Quality Assurance-Physical
Hardness Testing
Together with friability, hardness (or breaking force) is a defining physical characteristic for a tablet. High hardness values may indicate for example, longer disintegration and dissolution times, compromising the speed of drug delivery. On the other hand, if hardness is too low, then friability may be also high, giving rise to poor product stability and compromised dose uniformity. By examining correlations between hardness, disintegration, dissolution and friability, a dosage form with optimum characteristics can be produced.
Chapters Ph. Eur. 2.9.8 Resistance to Crushing of Tablets and USP Chapter <1217>Tablet Breaking Force describe standardised methods for the assessment of tablet hardness.
A tablet is placed between two platens (jaws), one of which is attached to a force gauge with load cell and the other to a motor which provides the mechanical drive. The motorised jaw drives forward pressing the tablet against the fixed jaw until the tablet breaks. The motorised jaw then retracts and the load force required to break the tablet is recorded. The units of force normally employed to quantify breaking force are Kiloponds (Kilogram-Force) or Newtons.
Rapid, no-fuss tablet hardness testers
Combining the economy of a simple, easy to use hardness tester with the accuracy of microprocessor-controlled data collection, the compact TBF 100i hardness tester delivers precise tablet hardness and diameter measurements. Tablet thickness and weight can also be recorded (optional).
Offering high tablet throughput, the intuitive touchscreen user interface of the TBF 100i streamlines test set-up procedures for users, whilst the built-in data processor provides analysts with tablet breaking force statistical analyses at the touch of a button.
TBF 100i: Key Features
- In-built guard for safe operation.
- Robust metal case with advanced corrosion protective coating.
- Intuitive touchscreen control with icon-based menu structure simplifies operation and clearly displays test parameters throughout run.
- In-built thermal printer for quick checks of test results and calibration data.
- Small unit footprint saves precious benchtop space.
- Convenient tablet waste drawer for dust-free tablet disposal.
Ideal for use in the production area for a quick check of compression force, the TH3 is a portable and simple-to-use tablet hardness tester.
Using a multi-turn, low-friction hand wheel to apply the load, the TH3 is available with two load ranges, which can apply up to 200 N or 500 N (TH3/200 and TH3/500 respectively). The resulting breaking force is displayed clearly on the LCD with a wide choice of data output options.
With easy calibration verification, this tester offers easy and convenient tablet hardness testing in busy production environments.
TH3: Key Features
- Easy calibration verification.
- Choice of force measurement unit (N, g, lbs, oz).
- Clear LCD display.
- Portable unit with debris collection tray.
- Extensive data reporting output options.
- Measures tablets < 30mm diameter.
