RE lecture 4

Question 1

Can the diffusion coefficient change?

Answer 1

no

Question 2

How can you reduce the thickness of the diffusion layer to increase dissolution?

Answer 2

Stirring

Question 3

What are the different USP apparatuses for dissolution testing?

Answer 3

1. USP apparatus 1: Basket
2. USP apparatus 2: Paddle
3. USP apparatus 3: Reciprocating cylinder
4. USP apparatus 4: Flow through cell

Question 4

What is the USP apparatus 2 best for?

Answer 4

Immediate release tablets

Question 5

What is the USP apparatus 3 best for?

Answer 5

Sustained release and Enteric coated tablets

Question 6

What is the purpose of dissolution testing?

Answer 6

1. Quality control
2. Comparability testing after the production is scaled up
3. Evaluate bioequivalence in a biowaiver application
4. Discriminate between candidates in formulation development

Question 7

In dissolution testing, what is considered good for a immediate release tablet?

Answer 7

80% release within 45 mins

Question 8

What solution is used for in vitro quality control dissolution test?

Answer 8

Phosphate buffer

Question 9

Which drugs are eligible for a biowaiver?

Answer 9

1. Class I and III
2. Immediate release
3. Same oral dosage from
4. Same API and dose strength

Question 10

What test is used to establish an in vitro-in vivo correlation?

Answer 10

Biorelevant dissolution tetsing

Question 11

What test is used to establish an in vitro-in vivo correlation?

Answer 11

Biorelevant dissolution testing

Question 12

What are the different physiological conditions simulated during biorelevant dissolution testing?

Answer 12

1. Fasted state
2. Fed state
3. Gastric fluid
4. Intestinal fluid
5. Colonic fluid