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Non-sterile Compounding > notes > Flashcards

notes Flashcards

1
Q

sterile and non-sterile compounding best prsactices are set by what department?

A

USP

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2
Q

sterile and non-steruile compounding are exempt from what FDA rule?

A

exempt from FDA approval and cGMP

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3
Q

what is the difference between simple, moderate and complex compounding?

A

simple: reconstituting (adding one or two ingredients like water or alcohol)
moderate: requires calculation and procedures
complex: requires special training, facilities, equipment, etc.

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4
Q

personnel training rules

A

personnel must be trained for specific type of compounding and the training must be documented

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5
Q

garb attire rules

A

garb attire will depend on the type of compounding performed

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6
Q

how should the space be allocated?

A

compounding area must be separate from rest of pharmacy

non-sterile compounding area must be separate from sterile compounding area

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7
Q

manufactured drugs must follow what department rule?

A

FDA approval and cGMP

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8
Q

when selecting a measuring device, which should be used?

A

equal capacity or slightly larger

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9
Q

What is a graduate?

A

it is a measuring equipment with lines on the glass to measure volume

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10
Q

what is the difference from a graduated cylinder and a conical graduate?

A

graduated cylinder has equal diameter from top to bottom and is more accurate than the conical graduate

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11
Q

why is the conical graduate less accurate?

A

because wider the mouth, the less accurate

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12
Q

where should the measurement be read?

A

at the bottom center of the meniscus read at eye-level

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13
Q

What is the most accurate device for measuring small volumes?

A

oral or a hypodermic syringe

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14
Q

What measuring device is particularly useful for measuring viscous liquids?

A

oral or a hypodermic syringe

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15
Q

What is a mohr pipette?

A

It is a volumetric pipette (graduated) that draws up a set volume. It is useful for very small volumes.

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16
Q

What are the types of weighing equipment used?

A 
electronic balance (analytical balance)
class torsion III balance (Class A balance)
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17
Q

What is the difference between the weighing equipment?

A

analytical is simpler, has higher sensitivity, and can weigh small amounts accurately

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18
Q

If a powder is supposed to be weighed, what should the powder be placed on?

A

a weight boat or a coated glassine weighing paper

must zero out on scale before placing powder in

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19
Q

What is the sensitivity requirement and minimum weighable amount of the class III or class A weighing equipment?

A

Sensitivity requirement is 6mg
minimum weighable amount is 120mg

measured with a 5% acceptable error rate

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20
Q

What types of mortar & pestle should be in a pharmacy?

A

a glass mortar & pestle AND either a wedgewood or porcelain mortar & pestle

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21
Q

what is a glass mortar & pestle good for?

A

liquids and oily or staining compounds

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22
Q

what is a wedgewood mortar & pestle good for?

A

it has a rougher surface so grinding harder crystals or harder powders

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23
Q

what is a porcelain mortar & pestle good for?

A

has a smoother surface so good for blending powders or pulverizing gummy consistencies.

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24
Q

what does it mean to reduce particle size?

A

grinding to smaller and more uniform size particles

this increases SA therefore speeding up absorption

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25
Q

What types of spatula are used?

A

stainless steel
plastic
hard rubber

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26
Q

When would you NOT use a stainless steel spatula?

A

for mixtures that contain metallic ions

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27
Q

what is used to mix ointments or roll out pills?

A

ointmint slab, pill tiles, disposable parchment ointment pad

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28
Q

what is an ointment mill?

A

it is an electric device that draws the ointment between rollers for a smoother product

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29
Q

what is a homogenizer?

A

it is an electric mortar and pestle that can also mix ointment, creams or other semi solids

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30
Q

What is a hot plate and magnetic stirrer used for?

A

the magnet in the hot plate causes the stir bar to continually spin therefore it is good for dissolving ingredients

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31
Q

What are 2 documents that each compounded product must have

A

a master formulation record and a compounding record

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32
Q

What is a QA plan?

A

it is an itemized standard of procedures to ensure maintenances of expected standards in a pharmacy.

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33
Q

What should a QA program include?

A

periodic testing of the finished compounded preparation. can either be done in-house or sent to an outsourcing facility to conduct sterility testing.

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34
Q

patient counseling of ADRs to compounded products

A

should be reported to he pharmacy and the pharmacist must record in compounding log

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35
Q

what is communition?

A

it is to reduce particle size

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36
Q

What are two ways of communition? what is the difference?

A

trituration and levigation

trituration is grinding the powder into finer particles in a mortar & pestle

levigation is like trituration except a wetting gent or levigating agent is used to help with the grinding process

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37
Q

what is spatulation?

A

When a spatula is used instead of a pestle in a mortar

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38
Q

what is geometric dilution?

A

when a small amount of drug is mixed with equal parts of other ingredients. Once this is mixed then another small amount of drug is mixed with equal amounts of other ingredients. This is to make a uniform product.

Akin to adding dry to wet in small amounts to prevent lumps in baking.

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39
Q

where should the compounding ingredients come from?

A

preferable from a FDA registered facility. If it is not from a FDA registered facility, then a certificate of analysis (CoA) should be obtained.

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40
Q

What should the pharmacist do if a compounding component does not have an expiration date?

A

the pharmacist must write on the container the date of receipt (arrival to pharmacy) and the conservative approach which is up to 3 years expiration date from the date of receipt.

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41
Q

what is magnesium stearate?

A

It is a glidant/lubricant that improves flowability of powder

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42
Q

what is sodium lauryl sulfate?

A

it is a surfactant that neutralizes static charge to prevent powder from floating away

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43
Q

What does the sieve number signify?

A

of holes per inch

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44
Q

What are eutectic mixtures?

A

When ingredients combined melt at a lower temperature than the melting temperature of the individual components

45
Q

What ingredients can keep eutectic mixtures dry?

A

magnesium carbonate
magnesium oxide
kaolin

46
Q

what are capsule shells made of?

A

gelatin (animal)

hypromellose (vegetable)

47
Q

what are glycerol and sorbitol used for in capsules?

A

they are plasticizers to make capsules less brittle and more flexible

48
Q

What is the most common tablet type made in compounding?

A

molded tablet

49
Q

active ingredients in hard lozenges are put into what base?

A

syrup or sucrose

50
Q

active ingredients in soft lozenges are put into what base?

A

PEG

51
Q

active ingredients in chewable lozenges are put into what base?

A

glycerin or gelatin

52
Q

What type of compounded preparation contains most water?

A

lotions

53
Q

what type of compounded preparation contains least amount of water?

A

ointment

54
Q

What are the 5 types of ointment (dependent on base)?

A 
oleaginous (oily/greasy)
absorption base
water in oil emulsion base
oil in water emulsion base
water soluble base
55
Q

what is the fusion method and how should it be applied?

A

when heat is required to mix ingredients well especially in ointments

melt ingredient with highest melting point first then add ingredients as melting temperature decreases. use lowest temp possible.

56
Q

What is the thickest ointment preparation?

A

paste

57
Q

What is pluronic lecithin organogel? (PLO)

A

it is commonly used in transdermal delivery and is used in gel preparation.

58
Q

What types of bases are suppositories?

A

either oleaginous (oil-soluble) or water soluble

59
Q

What are oleaginous suppositories made of?

A

cocoa butter (theobroma oil) and hydrogenated vegetable oils (palm, palm kernel, coconut)

60
Q

what are water soluble suppositories made of?

A

glycerinated gelatin and PEG

61
Q

Why is density factor needed when compounding suppositories?

A

the drug can displace the base, higher density means less displacement and lower densify factor means more displacement

62
Q

What is the paddock method?

A

density factor formula

density factor = B/A-C+B

B=weight of medication per suppository
A=weight of blank suppository
C=weight of medicated suppository

63
Q

Which type of suppository molding method requires knowing the weight of the mold and DF of drug?

A

compression molding

64
Q

what are the types of suppository molding?

A

hand molding
fusion molding
compression molding

65
Q

which type of suppository molding requires gentle heating?

A

fusion molding

66
Q

lubricants applied to mold make it easier to remove. What lubricants should be used for oil-based suppositories?

water-based?

A

oil-based: propylene glycerin or glycerin

water-based: vegetable oil spray or mineral oil

67
Q

When fusion molding, why do the molds have to be room temperature?

A

If cold, it can cause cracking and splitting.

68
Q

What type of base is used in hand molding?

A

cocoa butter

69
Q

what is an emulsion?

A

a liquid dispersed in liquid mixture. It is a 2-phase heterogeneous mixture

70
Q

What are emulsifiers?

A

a surfactant that reduces surface tension and allows two immiscible substances come closer together.

71
Q

list the emulsifiers

A 
acacia
agar
carbomer
glyceryl monostearate
pectin
PEG
sorbitan lipophilic esters (Arlacel, Span)
sorbitan hydrophilic esters (Myri, Tween)
72
Q

What is a suspension?

A

a solid dispersed in liquid. A two-phase heterogeneous mixture

73
Q

What is used to incorporate a insoluble drug into a liquid?

A

wetting/levigating agents

74
Q

list the levigating agents

A

glycerin
mineral oil
polyethylene glycol
propylene glycol

75
Q

what is a solution?

A

a solute dissolved in a solvent

it is a homogenous mixture

76
Q

what is precipitation/sedimentation?

A

when the dispersed phase settles together. Most often occurs with emulsions and suspensions.

77
Q

How to use the HLB number to choose emulsifiers.

A

HLB <10 –> more oil-soluble & used for water in oil emulsions

HLB >10 –> more water-soluble & used for oil in water emulsions

78
Q

What are the types of emulsion preparation methods? what is the difference?

A

continental (dry gum) method: 4:2:1 oil:water:emulsifier ratio. First levigate gum in oil then add water. shake and then add other ingredients in solution until QS.
english (wet gum) method: 4:2:1 oil:water:emulsifier ratio. Triturate gum in water and then slowly add oil while triturating. Then add other ingredients in solution until QS,

gum is acacia or other gum emulsifier

79
Q

What is Polybase commonly used for?

A

as a base in suppositories. Also a good emulsifier.

80
Q

What are the temperature definitions?

A

room: 68-77F or 20-25C
refrigerator: 36-46F or 2-8C
freezer: -10-14F or -25 - -10C

81
Q

USP BUD

A

nonaqueous –> earliest expiration of API or 6 months, whichever is earlier in room temp
water-containing oral formulation –> 14 days in refrigerator
water-containing topical/dermal/mucosal –> 30 days in room temp

82
Q

What labeling must be on all compounded products?

A

BUD
storage and handling info
label signifying that it is a compounded product

83
Q

what labels do hazardous compounded products need?

A

hazardous labels

84
Q

what labels do topical compounds need?

A

external use only

85
Q

what label do suppositories, some troches, some suspensions need?

A

refrigerate

86
Q

what label do suspensions/emulsions need?

A

shake well before use

87
Q

what is simethicone?

A

anti-foaming agent

88
Q

what are coating agents?

A

gluten, gelatin, shellac to mask unpalatable tastes, protect from oxygen, light, moisture

89
Q

what is ascorbic acid

A

an antioxidant

90
Q

what are diluents used for?

A

as a filler to add size to small dosages

91
Q

what diluents (fillers) are used when making tablets or capsules?

A

starches, calcium salts, lactose, mannitol, sorbitol, cellulose

92
Q

what are disintegrants used for?

A

allows for oral products to dissolve for absorption

93
Q

list the disintegrants

A 
cellulose
alginic acid
polacrilin potassium (e.g. Amberlite)
compressible sugar (e.g. Nutab)
starches
94
Q

what are emollients

A

can be used to soothe skin or mucus membranes and can be used as a barrier

95
Q

example of an emollient

A

petroleum jelly

96
Q

what is used for enteric coating

A

cellulose acetate phthalate

shellac

97
Q

what are the sweetening agents

A

sugar-free artificial: aspartame, saccharin

dextrose, lactose, mannitol, sorbitol, xylitol, stevia, phenylalanine, glycerin

98
Q

what are thickening agents used for?

A

increase viscosity and stabilize mixtures

99
Q

list the thickening agents

A 
acacia
agar
alginic acid
bentonite
cellulose
carbomer
gelatin
guar gum
starches
tragacanth
100
Q

which thickening agents are used most commonly?

A

gelatin and bentonite

101
Q

list glidants

A

magnesium stearate

colloidal silica

102
Q

list hydrophilic solvents

A

PEG and alcohols

103
Q

list hydrophobic solvents

A

oils: borage, coconut
fats: omega-3

104
Q

list anti-adherent lubricant

A

magnesium stearate

105
Q

list preservatives

A

topical/nasal: chlorhexidine

ophthalmic: benzoic acid, sodium benzoate, benzalkonium chloride, EDTA, thimerosal

106
Q

generic name for tween

A

polysorbate

107
Q

what is USP 800

A

for hazardous drugs

108
Q

list the humectants

A

glycerin
sorbitol
propylene glycol

109
Q

what type of agents are surfactants?

A

emulsifiers and wetting agents

Non-sterile Compounding (1 decks)

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