2

Question 1

Myocet, liposomal formulation of doxorubicin

Answer 1

•IV
•not PEGylated
•quickly accumulation in liver and spleen/don’t circulates in blood vessels
•slow release of drug in blood circulation, slow transfusion
prolonged therapeutic effect

Question 2

Trehalose

Answer 2

Can be used as cryoprotectants and lyoprotectants

Question 3

Stress test apparatus main feature

Answer 3

Stimulates
• the irregular motility pattern of GIT
•the pressure of Gastric-emptying of dosage form
•dosage form exposure to air and liquid
•discontinuous distribution of fluid in intestines

Question 4

gp-60 receptor

Answer 4

•present in the endothelial cells of all vessels of the body
•responsible for active targeting
•Abraxane is able to exploit the albumin activated gp60 transport mechanism to target tumor cells
•expressed not only tumor cells

Question 5

Smallest type of nanoparticles

Answer 5

Dendrimers

Question 6

Which test is enable to easily change the medium during test

Answer 6

Flow through cell system and reciprocating cylinder

Question 7

Which test can’t be change medium easily

Answer 7

Paddle and basket

Question 8

Which test might not be suitable for tablets that disintegrate into very small particles

Answer 8

Basket and reciprocating

Question 9

Which liposomes are most commonly used in commercial products

Answer 9

SUV

Question 10

Which apparatus has the gastric secretion controlled by volume and ph of food introduced

Answer 10

DGM

Question 11

Sink condition

Answer 11

•the concentration gradient remains large and constant
•dissolution rate depends only on the dosage form
•full drug solubilization cab be achieved

Question 12

Milk can be used as dissolution medium to

Answer 12

Stimulates the fed gastric content in the early stage of digestion

Question 13

Predictive dissolution test main use

Answer 13

Bioequivalence studies
Screening of formulations in product development

Question 14

How to achieve sink condition in poorly soluble drugs

Answer 14

1 Inc volume of medium, more than 1L in paddle apparatus
2 adding surfactants
3 changing ph for unionized drugs

Question 15

Milk and acetic acid buffer mixed in ratio 1:1 can be used in dissolution medium

Answer 15

The fed gastric emptying in the mid stage of digestion

Question 16

Which apparatus stimulates drug permeability in the intestines

Answer 16

TIM

Question 17

Which media contains more surfactants

Answer 17

FeSSIF

Question 18

Which media contains least surfactants

Answer 18

FaSSGF

Question 19

Predictive dissolution test

Answer 19

•more complicated than qc
•doesn’t just give yes/no but a close account of the product performance
•Sink condition not always used
•they can make use of a non compendial apparatus
•they try to stimulate in vivo conditions as closely as possible

Question 20

What are usually the dissolution limits of gastro resistant tablets

Answer 20

Need to insure: drug dissolution acidic+fast dissolution in small intestines
The limitations:
No more than 10% drug release in acid in 2hrs and at least 75% drug release in buffer