The disintegration test is performed using disintegration test apparatus which is used to check whether the dosage forms such as tablets, capsules, pessaries, and suppositories get disintegrated within a stipulated time or not.
Dosage forms are pharmaceutical products that are used to deliver the active pharmaceutical ingredients (API) to the specific site within the body for a particular time to treat the diseases. They are classified according to the physical form and route of administration, based on the physical form they are solid, liquid, semisolid, and gaseous dosage forms, and based on the route they are oral, parenteral, topical, inhalation, and some are installed in the body cavities, etc. The different dosage forms are tablets, caplets, capsules, powders, granules, sachets, lozenges, emulsion, suspension, liniment, drops, syrup, lotion, cream, paste, gel, ointment, aerosol, spray, inhaler, pessaries, suppositories, and mouthwash, etc.
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The quality control test for dosage forms involves different evaluation tests such as organoleptic properties, hardness test, weight variation test, friability test, content uniformity test, disintegration test, and dissolution test. These tests are carried out throughout manufacturing and verified after each batch is completed to evaluate whether product quality requirements are met standards limits as per the official or unofficial tests that are mentioned in different pharmacopeias such as USP, IP, and BP.
What is a disintegration test?
Disintegration is an official quality control test that determines if various solid dosage forms, such as tablets, capsules, and suppositories, disintegrate within a certain time when placed in a liquid medium under specific experimental conditions. In pharmaceutical industries, disintegration is a necessary test that is carried out to test the disintegration ability dosage forms, according to pharmacopeia standards such as IP, USP, and BP. This allows it to be completely dissolution and absorbed from the gastrointestinal tract (GI) after being separated from its primary. It is evaluated to ensure that the tablet dissolves or breaks up into granules or small particles upon contact with water under agitation.
Why disintegration test is performed?
A disintegration test is performed to calculate the time taken by a solid dosage form to completely disintegrate. The main purpose of doing the disintegration test is to verify the quality of the pharmaceutical dosage forms.
Working principle of disintegration test apparatus:
The equipment used to perform the disintegration test is known as the USP disintegration test apparatus or disintegration tester. This apparatus consists of a basket rack assembly of 6 cylindrical glass tubes. These tubes are placed vertically by two transparent plastic plates, which have six holes with a diameter similar to tubes. A wire gauge which is made of stainless steel is connected to the bottom of the lower plate. The upper and lower plates are placed in vertical metal rods in the periphery and the metal rod in the center of the upper plate is attached to the mechanical device. The assembly must be up and down 28 to 32 times per minute in liquid at 370C.
The tablets are immersed in the liquid surrounded by the tubes through the cylindrical guided disc. A tablet sample is positioned in every six tubes of the basket and a disc added to every tube. each tube and the basket rack is placed in a beaker (1liter) immersion liquid like water or simulated gastric or intestinal fluid such as phosphate buffer of specific pH, and 0.1 m hydrochloric acid (HCL), etc. at temperature 370C.
Disintegration test limits for tablets:
Generally, disintegration time for coated tablets is about 01 to 02 hours, for uncoated tablets is about 05 to 30 minutes, for and for immediate-release (IR) it is about 15 minutes or less.
Tablet passes the test if all six disintegrate, the test is going over on 12 extra tablets and not less than the 16 out of the total 18 tablets. The time of disintegration of enteric-coated and coated tablets should be not more than 1 and 3 hours correspondingly.
What is disintegration time?
Disintegration time is the time takes for a dosage form to break down into granules of a specific size (or smaller) under precisely controlled conditions is known as dissolution time.
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