quality control of immediate release tablets using BP

Question 1

examples of non-pharmacopoeial specifications

Answer 1

• general appearance
• size, shape, thickness
• organoleptic

Question 2

how much can the individual masses deviate from the average masses of tablets

Answer 2

if less than or equal to 80mg = 10%

if between 80 and 250mg = 7.5%

if greater than 250mg = 5%

Question 3

what percentage must each individual content be between to comply with uniformity of content

Answer 3

85-115% of the average content

Question 4

what can affect tablet disintegration

Answer 4

hardness

too high=tablet won’t disintegrate in time

too low=may not withstand handling

Question 5

typical range of N forces (resistance to tablet crushing)

Answer 5

40-70N

Question 6

friability meaning

Answer 6

tendency of a tablet to chip, fragment or powder

Question 7

what can friability effect

Answer 7

cosmetic elegance (decreases patient compliance)

Question 8

what can friability cause

Answer 8

weight (dose) variation

Question 9

how is friability tested

Answer 9

by putting 6.5g tablets in a tumbling motion 100 times

acceptance limit is a less or equal to 1% weight loss

Question 10

what determine the time limit for tablet disintegration

Answer 10

it varies and is drug dependent

Question 11

what is disintegration important for

Answer 11

initiating drug release from dosage form upon ingestion

Question 12

in vivo steps of immediate release tablets

Answer 12

tablet disintegrates and becomes granules

deaggregation to fine particles

fine particles dissolute and become in solution

Question 13

what is dissolution

Answer 13

the rate of drug release from tablet into solution

Question 14

what is the general tablet dissolution specification

Answer 14

70% release in 45 minutes

Question 15

Where is the largest drug absorption window

Answer 15

in the duodenum/jejunum