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Compounding Exam 1 > Lecture 1 Part 2 > Flashcards

Lecture 1 Part 2 Flashcards

(71 cards)

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1
Q

which USP chapter defines pharmaceutical packaging

A

659

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2
Q

packaging must provide ____ and must be _____

A

provide PROTECTION and be ECONOMICAL

also must ensure adequate stability

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3
Q

define “primary packaging component”***

A

packaging component in DIRECT CONTACT with or may come into direct contact with the article (drug)

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4
Q

define secondary packaging component***

A

packaging component in direct contact with a PRIMARY packaging component.

may provide additional protection for the article

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5
Q

true or false

a secondary packaging component is one in contact with the article

A

FALSE

this is primary

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6
Q

define tertiary packaging component***

A

in direct contact with SECONDARY packaging component

may provide additional protection for article during transportation and/or storage

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7
Q

define ancillary component vs associated component**

give examples of each

A

ancillary - component that may come into contact with tertiary component during the distribution/storage/transportatin of the packaged article
(ie: pallets, skids, shrink wrap, bubble wrap)

associated - packaging component intened to deliver drug article to patient but NOT stored in contact with the article for the shelf life (spoons, dosing cups, dosing syringes)

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8
Q

true or false

dosing syringes are considered associated components

A

true

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9
Q

a suppository mold is considered what kind of packaging

A

primary

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10
Q

name 2 materials that are almost always most likely primary packaging

A

glass and plastic

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11
Q

name 2 materials that are likely always secondary packaging

A

cardboard and paper

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12
Q

labels are considered what kind of packaging

A

secondary

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13
Q

a box to contain the primary packaging is what kind of packagin

A

secondary

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14
Q

a vaginal suppostory applicator is what kind of packaging

A

associated component

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15
Q

rx bottle containing SEALED SUPPOSITORIES is what kind of packaging??

a box containing this bottle is what class?

bubble wrap included in this box is what?

A

the Rx bottle is secondary

the box containing it is tertiary

bubble wrap is ancillary component

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16
Q

what is a hermetic container

A

impervious to air and other gas

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17
Q

what is a tight container

A

protects contents from contamination by outside liquids, solids, or vapors, from loss of article (drug), from efflorescence, deliquiscience, or evaporation

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18
Q

true or false

tight containers can contain sterile products

A

true

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19
Q

what does well closed container mean and give 2 examples

A

protects from extraneous (outside) solids and loss of article

amber vials and normal liquid vials

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20
Q

what do well closed containers NOT protect against

A

gasses or air

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21
Q

what kind of storaging is called for for citric acid and what does this say about its stability

A

well closed container

this means its pretty stable. does not exhibit efflorescence or deliquiescene or it would need tight container

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22
Q

how can a clear and colorless or a translucent container be made light resistant?

A

by using an opaque covering or secondary packaging

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23
Q

if a sterile preparation needs a light resistant container, what can we do?

A

cant use regular amber vials

we can put it in brown IV bag (secondary packaging) after preparing, and include an ancillary label to protect from light

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24
Q

name 4 factors that must be considered when selecting packaging

A

product
market
distribution system
manufacturing facilities

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25
tamper evident vs reclosable packaging vs non-reclosable packaging
tamper evident - cannot be accessed without obvious destruction of seal or packaging system reclosable - can be reclosed after opening with similar degree of security (ie: normal amber vial). may be child resistant, maybe not non reclosable - cannot be closed again after all or part of the contents have been removed
26
give an example of products that must have tamper evident packaging
sterile products for opthalmic or otic used also, OTC items (items without prescription_
27
as mentioned, sterile preparations for ophthalmic or otic use must have tamper evident packaging name an exception
except when it's been compounded for immediate dispensing
28
foil blisters, foil strips are what kind of packaging
non-reclosable
29
true or false non-reclosable packaging may be child resistant
true
30
********** the BUD for an opened/entered mutli dose container is.........
28 days (unless otherwise specified by manufacturer on the label)
31
true or false the BUD for a mutli dose container that has been needle punctured is 28 days
TRUE
32
define a multiple dose container
holds sterile medication for parenteral administration (whether injection or infusion) it has met antimicrobial effectiveness testing requirements, or is excluded
33
multiple dose containers are generally expected to contain _____ or less of medication
30mL
34
a _______ is an example of a multiple dose container
vial
35
explain what a single-dose container is
also holds a sterile medication for parenteral administration - but not required to meet antimicrobial effectiveness testing designed for a single patient as a single injection (or infusion)
36
give 3 examples of single dose containers
vials ampules prefilled syringes
37
she may just show 2 labels and ask which is multiple dose how can you tell
look for preservative!! if has preservative - assume multi dose
38
define BUD*******
beyond use date - day after which a compounded preparation must not be used
39
true or false the official label of a compounded preparation MUST contain a BUD
TRUE
40
BUD vs expiration date
BUD is set by pharmacist - lsat day can use compounded product exp date set by manufacturer - last day they can guarantee potency and safety
41
can BUD ever be exceeded?
yes, if there is supporting and valid scientific stability info directly applicable to compounded product
42
in the ABSENCE of stability info related to the compounded product, what BUD's should be followed for non sterile preps? how should they be packaged?
follow maximum BUDs tight, light resistant containers at controlled room temp
43
topical aqueous lotion with cresol what is BUD
35 days
44
what is aw
water activity an aqueous preparation has water activity greater than OR EQUAL TO 0.6******** nonaqueous has aw LESS THAN 6
45
non preserved aqueous storage conditions and BUD
14 days in fridge
46
preserved aqueous storage conditions and BUD
35 days fridge OR room temp is fine
47
anhydrous oral liquid storage conditions and BUD
room temp 90 days
48
anhydrous products - EXCLUDING nonaqueous oral liquids
180 days room temp
49
name 3 things that can be considered "anhydrous oral liquid"
oils w/o emulsion something with lot of alc if water activity less than 0.6
50
castor oil with water activity 0.2 what is BUD
90 days
51
capsules BUD
180 days
52
solid/semisolid dosage forms without water BUD
180 days
53
rectal suppositories with no water BUD
180 days
54
the water activity is a ratio between...
vapor pressure of your product/vapor pressure distilled water
55
water activity _____with increasing temperature
increases
56
true or false there is no difference between room temperature and controlled room temperature
FALSE controlled - maintained by thermostat at 20-25 degrees c (68-77) room temp is ambient temp - just temp that prevails in working environment
57
on a prescription label, should the numbers be written as "2" or "two"
2
58
how can you tell if a prescription is to be given topically or orally just by looking at the label****
how the API is expressed if expressed as per unit dose = oral (internal) if expressed as percent = external (topical)
59
which is better 320mg/5mL or 320 mg/5 mL
with the space is better
60
true or false the strength of ingredients in internal preparations is expressed as the amount of ingredient in each dose
true
61
Drug HCl -- how to express on label
write it all out ---- drug hydrochloride
62
normally, only the API should be included on the drug label name 2 exceptions where it would be recommended to add something else on the label
if there is a large amount of alcohol or large amount of preservative included
63
if the unit dose is 5mL/1 teaspoonful and it contains 100mg API, how should it be expressed on the label?
100 mg/5 mL
64
true or false no chemical abbreviations or symbols should be used on a prescription label
true
65
we have a very potent drug and need to measure MICROGRAMS what mortar and pestle should we use what if we have very coarse powder and want to reduce particle size
glass porcelain - has rough surface
66
true or false we cannot measure 45mL in a 50mL grad cylinder
FALSE - we can
67
100% oil formulation BUD
90 days
68
ut dict sig code
as directed
69
assumed units of specific gravity
g/mL
70
rectal supp with no water BUD
180 days
71

Compounding Exam 1 (9 decks)

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