Title: Disintegration
test for sugar-coated tablets.
Introduction:
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 is a measure of the time required under
a given set of conditions for a group of tablets to disintegrate into particles
which will pass through a 10 mesh screen. Generally, the test is useful as a
quality assurance tool for conventional dosage forms. The disintegration test
is carried out using the disintegration tester which consists of a basket rack
holding 6 plastic tubes, open at the top and bottom, the bottom of the tube is
covered by a 10-mesh screen. The basket is immersed in a bath of suitable
liquid held at 37 o C, preferably in a 1L beaker. For compressed uncoated
tablets, the testing fluid is usually water at 37 o C but some monographs direct
that simulated gastric fluid be used. If one or two tablets fail to
disintegrate, the test is repeated using 12 tablets. For most uncoated tablets,
the BP requires that the tablets disintegrate in 15minutes (although it varies
for some uncoated tablets) while for coated tablets, up to 2hours may be
required 3 . The individual drug monographs specify the time disintegration
must occur to meet the Pharmacopoeial standards.
Procedures:
1.
Apparatus for the disintegration test was set
up.
2.
The temperature for the disintegration medium
(water) was ensured at 37 ± 2°C.
3.
The time was set to 60 minutes. One tablet was
introduced to each tube and the disk was added into each tube and the operation
begins.
4.
At the end of the operation the tablet in each
tube was checked.
Results
All the tablets disintegrate within 60 minutes.
Discussion
Disintegration test is widely used in the pharmaceutical
industry for evaluation of disintegration capability of formulations (eg:
tablets) and quality control of different dosage forms.
The disintegration test is performed to find out the time it
takes for a solid oral dosage form like a tablet or capsule to completely
disintegrate. The time of disintegration is a measure of the quality. This is
because, for example, if the disintegration time is too high; it means that the
tablet is too highly compressed or the capsule shell gelatin is not of
pharmacopoeial quality or it may imply several other reasons. And also if the
disintegration time is not uniform in a set of samples being analysed, it
indicates batch inconsistency and lack of batch uniformity.
From the experiment, the time for tablets to disintegrate is
about 19 minutes and 44 seconds. So, the time for disintegration of these
tablets are low since it can disintegrate within the time given.
Conclusion
Disintegration process is important for the tablet to
break-up after oral administration to release the active ingredient. Since the
time taken for the tablet to disintegrate is 19 minutes 44 seconds, it means
that the tablet has a good quality.
Title:
Dissolution test for tablets
Introduction:
Tablets or capsules taken orally remain one of the most
effective means of treatment available. The effectiveness of such dosage forms
relies on the drug dissolving in the fluids of the gastrointestinal tract prior
to absorption into the systemic circulation. The rate of dissolution of the
tablet or capsule is therefore crucial.
Dissolution is the process by which a solid solute enters a
solution. In the pharmaceutical industry, it may be defined as the amount of
drug substance that goes into solution per unit time under standardized
conditions of liquid/solid interface, temperature and solvent composition.
Dissolution is considered one of the most important quality control tests performed
on pharmaceutical dosage forms and is now developing into a tool for predicting
bioavailability, and in some cases, replacing clinical studies to determine
bioequivalence. Dissolution behaviour of drugs has a significant effect on
their pharmacological activity. In fact, a direct relationship between in vitro
dissolution rate of many drugs and their bioavailability has been demonstrated
and is generally referred to as in vitro-in vivo correlation, IVIVC.
Procedure:
1.
Each of the dissolution vessels was filled with
the buffer solution up to 900 ml mark. The temperature was set to 37°C.
2.
The temperature of the dissolution medium was
ensured it is at 37°C.
3.
One Ibuprofen tablet was placed into each dry
basket assembly.
4.
The stirring speed was set to 150 rpm. The
basket assembly was lowered into position in the vessel and the operation
begins.
5.
After 30 minutes, 10 ml samples of dissolution
medium were withdrew from each vessel for analysis and the solution was
filtered using suitable filter. The sampling was 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. The volume of
aliquot withdrawn for analysis was replaced with an equal volume of the same dissolution
medium.
6.
A standard solution of ibuprofen was prepared by
diluting 10.0 mg of ibuprofen reference standard to 50 ml with dissolution
medium.
7.
2.0 ml of sample solution and 2.0 ml of standard
solution were diluted with dissolution medium in separate volumetric flasks.
8.
The absorption of both solutions were measured
in a 1 cm cell at a wavelength of 221 nm.
9.
The percentage amount of ibuprofen dissolved was
calculated using the formula:
At/As × W/50 × 2/25 × 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.
10.
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:
|
Absorbance of sample solution (At)
|
0.790
|
|
Absorbance of the standard solution
(As)
|
3.612
|
At/As × W/50 × 2/25 × P × 900 × 25/2 ×
100/200
= (0.790/3.612) x (10/50) x (2/55)x 0.98 x
900x (25/2) x (100/200)
= 9.74x10-3 %
Discussion:
One of the most important factors to understand during drug development
is the dosage form’s “bioavailability”. This refers to the rate at which
the drug product becomes available for absorption by the body. The rate
is governed by the time required for the drug product to dissolve in the
gastrointestinal tract, and release the drug product contained in the tablet or
capsule.
Dissolution testing allows bioavailability to be measured, which is done
using a tablet dissolution apparatus. This system simulates the
environment of the human gastrointestinal tract. Samples are taken
periodically through the study and assayed to measure drug product
concentration. A plot of the concentration over time of the study can be
created that shows the rate of release of the drug substance from the dosage
form.
As we know the limit in USP the percentage for dissolution is 75 % but
for this experiment we only get 9.74x10-3 %. This shows that the
dissolution rate for this tablet very poor. This condition may be cause by
several factors which are the tablet that we use already upon expiring date.
Besides that it also may be caused by the error when test by using spectrometer
due to lack of knowledge on how to use it.
Conclusion:
The dissolution percentage for this tablet is 9.74x10-3 %
which is not under the limit that had been fixed by USP.
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