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Naplex 2023 > Compounding 3: Documentation and Preparation > Flashcards

Compounding 3: Documentation and Preparation Flashcards

1
Q

master formula record

A

recipe for compound
what you should do

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2
Q

compounding log or record

A

log book of all products made at the pharmacy
must have detailed enough documents that another can replicate
what you did

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3
Q

preparation steps

A

review SDS for each bulk ingredient
garb: minimally clean lab goat and gloves for non-sterile, non-HD
make product according to master formula

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4
Q

reducing particle size

A

comminution: reduce particle size by grinding, crushing, milling, vibrating
powders must be finely ground and then it will be placed into sieve (sifters; ensure uniform particle size)
once in sieve, brush or plastic spatula is used to force particles through mesh
sieve number = # of holes/in

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5
Q

types of comminution

A

trituration: “mix thoroughly”; make homogenous; grinding tablets with mortar and pestle; can describe liquids (shaking emulsion)

levigating: triturating powder with mortar and pestle and adding liquid (levigating agent/wetting agent) to help grinding process

spatulation: like levigation but on ointment slab with spatula

pulverization by intervention: for crystalline powders that do not crush easily; crystals are dissolved intervening solvent and mixed until solvent evaporates

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6
Q

geometric dilution

A

ensure ingredients evenly distributed
small amount of drug is mixed into equal amount of diluent

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7
Q

solution

A

solute in solvent
homogenous
syrups
elixirs
tinctures
spirits

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8
Q

suspension

A

solid in liquid
two-phase heterogenous
wetting agent/levigating agent puts insoluble drug into liquid = suspension
particles redisperse easily by shaking

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9
Q

emulsion

A

liquid dispersed in liquid
two-phase heterogenous
oil-in-water or water-in-oil
emulsifier (surfactant) used to reduce surface tension bt two liquids = emulsion
use HLB number to choose best emulsifier

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10
Q

preciptation/sedimentation

A

happens in suspensions and emulsion

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11
Q

how to prepare solutions

A

find if solute will dissolve in solution
dissolution rate = Fick’s First Law of Diffusion
larger surface area, stirring, and heat = inc dissolution rate
buffer system may be needed to resist changes in pH
preservative may be needed
flavorings, sweeteners, coloring agents can be added

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12
Q

how to prepare suspension

A

wet powder and levigate to form paste
homogenizer can make uniform suspension
preservative may be needed
flavorings, sweeteners can be added
can use surfactants as suspending agents but still need to shake to redisperse before use

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13
Q

how to prepare emulsion

A

continental/dry gum method:
levigate gym with oil
add water all at once
triturate until cracking heard and looks creamy white
homoginize with homogenizer machine

English/wet gum method:
triturate gum with water to form mucilage
add oil slowly

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14
Q

powders

A

often include glidant/lubricant to improve flowability (magnesium stearate)
often include surfact to neutralize static change (sodium lauryl sulfate)

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15
Q

how to prepare powders

A

add inert filler/diluent if very small amount of powder per dose

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16
Q

melting point order

A

melt ingredient with highest melting point prior to adding ingredients with lower melting points

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17
Q

eutectic mixtures

A

combo of ingredients will melt at lower temp than any of individual components
can lead to melting and turning into sticky mess
adsorbant can be used - magnesium oxide, magnesium carbonate, kaolin

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18
Q

capsules

A

soluble shells of gelatin (animal product) or hypromellose (vegetable product)
glycerol and sorbital - plasticizers to make less brittle and more flexible
sizes from larges (000) to smallest (5)

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19
Q

how to prepare capsules

A

can hand fill or punch method
use hand for small number, machine for larger number

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20
Q

tablets

A

molded tablet most common in compounding
compressed tablet most common in manufacturing

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21
Q

how to preare molded tablets

A

alcohol and/or water added to moisten powder
mold pasty mixture into tablets with mold and then dry

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22
Q

lozenges/troches

A

used for drug that acts in mouth
hard lozenge base: sucrose or syrup
soft lozenge base: PEG
chewable lozenge base: glycerin or gelatin

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23
Q

how to prepare ointment

A

triturate well with levigating agent
mix powder into ointment base with geometric dilution
some must heat to mix - fusion method
start with ingredient that has highest melting point and then add by decreasing melting point

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24
Q

Gels

A

pluronic lecithin organogel (PLO gel) can be used for transdermal drug administration

25
suppository
oil-soluble base: cocoa butter/theobroma oil; hydrogenated vegetable oils water-soluble base: PEG; gelatin if prep soften/melts easy, like theobrome oil/cocoa butter - store molds in refrigerator; will melt in hand to calculate amount of drug displaced, use densitity factor: weight of med per suppository/(weight of suppository blank - weight of medicated suppository + weight of medication per suppository)
26
how to prepare suppositories
hand molding can be used when only few needed fusion molding: mixture poured into room temp molds compression molding: use density factor to find amount of base needed for each suppository, mix with drug, and put into cold compression mold if using lubricant, must be opposite solubility as suppository base
27
BUD for nonaqueous formulations
6 months store at room temp nonaqueous: white petrolatum, hypromellose capsule,PEG lozenge, oleaginous base, propylene glycol
28
BUD for water-containing oral
14 days store at cold temp/refrigerator
29
BUD for water-containing topical
30 days store at room temp aqueous topical: emulsion cream, Verabase lotion, glycerin in 70% IPA, poloxamer gel with leciithin/isopropyl palmitate
30
BUD for repackaged drugs
expiration date from manufacturer or 6 months from repackaging, whichever is earlier
31
patient counseling
report ADRs to pharmacy pharmacy record ADRs in compounding record
32
physiochemical considerations
sterile preps should be isotonic to human blood and similar osmolarity of ~285 mOsm/L pH of sterile should be close to neutral non-PVC bags used for meds with leaching/sorption issues
33
ampules
filter needle or filter straw needed to remove glass in drug solution after opening ampule
34
vials with lyophilized or free-dried powder
needs to be reconstituted by adding sterile water
35
small volume parenteral (SVP)
IV bag or syringe with 100 mL or less
36
ready-to-use medications (RTU)
prepared IV bags or prefilled syringes no CSP risk level bc not compounded
37
ready-to-use vial/bag systems
ADD-Vantage
38
how to set up items in sterile hood
all work done at least 6 inches into hood to prevent hood and buffer room air from mingling put items side-by-side nothing between sterile object and HEPA filter in horizontal airflow hood do not tear open components
39
how to transfer solutions and inject into IV bags
use smallest syringe possible for desired amount swab top of vial or ampule neck with 70% IPA inject volume of air equal to volume of fluid to be removed UNLESS a HD (negative pressure: put air into syringe and then inject into vial and invert; pull on trigger and drug will go into syringe puncture bevel up bring needle straight up to 90 degrees to inject invert vial with syringe attached after injecting air measure at point between rubber piston and side of syringe barrel coring: stopper rubber gets into needle and into solution; look for small cored pieces during visual inspection if ampule - open by snapping neck away; use filter straw/needle to remove glass then change needle before injecting into IV bag
40
visual inspection
verify correct volume of product before compounding continues to actually see volume in syringe "syringe pull-back" = pharmacist verifies empty syringe after compounding done - not recommended finished CSP. visually inspected for particulates, cored pieces, precipitates, cloudiness; lightly squeeze to check for leaks
41
terminal sterilization
required for high-risk CSPs steam sterilization with autoclave do not use heat on heat-sensitive drugs
42
bubble-point test and filter integrity
heat-labile drugs (hormones, insulin, other proteins) can be sterilized with filtration with 0.22-micron filter if filtering - use bubble-point test; tests pressure needed for liquid to bubble out of filter; tests filter integrity
43
label requirements
names and concentrations of ingredients BUD route of admin storage requirements HD: label "chemotherapy - dispose of properly" - or similar auxiliary labels high-alert meds
44
pyrogen (bacterial endotoxin) testing
endotoxins ar emade by Gram + and Gram - bacteria/fungi from Gram - = more potent pyrogens: can be from using equipment washed with tap water (rinse with steile water and depyrogenated using dry-heat (steam) sterilization with autoclave
45
sterile preparation and risk
risk of contamination categories by USP (low, medium, and high) other special categories: low with less than 12 hour BUD and immediate-use - determine appropriate BUD
46
low-risk sterile compounding
uses 1-3 components supplied as sterile from manufacturer
47
medium-risk sterile compounding
contamination inc each time bag is entered if more than 3 components needed = medium risk eg: parenteral nutrition (many additives); batch of drugs
48
high-risk sterile compounding
uses non-sterile ingredients and equipment - will need to sterilize end product includes sterile components outside of ISO 5 air for >1 hr certain high-risk CSPs and CSPs intended for use beyond recommended BUD need sterility testing (tryptic soy broth or fluid thioglycollate medium; include bacterial endotoxin testing prior to use)
49
determining BUD based on CSP risk level
determined by USP 797 standards and stability/expiration date of individual ingredients whichever shorter high CSP risk = shorter BUD cold temp = longer BUD sterility testing can see if longer BUD possible
50
low-risk CSPs with 12-hr or less BUD
ISO 5 PEC or C-PEC in SCA/C-SCA (reconstitute antibiotic single dose vial and transferring to small IV bag in satellite pharmacy not clean room
51
clean, uncluttered, functionally separate area compounding
for immediate use only must administer within 1 hr
52
low CSP risk BUD
room temp: 48 hours regrigerated BUD: 14 days frozen BUD: 45 days
53
medium CSP risk BUD
room temp: 30 hours refrigerated: 9 days frozen: 45 days
54
high risk CSP BUD
room temp: 24 hours refrigerated: 3 days frozen: 45 days
55
low-risk CSP in ISO 5 PEC or C-PEC in SCA or C-SCA (not cleanroom) BUD
room temp: 1 hour refrigerated/frozen: NA
56
recalls
high-risk CSPs dispensed before sterility test results require written procedure with daily observation of specimens and immediate recall of dispensed if evidence of microbial growth
57
osmolarity and tonicity
both express solute concentration in solution osmolarity includes all solutes tonicity includes only solutes that do not cross vasculature
58
osmolarity in IV formulations
hypertonic = >0.9% saline hypertonic saline (3 or 23.4%) for various acute things like hyponatremia hypertonic = water out of RBC to dilute; RBCs shriveled and syfunctional hypertonic saline often restricted to pharmacy and only dispensed for areas where safety can be monitored solutions with high osmolarity need central line to avoid phlebitis hypotonic: RBCs absorb fluid nad hemolysis occurs; can be fatal

Naplex 2023 (21 decks)

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