Disintegration tester shows the time required for the tablet to break
into particles.
Disintegration is a test that determines whether tablets, capsules, pessaries, and suppositories will separate into their component parts within a specified period of time. The purpose of this test is to demonstrate the safety of components in tablet form after they have been added to solvents or used as a pharmaceutical ingredient.
The disintegration test is designed to determine the stability of a tablet or capsule in the market.
The 5.3 disintegration test is a dissolution test that measures the time it takes for tablets and capsules to dissolve completely in liquid. When provided with the appropriate conditions, it is shown that tablets and capsules are able to dissolve completely in liquid under these circumstances.
The test is performed by submerging a tablet or capsule sample in water for a defined period of time. This duration is called the dissolution period, which must be precise in order to evaluate the strength of tablets and capsules as pharmaceuticals.
These units are only dissolved to a certain degree. If you want to know if a tablet or capsule will be completely disintegrated, you can use this test.
The tablet is considered to comply with the test if each of the six tablets used in the test disintegrates in the manner prescribed. The tablets must be clean and dry, they may not contain any other substances than those necessary for their disintegration, and they must be in a plastic or glass container. Only 6 tablets are used for the disintegration tester. If 1 or 2 tablets fail to disintegrate then, repeat the test on 12 additional tablets.
The equipment consists of two hot plates provided to maintain the temperature of the liquid medium (100 ml beaker). Solid-state regular heat is provided to control the temperature of the hot plates. Two batches of six tablets each can be tested simultaneously. The unit is provided with two glass beakers having a capacity of 1000 ml with an arrangement to hold the temperature sensor placed in the sturdy, acrylic water bath. The large spread-out stainless steel heater ensures perfectly uniform heating.
The apparatus consists of a basket rack assembly, a 1 liter breaks thermostatic arrangements of heaters to fluid, and a mechanical device for raisins and lowering the basket in the immersion fluid at a constant frequency rate.
The U.S. Pharmacopeia standard disintegration tester uses three baskets with mesh bottoms (or mesh-bottomed sample tubes), which are slowly moved up and down in a water bath at 37 �C. The basket on the left and the basket on the right are both graduated, although the size of each increment may vary from batch to batch.
The disintegration time of a tablet refers to the time required for the active ingredients to be entirely released from the coating.
Uncoated tablets must disintegrate3 in not more than 45 minutes. Plain-coated tablets must disintegrate in not more than 60 minutes.
The dissolution test is performed at 37�C. The temperature of the dissolution fluid should mimic the temperature of human tissue. The Physiological conditions should maintain a sink condition at all times (generally, the final drug concentration of the dissolution fluid should be less than 10% of the solubility of the drug being tested).