A) DISINTEGRATION TEST FOR SUGAR COATED TABLETS
MATERIAL AND APPARATUS: Tablet Disintegration Test Apparatus,
3 Ibuprofen tablet and water for disintegration medium.
Method:
The apparatus was set up for disintegration test according
to its operation manual and the temperature of disintegration medium was
ensured at 37±2°C. The apparatus was set for 60 minutes and then one
tablet was added into each tube and was allowed to sink at bottom of tube.
Next, before the operation was started the disked was added to each tube. After
60 minutes, the tablet in each tube is checked to know it’s disintegrated or
not. If all the tablets disintegrated in 60 minutes that’s means the tablet
comply with the test. Next, if there was
any tablet that did not disintegrated, the experiment was repeated using new
tablets but the disintegration medium was replaced with 0.1M hydrochloric acid.
The tablets were considered comply with the test if all tablets disintegrated
in acidic medium.
Results:
All the 3 tablets disintegrate after the test. When the test
ended, there still have solid particle in the tube but when we presses the
solid particle by using hand it was disintegrate. In this situation the tablet
are still considered to pass the disintegration test.
Discussion:
For a drug to be absorbed from a solid dosage form after
oral administration, it must first be in solution, and the first important step
toward this condition is usually the break-up of the tablet; a process known as
disintegration.
The disintegration test determines whether tablets or
capsules disintegrate within the prescribed time when placed in a liquid medium
in the experimental conditions prescribed above. Disintegration is considered
to be achieved when:
a) No residue remains in the tube, or
b) If there is a residue, it consists of a soft mass having
no palpably firm, unmoistened core, or
c) Only fragments of coating (tablets) or only fragments of shell
(capsules) remain in the tube; if a disc has been used (capsules), fragments of
shell may adhere to the lower surface of the disc.
In this experiment, Ibuprofen tablet passes the
disintegration test because no residue left after 60 minutes. The possible
errors that occur during the experiment are the temperature is less than 37°C
so the tablet does not disintegrate according to the body temperature. Other
than that, the tablet use has already reached its expiry date and does not
disintegrated properly.
Conclusion:
Ibuprofen tablet disintegrated at 37±2°C after 60 minutes.
MATERIAL AND APPARATUS: Tablet Dissolution Test Apparatus, 1
tablet of Ibuprofen, 25 ml volumetric flask, syringe and spectrophotometer.
Method:
Firstly, the dissolution vessel was filled up with the
buffer solution to 900ml mark and the temperature was set to 37°C.
The dissolution medium temperature was ensured at 37±0.5°C. Next, one tablet of
Ibuprofen was placed into the dry basket assembly and before start the
operation, the stirring speed was set to 150rpm and the basket assembly was
then lowered into position in the vessel. The operation was left for 30 minutes
and after that, 10 ml of sample was withdrawn from dissolution medium using
syringe for analysis. Sampling should be done from a point half away between
the surface of dissolution medium and top of rotating basket and not less than
10 mm from the wall of vessel. The volume of aliquot withdrawn was replaced
with an equal volume of same dissolution medium.
Next, the standard solution of Ibuprofen was prepared by
diluting 10mg of Ibuprofen reference standard to 50 ml with dissolution medium.
After that, 2.0ml sample solution and 2.0 ml standard solutions was diluted to
25ml with dissolution medium in separated volumetric flask. The sample then analyzed for absorbance in 1
cm cell at a wavelength of 221 nm using spectrophotometer.
The percentage amount of ibuprofen dissolved was calculated
using the following formula:
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Where:
At
=absorbance of sample solution
As
=absorbance at standard solution
W
=weight of ibuprofen reference standard used
P
=purity of ibuprofen reference standard
The result obtained was determined whether the tablets
comply with the requirement of United State Pharmacopoeia.
USP limits: not less than 75% of stated amount of ibuprofen
dissolve in 30 minutes.
Result:
ABS
|
K*ABS
|
|
Standard
|
3.215
|
3.2148
|
Sample solution
|
0.697
|
0.6969
|
W=0.01g
P=0.98
So, the percentage amount of ibuprofen dissolved using the
formula are:
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Discussion:
The release of drug from the tablet into
the solution per unit time under standardize condition is called dissolution
test. In this experiment, we using USP apparatus I that using basket.
In vitro dissolution testing of solid
dosage forms is important because:
Dissolution studies in the early stages
of a product’s development allow differentiation between formulations and
correlations identified with in vivo bioavailability data. The conduct of such
testing from early product development through approval and commercial
production ensures control of any variables of materials and processes that
could affect dissolution and quality standards. Consistent in vitro dissolution
testing ensures bioequivalence from batch to batch. It is a requirement for
regulatory approval of marketing for products registered with the FDA and
regulatory agencies of other countries.
In this experiment by using the formula,
the percentage of ibuprofen dissolve is 23.9%. This amount is does not achieved
USP limit that stated that not less than 75% of stated amount of
ibuprofen dissolve in 30 minutes. The possible errors that may occur during the
experiment are the temperature is less than 37°C so the tablet does not
dissolve properly. Other than that, the tablet use has already reached its
expiry date and does not dissolve to get it optimum percentage concentration.
In order to reduce error, the method of dissolution testing must be controlled
to minimize important variables such as basket rotational speed, vibration, and
disturbances by sampling probes.
In addition to method of dissolution, formulation and
manufacturing controls also play important role why the tablet does not achieved
USP dissolution unit. A number of formulation and manufacturing factors can
affect the disintegration and dissolution of a tablet, including particle size
of the drug substance; solubility and hygroscopicity of the formulation; type
and concentration of the disintegrant, binder, and lubricant; manufacturing
method, particularly the compactness of the granulation and compression force
used in tableting.
Conclusion:
The percentage amount of Ibuprofen dissolve is 23.9%. The
dissolution test on Ibuprofen at 37±0.5°C does not reach USP limit that
is not less than 75% of Ibuprofen must dissolve in 30 minutes. The method of
dissolution, manufacture and formulation play important role in order for
tablet to dissolve.
2. State the type of
tablet and capsules that must be tested for uniformity of diameter and
uniformity of content.
-uncoated and coated
tablet
-suspension in soft
capsule
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