Lecture 1 Part 2 Flashcards
which USP chapter defines pharmaceutical packaging
659
packaging must provide ____ and must be _____
provide PROTECTION and be ECONOMICAL
also must ensure adequate stability
define “primary packaging component”***
packaging component in DIRECT CONTACT with or may come into direct contact with the article (drug)
define secondary packaging component***
packaging component in direct contact with a PRIMARY packaging component.
may provide additional protection for the article
true or false
a secondary packaging component is one in contact with the article
FALSE
this is primary
define tertiary packaging component***
in direct contact with SECONDARY packaging component
may provide additional protection for article during transportation and/or storage
define ancillary component vs associated component**
give examples of each
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)
true or false
dosing syringes are considered associated components
true
a suppository mold is considered what kind of packaging
primary
name 2 materials that are almost always most likely primary packaging
glass and plastic
name 2 materials that are likely always secondary packaging
cardboard and paper
labels are considered what kind of packaging
secondary
a box to contain the primary packaging is what kind of packagin
secondary
a vaginal suppostory applicator is what kind of packaging
associated component
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?
the Rx bottle is secondary
the box containing it is tertiary
bubble wrap is ancillary component
what is a hermetic container
impervious to air and other gas
what is a tight container
protects contents from contamination by outside liquids, solids, or vapors, from loss of article (drug), from efflorescence, deliquiscience, or evaporation
true or false
tight containers can contain sterile products
true
what does well closed container mean and give 2 examples
protects from extraneous (outside) solids and loss of article
amber vials and normal liquid vials
what do well closed containers NOT protect against
gasses or air
what kind of storaging is called for for citric acid and what does this say about its stability
well closed container
this means its pretty stable. does not exhibit efflorescence or deliquiescene or it would need tight container
how can a clear and colorless or a translucent container be made light resistant?
by using an opaque covering or secondary packaging
if a sterile preparation needs a light resistant container, what can we do?
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
name 4 factors that must be considered when selecting packaging
product
market
distribution system
manufacturing facilities
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
give an example of products that must have tamper evident packaging
sterile products for opthalmic or otic used
also, OTC items (items without prescription_
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
foil blisters, foil strips are what kind of packaging
non-reclosable
true or false
non-reclosable packaging may be child resistant
true
** the BUD for an opened/entered mutli dose container is………
28 days (unless otherwise specified by manufacturer on the label)
true or false
the BUD for a mutli dose container that has been needle punctured is 28 days
TRUE
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
multiple dose containers are generally expected to contain _____ or less of medication
30mL
a _______ is an example of a multiple dose container
vial
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)
give 3 examples of single dose containers
vials
ampules
prefilled syringes
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
define BUD***
beyond use date - day after which a compounded preparation must not be used
true or false
the official label of a compounded preparation MUST contain a BUD
TRUE
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
can BUD ever be exceeded?
yes, if there is supporting and valid scientific stability info directly applicable to compounded product
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
topical aqueous lotion with cresol
what is BUD
35 days
what is aw
water activity
an aqueous preparation has water activity greater than OR EQUAL TO 0.6**
nonaqueous has aw LESS THAN 6
non preserved aqueous
storage conditions and BUD
14 days in fridge
preserved aqueous
storage conditions and BUD
35 days
fridge OR room temp is fine
anhydrous oral liquid
storage conditions and BUD
room temp
90 days
anhydrous products - EXCLUDING nonaqueous oral liquids
180 days
room temp
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
castor oil with water activity 0.2
what is BUD
90 days
capsules BUD
180 days
solid/semisolid dosage forms without water BUD
180 days
rectal suppositories with no water BUD
180 days
the water activity is a ratio between…
vapor pressure of your product/vapor pressure distilled water
water activity _____with increasing temperature
increases
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
on a prescription label, should the numbers be written as “2” or “two”
2
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)
which is better
320mg/5mL or 320 mg/5 mL
with the space is better
true or false
the strength of ingredients in internal preparations is expressed as the amount of ingredient in each dose
true
Drug HCl – how to express on label
write it all out —- drug hydrochloride
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
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
true or false
no chemical abbreviations or symbols should be used on a prescription label
true
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
true or false
we cannot measure 45mL in a 50mL grad cylinder
FALSE - we can
100% oil formulation BUD
90 days
ut dict sig code
as directed
assumed units of specific gravity
g/mL
rectal supp with no water BUD
180 days
