tablet quality

Question 1

What is variation in tablet thickness caused by:

Answer 1

compressive loads 
die fill: 
- Raw materials 
- punch length 
- machine separation 
- granule properties

Question 2

variations in tablet weight caused by:

Answer 2

dimensions of die cavity
amount of fill
density of material

Question 3

how to determine tablet weight:

Answer 3

weigh 20 tablets individually and determine average mass
≤80 mg 10%
80-250mg 7.5%
≥250mg 5%
not more than 2 individual masses deviate from average mass by more than % deviation and none deviates by more than 2x

Question 4

What is the friability test for:

Answer 4

ensure that tablets can withstand mechanical shocks and abrasion during manufacturing, packaging ad transportation processes

Question 5

How to conduct friability tests (acceptance criteria):

Answer 5

if weight >650mg, take 10 tabs
<650mg, take close to 6.5g worth of tabs
run once (15mins), if tabs visually damaged, test has failed
if loss <1%, pass
if >1%, repeat 2 more times and ensure that mean of 3 tests do not > 1%

Question 6

what is tablet hardness?

Answer 6

Breaking force/crushing strength

Question 7

how is tablet hardness tested?

Answer 7

Tested across diameter/parallel to longest axis – give information on tablet strength along weakest point in structure

Question 8

What is the BP recommendation for tablet hardness?

Answer 8

just need to do measurement on 10 tabs and report mean, min, max in N
also need to note down the type of apparatus and orientation of shaped tablets

Question 9

Why do we need to test for tablet disintegration:

Answer 9

help ensure that tablets/capsules break up after ingestion to ensure rapid dissolution

Question 10

USP recommendation for tablet disintegration tests:

Answer 10

use Mesh aperture (2mm) and 6 tabs

run the test for 28-32 cycles over 50-60 mm at 37+/-2deg cel for 15 min

Question 11

Acceptance criteria for tablet disintegration tests:

Answer 11

all particles must pass through #10 mesh screen in time specified. if residue remains, must be soft mass without core
if 1-2 tabs fail, repeat with 12 more units. pass only when ≥16 out of 18 tabs tested disintegrated

Question 12

Why do we need to do tablet release testing:

Answer 12

meet compendial requirements
design extended/delayed release products
predict biopharmaceutical performance

Question 13

Acceptance criteria for tablet thickness:

Answer 13

≤5% standard value from mean of 20 tablets