compounding III: doc and prep Flashcards
solution
solute dissolved in a solvent
types of solutions
syrup: sucrose and other sugars or artificial sugars
elixirs: hydroalcoholic solution for drugs that are insoluble in a purely aqueous formulation. mixture of alcohol and water
suspension: solid dispersed in liquid
emulsion: liquid dispersed in liquid w/o or o/w
A tincture is typically an extract of plant or animal material dissolved in ethanol (ethyl alcohol)
how to prep emulsions
4 parts oil + 2 parts water + 1 gum (acacia)
eutectic mixture
combo of ingredients will melt at a lower temp than either of the individual compounds
beyond used date for non-sterile products
nonaqueous formulation
no later than 6 months, 180 days. store at room temp
beyond used date for non-sterile products
water-containing oral formulations (such as oral suspensions)
no later than 14 days, when stored at cold temps. store in refrigerator
beyond used date for non-sterile products
water-containing topical/dermal and mucosal liquid and semisolid formulations (cream or lotion)
no later than 30 days, store at room temp
low CSP level risk
≤ 3 sterile ingredients
ex: single dose vial antibiotics
medium CPS level risk
> 3 sterile ingredients or multple dose of sterile products withdrawn for same vial to make severe CPS products
complex aseptic manipulations
ex: multi-dose vial of antibiotics
high CSP level risk
- non-sterile ingredients
- non-sterile equipment
beyond use dates for compounded sterile products
low CSP risk
room temp 48 hrs
refrigerated BUD 14 days
frozen 45 days
beyond use dates for compounded sterile products
medium CPS risk
room temp 30 hrs
refrigerated BUD 9 days
frozen 45 days
beyond use dates for compounded sterile products
high CPS risk
room temp 24 hrs
refrigerated BUD 3 days
frozen 45 days
beyond use dates for compounded sterile products
low-risk CSP prepared in an ISO 5 PEC or C-PEC in a SCA or C-SCA (not clean room)
12 hr
beyond use dates for compounded sterile products
Immediate-use
1 hr `
BUD for single-dose containers
SDC- vail, bag, bottle, syringe outside of ISO 5 environment
1 hr from the time of puncture or opening
BUD for single-dose containers
SDC- vail, bag, bottle, syringe inside of ISO 5 environment
up to 6 hrs from the time of puncture or opening
BUD for single-dose containers
SDC- ampule inside or outside ISO 5 environment
any unused contents left in the ampule cannot be stored and must be discarded
BUD for single-dose containers
MDC- inside or outside of ISO 5 environment
up to 28 days from the time of puncture or opening, unless otherwise specified by the manufacturer
recall class I
use or exposure will cause serious harm
recall class II
use or exposure will cause temporary or reversible adverse health consequences
recall class III
use or exposure will not likely cause harm
bubble-test is for?
to test filter integrity
