Quality Assurance-Physical
Disintegration Testing
Before the active ingredient(s) of an oral solid dose drug can be absorbed into the body, the tablet or capsule in which they are contained must first disintegrate into smaller particles.
Chapters Ph. Eur. 2.9.2 and USP <701> and <2040> describe reproducible and standardised methods for quantifying the disintegration behavior of solid dosage forms.
Typically, the tablets and capsules to be tested are each placed in one of six vertical tubes each measuring approx. 77.5mm long x 21mm inside diameter, positioned in a circular basket arrangement. The lower end of each tube is covered by a 2mm sieve mesh. Large tablets, capsules and boluses may require a larger basket. The basket assembly is raised and lowered in simulated gastric fluid at body temperature (37 °C ) through a distance of 55mm, at a constant stroke frequency of 30 cycles per minute. A plastic disc of precise geometry "hammers" the tablet during the operation, thus assisting in the disintegration process. The tablet is said to pass the test providing that no tablet residue remains on the sieve mesh after the designated time, typically 30 minutes for ordinary tablets and 60 minutes for enteric coated tablets.
Reproducible, standardised and affordable disintegration testing.
The result of decades of innovation and experience in the field of pharmaceutical testing, the Copley DTGi series of disintegration testers simplifies testing within R&D and QC environments. Suitable for a wide range of tablet and capsule types (e.g. plain-coated tablets, delayed-release, gelatine etc.), the DTGi tester series is an affordable range of disintegration testers, that complies fully with specifications defined in Ph. Eur., USP and associated Pharmacopoeias.
Controlled via our intuitive touchscreen interface, the Copley DTGi Series features one (DTG 100i), two (DTG 200i), three (DTG 300i) and four (DTG 400i) station units as well as a 2-station independent control unit (DTG 200i-IS), ideal for testing tablets and capsules under varying conditions. The user-friendly design makes assessing disintegration characteristics a simple touch-of-a-button task.
DTGi Series: Key Features
- Quick-release baskets for rapid sample loading, unloading and cleaning.
- Intuitive touchscreen control with icon-based menu structure simplifies operation and clearly displays test parameters throughout run.
- Robust metal case with advanced corrosion protective coating.
- Basket rack assemblies are automatically lowered and raised to/from test media at start and end of test.
- Independent digital heater/circulator maintains a constant temperature and minimises vibration.
- Easily removable leak-proof water bath with convenient drain tap eases bath water emptying.
- Maximum fill line indicator.
- PT100 temperature probe monitors bath and media temperature.
