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PH 107 - Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices (Lec.) > MIDTERM 01 - Dosage Form Design Considerations > Flashcards

MIDTERM 01 - Dosage Form Design Considerations 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 (SS)

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 (OCT)

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

Rule that 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

Forms that usually exhibit different physicochemical properties

A

Polymorphic forms

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22
Q

Is defined as the maximum concentration of a substance that can be completely dissolved in a given solvent at a certain temperature and pressure level

A

Drug solubility

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23
Q

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

A

Dissolution rate

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24
Q

2 methods in determining dissolution rates of chemical compounds (CP)

A

Constant surface method, Particulate dissolution

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25
Q

Method that involves the characteristic of compound and solvent under fixed experimental conditions (Methods in determining dissolution rates)

A

Constant surface method

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26
Q

The value of the constant surface method is expressed as __________

A

mg dissolved/min/cm2

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27
Q

Used to study the influence of particle size, surface area, and excipients upon the active agent (Methods in determining dissolution rates)

A

Particulate dissolution

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28
Q

Law that describes the relationship of diffusion and dissolution of the active drug in the dosage form and when administered in the body

A

Fick’s law (Law of diffusion)

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29
Q

Law that relates to a steady-state flow (Fick’s law)

A

Fick’s 1st law

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30
Q

Law that relates to a change in concentration of drug with time, at any distance, or a non-steady state of flow (Fick’s law)

A

Fick’s 2nd law

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31
Q

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

A

Membrane permeability

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32
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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33
Q

Extent of ionization of drug (strong effect on formulation and pharmacokinetic parameters of the drug); is determined by potentiometric titration

A

pKa/Dissociation constants

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34
Q

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

A

Stability

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35
Q

Drug molecules interact with water molecule to yield breakdown product (Types of destructive process)

A

Hydrolysis/Solvolysis

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36
Q

Involves the loss of electrons from an atom or molecule (Types of destructive process)

A

Oxidation

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37
Q

Are molecules or atoms containing one or more unpaired electrons

A

Free radicals

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38
Q

The active ingredient retains chemical integrity and labeled potency within the specified limits (Types of stability)

A

Chemical stability

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39
Q

The original physical properties, appearance, palatability, uniformity, dissolution, and suspendability are retained (Types of stability)

A

Physical stability

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40
Q

Involves the sterility/resistance to microbial growth (Types of stability)

A

Microbiologic stability

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41
Q

The therapeutic effect remains unchanged (Types of stability)

A

Therapeutic stability

42
Q

No significant increase in toxicity occurs (Types of stability)

A

Toxicologic stability

43
Q

Description of the drug concentration with respect to time

A

Rate reactions

44
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

45
Q

Is a major determinant in stability

A

pH

46
Q

Optimum pH range for stability

A

pH 5 & 6

47
Q

Are agents used to increase stability

A

Buffering agents

48
Q

Are drugs prepared in dry state; they are packaged in sealed containers with air replaced by inert gas

A

Oxygen sensitive drugs

49
Q

Catalyst to oxidation reactions

A

Light

50
Q

Reaction between two or more identical molecules with resultant formation of new and generally larger molecules

A

Polymerization

51
Q

2 processes where one or more active chemical groups are removed (CD)

A

Chemical decarboxylation, Deamination

52
Q

Process that involves the decomposition of carboxylic acid and release of carbon dioxide

A

Decarboxylation

53
Q

Process that involves the removal of nitrogen containing group from organic amine

A

Deamination

54
Q

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

A

Accelerated stability testing

55
Q

Studies that determine the most stable of the proposed formulations for a drug product

A

Short term accelerated studies

56
Q

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

A

Stress testing

57
Q

The product is subjected to different climatic zones nationally and internationally

A

Long term stability studies

58
Q

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

A

Container

59
Q

It is in direct contact with the article at all times

A

Immediate container

60
Q

Part of the container

A

Closure

61
Q

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

A

Closure and container

62
Q

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

A

Packaging materials

63
Q

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

A

Oral liquids

64
Q

Required by many pharmaceutical products to protect them from photochemical deterioration

A

Light resistant containers

65
Q

May be added to plastic to decrease the transmission of short UV rays

A

UV absorbers

66
Q

Light resistant containers must meet the USP standards which define the acceptable limits of light transmission at any wavelength of light between __________ and __________ nm

A

290-450 nm

67
Q

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

A

Child-resistant container

68
Q

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

A

Child-proof closures

69
Q

Highly resistant, borosilicate glass

A

Type I glass

70
Q

Treated soda-lime glass

A

Type II glass

71
Q

Soda-lime glass

A

Type III glass

72
Q

General purpose soda-lime glass

A

Type NP glass

73
Q

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

A

Pharmacist

74
Q

Used to dissolve the drug substance (Types of pharmaceutical ingredients and excipients)

A

Solvents

75
Q

Used to make the product more palatable (Types of pharmaceutical ingredients and excipients)

A

Flavors and sweeteners

76
Q

Used to enhance the appeal (Types of pharmaceutical ingredients and excipients)

A

Colorants

77
Q

Used to prevent microbial growth (Types of pharmaceutical ingredients and excipients)

A

Preservatives

78
Q

Used to prevent decomposition (Types of pharmaceutical ingredients and excipients)

A

Stabilizers

79
Q

Used to increase bulk of the formulation (Types of pharmaceutical ingredients and excipients)

A

Diluents/Fillers

80
Q

Used to cause adhesion of the powdered drug (Types of pharmaceutical ingredients and excipients)

A

Binders

81
Q

Used to promote tablet breakup after administration (Types of pharmaceutical ingredients and excipients)

A

Antiadherents/Lubricants

82
Q

Used to promote tablet breakup after administration and coatings (Types of pharmaceutical ingredients and excipients)

A

Disintegrating agents

83
Q

Can mask unwanted taste (Types of pharmaceutical ingredients and excipients)

A

Sweetening pharmaceuticals

84
Q

Most commonly used sweetening pharmaceutical

A

Sucrose

85
Q

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

A

Delaney clause

86
Q

2 sweetening pharmaceutical used in foods; “generally recognized as safe” (SC)

A

Saccharin, Cyclamate

87
Q

Sweetening pharmaceutical that is banned due to possible carcinogenicity, genetic damage, and testicular atrophy

A

Cyclamates

88
Q

First artificial sweetener with requirement for pre-marketing proof of safety

A

Aspartame

89
Q

Sweetening pharmaceutical that is structurally similar to saccharin; 130 times as sweet as sucrose and is excreted unchanged in the urine

A

Acesulfame potassium (nonnutritive sweetener)

90
Q

New sweetening agent; is natural, nontoxic, safe, and is 30x sweeter than cane sugar/sucrose

A

Stevia (Stevia rebaudiana Bertoni)

91
Q

Used in pharmaceutical preparations for aesthetics (Types of pharmaceutical ingredients and excipients)

A

Coloring pharmaceuticals

92
Q

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

A

Coal tar (pix carbonis)

93
Q

Added to pharmaceutical preparation in the form of diluted solutions (Coloring pharmaceuticals)

A

Dyes

94
Q

Commonly used in the form of fine dispersions or suspensions (Coloring pharmaceuticals)

A

Lakes

95
Q

90% of the dyes used in products are synthesized from the derivative of __________

A

Benzene (Aniline)

96
Q

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

A

FDA

97
Q

Additives which are added in foods, drugs, and cosmetics

A

FD&C color additives

98
Q

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

A

D&C color additives

99
Q

Additives which are restricted to external parts of the body

A

External D&C color additives

100
Q

Are suitable substances added to enhance a drug’s permanency or usefulness

A

Preservatives

PH 107 - Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices (Lec.) (15 decks)

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