Disintegration testers are pharmaceutical apparatus used to record the time it takes a sample to dissolve in a beaker of test media. Specifically, disintegration testers record the moment the sample breaks down from its original form into one that can then become a solute with the test media. Disintegration units are used by QC and research laboratories to confirm that tablets breakdown within a required, uniform amount of time, which can aid in compliance and development studies. Disintegration testing determines whether tablets or capsules disintegrate within a defined period of time when placed in a liquid medium. Disintegration testers as required by current Pharmacopeia should be able to provide a reproducible and standardized method of ensuring that disintegration has taken place. In automatic tablet disintegration testing, the disintegration time including disintegration characteristics is recorded automatically. The primary purpose of disintegration testers is to measure the amount of time it takes a sample to totally disintegrate inside a liquid medium. The liquid used in the disintegration tester vessel is often an acidic mixture, designed to replicate the inside of the human stomach. Disintegration testers allow researchers and quality control technicians to ascertain if a sample does indeed breakdown inside the human body, and how long it takes to do so. This can provide information useful to improving and manufacturing pharmaceutical drugs and also confirm that standards of compliance and regulation are being maintained. Disintegration testers work by raising and lowering a ‘basket’ in and out of the test medium, for a set period of time, to see if the tablet dissolves or not. The test medium sits inside the vessel, which sits inside a bath of warmed water, used to replicate the temperature of the human body. The disintegration testers raise and lower the basket in an attempt to create movement, similar to the conditions indie the human stomach, so that the tablet can move about and the test medium circulate around it in a manner similar to inside the body. At no point does the basket raise itself completely out of the test medium, so the tablet is always submerged throughout the disintegration tester’s operation. Disintegration testers are commonly comprised of a basket, a vessel, a water bath and the actual disintegration unit itself (which operates the basket motion and heats and pumps the water in the bath). Traditionally, disintegration testers required a laboratory technician to manually lower the basket into the vessel before the test commenced. It was also common place to have to manually set the teste time, then visually remove and inspect the basket, to see if the tablet had dissolved. In recent years, automation has become increasingly more desirable, whereby disintegration testers can automatically lower and raise their own baskets into the medium, and in some cases, even determine the exact time of tablet disintegration too. Disintegration testers are an effective analytical solution for the testing of fast release, oral tablets which require short assessment times. There are times when tablets are required to dissolve quickly in the mouth, and on occasion release their API before reaching the human stomach tract. This can present a few challenges when attempting to perform accurate in vitro testing, such emulating the environment of the human mouth and taking samples very quickly after the tablet has be submersed into the media. Disintegration testers can offer a solution to this problem where other lab equipment can struggle. USP 4 systems are more adept for long term, slow release testing, and dissolution apparatus does not always offer the correct vessel and paddle size required when considering the human mouth has just 5mm of liquid within it. Taking fast samples in a short amount of time from these methods is also a little tricky. Disintegration testers on the other hand, have a slightly more assessable media vessel, and can function with a lower volume of test media inside them, allowing for a more accurate testing environment, where fast testing can be more easily performed. A test of just 2 minutes, with several sample extractions can be performed in lower media volumes. This makes disintegration testers the preferred option for testing fast release oral samples. It will be very interesting to see how USP continues to adapt and develop protocol to account for the testing of orally releasing samples.
Disintegration testers (like most other lab equipment) provide useful, important information that is used in compliance, manufacturing and R&D departments throughout pharmaceutical and research organisations. It is of course the test results themselves that contain this all-important material, but what can you do to protect and preserve both the disintegration testers and their test result’s integrity and safety?
Taking back up your test results is a proven method of data security, even in the face of theft or machine destruction. Backing up test results from all your disintegration testers is easy, simple and a real life saver should anything ever go wrong. Export your test results similar to backing up, exporting your test results at the end of every test, directly from the disintegration testers to a computer or memory stick saves you the trouble of having to remember to back up in the first place. Backup your disintegration tester’s settings a fantastic way to safeguard yourself in the event of a fire, serious breakdown or theft. The ability to export everything from one machine and re-install it on another is a must have capability. You can export settings, user accounts, methods, products and more with ease between all of your disintegration testers. User logging: a practically faultless trail of what every user does on the machine, from first logging in, to running tests, printing, exporting, adding products and logging out. You will always know who has done what and on which disintegration testers they have done it. User accounts: the best way to restrict user access to certain tasks and areas, while having an administrator account capable of doing and monitoring everything else also adds an extra layer of security and integrity.
Many analytical testing service providers have disintegration testers with the above mentioned capabilities.
The next stage of evolution in the field of disintegration testers has arrived having features including a built-in touch-screen display, capable of storing product test results, methods and basket configurations, along with calibration parameters and user login accounts, automatically recording and determining the disintegration time of the sample without human participation, making such disintegration testers truly advanced. The disintegration tester comes with either one or two individually driven basket rack assemblies as well, offering flexibility and staggered testing possibilities.
When it comes to disintegration, there are generally only two varieties of testers to choose from – manual, and automatic.
Manual disintegration testers require a lab technician to lower and raise the test station into the test media, and start the programed timer. When the testing is complete, the technician then rises the tests station and visually inspects to see if disintegration has occurred.
Automated disintegration testers automatically lower and raise the test station can start the timer without human intervention, and some can then determine the exact point of disintegration during the test too. When the timer is expired, the test station then raises of its own accord.
Most manufacturers of disintegration testers offer between 1 and 4 test stations per machine, and you can have a choice between two types of basket to contain the samples as well. Each basket type can contain either 6, or 3 samples, of different sizes.