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1. NAPLEX Prep > Compounding III > Flashcards

Compounding III Flashcards

1
Q

Master formula record

A

The recipe that is followed to compound a preparation

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2
Q

Compounding log

A

The log book of all products made at the pharmacy

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3
Q

The documentation in the compounding log must be

A

detailed enough to replicate.

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4
Q

The pharmacy must keep record of all____________________related to compounding

A

all steps and processes

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5
Q

When ready to compound, the ________________will be similar for most formulations, including

A

Initial steps
-Weighing ingredients
Final steps will also be similar

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6
Q

What should you review for each bulk ingredient to determine safety procedures?

A

SDS

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7
Q

Master formula: What you

A

SHOULD do

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8
Q

Compounding record log: What you

A

DID

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9
Q

Minimal PPE for non sterile non hazardous drugs

A

Clean lab coat
Gloves

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10
Q

Comminution

A

Reduce particle size by grinding, crushing, milling, vibrating

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11
Q

How to reduce particle size

A

Comminution
-Trituration, levigation and spatulation, pulverization

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12
Q

After powders are finely ground, what are they placed in?

A

Sieve (sifter) to ensure uniform particle size

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13
Q

Once placed in a sieve, the powder is

A

stirred with a sieve brush or plastic spatula to force the particles through the mesh.
The sieve number is based on the number of holes per inch

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14
Q

Trituration

A

“mix thoroughly” or make homogenous
-Grinding tablets with a mortar and pestle
-Triturating an emaulsion by shaking it

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15
Q

Levigation

A

Using a liquid (levigating or wetting agent) to help with the grinding process and form a uniform paste.

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16
Q

Spatulation

A

Similar to levigation, but performed on ointment slab with a spatula instead of on a mortar and pestle

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17
Q

Pulverization by intervention

A

Used for powders not easily crushed.
The crystals are dissolved with an intervening solvent and mixed until the solvent evaporates.

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18
Q

Geometric dilution

A

Small amount of drug is mixed with equal amount of diluent. After thoroughly mixed, another equal amount is mixed in. Repeat until all mixed.

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19
Q

Solution

A

Solute dissolved in a solvent
Homogenous

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20
Q

Types of solutions

A

Syrups
Elixirs
Tinctures
Spirits

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21
Q

Suspension

A

Solid dispersed in liquid
Heterogenous
Wetting agent/levigating agent is used to incorporate the drug into the liquid.
Must redisperse easily by shaking

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22
Q

Emulsion

A

Liquid dispersed in a liquid
Heterogenous mixture, either oil-in-water or water-in-oil
Make sure emulsifier is chosen according to HLB

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23
Q

Precipitation/sedimentation

A

Occurs with suspensions and emulsions
Shake or roll to redisperse

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24
Q

How to prepare solutions

A

1.) Solute must dissolve in solvent. The drug must remain soluble at various temps.
2.) Calculate dissolution rate base don Ficks First Law of Diffusion
Larger SA- stir and use heat to increase dissolution rate
3.) Determine need for buffer system, preservative, flavorings, etc.

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25
Q

How to prepare suspensions

A

1.) Wet powder and levigate to form paste.
2.) Homogenizer will help form a uniform suspension
3.) Preservative, flavorings, sweeteners may be needed

Even with sufactants used as suspending agents, will still need to be redispersed

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26
Q

How to prepare emulsion

A

4 parts oil
2 parts water
1 part gum (acacia)

Levigate gum with either oil or water. If oil, must be added slowly, Water can be added all at once.

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27
Q

Glidant/lubricant used to improve the flowability of powder

A

Magnesium stearate

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28
Q

Surfactant used to neutralize static charge of powder

A

Sodium lauryl sulfate

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29
Q

Melting point order

A

Melt ingredient with the highest melting point prior to adding the ingredients with a lower melting point

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30
Q

Eutectic mixtures

A

The combination of ingredients will melt at a lower temperature than the individual ingredients

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31
Q

Adsorbent powder

A

Magnesium oxide
Magnesium carbonate
Kaolin

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32
Q

What plasticizers are used to make capsules less brittle?

A

Glycerol
Sorbitol

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33
Q

How to prepare capsules

A

Hand filling- punch method, open end of the capsule is punched into the powder.
Manual capsule filling machine

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34
Q

Largest capsule size

A

000

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35
Q

Smallest capsule size

A

5

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36
Q

What is the most common tablet type used in compounding

A

Molded tablet

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37
Q

What is the most common tablet type used in manufacturing

A

Compressed tablet

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38
Q

How to prepare molded tablets

A

Triturate dry ingredients by geometric dilution
Alcohol and/or water added to moisten the powder.
Mold the pasty consistency into tablets using a tablet mold and allow to dry

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39
Q

Lozenges

A

troches
Contains a base of sucrose or syrup for hard lozenges
PEG for soft lozenges
Glycerin or gelatin for chewable lozenges

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40
Q

How to prepare ointments

A

Powders should be triturated well using a levigating agent and mixed with base using geometric dilution.
Some require heat- fusion method
Melt highest melting point followed by lowest

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41
Q

What should be used for transdermal drug admin

A

PLO gel

42
Q

Oil-soluble suppository base

A

Cocoa butter/ theobroma oil
Hydrogenated vegetable iol

43
Q

Water-soluble suppository base

A

PEG
Gelatin

44
Q

If a suppository melts easily

A

such as theobroma oil/cocoa butter, need to store in refrigerator. Will start to melt when helt.

45
Q

Density factor

A

Calculate the amount of base needed

46
Q

How to prepare suppositories

A

Hand molding
Fusion molding- RT molds and left to harden
Compression molding- uses drugs density factor

47
Q

If a lubricant is used in a suppository, it must be

A

opposite of the base in terms of solbility
Glycerin and PEG are good lubricants for oil-soluble supp bases
Mineral oil or vegetable oil are good lubricants for water-soluble supp bases

48
Q

Nonaqueous formulations BUD

A

no later than 6 months RT

49
Q

Water containing oral formulation BUD

A

Not later than 14 days at refrigerator

50
Q

Water containing topical formulations BUD

A

Not later than 30 days RT

51
Q

BUDs for repackaged drugs

A

Manufacturers expiration date or 6 months from repackaging date, whichever is earlier

52
Q

Lidocaine, alcohol USP and distilled water buccal dental gel BUD

A

30 days

53
Q

Diclofenac powder in propylene glycol BUD

A

180 days

54
Q

Lidocaine and Benadryl in poloxamer gel with lecithin/isopropyl palmitate BUD

A

30 days

55
Q

Calamine powder prepared with glycerin and alcohol BUD

A

30 days

56
Q

Progesterone supp in an oleaginous base BUD

A

180 dys

57
Q

Morphine powder with stevia sweetener in a PEG lozenge BUD

A

180 days

58
Q

Estradiol powder, black cohosh powder, soybean oil capsules BUD

A

180 days

59
Q

Cipro and dex in Versabase lotion BUD

A

30 days

60
Q

Polymyxin and hydrocortisone emulsion cream BUD

A

30 days

61
Q

Nystatin popsicle with 80% sorbitol and water solution BUD

A

14 days refrigerated

62
Q

Topical preparation of zinc oxide and white petrolatum BUD

A

180 days

63
Q

APAP, benadryl, hydroxyzine oral suspension in lemon syrup (citric acid, water, lemon) BUD

A

14 days refrigerated

64
Q

Metronidazole topical solution with propylene glycol and water BUD

A

30 days

65
Q

Quality Assurance Plan

A

includes SOPs (how to perform routine and expected tasks)
Include periodic testing of finished products- either in house or outsourex

66
Q

Labeling of all compounded products

A

BUD
Storage and handling
Topical- for external use only
Emsulsions, suspensions- shake well

67
Q

ADRs from a compounded product should be

A

Reported to the pharmacy and the pharmacist must record in the compounding record

68
Q

Isotonic to human blood

A

285 mOsm/L

69
Q

Non-PVC bags should be used for

A

IV meds that have leaching or sorption issues

70
Q

Prior to withdrawing any liquid from a vial,

A

inject a volume of air equal to the volume of fluid to be removed.
DO NOT inject air prior to removing HD from vials.

71
Q

Terminal sterilization

A

Required for high risk CSPs
Steam sterilization-autoclave
Do not use heat on heat sensitive drugs

72
Q

CSPs that are heat labile

A

Hormones, insulin, other proteins
Can be sterilized with filtration using a 0.22 micron filter
Must use the bubble-point test to test the filter integrity

73
Q

Label requirements on CSPs

A

Names and conc of ingredients
Storage requirements
If HD- label
Auxilliary labels
High alert meds have additional labels

74
Q

Endotoxins

A

Produced by gram positive, negative, and fungi
Gram negative is most potent.
Pyrogens can come from using equipment washed with tap water

75
Q

How to avoid pyrogens

A

Glassware and utensils should be rinsed with sterile water and depyrogenated using dry-heat/steam sterilization using an autoclave

76
Q

If a CSP needs to be tested for endotoxins

A

Reagent for the bacterial endotoxin test is called limulus amebocyte lysate

77
Q

Low risk sterile compounding

A

Uses 1-3 components that are supplied as sterile from the manufacturer

78
Q

Medium risk sterile compounding

A

> 3 ingredients added
TPN
Batch drugs

79
Q

High risk sterile compounding

A

Non sterile ingredients used
End product needs to be sterilized

80
Q

CSPs intended for use beyond the recommended BUD must have

A

sterility testing using either TSB or fluid thioglycollate medium and include bacterial endotoxin testing prior to use

81
Q

Low risk CSP BUD

A

48 hours RT
14 days refrigerated
45 days frozen

82
Q

Medium risk CSP BUD

A

30 hr RT
9 days refrigerated
45 days frozen

83
Q

High risk CSP BUD

A

24 hour RT
3 days refrigerated
45 days frozen

84
Q

Low risk CSP prepared in an isolator BUD

A

12 hours

85
Q

CSP prepared for immediate use BUD

A

1 hour

86
Q

SDC punctured outside of ISO 5 BUD

A

1 hr

87
Q

SDC punctured inside of ISO 5 BUD

A

Up to 6 hours

88
Q

Ampule BUD

A

discard immediately

89
Q

MDC BUD

A

28 days whether punctured in ISO 5 environment or not

90
Q

Class I recall

A

Reasonable probability that exposure will cause serious AE

91
Q

Class II recall

A

Probability of harm is remote

92
Q

Class III recall

A

Exposure not likely to cause health effects

93
Q

Osmolarity

A

Includes all solutes

94
Q

Tonicity

A

Includes only solutes that do not cross the vasculature

95
Q

Hypertonic saline

A

Causes water to move out of RBCs in an attempt to dilute the solute concentrations.
Often restricted.

96
Q

High osmolarity should be administered via

A

central line to avoid phlebitis

97
Q

Hypotonic

A

Lower osmolarity than blood

98
Q

When pH rises,

A

hydrogen ions will be released to make the blood more acidic

99
Q

When pH falls,

A

Hydrogen ions will be picked up by bicarbonate to make the blood more basic

100
Q

Preparations must be kept in narrow pH range to

A

avoid damaging tissue and causing pain

101
Q

Compounding products with a narrow pH range need a

A

buffer system- consists of an acid and its salt

1. NAPLEX Prep (15 decks)

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