Exam 2: Definitions

Question 1

Rate of dissolution

Answer 1

Amount of drug substance that goes in solution per unit time under standardized conditions of liquid/solid interface, temperature, and solvent composition

Question 2

Tablet

Answer 2

Very fine powder compressed into a single dosage unit

Question 3

Capsule

Answer 3

Solid dosage forms in which the drug substance is enclosed within a hard/soft soluble shell (usually formed from gelatin)

Question 4

USP definition of IVIC

Answer 4

Establishment of rational relationship between a biological property or a parameter derived from a biological property produced by a dosage form and physicochemical property of same dosage form

Question 5

FDA definition of IVIC

Answer 5

Predictive mathematical model describing the relationship between in vitro property of dosage form and a relevant in vivo response

Question 6

Mixer: Drum

Answer 6

Mixing mech: diffusive 
Segregation: bad
Axial mixing: bad
Ease of emptying: bad
Segregation on emptying: bad

Question 7

Mixer: V-Mixer

Answer 7

Mixing mech: diffusive
Segregation: bad
Axial mixing: bad
Ease of emptying: good
Segregation on emptying: bad

Question 8

Mixer: Cone

Answer 8

Mixing mech: diffusive
Segregation: bad
Axial mixing: bad
Ease of emptying: good
Segregation on emptying: bad

Question 9

Mixer: Ribbon

Answer 9

Mixing mech: convective
Segregation: good
Axial mixing: slow
Ease of emptying: good
Segregation on emptying: fair

Question 10

Mixer: Fluidize

Answer 10

Mixing mech: convective
Segregation: fair
Axial mixing: good
Ease of emptying: good
Segregation on emptying: good

Question 11

Mixer: Screw

Answer 11

Mixing mech: shear
Segregation: bad
Axial mixing: good
Ease of emptying: good
Segregation on emptying: bad

Question 12

Level A IVIVC

Answer 12

Point-to-point relationship between in vitro dissolution time and the in vivo input rate

Question 13

Level B IVIVC

Answer 13

Mean in vitro dissolution time compared to mean in vivo dissolution time

Question 14

(Multiple) Level C IVIVC

Answer 14

Single point comparison of drug dissolved to one PK parameter
Ex) T50% linked to AUC/Cmax/Tmax

Question 15

How to calculate % Prediction Error (PE)

Answer 15

%PE = [(AUCobserved - AUCpredicted)/AUCobserved] * 100 = [(Cmaxobserved - Cmaxpredicted)/Cmaxobserved] *100

Question 16

How to calculate rate of dissolution? (Know what each variable stand for)

Answer 16

dC/dt = k1A(Cs - Ct) = DA/Vh (Cs - Ct)

Question 17

How to calculate dissolution rate at sink conditions? (Know conditions and variables)

Answer 17

dC/dt = k2ACs

Question 18

Sink conditions vs Non-sink conditions

Answer 18

Sink conditions: complete dissolution of drug, excess solubilizing capacity of the dissolution medium (zero order)

Non-sink conditions: non-excess solubilizing capacity of dissolution medium (first order)

Question 19

Absolute surface area vs Effective surface area

Answer 19

Absolute: total SA of particle

Effective: SA of particle exposed to dissolution medium

Question 20

How to calculate D value for microbial death?

Answer 20

D = T/[log(original)-log(remaining)]

Question 21

Dissolution

Answer 21

Process in which a solid substance solubilizes in a given solvent