Dosage forms are pharmaceuticals used to deliver Active Pharmaceutical Ingredients (APIs) to a specific site in the body for a specified duration to treat diseases. They are classified according to the physical form and the route of administration, according to the physical form, they are solid, liquid, semi-solid and gaseous pharmaceutical forms, and according to the route, they are oral, parenteral, topical, by inhalation and some are installed. in body cavities, etc. The different dosage forms are tablets, tablets, capsules, powder, granules, sachets, lozenges, emulsion, suspension, liniment, drops, syrup, lotion, cream, paste, ice cream, ointment, aerosol, spray, inhaler, pessaries, suppositories and bath of mouth, etc.
The quality control test of dosage forms includes different evaluation tests such as organoleptic properties, hardness test, weight variation test, friability test, content uniformity test, disintegration and dissolution test. These tests are performed throughout manufacturing and are checked after the end of each batch to assess whether the quality requirements of the product meet the standard limits based on official or unofficial tests which are mentioned in different pharmacopoeias such as USP, IP and BP.
What is a disintegration test?
Disintegration is an official quality control test that determines whether various solid dosage forms, such as tablets, capsules, and suppositories, disintegrate within a given time when placed in a liquid medium under specified experimental conditions. In pharmaceutical industries, disintegration is a necessary test that is performed to test the disintegration ability of dosage forms, according to pharmacopoeial standards such as IP, USP and BP. This allows it to completely dissolve and be absorbed through the gastrointestinal (GI) tract after separation from its parent. It is tested to ensure that the pill dissolves or breaks into granules or small particles upon contact with water with agitation.
Why is the disintegration test performed?
A disintegration test is performed to calculate the time it takes for a solid dosage form to completely disintegrate. The main purpose of performing the disintegration test is to check the quality of pharmaceutical forms.
Principle of operation of the disintegration test apparatus:
The equipment used to perform the disintegration tests is known as a USP disintegration tester or disintegration tester. This device consists of a basket frame 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 the tubes. A stainless steel wire gauge is attached to the bottom of the bottom plate. The upper and lower plates are placed on vertical metal rods on the periphery, and the metal rod in the center of the upper plate is connected to the mechanical device. The assembly should move up and down 28 to 32 times per minute in the liquid at 370vs.
The tablets are immersed in the liquid surrounded by the tubes through the cylindrical guided disc. A sample of tablets is placed in all six tubes of the basket and a disc is added to each tube. each tube and basket is placed in a beaker (1 liter) of immersion liquid such as water or simulated gastric or intestinal fluid such as specific pH phosphate buffer and hydrochloric acid (HCL) 0, 1m, etc at temperature. 370vs.
Limitations of the tablet disintegration test:
Generally, the disintegration time for coated tablets is around 01-02 hours, for uncoated tablets it is around 05-30 minutes, and for immediate release (IR) it is around 15 minutes or less.
The tablet passes the test if all six disintegrate, the test is continued with 12 more tablets and no less than 16 of the total 18 tablets. The disintegration time of fully coated and coated tablets should not exceed 1 and 3 hours respectively.
What is decay time?
Disintegration time is the time it takes for a dosage form to break down into granules of a specific size (or smaller) under precisely controlled conditions, known as dissolution time.
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