EXPERIMENT # 7

TABLET DISINTEGRATION TEST

(Endterm)
Materials:
Commercial Sodium
Bicarbonate Tablets
 Mechanical Device for
lowering & raising the
Thermometer Basket-Rack Assembly

Heater

Vessel

1-L Beakers
Basket-Rack
Assembly Filter
(6 tubes each)

Monitor &
Disks
Input Keys

Disintegration Machine Testing (TD 20S, THERMONIK)

 6 Transparent
Open-ended
Tubes

Lower plate of
stainless steel
wire mesh

Disks made of
transparent
Plastic Material
with 5 holes (4
parallel and 1 in
the center) Basket-Rack Assembly
Status of Test

Heater
Status

Time

Temperature
Monitor

Monitor
Commercial Sodium Bicarbonate Tablets
1. Place 1 dosage unit in each of the six tubes and
add a disks.
Commercial Sodium Bicarbonate Tablets
2. Operate the apparatus,
Disintegration Machine
Testing (TD 20S,
THERMONIK) using water as
the immersion fluid.
3. Maintain the temperature at
37o ± 2o C

Note: Wait for the temperature

of the immersion medium to
rise at 37o C
Commercial Sodium Bicarbonate Tablets

4. Click START once

the temperature has
been maintained.
Commercial Sodium Bicarbonate Tablets

5. The tablet should have

been disintegrated within
15 minutes (according to
BP).
Commercial Sodium Bicarbonate Tablets

6. Click STOP and

take note the time.
Commercial Sodium Bicarbonate Tablets
7. Lift the basket from the fluid
and observe the tablets.

First Criterion:
All of the tablets should be
disintegrated completely.

Proceed to second criterion if not met.

Commercial Sodium Bicarbonate Tablets
Second Criterion:
If 1 or 2 tablets failed to
disintegrate completely, repeat
the step on 12 additional
tablets.

The requirement is met if not

fewer than 16 of the total 18 (6
tabs initially + 12 additional if
did not pass the first criterion)
tablets tested are disintegrated.
 RESULTS

Commercial Sodium Bicarbonate

TIME # of tabs # of tabs did NOT
disintegrated disintegrated

10 mins   6 tabs
none
 To assure that the drug product will
release the active ingredient.
What there is
a need to
conduct a For the API to be solubilized.
disintegration
test for
tablets? API will not be absorbed in the
Systemic Circulation once it will not be
disintegrated from the dosage form
and then solubilized in the GI fluid.
Other than Tablets, Capsules
what are the other
dosage forms
applicable for
Disintegration Enteric Coated Tablets
Testing?

Coated Tablets
 Based on the Experiment, is there
an additional 12 tablets subjected to
disintegration test? If YES, justify
your answer. If NO, justify your
answer also.

NO
Liquids used in disintegration
oWater,
osimulated gastric fluid (PH = 1.2 HCl),
oSimulated intestinal fluid (PH = 7.5, KH2PO4
(phosphate buffer) + pancreatin enzyme +NaOH)
• Limits:
For Uncoated tablets:
Medium Temperatur Time limit
e
According to U.S.P. Simulated 37 Not exceed
gastric fluid 30min

According to B.P. water 37 ± 2 ֯C Not exceed

15min
U.S.P. method for uncoated tablets:
oStart the disintegration test on 6 tablets.
oIf one or two tablets from the 6 tablets fail disintegrate
completely within 30min repeat the same test on another 12
tablet. (i.e. the whole test will consume 18 tablets).

Acceptance Criteria:
oNot less then 16 tablets disintegrate completely within the
time
oif more than two tablets (from the 18) fail to disintegrate,
the batch must be rejected.
For Coated tablets:
oTo remove or dissolve the coat, immerse the tablet in distilled
water for 5min.
oPut the tablet in the apparatus in water or HCl for 30min at 37 oC
(according to the U.S.P). If not disintegrated, put in intestinal
fluid.
oIf one or two tablets fail to disintegrate, repeat on 12 tablets.

Acceptance Criteria:
o 16 tablets from the 18 must completely disintegrate within the
time
o if more than two tablets (from the 18) fail to disintegrate, the
batch must be rejected.
U.S.P. Method for Enteric coated tablets:

o Put in distilled water for five minutes to dissolve the coat.

o Then put in simulated gastric fluid (0.1M HCl) for one hour.
o Then put in simulated intestinal fluid for two hours.
o If one or two tablets fail to disintegrate, repeat this test on
another 12 tablets.

Acceptance Criteria:
o 16 tablets from the 18 must completely disintegrate within the
time
o if more than two tablets (from the 18) fail to disintegrate, the
batch must be rejected.