Q

Holds the article and is or may be in direct contact with the article

A

Container

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42
Q

It is in direct contact with the article at all times

A

Immediate container

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43
Q

Part of the container

A

Closure

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44
Q

It is cleaned and dried prior to it being filled with the drug

A

Closure and container

45
Q

Protects the contents from extraneous solids

A

Well-closed container

46
Q

Protects the contents from contamination by extraneous liquids

A

Tight container

47
Q

Container impervious and resistant to air or any other gas

A

Hermetic container

48
Q

Container where the quantity of drug contained is intended as a single dose

A

Single-dose container

49
Q

Hermetic container that permits withdrawal of successive portions of the contents

A

Multiple-dose container/Vials

50
Q

Convenient and sanitary means of maintaining and utilizing the medication

A

Single-unit packages

51
Q

May be combinations of paper, foil, plastics, or cellophane

A

Packaging materials

52
Q

Most popular method of single-unit packaging

A

Clear plastic/Aluminum blister wells

53
Q

May be single-unit dispensed in paper, plastic, and foil cups

A

Oral liquids

54
Q

Required by many pharmaceutical products to protect them from photochemical deterioration

A

Light resistant containers

55
Q

Container that is significantly difficult for children under 5 years of age to open

A

Child-resistant container

56
Q

Includes initial regulations called for its use for aspirin products and certain household chemical products

A

Child-proof closures

57
Q

Highly resistant, borosilicate glass

A

Type I glass

58
Q

Treated soda-lime glass

A

Type II glass

59
Q

Soda-lime glass

A

Type III glass

60
Q

General purpose soda-lime glass

A

Type NP glass

61
Q

Movement of components of a container into the contents

A

Leaching

62
Q

Binding of molecules to polymer materials

A

Sorption

63
Q

Should make up only at most a 14 days supply and must be stored in a refrigerator

A

Pharmacist

64
Q

Has a shelf life of 2 or more years to ensure stability at the time of consumption

A

Manufactured products

65
Q

Limits the time during which the product may be dispensed by the pharmacist or used by the patient

A

Expiration date

66
Q

Presents monographs on more than 250 excipients used in dosage form preparation

A

Handbook of pharmaceutical excipients

67
Q

USP-NF

A

United States Pharmacopoeia-National Formulary

68
Q

BP

A

British Pharmacopoeia

69
Q

EP

A

European Pharmacopoeia

70
Q

JP

A

Japanese Pharmacopoeia

71
Q

Used to dissolve the drug substance

A

Solvents

72
Q

Used to make the product more palatable

A

Flavors and sweeteners

73
Q

Used to enhance the appeal

A

Colorants

74
Q

Used to prevent microbial growth

A

Preservatives

75
Q

Used to prevent decomposition

A

Stabilizers

76
Q

Used to increase bulk of the formulation

A

Diluents/Fillers

77
Q

Used to cause adhesion of the powdered drug

A

Binders

78
Q

Used to promote tablet breakup after administration

A

Antiadherents/Lubricants

79
Q

Used to promote tablet breakup after administration and coatings

A

Disintegrating agents

80
Q

Can mask the disagreeable taste

A

Flavoring pharmaceuticals

81
Q

Include soybean and other edible oils

A

Oil soluble carriers

82
Q

Include water, ethanol, propylene glycol, glycerin, and emulsifiers

A

Water soluble carriers

83
Q

Include maltodextrins, corn syrup solids, modified starches, gum arabic, salt, sugars, and whey protein

A

Dry carriers

84
Q

Flavor that masks the taste of bitter drugs

A

Cocoa flavored vehicles

85
Q

Used for sour or acid-tasting drugs

A

Fruit or citrus flavors

86
Q

Used for salty rugs

A

Cinnamon, Orange, Raspberry

87
Q

Includes essential oil, oleoresin, essence or extractives, etc.

A

Natural flavor

88
Q

Any substance used to impart flavor that is not derived from a spice, fruit, or fruit juice

A

Artificial flavor

89
Q

Any aromatic vegetable substance in whole, broken or ground form

A

Spice

90
Q

It is excreted by the kidney virtually unchanged

A

Saccharin

91
Q

Is metabolized or processed in the digestive tract and its byproducts are excreted in the kidneys

A

Cyclamate

92
Q

Breaks down in the body to 3 basic components; phenylalanine, aspartic acid, and methanol

A

Aspartame

93
Q

GRA (generally recognized as sage)

A

Saccharin and cyclamate

94
Q

Clause that states that no new food additives may be used if animal studies/appropriate tests showed it it caused cancer

A

Delany clause

95
Q

Structurally similar to saccharin; 130 times as sweet as sucrose

A

Acesulfame potassium (nonnutritive sweetener)

96
Q

New sweetening agent; is 30x sweeter than cane sugar/sucrose

A

Stevia (Stevia rebaudiana Bertoni)

97
Q

Used in pharmaceutical preparations for aesthetics

A

Coloring pharmaceuticals

98
Q

Yellow

A

Sulfur, Riboflavin

99
Q

Blue

A

Cupric sulfate

100
Q

Bluish green

A

Ferrous sulfate

101
Q

Red

A

Cyanocobalmin

102
Q

Vivid red

A

Red mercuric iodide

103
Q

Thich black viscid liquid that is a byproduct of destructive distillation of coal

A

Coal tar (pix carbonis)

104
Q

Added to pharmaceutical preparation in the form of diluted solutions

A

Dyes

105
Q

Commonly used in the form of fine dispersions or suspensions

A

Lakes

106
Q

Regulates the use of color additives in foods, drugs, and cosmetics

A

FDA

107
Q

Additives which are added in foods, drugs, and cosmetics

A

FD&C color additives

108
Q

Additives which are added in drugs, some in cosmetics and medical devices

A

D&C color additives

109
Q

Additives which are restricted to external parts of the body

A

External D&C color additives

ph 107 - pharmaceutical dosage forms, drug delivery systems, and medical devices (lec.) (3 decks)

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