By Charles Ischi…
Charles Ischi Tablet disintegration testing
Charles Ischi Testing Technology offers a range of high precision tablet and capsule disintegration testers that allow exact determination of disintegration time for tablets, in line with USP and EU Ph. guidelines and the requirements of FDA 21 CFR Part 11.
The disintegration test agitates tablets in a beaker, continuously monitoring decrease in tablet thickness with every upward stroke of the disintegration apparatus that, with all operations controlled and data analysis safely and easily managed via computer and PH21 software. The efficiency of the process is enhanced by DISI electromagnetic Basket Technology that allows easier use and labour saving.
To disintegrate a substance involves breaking it into small chunks, particles and molecules to improve their solubility. At times the process of disintegration can integrate with dissolution where a solid substance disintegrates into small pieces while dissolving in a solvent until it forms a uniform solution of the solute and the solvent.
In the pharmaceutical industry, there is a disintegration test undertaken on drugs to make them ready for absorption into the blood stream. For any dosage to be absorbed by the body, it has to be in a solution. Disintegration of tablets is a process in which the API is broken down into tiny fragments or granules to improve its solubility. Disintegration time is the time needed for the drug to break into fragments under certain conditions. Some disintegration tests are done with simulated gastric or intestinal fluid to see how the dosages will perform when ingested.
International Council for Harmonisation (ICH) guideline Q6A states that disintegration testing can substitute for specific dissolution testing in cases where immediate release solid oral drug products, made from highly water soluble drug substances, have been demonstrated to have consistently rapid drug release characteristics.
It is possible to establish relationships between dissolution and disintegration, by for example correlating disintegration times in the dissolution vessel with the dissolution rate at selected sampling times. Direct correlation of disintegration times in the disintegration tester with dissolution rate at any selected sampling time this supports direct relationship between dissolution and disintegration testing for the selected formulation. Additionally, it can also be shown that the disintegration test method exhibits at least a similar discriminatory power compared to the proposed dissolution method, based on a statistical approach and data from bioavailability study to establish a clinical relevant specification for the disintegration time. All presented data support the replacement of dissolution by disintegration testing according to ICH Q6A for the selected fixed-dose combination product.
Standard disintegration and dissolution testing must accord to United States Pharmacopeia (USP) [General Chapter 〈711〉], European Pharmacopeia (EP) and US FDA guidelines for solid dose products, with specific dissolution approaches that are matched to the product’s specified release characteristics, in order to identify changes in critical quality attributes. This includes selection of the dissolution media, the dissolution test apparatus and agitation rates.
CI-AG Disintegration Tester USP Features & Functions
The CI-AG disintegration testers are designed for precise and reliable functionality and ease of use with three levels of automation and up to four independent test stations.
All disintegration apparatus in the range can be specified with one, two, three, or four individual testing stations that can be run independently of each other, using magnetically coupled baskets, which allows quick attachment or removal, with easy dismantling for cleaning. They all feature Softstart operation to immerse baskets in testing medium in a controlled manner.
The DISI disintegration tester application can be interconnected via the DIN Measurement bus to hardness testing systems like the UTS universal tablet testing system and weighing systems like CIW tablet weight checkers to form a completely integrated Ph21 production control system.
The CI-AG disintegration testers offer increasing levels of automation and functionality across the range, which comprises three basic platforms:
- DISI-M Manual Disintegration Tester: The DISI-M Manual Tablet Disintegration Tester has been developed provides an economic solution at a high quality standard and combines innovative technologies and user friendliness. All DISI-M operations are performed via the front panel machine operating interface, featuring LCD-Display and individual timer control. Testing baskets move vertically by stepping motors running in micro step mode, moving baskets smoothly in and out of the media in strictly sinusoidal motion for reliable and consistent results compliant with USP and EU Ph. testing standards.
- DISI-A Automatic Disintegration Tester: The DISI-A features automatic operations performed via PC Windows operating system, allowing easy access and familiarity. The operating system features menus of predefined disintegration test USP and Ph EU. and disintegration test for tablet routines with full information on detailed disintegration characteristics, including disintegration curve displays and real time display of Time / Remaining tablet thickness. Compared with DISI-M, DISI-A also features precise thermostat-controlled media heating, automatic detection of disintegration time, continuous display of remaining rest height and Ph21 software package
- DISI-A Touch Automatic Disintegration Tester: This offers a standalone automated testing solution, thanks to its integrated touchscreen control module, with 4GB of onboard memory and integrated operating system conforming to EU Ph. & USP requirements. Compared with DISI-A, DISI-A Touch also features onboard thermostat heating regulation and access control. Disintegration times for tablets are indicated in real-time on the touch panel display with full disintegration-process monitoring.