compounding III Flashcards
a compounding record should have
what you did
specific to the compound
staff invoilved with the prep along with
BUD Steps etc
make products accordnign to the
master formula
comminution
trituration grind into fine pwoder
levigation (levigating agent
solutions
syrups- sucrose
elixirs sweet hydroalcholoics
tinctures - plant or aminal extract
spirits alcohol
suspension
wetting/levigating agent used to mix solid with liquid
emulsion
liquid immix=scible to another liquid
how to prepare emulsion
4 oil
2 water
1 gum
ficks law
dissolution rate
sodium lauryl sulfate
surfactant
for static charge
melting point order
highest first to lowest
eutectic mixtures
two compounds that when mixed together hav elower melting point
MGO used to keep powder dry
lozenge
PEG for soft
sucrose/syrup for harder
GEls
PLO
pluronic lecithin organogel for transdermal drug administration
ppository
oil- cocoa , theoroma
veg oil cocnut
water- peg, gelatin
density factor
B/A-C+B
weight of med per suppository/ weight of black - weight of medicated suppo +medicated suppository
non aquas BUD
6 months
water containing
14 days
water containing topical
30 days at RTP
unit dose expiration
6 months or manufaturers exp if earlier than 6 months
testing high risk product
tryptic soy agar
fluid thioglycolate
baterial endotoxin test
label requirements i
name
strength
volume
BUD
route
storage
aux labels ( high alert, hazardous etc
bacterial endotoxin test
limulus amebocyte lysate
low risk sterile compounding
1-3 sterile components
<2 entries
48 hours 14 days 45days
medium risk sterile compounding
preparing a batch
30 hours 9 days 45 days
high risk sterile compounding
non sterile ingredients or equipments
sterile components held outside ISO 5 air for more than 1 hour
24 hours 3 days and 45 days
low risk but in an iso 5 or not in a clean room
12 hours 12 hours N/A
test to find out the integrity of the filter
bubble point test
heat labile csps need to be filtered through
filter needle 0.22mcg
single dose container BUDs ampule
discard no bud
singel dose container bud inside ISO5 bud
upto 6 hours
singel dose container bud outside ISO5
1 hour
quality assurance
presonnel training and assessment
environement monitoring
equipment calibration
recall
class 1 death
class2 temporary reversible AE
class3 does not cause any health consequences
tonicity
solutes that do not cross
osmolarity
solute concentration including tonicity