OBJECTIVES
- To determine how long the time taken needed for the tablet to disintegrate and whether it is disintegrate properly when placed in a liquid medium under the experimental condition.
- To determines the amount of active ingredient(s) released from a solid oral dosage form; tablet, using a known volume of dissolution medium within a predetermined length of time.
INTRODUCTION
There are
two part conducted in this experiment which is first, disintegration for
sugar-coated tablet and second is dissolution test for tablets. The performance
test is one of a series of tests that compose the specification in a United
States Pharmacopeia (USP) dosage form monograph. For an orally administered,
non-solution dosage form, it is usually satisfied by either a dissolution or
disintegration procedure. Dissolution acceptance criteria are usually set in
private negotiations between an applicant and a regulatory agency. With
information about this private agreement and other information provided in a
sponsor's Request for Revision to USP, the USP's Council of Experts elaborates
a public dosage form monograph. Based on the relationship between the
regulatory decisions and the Request for Revision, the USP dissolution
procedure links to a regulatory judgment about bioavailability and
bioequivalence and, ultimately, to a judgment about safety and efficacy. The
current dissolution procedure and acceptance criteria are perceived as having
worked well over the years and are generally accepted.
PROCEDURES
Disintegration test for sugar-coated tablets
1.
The
apparatus for the distegration test is set up according to its operation
manual.
2.
The
temperature is literally at 37+- 2⁰C
3.
The time is
set up to 60minutes, and one paralgin tablet is introduced into each tube, add
the disk into each tube and start operation.
4.
Time is
taken for the disintegration of the 6 tabs accordingly.
Dissolution test for tablets
1.
Dissolution
vessel was filled with the buffer solution to 900 ml mark. The temperature was
setted to 37°C.
2.
One
Ibuprofen Tablet was placed into each dry basket assembly.
3.
The stirring
speed was setted to 150 rpm. The basket assembly was lowered into position in
the vessel and the operationwas stated.
4.
10 ml
samples of the dissolution medium was withdrawed using syringes that
include with filter to prevent any solid d particle from drug enter the
solution from each vessel for analysis and filter the solution using suitable
filter. Sampling should be done from a point half-way between the surface of
the dissolution medium and the top of the rotating basket, and not less than 10
mm from the wall of the vessel.
5.
A
standard solution of ibuprofen was prepared by diluting 10.0 mg of ibuprofen
reference standard to 50 ml with dissolution medium.
6.
2.0 ml
of sample solutionwas dilluted and 2.0 ml of standard solution to 25 ml with
dissolution medium in separate25 mL of volumetric flasks.
7.
The
absorption of both solutions was measured in a 1 cm cell at a wavelength of 221
nm.
8.
The
percentage of amount of ibuprofen dissolved was calculated using the
following formula:
At/As × W/50 ×
2/25 x P × 900 × 25/2 × 100/200
Where
At= absorbance of sample solution
As = absorbance of the standard
solution
W = weight of ibuprofen
reference standard used.
P = purity of ibuprofen reference
standard.
9.
From
the results obtained, determine whether the tablets comply with the
requirements of the United States Pharmacopoeia. USP limits: Not less than 75%
of the stated amount of C13H18O2 dissolved in 30 minutes.
RESULTS
Disintegration test
Observation : All six paralgin tablets
literally disintegrated after 2 minutes and 50 second. No left residue seen.
Dissolution test
Percentage amount of ibuprofen
dissolved
= At/As × W/50 × 2/25 x P × 900 × 25/2 × 100/200
= At/As × W/50 × 2/25 x P × 900 × 25/2 × 100/200
= 26.4 %
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