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Compounding Exam 1 > Lecture 1 Part 2 > Flashcards

Lecture 1 Part 2 Flashcards

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
Q

tamper evident vs reclosable packaging vs non-reclosable packaging

A

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

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26
Q

give an example of products that must have tamper evident packaging

A

sterile products for opthalmic or otic used

also, OTC items (items without prescription_

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27
Q

as mentioned, sterile preparations for ophthalmic or otic use must have tamper evident packaging

name an exception

A

except when it’s been compounded for immediate dispensing

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28
Q

foil blisters, foil strips are what kind of packaging

A

non-reclosable

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29
Q

true or false

non-reclosable packaging may be child resistant

A

true

30
Q

** the BUD for an opened/entered mutli dose container is………

A

28 days (unless otherwise specified by manufacturer on the label)

31
Q

true or false

the BUD for a mutli dose container that has been needle punctured is 28 days

A

TRUE

32
Q

define a multiple dose container

A

holds sterile medication for parenteral administration (whether injection or infusion)

it has met antimicrobial effectiveness testing requirements, or is excluded

33
Q

multiple dose containers are generally expected to contain _____ or less of medication

A

30mL

34
Q

a _______ is an example of a multiple dose container

A

vial

35
Q

explain what a single-dose container is

A

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
Q

give 3 examples of single dose containers

A

vials
ampules
prefilled syringes

37
Q

she may just show 2 labels and ask which is multiple dose

how can you tell

A

look for preservative!!

if has preservative - assume multi dose

38
Q

define BUD***

A

beyond use date - day after which a compounded preparation must not be used

39
Q

true or false

the official label of a compounded preparation MUST contain a BUD

A

TRUE

40
Q

BUD vs expiration date

A

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
Q

can BUD ever be exceeded?

A

yes, if there is supporting and valid scientific stability info directly applicable to compounded product

42
Q

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?

A

follow maximum BUDs

tight, light resistant containers at controlled room temp

43
Q

topical aqueous lotion with cresol

what is BUD

A

35 days

44
Q

what is aw

A

water activity

an aqueous preparation has water activity greater than OR EQUAL TO 0.6**

nonaqueous has aw LESS THAN 6

45
Q

non preserved aqueous

storage conditions and BUD

A

14 days in fridge

46
Q

preserved aqueous

storage conditions and BUD

A

35 days

fridge OR room temp is fine

47
Q

anhydrous oral liquid

storage conditions and BUD

A

room temp

90 days

48
Q

anhydrous products - EXCLUDING nonaqueous oral liquids

A

180 days

room temp

49
Q

name 3 things that can be considered “anhydrous oral liquid”

A

oils
w/o emulsion
something with lot of alc

if water activity less than 0.6

50
Q

castor oil with water activity 0.2

what is BUD

A

90 days

51
Q

capsules BUD

A

180 days

52
Q

solid/semisolid dosage forms without water BUD

A

180 days

53
Q

rectal suppositories with no water BUD

A

180 days

54
Q

the water activity is a ratio between…

A

vapor pressure of your product/vapor pressure distilled water

55
Q

water activity _____with increasing temperature

A

increases

56
Q

true or false

there is no difference between room temperature and controlled room temperature

A

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
Q

on a prescription label, should the numbers be written as “2” or “two”

A

2

58
Q

how can you tell if a prescription is to be given topically or orally just by looking at the label**

A

how the API is expressed

if expressed as per unit dose = oral (internal)

if expressed as percent = external (topical)

59
Q

which is better

320mg/5mL or 320 mg/5 mL

A

with the space is better

60
Q

true or false

the strength of ingredients in internal preparations is expressed as the amount of ingredient in each dose

A

true

61
Q

Drug HCl – how to express on label

A

write it all out —- drug hydrochloride

62
Q

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

A

if there is a large amount of alcohol or large amount of preservative included

63
Q

if the unit dose is 5mL/1 teaspoonful and it contains 100mg API, how should it be expressed on the label?

A

100 mg/5 mL

64
Q

true or false

no chemical abbreviations or symbols should be used on a prescription label

A

true

65
Q

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

A

glass

porcelain - has rough surface

66
Q

true or false

we cannot measure 45mL in a 50mL grad cylinder

A

FALSE - we can

67
Q

100% oil formulation BUD

A

90 days

68
Q

ut dict sig code

A

as directed

69
Q

assumed units of specific gravity

A

g/mL

70
Q

rectal supp with no water BUD

A

180 days

71
Q
A

Compounding Exam 1 (9 decks)

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