Study Set Content:
30 min/As per individual monograph
Uncoated, Coated
Enteric - coated 1 hr in simulated gastric fluid TS:
No disintegration
Enteric - coated As per individual monograph
Simulated intestinal fluid TS
As per individual monograph
Sublingual
4 hours
Buccal
Put ECT in
dist. H2O
Put ECT in dist. H2O for (blank) to dissolve the coat
5 min
Then put the ECT in the
simulated gastric fluid (0.1M HCL)
Then put the ECT in the simulated gastric fluid (0.1M HCL) for
1 hour
Next, put the ECT in the
simulated intestinal fluid
Next, put the ECT in the simulated intestinal fluid for
2 hours
If one or two tablets fail to disintegrate, repeat this test on another
12 tablets
If one or two tablets fail to disintegrate, repeat this test on another 12 tablets. (blank) out of 18 tablets should completely disintegrate.
16
If more 2 tab fail to disintegrate, the batch must be
rejected
USP Method for uncoated tablets Start the disintegration test on
6 tablets
If one or two tablets from the 6 tablets fail to disintegrate completely within (blank), repeat the same test on another 12 tablet. (whole test will consume 18 tablets)
30min
Not less than (blank)tablets disintegrate completely within the time.
16
If more than two tablets (from the 18) fail to disintegrate, the batch must be
rejected
To remove the coat, immerse the tablet in
dist. H2O for 5 min.
Put the tablet in the apparatus in
water or HCL
