TABLET AND CAPSULES (Experiment 4)

Experiment 4: Dosage performance test

Disintegration test for sugar-coated tablets  

Aim: To study the disintegration rate for sugar-coated tablets

     

Procedure:

   1.     The apparatus for the disintegration test was set up according to it’s operation manual.

   2.    The temperature of disintegration medium was ensured at 37 +/- 2^oC.

   3.    The time was set to 60 minutes. One tablet was introduced into each tube and the disk was added into        each tube. The operation was started.

   4.   The tablet was checked in each tube at the end of the operation.

   5.   Tablets comply with the test if all 3 tablets disintegrate in 60 minutes. If there is any tablet that does not disintegrate, the test should be repeated using 3 new tablets and disintegration medium(water) was replaced with 0.1M hydrochloric acid. Tablets comply with the test if all 3 tablets disintegrate in the acidic medium. 

 Results:

Drug (paralgin tablets)	Disintegration test	Time Taken For The Drug Completely Disintegrate
1	With water	2.23 minutes
2	With water	2.40 minutes
3	With water	2.34 minutes
Average	With water	2.32 minutes

Discussion:

The disintegration test is performed to find out the time taken 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, 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.

            In this experiment, paralgin was being used to perform disintegration test as it is one of sugar coated tablets. Each paralgin’s tablet contain 500mg paracetamol and 8mg of codeine phosphate hemihydrates. From this experiment, average of a Paralgin tablet would need 2.32 minutes to disintegrate completely. As Paralgin tablet disintegrate completely not more than one hour, it considered succeeded in this experiment. However, this result not guarantee to be the same as in an actual person as several other factors also need to be included. Other factors that need to be include are different pH and motility in different parts of gastrointestinal tract. During the experiment was conducted, the temperature was maintained at 37^oC  as it equal to our body temperature and to make sure the disintegration rate of Paralgin did not disturbed by the temperature.

Conclusion:

The average time taken for the Paralgin to disintegrate completely is 2.32 minutes. This duration of disintegration might not be the same as in real human body. However, as the result not exceed 60 minutes, the result is acceptable for the tablet to be used in the pharmaceutical.

Dissolution test for tablets

Aim

To test on the dissolution capability of the ibuprofen tablet

Method

i) Apparatus and Materials

Volumetric flask (50 mL), filter funnel, dropper, measuring cylinder (10 mL), weighing boat, Ultraviolet Spectrophotometer, dissolution machine, buffer solution, Ibuprofen tablet and Ibuprofen Standard Solution.

Ibuprofen tablet

Ibuprofen tablet placed in the basket.

Ibuprofen standard solution

Ultraviolet Spectrophotometer

ii) Procedure

1.      One Ibuprofen tablet was placed into each dry basket assembly.

2.      The stirring speed was set to 150 rpm. The basket was lowered assembly into position in the vessel and the operation was started.

3.      After 30 minutes, 10 mL of samples of dissolution medium was drawn from each vessel for analysis. The solution was filtered using suitable filter.

4.      A standard solution of ibuprofen was prepared by diluting 10.0 mg of ibuprofen reference standard to 50 mL with dissolution medium.

5.      4.0 mL of sample solution and 4.0 mL of standard solution were diluted to 50 mL with dissolution medium (buffer solution) in separate volumetric flasks.

6.      The absorption of both solutions was measured in a 1cm cell at a wavelength 221 nm.

7.      The percentage amount of ibuprofen dissolved was calculated. From the result obtained. It was determined whether the tablets comply with the requirements of the United States Pharmacopoiea.
      
     Results and Calculation
      Absorbance of sample solution : 0.790
      Absorbance of the standard solution : 3.311
      The percentage amount of ibuprofen dissolved using the following formula :

0.790/3.311 X 10/50 X 2/25 X 0.98 X 900 X 25/2 X 100/200 = 21.04 %

Therefore, the percentage amount of ibuprofen dissolved is 21.04 %.

Discussion

In determining the dissolution of tablet, a test can be conducted using Ultraviolet spectrophotometer. This equipment is used to measure the absorbance of solutions tested at a wavelength of 221 nm. By applying the formula given, the percentage amount of ibuprofen dissolved can be calculated. A high value of absorbance indicated that there is a high amount of drug dissolved. The tablet is said to comply with the measurements of the United State Pharmacopoiea (USP) if there is not less than 75 % of the stated amount of Ibuprofen dissolved in 30 minutes. In this experiment, the percentage of amount of ibuprofen dissolved showed that the Ibuprofen tablet tested did not comply with the requirements of the USP as the percentage is 21.04 %. The result obtained might be influenced by possible errors occurred throughout the experiment. One of the errors comes from the tablet itself. The tablet tested might have reached the expiry date, hence the performance or dissolution ability does not comply with the standard. Next, error might come from the incomplete dissolution of the tablet when placed in the dry basket. Due to improper filtration, the dissolved and some undissolved sample may contain in the sample withdrawn and this will affect the result obtained. Other than that, there might also errors due to poor calibration or measuring error which may lead to inaccurate result obtained.

Conclusion

The percentage amount of ibuprofen dissolved is 21.04 %. This value obtained shows that the tablet does not comply with the requirements of the United States Pharmacopoiea.

References
1. Ibuprofen: A Critical Bibliographic Review edited by K.D Rainsfort. Taylor and Francis
(http://books.google.com.my/books?id=yEhuuidCJ7IC&pg=PA67&lpg=PA67&dq=ibuprofen+dissolution+test+usp&source=bl&ots=w8R2xmi4hD&sig=uTi0XNgHWgAKM3UP_l_sPW5HmeY&hl=en&sa=X&ei=mrS7Up37GIOMrQe1yYDwBw&sqi=2&redir_esc=y#v=onepage&q=ibuprofen%20dissolution%20test%20usp&f=false)