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NAPLEX 2023 > Chapter 17: Compounding III - Documentation and Preparation > Flashcards

Chapter 17: Compounding III - Documentation and Preparation Flashcards

1
Q

What is the master formula record

A

Recipe that is followed to compound a preparation

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2
Q

What is the compounding log (or record)

A

the log book of all products made at the pharmacy

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3
Q

What is the minimum PPE required when preparing non-sterile, non-hazardous preparations

A

Clean lab coat and gloves

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4
Q

The compounded product should be made using

A

the master formula

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5
Q

Unit-dose repackaging require beyond-use-dates, which should be:

A

the manufacturer’s expiration date from the original container or 6 months from the repackaging date, whichever is earlier

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6
Q

what is comminution?

A

To reduce particle size by grinding, crushing, milling, vibrating or other processes

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7
Q

After particles have been finely ground, it is placed into a ____

A

Sieve (or sifter)
They are used to ensure that particle size is uniform

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8
Q

The sieve number is based on

A

the number of holes per inch (e.g., #100 sieve has 100 openings/inch)

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9
Q

What are the 3 main methods of comminution

A

Trituration
Levigation
Pulverization

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10
Q

General term used to mean “mix thoroughly” (or make the product homogenous)

A

Trituration

can describe liquids too, e.g., triturating an emulsion by shaking it

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11
Q

What is levigating

A

Involves triturating the powder with a mortar and pestle by incorporating a small amount of liquid (called a levigating agent or wetting agent) to help with the grinding process

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12
Q

What is spatulation

A

Similar to levigation, but performed on an ointment slab with a spatula

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13
Q

What is pulverization by intervention

A

It is used for crystalline powders that will not crush easily. The crystals are dissolved with an intervening solvent and mixed until the solvent evaporates. When the powder crystallizes, the particles are finer and easier to work with

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14
Q

What is the method used to ensure the ingredients are evenly distributed in a diluent or delivery vehicle

A

Geometric dilution

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15
Q

Approved substances for compounding should be manufactured at a(n)

A

FDA-registered facility

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16
Q

If any substance for compounding comes from a non-FDA registered facility, what should be obtained to confirm the specification and quality requirements

A

Certificate of Analysis (CoA)

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17
Q

If there is a component without an expiration date, the label should contain which 2 dates

A

Date of receipt and assigned expiration date

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18
Q

What is a type of surfactant used to incorporate an insoluble drug into a liquid, which makes a suspension

A

A wetting agent/levigating agent

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19
Q

What is a type of surfactant that is used to reduce the surface tension between oil and water & allows them to come closer together

A

An emulsifier

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20
Q

To make an emulsion, the emulsifier will need to be carefully chosen, according to

A

hydrophilic-lipophilic balance (HLB)

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21
Q

Examples of common emulsifiers

A

Acacia, PEG

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22
Q

Precipitation/sedimentation can happen with

A

Suspensions and emulsions

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23
Q

What is the initial step in preparing any solution?

A

To determine if the solute will dissolve in the solution

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24
Q

The dissolution rate of a solution can be used to determine the time it will take for the solute to dissolve and can be calculated using

A

Fick’s First Law of Diffusion

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25
Q

What can increase the dissolution rate of a solution

A
  • Large surface area (i.e., smaller particles)
  • stirring the preparation
  • Using heat
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26
Q

To prepare an emulsion, the Continental gum method (aka ____) uses oil, water and an emulsifier in a ____ : ____ : ____ mixture in the order ____

A

Dry gum method
4:2:1
OWE (4 parts oil, 2 parts water, and 1 part emulsifier)

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27
Q

How to prepare an emulsion with the Continental gum method

A
  • Levigate the gum with oil
  • Ddd water all at once
  • Triturate the mixture by shaking it until the cracking sound is heard and the mixture looks creamy white
  • Add other ingredients up to the final volume
  • Homogenize with machine

the continent is dry - so can add water all at once

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28
Q

To prepare an emulsion, the English gum method (aka ____) uses oil, water and an emulsifier in a ____ : ____ : ____ mixture in the order ____

A

The Wet Gum method
4:2:1
OWE (4 parts oil, 2 parts water, and 1 part emulsifier)
(same as dry gum)

rains a lot in england = wet method

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29
Q

How to prepare an emulsion with the English gum method

A
  • Triturate the gum (emulsifier) and water to form a mucilage (which is thick and sticky)
  • Add oil slowly while triturating (shaking) to form the emulsion
  • Add other ingredients up to the final volume
  • Homogenize with machine
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30
Q

Which excipient is used as a glidant/lubricant to improve the flowability of a powder

A

Magnesium stearate

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31
Q

Which excipient is used to neutralize the static charge and keep the powder from floating away

A

Sodium lauryl sulfate

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32
Q

For any formulation, if melting ingredients, melt the ingredient with the ___ melting point prior to adding the ingredients with the ___ melting point

A

Higher
lower

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33
Q

What is a eutectic mixture?

A

The combination of the ingredients (when mixed together) will melt at a lower temperature than either of the individual component’s melting temperatures

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34
Q

An adsorbent powder such as ___, ___ or ___ can be used to keep powder dry

A

Magnesium oxide
Magnesium carbonate
Kaolin

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35
Q

If the amount of powder per dose is very small, it will be necessary to add a(n) ____

A

inert filler (diluent)

36
Q

What ingredients are used as plasticizers to make capsules less brittle and more flexible

A

Glycerol and Sorbitol

37
Q

Powder is put into capsules by either hand filling (aka ____) or by using a machine

A

punch method

38
Q

The ____ tablet is the most common tablet type made in compounding, and the ____ tablet is the most common type made in manufacturing

A

Molded
Compressed

39
Q

A lozenge contains the active drug in what bases?
1. hard lozenges
2. soft lozenges
3. chewable lozenges

A

Hard: sucrose or syrup

soft: PEG
chewable: glycerin or gelatin

40
Q

Which kind of gel can be used for transdermal drug administration

A

Pluronic lecithin organogel

41
Q

Poloxamer is ___ at low temperatures but forms a ____ at room temperature

A

liquid
gel

42
Q

Oil-soluble bases for suppositories include

A

cocoa butter (known as theobroma oil) and hydrogenated vegetable oils

Cocoa is brown like poop

43
Q

Water soluble bases for suppositories include

A

PEG and gelatin

44
Q

To calculate the amount of base displaced in a suppository, the ____ of the drug is needed

A

density factor

45
Q

How to calculate densitive factor

A

DF = B / (A-C+B)
A = weight of suppository bank
B = weight of medication per suppository
C = weight of medicated suppository

46
Q

What are the 3 ways to prepare suppositories

A
  • Hand molding (no heating)
  • Fusion molding (heating)
  • Compression molding (need weight of empty molds and DF)
47
Q

A ____ plan outlines the steps and actions that ensure the maintenance of proper standards for the compounded preparation

A

Quality assurance

48
Q

The QA plan includes the ____, which are itemized steps on how to perform routine and expected tasks

A

Standard Operating Procedures

49
Q

BUD for nonaqueous formulations (such as a drug in petrolatum)

A

not later than 6 months
Store at room temp

50
Q

BUD for water-containaing oral formulations (such as an oral suspension)

A

Not later than 14 days
Store in refrigerator (ALL water-containing oral formulations required by USP)

51
Q

BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations (such as a cream or lotion)

A

Not later than 30 days
Store at room temperature

52
Q

Must know BUDs:
1. water-containing oral
2. water-containing topical
3. non-aqeuous

A
  1. ≤ 14 days - REFRIGERATE
  2. ≤ 30 days - room temp
  3. ≤ 6 months - room temp
53
Q

What should be done if there is an ADR resulting from a compounded product

A

The patient should report it to the pharmacy and the pharmacist will need to record the ADR in the compounding record

54
Q

The pH of sterile preparations should be close to ___

A

neutral (7)

55
Q

___ bags should be used for IV medications that have leaching or sorption issues issues

A

Non-PVC bags

LATTIN = lorazepam, amiodarone, tacrolimus, taxanes, insulin, NTG

56
Q

What is needed to when drug is from an ampule

A

Filter needle or filter straw to remove broken glass pieces

57
Q

Vials that contain lyophilized or freeze-dried powder needs to be reconstituted by adding ____

A

sterile water

58
Q

What mOsm/L is considered isotonic for the human body?

A

~285 mOsm/L

59
Q

___ are IV bags or syringes that contain a small volume (up to 50-100 mL)

A

Small volume parenterals

60
Q

What is an example of a ready-to-use vial/bag system

A

ADD-Vantage
(used at bedside for immediate use)

61
Q

Prior to withdrawing any liquid from a vial, inject a volume of air equal to the volume of fluid to be removed, with the exception of

A

hazardous drugs from vials

62
Q

How should a glass ampule be opened

A

Snap the neck so sharp end away from you

63
Q

Which technique should be used to inject HD vials

A

negative-pressure technique
(inject needle, invert, with needle in air part pull back to get air, move needle to liquid portion which will act as suction to pull liquid into syringe - do in small increments)

64
Q

___ sterilization is required for high-risk CSPs

A

Terminal sterilization
most things - steam sterilization with an autoclave
proteins - use 0.22 micron filter

65
Q

Which compounded sterile products are heat-labile

A

Hormones, insulin, other proteins

66
Q

compounded sterile products that are heat-labile can be sterilized with filtration using

A

a 0.22 micron filter

67
Q

If filtering is used, what test must be done to test the filter integrity

A

the bubble-point test
(uses pressure to push out bubble)

68
Q

To avoid pyrogens from washing equipment with tap water, glassware and utensils should be rinsed with ___ and depyrogenated using ____ sterilization with an ____

A

sterile water and depyrogenated using dry-heat (steam) sterilization with an autoclave

69
Q

The reagent for the bacterial endotoxins test is called the

A

Limulus Amebocyte Lysate (LAL)

70
Q

USP categorizes CSPs by

A

risk of contamination (low, medium, high)

71
Q

Low-risk sterile compounding uses ____ - ____ components that are supplied as sterile from the manufacturer

A

1-3

72
Q

If more than ___ sterile components are injected into an IV bag, the CSP is medium risk

A

3

73
Q

Examples of medium risk CSPs

A

PNs and making a batch of drugs

74
Q

high-risk sterile compounding uses ____ ingredients and will need to be ____ before use

A

non-sterile ingredients
sterilized

75
Q

Sterility testing for high-risk CSPs and CSPs intended for use beyond the recommended BUD must use either ___ or __, and include __ testing prior to use

A

Tryptic soy broth (TSB) or fluid thioglycollate medium (FTM) and include bacterial endotoxin testing prior to use

76
Q

The BUD is determined by USP ___ standards & the stability/expiration date of the individual ingredients, whichever is shorter

A

797

77
Q

The BUD is determined by the ____ and ___

A

CSP risk level and the storage temperature

78
Q

CSPs administration times of **low risk **
1. room temp BUD
2. refrigerated BUD
3. frozen BUD

A
  1. 48 hours
  2. 14 days
  3. 45 days
79
Q

CSPs administration times of medium risk
1. room temp BUD
2. refrigerated BUD
3. frozen BUD

A
  1. 30 hours
  2. 9 days
  3. 45 days
80
Q

CSPs administration times of high risk
1. room temp BUD
2. refrigerated BUD
3. frozen BUD

A
  1. 24h
  2. 3d
  3. 45d
81
Q

CSPs administration times of low risk in SCA (not cleanroom):
1. room temp BUD
2. refrigerated BUD

A
  1. 12h
  2. 12h
82
Q

CSPs administration times for emergency/immediate use
at room temp BUD

A

1h

83
Q

___ includes all solutes and ___ includes only the solutes that do not cross the vasculature (membranes)

A

Osmolarity
Tonicity

84
Q

Saline concentrations that are greater than 0.9% are

A

hypertonic

85
Q

When hypertonic saline is administered into a peripheral vein, the high conc of solutes relative to the conc in the blood will cause water to move ____ of the RBCs in an attempt to ___ the solute conc

A

out
dilute

86
Q

Solutions with higher osmolarity should be administered via a

A

central line (to avoid phlebitis)

87
Q

What labeling is required on CSPs

A

names and concentrations of ingredients
total volume
BUD
route of administration
storage requirements
+ HD need special HD label
+ auxillary label
+ high alert medications special lables

NAPLEX 2023 (88 decks)

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