Compounding Prep + Procedures Flashcards
Communition
reduction of particle size
3 methods:
1. Trituration = mixing with mortar and pestile
2. Levigation = grinding with liquid creating a paste
3. Pulverization = used for HARD solids like crystalline
Sieves
“sifters”
ensure particle size is uniform
Geometric Dilution
small amount of drug, add an equal amount of diluent, keep doubling the amount untill it is evenly mixed
Solution
Solute fully dissolved in a solvent
Suspension
a solid dispersed throughout a liquid
**needs a levigating agent (type of surfactant) for wetting the solid before incorpation into liquid
Emulsion
a liquid dispersed into liquid (water in oil or oil in water)
**need emulsifier (type of surfacant)
Suppository Preparation
Need to calulcate density factor to assess how much of the drug will be displaced
BUD for nonaqueous formulation
6 months
store at room temp
BUD for aqueous oral formulation
14 days
store in fridge
BUD for aqueous topical/dermal
(cream/lotion)
30 days
store at room temp
How many days should a max BUD for a product that has diclofenac powder in propylene glycol?
180 days (6 months)
What is the max BUD for a topical zinc oxide in white petrolatium?
6 months (180 days)
What is the max BUD for Cipro in Versabase lotion?
30 days
How long can you store a nystatin popsicle in 80% sorbitol and water?
14 day in the fridge
unit dose repackaging expiration date
6 months (180 days)
Small Volume Parenteral
< or = 100 mL
Large volume parenteral
> 100 mL
Low risk sterile compounding
1 - 3 components supplied as “sterile
Medium risk sterile compounding
> 3 componetns supplied as “sterile”
High risk sterile compounding
When you must sterilize the formulation AFTER it has been compounded — not common
With high risk CSP what is the room temp, fridge and freezer BUD?
Room temp BUD = 24 hours
Fridge = 3 days
Freezer = 45 days
With medium risk CSP what is the room temp, fridge, and freezer BUD
Room temp BUD = 30 hours
Fridger = 9 days
Freezer = 45 days
With low risk CSP what is the room temp, fridge, and freezer BUD?
Room temp = 48 hours
Fridge = 14 days
Freezer = 45 days
BUD for single dose container of a bag or vial when it outside the ISO 5 environment?
1 hour from puncture
BUD for single dose container of a bag or vial when it inside the ISO 5 environment?
6 hours from time of puncture
BUD for multi dose container when its inside or outside the ISO 5 environment?
up to 28 days from puncture
Recalls by class
Class I = reasonable probability of serious ADR or death
Class II = causing temporary or reversible health consequences
Class III = unlikely to cause any harm
