Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Compounding Exam 1 > Lecture 1 Part 2 > Flashcards

Lecture 1 Part 2 Flashcards

1
Q

which USP chapter defines pharmaceutical packaging

A

659

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

packaging must provide ____ and must be _____

A

provide PROTECTION and be ECONOMICAL

also must ensure adequate stability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

define “primary packaging component”***

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

define secondary packaging component***

A

packaging component in direct contact with a PRIMARY packaging component.

may provide additional protection for the article

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

true or false

a secondary packaging component is one in contact with the article

A

FALSE

this is primary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

true or false

dosing syringes are considered associated components

A

true

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

a suppository mold is considered what kind of packaging

A

primary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

name 2 materials that are almost always most likely primary packaging

A

glass and plastic

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

name 2 materials that are likely always secondary packaging

A

cardboard and paper

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

labels are considered what kind of packaging

A

secondary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

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

A

secondary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

a vaginal suppostory applicator is what kind of packaging

A

associated component

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

what is a hermetic container

A

impervious to air and other gas

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

true or false

tight containers can contain sterile products

A

true

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

what do well closed containers NOT protect against

A

gasses or air

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

name 4 factors that must be considered when selecting packaging

A

product
market
distribution system
manufacturing facilities

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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_

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

foil blisters, foil strips are what kind of packaging

A

non-reclosable

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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 (4 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions