Tablet Disintegration Testers
Why use a Tablet Disintegration Tester:
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 is a measure of the time required under a given set of conditions for a group of tablets to disintegrate into particles which will pass through a 10 mesh screen. Generally, the test is useful as a quality assurance tool for conventional dosage forms. The disintegration test is carried out using the disintegration tester which consists of a basket rack holding 6 plastic tubes, open at the top and bottom, the bottom of the tube is covered by a 10-mesh screen. The basket is immersed in a bath of suitable liquid held at 37 o C, preferably in a 1L beaker. For compressed uncoated tablets, the testing fluid is usually water at 37 o C but some monographs direct that simulated gastric fluid be used. If one or two tablets fail to disintegrate, the test is repeated using 12 tablets. For most uncoated tablets, the BP requires that the tablets disintegrate in 15minutes (although it varies for some uncoated tablets) while for coated tablets, up to 2hours may be required. The individual drug monographs specify the time disintegration must occur to meet the Pharmacopoeial standards.
In the past, the only release index required for a tablet was its disintegration time which does not necessarily measure the physiological availability of the drug in a patient. Studies have shown that the agitation of the gastric contents during normal contractions is quite mild in contrast to the turbulent agitation produced in the disintegration test apparatus . The low order magnitude of agitation in the stomach produces substantially higher disintegration in vivo than those obtained using the USP apparatus. Furthermore, the particles of the disintegrated tablets are not dispersed throughout the stomach but remains as an aggregate. Thus, the tablet disintegration test is limited to manufacturing control of lot-to-lot variations in individual products and is not a measure of bioavailability. Nevertheless, it is used to provide a simple and useful means for monitoring and controlling the quality of tablets.
JB Pharmatron offers a complete range of disintegration testers. The ED-2L is a cost effective manual disintegration tester; ED-2L SAPO is a semi-automatic system with the option for operators to log the tablet disintegration times and obtain a printed report; two and three basket systems are available on the SAPO.
For customers that require a precise tablet disintegration end point we offer the Pharmatron DisiTest 50. This fully automatic tester is the most sophisticated, user friendly and has the complete reporting package currently on the market.
JB Pharmatron offers free demos and trials so you can perform a complete evaluation before any purchasing decision is taken. Please click through for more information on our range of tablet disintegration testers and should you require any further assistance then please do not hesitate to contact us using the on line form or give us a call.
Tablet Disintegration Testers
