Non-Sterile Compounding (Ch4 Rx17)

Question 1

What is the minimum weighable quantity? (Rx17)

Answer 1

1. Applies to old torsion balances
2. MWQ = Sensitivity Requirement (SR) / 0.05 (5% is the acceptable error rate)
3. Example: SR (6 mg) / 0.05 = 120 mg minimum weighable quantity

Question 2

What is comminution? (Rx17)

Answer 2

1. Reducing solids to a smaller average particle sizes

2. By crushing, grinding or similar process

Question 3

What are two very common processes in which comminution is done? (Rx17)

Answer 3

1. Trituration

2. Levigation

Question 4

What is trituration? (Rx17)

Answer 4

1. Grinding the powder into smaller, finer particles

2. This can be done with a mortar and pestle

Question 5

What is the one big difference between levigation and trituration? (Rx17)

Answer 5

The use of a wetting agent also called levigating agent

Question 6

What is a common example of a levigating agent used for oil-based products? (Rx17)

Answer 6

Mineral Oil

Question 7

What is a common example of a levigating agent used for aqueous products? (Rx17)

Answer 7

Glycerin

Question 8

What is an eutectic mixture? (Rx17)

Answer 8

Two components, when mixed, will melt at a lower temperature than the melting temperature of the individual components

Question 9

What is an example of a common diluent for powders? (Rx17)

Answer 9

Lactose

Question 10

Which topical formulation contains the most water? (Rx17)

Answer 10

1. Lotions

2. Since lotions contain a lot of water, they can be delivered in pumps

Question 11

What is theobroma oil aka? (Rx17)

Answer 11

Cocoa butter

Question 12

What is an emulsion? (Rx17)

Answer 12

1. A liquid dispersed in a liquid
2. Two phase heterogeneous mixture
3. Can be oil-in-water (oil droplets in an aqueous vehicle) or water-in-oil

Question 13

What is an emulsifier? (Rx17)

Answer 13

1. Type of surfactant that is used to reduce the surface tension between oil-and-water
2. Allows the two phases to come closer together

Question 14

What is a suspension? (Rx17)

Answer 14

1. Solid dispersed in a liquid

2. Two phase heterogeneous mixture

Question 15

What is a solution? (Rx17)

Answer 15

1. A solute dissolved in a solvent (such as NaCl)

2. Solutions are homogeneous

Question 16

Surfactants are used to do what? (Rx17)

Answer 16

1. Help two compounds that resist each other to move closer together
2. Reduces the surface tension

Question 17

When a surfactant is used to reduce the surface tension between a solid particle (an insoluble drug) and a liquid it is referred to as what? (Rx17)

Answer 17

A wetting agent or levigating agent

Question 18

What is the hydrophilic-lipophilic balance (HLB) number? (Rx17)

Answer 18

1. Used to describe how hydrophilic or lipophilic a surfactant is
2. Range is 0-20
3. Agents with a low HLD number <10 are more oil soluble and are used for water-in-oil (lipophilic)
4. High HLB number >10 are more water soluble and are used for oil-in-water emulsions (hydrophilic)

Question 19

What are the parts of the Continental Gum Method (Dry Gum Method)? (Rx17)

Answer 19

4 parts oil
2 parts water
1 part emulsifier

Question 20

What is an emollient? (Rx17)

Answer 20

1. Softens and soothes the skin or mucous membrane

2. Provides a barrier

Question 21

What is enteric coating? (Rx17)

Answer 21

1. An acid resistant protective layer to prevent dissolution in the stomach
2. Also can be used to mask poor taste

Question 22

Hazardous drug storage/handling is managed according to what? (Rx17)

Answer 22

USP 800

Question 23

What is the beyond use date for nonaqueous formulations? (Rx17)

Answer 23

Not later than any active pharmaceutical ingredient or

6 months

Question 24

What is the beyond use date for water-containing oral formulations? (Rx17)

Answer 24

Not later than 14 days when stored at refrigerator temperature

Question 25

What is the beyond use date for water-containing topical formulations? (Rx17)

Answer 25

Not later than 30 days