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NAPLEX 2023 > Chapter 16: Compounding II - Equipment, Stability & Excipients > Flashcards

Chapter 16: Compounding II - Equipment, Stability & Excipients Flashcards

1
Q

A graduate should not be used to measure anything < ___% of its volume

A

20%

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2
Q

What are glass mortars used for?

A

Liquids such as suspensions and solutions & for compounds that are oily or can stain

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3
Q

What are wedgwood mortars used for?

A

For grinding dry crystals and hard powders (rough edges like wood)

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4
Q

What are porcelain mortars used for?

A

For blending powders and pulverizing gummy consistencies

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5
Q

What compounds should you avoid using a metal spatula with?

A

a mixture containing metal ions (will react with each other)

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6
Q

What is the largest and smallest size capsule

A

Largest: 000
Smallest: 5

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7
Q

Recommended compounding ingredients are listed in reputable sources such as

A

USP National formulary (USP-NF)
The Food Chemicals Codex (FCC)

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8
Q

If any substance comes from a non-FDA registered facility, a ____ should be obtained that confirms the specifications and quality

A

Certificate of Analysis (CoA)

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9
Q

If there is an ingredient without an expiration date, the pharmacist will assign a conservative date that is no more than ____ from the date of receipt. The label on the container should include which 2 things

A

3 years

Date of receipt and assigned expiration date

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10
Q

What is a surfactant used for?

A

To make two ingredients easier to mix together & keep the phases from quickly separating by lowering the surface tension (or the interfacial tension)

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11
Q

What is a wetting agent?

A

A type of surfactant
Reduces the surface tension between a liquid and a solid to allow the substance to more easily spread

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12
Q

Another name for wetting agent

A

Levigating agent

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13
Q

What is an emulsifier?

A

A type of surfactant
2 or more liquids which are not able to be blended together (such as water in oil). An emulsifier is added to an emulsion to help keep the liquid droplets dispersed throughout the liquid vehicle

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14
Q

What is a suspending agent?

A

A type of surfactant
A suspension is a solid in a liquid - to get the solid dispered suspending agents are used. These must still be shaken to redisperse before use

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15
Q

What is a levigating agent?

A

examples: glycerin or mineral oil
helps aid in grinding

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16
Q

What is added to suspensions to help keep the solid particles from settling?

A

Suspending agents (or dispersants or dispersing agents)

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17
Q

A suspending agent can also be a plasticizer, which means ….

A

It will make the preparation easier to shape or mold

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18
Q

Levigation and trituration are both used to …

A

grind down particles

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19
Q

What is the difference between levigation and trituration

A

Levigation uses a levigating agent like glycerin or mineral oil to aid in grinding & trituration is the grinding of particles without the addition of a liquid (the powder stays dry)

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20
Q

Mineral oil is a commonly used levigating agent for ____ compounds, and glycerin or propylene glycol are used for ____ compounds.

A
  1. lipophilic (oil-soluble)
  2. aqueous (water-soluble)
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21
Q

The ____ number determines the type of surfactant required to make an emulsion

A

hydophilic-lipophilic balance (HLB)

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22
Q

Surfactants with low HLB (<10) are more ____-soluble and are used for _____ (o/w or w/o)

A

Lipid (remember, Low = Lipid)
w/o (water-in-oil)

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23
Q

Surfactants with high HLB (>10) are more ____-soluble and are used for _____ (o/w or w/o)

A

Water (remember, High = H2O)
o/w (oil-in-water)

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24
Q

What is an example of a chelating agent to avoid metal ions from oxidating a drug?

A

Edetate disodium (EDTA)

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25
Q

What happens when epinephrine is oxidized?

A

Changes color to be amber (yellow/orange)

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26
Q

oxidation usually occurs at which functional group?

A

-OH (hydroxyl)

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27
Q

how to protect from oxidation?

A
  1. light protection
  2. correct storage temperature
  3. chelating agents
  4. antioxidants (free radical scavengers)
  5. control pH
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28
Q

What blocks metal ions from catalyzing oxidation reactions?
provide an example

A

chelating agents (EDTA, EDetate calcium disodium)

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29
Q

What binds to free radicals?

A

antioxidants

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30
Q

What are common antioxidants

A

Ascorbic acid (Vitamin C) and tocopherols (Vitamin E)

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31
Q

How do you maintain pH to avoid drug oxidation & hydrolysis?

A

Using a buffer

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32
Q

How can you prevent hydrolysis?

A
  1. avoid moisture
  2. Adsorbents (desiccants) to absorb moisture that enters container
  3. lyophilized (Free-dried) powder
  4. light protection, chelating agents
  5. hygroscopic salt (water absorbing)
  6. prodrug formulation (release drug from hydrolysis)
  7. control temperature
  8. control pH
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33
Q

functional groups susceptible to hydrolysis

A

esters, amides, lactams

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34
Q

Drugs can be stored as a ____ powder instead of a solution to avoid hydrolysis.

A

lyophilized (freeze-dried) powder

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35
Q

What kind of salt form of a drug can you use to absorb less water and will be less likely to degrade from hydrolysis

A

a salt form with lower hygroscopic properties
(hydroscopic = water-absorbing)

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36
Q

Hydrolysis occurs more rapidly at ____ (higher/lower) temperatures

A

Higher

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37
Q

compounds susceptible to UV light

A

ascorbic acid, nitroprusside, phytonadione (PM DEN = phynatodione, micafungin, doxycycline, epoprostenol, nitroprusside)

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38
Q

what are the 3 other reactions that degrade drugs?

A
  1. isomerization
  2. epimerization
  3. decarboxylation
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39
Q

Binders role

example

A

add cohesion to powders/tablets to allow them to stick together

acacia

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40
Q

Diluent and fillers role

A

diluents: dilute
fillers: bulk up small amount
both add size

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41
Q

diluent/filler examples (tabs/caps, liquids, topicals)

A
  • tabs/caps: lactulose, starches, calcium salts, cellulose
  • liquids: water, alcohol
  • topicals: petrolatum
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42
Q

Disintegrants role

exs

A

facilitates the breakup of a tablet after oral administration
- aliginates and cellulose absorb water and cause tab to swell and burst

alginic acid, cellulose products polacrilin potassium, starches

43
Q

disintegrant examples

A

alginic acid, cellulose products polacrilin potassium, starches

44
Q

Sweeteners examples

A

aspartame, sucralose
glycerin, dextrose, mannitol, sorbitol, xylitol, stevia

45
Q

Lubricants role

example

A

prevent ingredients from sticking to each other and equipment
(glidants improve powder flowability)

magnesium stearate

46
Q

____ are most accurate for measuring small volumes and viscous liquids

A

Syringes

47
Q

All syringe packages should be wiped off with ___ prior to being brought into the SEC or PEC

A

70% IPA

48
Q

T/F: syringes should be recapped to prevent needle-stick injuries

A

False - do not recap

49
Q

Which part of the syringe should not be touched due to contamination risk

A

plunger

50
Q

Providing a quick bolus dose into a vein or into a vein through the catheter is called

A

IV push

51
Q

A ___ pipette draws up a set volume only, which is the volume the pipette can hold

A

Volumetric

52
Q

A ____ pipette is graduated and is used to measure different volumes

A

Mohr

53
Q

____ balances have internal weights, which are used to weight quantities ≤ 1 gram

A

Class III (Class A) torsion balances

54
Q

Torsion balances have a ____ requirement

A

Sensitivity

55
Q

The minimum weighable quantity (MWQ) on a torsion balance calculation

A

0.05 or 5%

MWQ = SR / acceptable error rate (0.05 or 5%)

56
Q

What is the most commonly used balance

A

electronic balance aka analytical balance or scale

57
Q

Electronic balances are simple to use and have higher ____

A

sensitivity

58
Q

A compounding pharmacy needs at least one ___ and one ____ mortar and pestle

A

1 glass

1 Wedgwood or porcelain

59
Q

What equipment can be used to mix ingredients

A

Ointment mills, homogenizers, and grinders

60
Q

Small particle size and increased surface area = (increased or decreased) rate of absorption

A

Increased

61
Q

What is an ointment mill

A

Draws the ointment or another semi-solid preparation between rollers that grind and homogenize (i.e., make non-gritty, smooth and uniform) the ingredients in the preparation

62
Q

Capsule shells are made from

A

gelatin, which is pork-derived or hypromellose or a similar plant-derived product

63
Q

What are examples of commercially available suspending agents

A

Ora-Plus & Ora-Sweet

64
Q

Example of an anti-foaming agent used in non-sterile compounding

A

Simethicone

65
Q

What are both PEG and poloxamer used for?

A

delivery vehicles and surfactants

66
Q

Poloxamer is useful for ___ drug delivery

A

topical
[poloxamer can be used to distribute ingredients in a preparation into the “like” phase (hydrophobic –> organic lipophilic phase)]

67
Q

What are the 3 types of chemical reactions that can cause most drug products to become unstable and degrade

A

Oxidation-Reduction (OIL-RIG)
Hydrolysis
Photolysis

68
Q

What are free radicals

A

metal ions that have an unshared electron. They can catalyze oxidation chain reactions. Chelators can be used to chelate the metal ions with the unshared electron

69
Q

Examples of common fillers

A

Lactose, starches (many, including corn, rice, wheat), calcium salts, bentonite, cellulose, petrolatum

70
Q

___ absorb water, causing tablets to swell and burst. ____ from plants can also absorb water well

A

Alginates

Cellulose

71
Q

____ is a common anti-adherent and is used to improve powder flowability

A

Magnesium stearate

72
Q

Examples of preservatives
Do not use preservatives in what population?

A

Chlorhexadine (used as a surgical scrub also), Povidone iodine, Sodium benzoate/benzoic acid, benzalkonium chloride, sorbic acid/potassium sorbate, methyl/ethyl/propyl parabens, EDTA, thimerosal, cetylpyridium chloride
NEONATES

73
Q

____ compounds are more polar, which makes compounds more ___-soluble

A

Ionized

water-soluble

74
Q

The pH of a buffer system can be calculated with

A

The Henderson-Hasselbalch equation

75
Q

Types of purification (of water)

A

distillation, deionization, reverse osmosis

76
Q

Distilled water is often used for

A

reconstitution to prepare oral suspensions and in non-sterile compounding preparations

77
Q

sterile water must be free of ____ which is also known as ____

A

bacterial endotoxins = pyrogens

78
Q

Alcohols have high miscibility (mixes easily) with ____

A

water

79
Q

benzyl alcohol uses

A

solvent, preservative and fragrance

80
Q

What is the preferred disinfectant in sterile compounding

A

IPA 70%

81
Q

PEG is ___-soluble and ___-miscible

A

water
water

82
Q

PEG is used as a

A

surfactant, solvent and lubricant

83
Q

When PEG is linked to a protein drug (pegylated), such as PEG-filgrastim, it increased the

A

half-life

84
Q

___ is a PEG mixture that is commonly used as a suppository base and is a good emulsifier

A

Polybase

85
Q

An emollient is a product that

A

softens and soothes the skin

E mole on the skin

86
Q

Purpose of occlusive ointments

A

form a protective barrier to prevent the loss of water molecules from the top layer of the skin

87
Q

___ are put into many emollient formulations to pull in water from the atmosphere to moisturize the skin

A

Humectants

88
Q

Examples of humectants

A

Glycerin or glycerol, propylene glycol and PEG

89
Q

What percent of an ointment is water

A

0-20%

90
Q

Ointments are best for

A

extremely dry skin and thick skin

91
Q

Examples of ointments

A

petrolatum, polybase, aquaphor, aquabase

92
Q

What is an oleaginous ointment?
example?

A

contains no water
petrolatum (vasoline)

93
Q

Creams are greater than __% water and up to __% oil

A

20%
50% (about half and half)

94
Q

Creams are best for

A

normal and dry skin

95
Q

___ have the most water

A

Lotions
- can have a small amount of alcohol to solubilize ingredients

96
Q

What is best for oily skin

A

Lotions

97
Q

What are the 4 ointment groups

A
  • Hydrocarbon bases - aka oleaginous (contain no water; examples are Vaseline)
  • Absorption bases
  • Water-removable bases (creams)
  • Water-soluble bases (gels)
98
Q

Aqueous solutions of poloxamers are ___ when refrigerated and ___ at room temp

A

liquid
gel

99
Q

what is Poloxamer Lecithin Organogel (PLO)?

A

gel - contains one hydrophobic and 2 hydrophilic chains - can be used for both phobic and philic drug delivery

100
Q

polybase, hydrogenated vegetable oils and gelatin can be used as ____

A

suppository bases

101
Q

Examples of adsorbents

A

Magnesium oxide/carbonate, kaolin

102
Q

Shellac, gelatin, gluten are used for ____

A

regular coating

103
Q

cellulose acetate phthalate is used for

A

enteric coating

104
Q

Avoid these agents in what patients:
1. alcohol
2. aspartame
3. gelatin
4. gluten
5. lactose
6. preservatives
7. sorbitol
8. sucrose
9. xylitol

A
  1. children
  2. phenylketonuria
  3. vegetarians and vegans (contains pork)
  4. celiac
  5. lactose intolerance
  6. neonates
  7. IBS
  8. diabetes
  9. dogs

NAPLEX 2023 (88 decks)

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