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DDS > Exam 2 > Flashcards

Exam 2 Flashcards

1
Q

_____ coating gives a smooth, rounded tablet without indentations or scores

A

sugar

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2
Q

There are ____ g in one oz

A

28.4

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3
Q

Stratification of powder mixes can occur because different particles in the mix may have different ___ properties

A

flow

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4
Q

Complete disintegration is…

A

In USP tablet test, defined as that state in which any residue of the unit (except fragments of insoluble coating or capsule shell remaining on the screen of the test apparatus) is a soft mass having no palpably firm core.

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5
Q

Triturating a colored powder in a glazed porcelain can cause the mortar to _____

A

stain (color, potent powders can get embedded in the pores)

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6
Q

For a USP dissolution test for weak base drug salt, such as propranolol hydrochloride, the medium’s pH would be expected to be on the (acidic or basic) side of neutral

A

acidic

to keep the drug in its more soluble ionized form, which is more likely to dissolve in the stomach

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7
Q

For compounding with hazardous drugs C-SECs must be (positive or negative) pressure to all adjacent areas

A

negative

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8
Q

API stands for…

A

Active Pharmaceutical Ingredient

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9
Q

Enteric coating can be applied to either granules within a tablet or capsule, or to a whole tablet in order to prevent disintegration and exposure of the drug in an _____ environment

A

acidic

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10
Q

For empty capsule shells, the greater the capsule number, the (larger or smaller) the size

A

smaller

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11
Q

Disintegrant is…

A

type of excipient helps to solve the tablet paradox of need to be hard, yet fall apart easily in the body

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12
Q

The low pH of the stomach can enable rapid dissolution of weak (acid or base) drugs

A

base

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13
Q

The category of compound for nonsterile preparations that require special training, facilities, equipment, or procedures is….

A

Complex

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14
Q

Fast-dissolving / Orally disintegrating tablets generally must be well-protected, because they can be____ and sensitive to moisture

A

brittle

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15
Q

In tablet disintegration assessment for some tablets, medium is changed from ( basic to more acid or acid to more basic) to stimulate GI passage

A

acid to more basic

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16
Q

The two main claims for fast-dissolving/ orally disintegrating tablets are:

A
  1. Easier to take + Swallow

2, Possible faster onset of action, but often not true

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17
Q

A capsule diluent with this property can draw in GI fluids, thereby increasing dispersion and thus dissolution rate.

A

Hydrophilicity

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18
Q

A tablet hardness tester measures the _____

A

crushing strength

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19
Q

A chart is…

A

old term used to describe folded powder papers

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20
Q

A trituration is…

A

defined as a potent powdered drug mixed with suitable diluent.

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21
Q

A _____ is used to assess the durability of the tablet

A

friabilator

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22
Q

According to Compounding Quality Act, Section ____ addresses the “traditional pharmacies”

A

503a

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23
Q

According to Compounding Quality Act, Section ____ addresses the outsourcing facilities

A

503b

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24
Q

Active Pharmaceutical Ingredients that can be used in compounding appear on this list issued by the FDA called…

A

positive list

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25
Q

Camphor and menthol can liquefy when mixed together because the melting points are lowered to below room temperature. This is an example of _____

A

eutectic formation

occurs because each substance is an impurity to the other

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26
Q

Geometric dilution is …

A

defined as successive equal volume additions of diluent to a concentrate, with thorough mixing between each addition

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27
Q

Communition is….

A

the process of particle size reduction

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28
Q

Compressing tablets directly from powdered material without modifying their physical nature is called …

A

direct compression

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29
Q

_____ is defined as a tablet or capsule excipient used to reduce particle to metal adhesion, thereby assisting free flow of the particles

A

lubricant

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30
Q

Disintegrants can significantly improve drug dissolution from a tablet by increasing exposed _____

A

surface area

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31
Q

Drugs on FDA (positive or negative) list may be not used in compounding, due to problems with safety or efficacy

A

negative

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32
Q

Food, liquid, and medications are emptied into the small intestines by the opening of the _____

A

pyloric sphincter

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33
Q

Gelatin is derived from this animal-based protein called ____

A

Collagen

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34
Q

Glycerin and propylene glycol are two examples of water ______ liquids used as vehicles in softgel caps

A

miscible

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35
Q

Hard gelatin capsule can contain liquids but not aqueous liquids

A

Turgor Pressure ???

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36
Q

If there is not enough of ____ in a gelatin capsule shell, it can become brittle

A

water

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37
Q

In chewable tablets, xylitiol or mannitol are often included to give a _____ sensation

A

cooling

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38
Q

In compounding, the _____ record provides a consistent source document for step-by-step preparation of the compound and is not for a specific patient, for first-time preparation.

A

Master Formulation

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39
Q

In compounding, ____ is the name given to the practitioner/patient/pharmacist/compounder relationship.

A

Triad

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40
Q

In the manufacture of tablets, the process of granulation helps to prevent stratification, and improve powder ____ and ____

A

Fluidity + Compressibility

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41
Q

In the small intestines, the ___is the major site for passive drug absorption, because of high ___ + and high ____

A

Duodenum

HIgh- Surface Area + Perfusion

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42
Q

In the stomach, ___ and small particles are generally emptied faster than digest and undigested solids (including non-disintegrated tablets)

A

liquids

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43
Q

In USP disintegration tablets, specific fluids and disintegration times are found in ____ in the USP

A

monographs

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44
Q

Magnesium stearate is a common example of this type of capsule and tablet diluent

A

Lubricant

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45
Q

One potential advantage of liquid-filled softgel caps over powder-filled hard gel caps is an improvement in ________ as exemplified by methoxsalen products.

A

bioavailability

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46
Q

One potential misunderstanding of the correct method of oral powder use is that some may choose to take it ____

A

dry

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47
Q

Oral powders can be a good alternative for (high or low) dose drugs

A

high

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48
Q

Sodium bicarbonate and citric acid are powder excipients that combine to produce ______ when the powders dissolve

A

effervescence

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49
Q

Softgel caps can appear hard because of this property…

A

Turgor Pressure

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50
Q

Soybean oil is an example of a water-(miscible or immiscible) liquids used as vehicles in softgel caps

A

immiscible

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51
Q

Tablet capping or splitting can indicate _____ problems

A

compression

52
Q

Tablet ____ may indicate coating problems

A

mottling

53
Q

Tablets prepared from enteric coated granules will ______ but will not dissolve in the stomach

A

disintegrate

54
Q

The basket rack assembly is used to assess tablet …

A

disintegration

55
Q

The behavior of enteric coating is because on their backbone, they have carboxyl groups that (ionized or do not ionized) until the higher pH of the intestines, enabling the coating to dissolve

A

do not ionized

56
Q

The judgement of BUD must be based on the specific drug and ____

A

preparation

57
Q

The most common granulation approach in tablet manufacture is ______granulation

A

wet

58
Q

The most common method of tablet coating is called ____ coating, which leaves ____and ____ visible

A

film,

indentation + scores

59
Q

The name of the finished dosage form in compounding, product or preparation.

A

preparation

60
Q

The two main purposes of enteric coating are:

A

(1) To prevent acid attack on labile ingredients

(2) To protect the stomach from irritation

61
Q

The two main reasons for locking or sealing capsules are:

A

(1) To ensure that they will not easily come apart during handling
(2) To provide tamper-resistance or tamper-evidence

62
Q

The USP BUD for Water-Containing Oral Formulations is not later than ____ days when stored at controlled cold temp

A

14

63
Q

The USP BUD for Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations is not later than ____ days

A

30

64
Q

The ____ is the date after which a compounded preparation shall not be used and is determined from the date that the preparation is compounded

A

beyond use date (BUD)

65
Q

____is a detailed information document prepared by the manufacturer or importer of a chemical that describes important safety considerations

A

Material Safety Data Sheet

66
Q

There are ____ mL in one fluid ounce

A

29.6 or 30

67
Q

There are ___ mg in one grain

A

65

68
Q

This tablet excipient helps to produce a smooth granule surface

A

Glidant

69
Q

Uptake of moisture in powders can increase chemical degradation and can cause powder _____

A

agglomeration

70
Q

USP Chapter ____addresses nonsterile compounding

A

795

71
Q

USP Chapter ____ is best practice recommendations and mandates for reducing occupational exposure to healthcare workers who handle nonsterile and sterile hazardous drugs

A

800

72
Q

USP tablet tests for drug content are:

A

Weight variation, Drug content uniformity

73
Q

USP tablet tests for drug release are:

A

Disintegration test, dissolution test

74
Q

When making by hand or machine, only this part of the capsule shell is filled

A

Body

75
Q

Whether using an electronic balance or a torsion balance, it is important to know how to do this properly with an empty capsule shell

A

Tare

76
Q

Levigation can be described as _____

A

wet grinding

77
Q

ʒ or ℨ is the symbol for ____ and it comes from Apothecary to Avoirdupois

A

dram (teaspoon)

78
Q

Specific gravity of water is

A

1

79
Q

Specific gravity of propylene glycol is

A

1

80
Q

Specific gravity of ethanol is

A

0.8

81
Q

Specific gravity of Glycerin is

A

1.25

82
Q

What is the units used for percentage calculations?

A

g/100 mL

83
Q

All should be avoided except:

Trailing zero (5.0)

Number at or above 1000 w/o commas

Writing “Unit”

Naked Decimal points (.5)

A

writing “unit”

84
Q

____ increased the role of the federal government in compounding practice

A

DQSA - HR 3204- Drug Quality and Security Act

85
Q

___ sets standards addressing a broad array of issues related to compounding

A

USP/NF

86
Q

____ is the most acceptable range for most compounded preparations.

A

+/- 10%

87
Q

Beyond use date for a compound capsule lacking specific stability information is…

A

6 months or earliest expiration date of any API (non-aqueous formulations– powders, capsules, ointments)

88
Q

_____ compounded product would be considered moderate level.

A

preps with a special calculation or procedure

89
Q

____ compounded product would be considered simple level

A

preps with USP monographs or found in peer-reviewed articles

90
Q

_____ compounded product would be considered complex level

A

Preps requiring special training, procedures, or equipment

91
Q

____ type of mortar and pestle is best for comminution (rough surface area and highly porous)

A

Wedgewood

92
Q

_____ is the wet form of comminution

A

levigation

93
Q

____ is the primary material for most capsule shells.

A

gelatin

94
Q

_____ is the common alternative material to gelatin for capsule shells.

A

cellulose

95
Q

Most common diluent for compounded capsules are…

A

lactose

96
Q

USP ____ provides quality control for capsules made by filling machines

A

1163

97
Q

_____ are plasticizers (substance added to achieve softness/flexibility).

A

glycerol
propylene glycol
sorbitol

98
Q

In tablet formation, wet granulation is the most common approach in production of tablets. What is the fourth step?

A

drying

Blending-Wetting-Granulation-Drying-Sizing -Blending-Compression

99
Q

What is an example of disintegrant?

corn starch

Colloidal silica

povidone

A

Answer: Corn starch

Colloidal silica (glidant)

Povidone (adhesive/binding agent)

100
Q

____ USP chapter sets the standard for handling hazardous drugs in healthcare settings.

A

800

101
Q

____ defined as a tablet or capsule excipient used to reduce interparticulate friction.

A

glidant

102
Q

_____ is a process in tablet manufacturing that helps prevent stratification, improve powder fluidity, and improve powder compressibility.

A

Granulation

103
Q

A drug available as a softgel capsule has the following inactive ingredients: Citric acid, glycerin, PEG400, Purified water. Which is least likely purpose of glycerin in formulation?

To serve as vehicle for drug

To serve as cosolvent for drug

To make shell opaque

To soften the shell

A

to make shell opaque

104
Q

Title 2 of DQSA: Drug supply chain security act requires…

A

tracing of pharmaceutical products throughout supply chain

105
Q

(States or federal) are primary regulators of section 503a pharmacies

A

Answer: States

if pharmacies deviate from section 503a then they become subject to federal inspection or enforcement action

106
Q

Requirements of 503a include…

A

Compounded medication must be for identified pt on receipt of order/Rx.

Have limited quantity of allowed anticipatory compounding (not a warehouse full)

Drugs taken off market CANNOT be used in compounding (negative list)

May not be a “essentially a copy” of FDA-approved drug unless preparation produce significant difference (removal of excipient)

CANNOT compound on “demonstrably difficult to compound” list (e.g. patch, MDIs inhalers)

APIs must: comply with USP/NF monograph, component of FDA-approved drug, or appeared on the positive list

107
Q

USP/NF stands for…

A

U.S. Pharmacopeia/ National Formulary

108
Q

According to Compounding Quality Act, Section ____ can produce and ship large numbers of sterile preps without a prescription

A

503b

109
Q

Main regulators of Outsourcing Facilities (503b) are (state or federal/FDA), they are not required to obtain patient-specific prescription, may not be licensed pharmacy, must comply with cGMP (just like manufacturer) requirements.

A

Answer: Federal

FDA is heavily involved in this

110
Q

The USP BUD for Nonaqueous Formulations is no later than ____

A

6 months or earliest expiration date of any API (whichever is first)

111
Q

In absence of supporting literature (BUD) , stability testing must be performed using a stability indicating assay which is…

to identify intact drug verses degradants and use this assay to get extended beyond use date.

A

an assay that can accurately and selectively differentiate an intact drug from its potential decomposition products and other components of the formulations

112
Q

In compounding, when you compound for particular patient, for each preparation and including first-time preparation, you produce this _____ record for that specific time you compound the preparation

A

Compounding Record

patient- specific

113
Q

Unit for Molecular Weight…

A

mg/mmol

114
Q

Percentage of w/v, v/v, and w/w …

A

x g/100mL
x mL/100mL
x g/ 100g

115
Q

Unit for Osmolarity…

A

mOsm/mmol

116
Q

Determine osmolarity by ..

A

number of ions

ex. NaCl will be 2 mOsm/mmol
ex. CaCl2 will be 3 mOsm/mmol

117
Q

Determine milliequivalents and the unit used is…

A

determine by highest valence electron; unit used is mEq/mmol

118
Q

Typical documentation needed for quality assurance program: _____= documents that describe how to perform routine and expected tasks in the compounding environment.

A

Standard Operating Procedures (SOPs)

119
Q

(Master Formulation or compounding) record is not for a specific preparation for a patient

A

Master Formulation

120
Q

MSDS (Material Safety Data sheets) are…

A

a detailed information document prepared by manufacturer or importer of a chemical that describes important safety considerations.

Documentation that comes with imported chemical includes reactivity data, health hazard, precaution with handling etc.

121
Q

Extemporaneous methods are done …

A

at the time of preparation (comminution with mortar and pestle)

122
Q

___ type of mortar is most preferred when working with colored and potent materials.

A

Glass

123
Q

Sodium benzoate

A

preservative

124
Q

Sodium citrate

A

buffering agent

125
Q

Effervescent powders/granules are prepared with acid/base excipient mixture that liberates ____ when combined with water, and aid in taste-masking.

A

CO2 (create gas/fizz)

126
Q

Questran Powder (Cholestyramine Resin) is a major ___ product

A

bulk

127
Q

(weak base or acid) becomes bitter if added to acidic liquid

A

weak base; bc it dissolves more readily, becomes protonated and reach taste buds quicker

DDS (29 decks)

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