Compounding Prep + Procedures

Question 1

Communition

Answer 1

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

Question 2

Sieves

Answer 2

“sifters”
ensure particle size is uniform

Question 3

Geometric Dilution

Answer 3

small amount of drug, add an equal amount of diluent, keep doubling the amount untill it is evenly mixed

Question 4

Solution

Answer 4

Solute fully dissolved in a solvent

Question 5

Suspension

Answer 5

a solid dispersed throughout a liquid
**needs a levigating agent (type of surfactant) for wetting the solid before incorpation into liquid

Question 6

Emulsion

Answer 6

a liquid dispersed into liquid (water in oil or oil in water)
**need emulsifier (type of surfacant)

Question 7

Suppository Preparation

Answer 7

Need to calulcate density factor to assess how much of the drug will be displaced

Question 8

BUD for nonaqueous formulation

Answer 8

6 months
store at room temp

Question 9

BUD for aqueous oral formulation

Answer 9

14 days
store in fridge

Question 10

BUD for aqueous topical/dermal
(cream/lotion)

Answer 10

30 days
store at room temp

Question 11

How many days should a max BUD for a product that has diclofenac powder in propylene glycol?

Answer 11

180 days (6 months)

Question 12

What is the max BUD for a topical zinc oxide in white petrolatium?

Answer 12

6 months (180 days)

Question 13

What is the max BUD for Cipro in Versabase lotion?

Answer 13

30 days

Question 14

How long can you store a nystatin popsicle in 80% sorbitol and water?

Answer 14

14 day in the fridge

Question 15

unit dose repackaging expiration date

Answer 15

6 months (180 days)

Question 16

Small Volume Parenteral

Answer 16

< or = 100 mL

Question 17

Large volume parenteral

Answer 17

> 100 mL

Question 18

Low risk sterile compounding

Answer 18

1 - 3 components supplied as “sterile

Question 19

Medium risk sterile compounding

Answer 19

> 3 componetns supplied as “sterile”

Question 20

High risk sterile compounding

Answer 20

When you must sterilize the formulation AFTER it has been compounded — not common

Question 21

With high risk CSP what is the room temp, fridge and freezer BUD?

Answer 21

Room temp BUD = 24 hours
Fridge = 3 days
Freezer = 45 days

Question 22

With medium risk CSP what is the room temp, fridge, and freezer BUD

Answer 22

Room temp BUD = 30 hours
Fridger = 9 days
Freezer = 45 days

Question 23

With low risk CSP what is the room temp, fridge, and freezer BUD?

Answer 23

Room temp = 48 hours
Fridge = 14 days
Freezer = 45 days

Question 24

BUD for single dose container of a bag or vial when it outside the ISO 5 environment?

Answer 24

1 hour from puncture

Question 25

BUD for single dose container of a bag or vial when it inside the ISO 5 environment?

Answer 25

6 hours from time of puncture

Question 26

BUD for multi dose container when its inside or outside the ISO 5 environment?

Answer 26

up to 28 days from puncture

Question 27

Recalls by class

Answer 27

Class I = reasonable probability of serious ADR or death
Class II = causing temporary or reversible health consequences
Class III = unlikely to cause any harm