A) DISINTEGRATION TEST FOR SUGAR COATED TABLETS
MATERIAL AND APPARATUS: Tablet Disintegration Test Apparatus, 3 Ibuprofen tablet and water for disintegration medium.
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.
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.
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.
Ibuprofen tablet disintegrated at 37±2°C after 60 minutes.
B) DISSOLUTION TEST FOR TABLETS
MATERIAL AND APPARATUS: Tablet Dissolution Test Apparatus, 1 tablet of Ibuprofen, 25 ml volumetric flask, syringe and spectrophotometer.
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:
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.
So, the percentage amount of ibuprofen dissolved using the formula are:
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.
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