Together with friability testing, the testing of a tablet’s hardness (or more correctly breaking force) plays a vital role in both product development and subsequent quality control.
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Introduction Hardness Tester
Modern day tablets come in a variety of forms – uncoated, coated, dispersible, effervescent, gastro-resistant, modified release, soluble, rapidly disintegrating, slowly disintegrating, etc. Each type places different demands on the formulation concerned.
Manufacturing processes such as coating, printing, packaging and rigours of handling and transport place additional demands on the mechanical integrity of the finished product.
Together with friability testing, the testing of a tablet’s hardness (or more correctly breaking force) plays a vital role in both product development and subsequent quality control.
In this test method, the tablet is placed between two platens (jaws), one of which is attached to a load cell and the other to a motor which provides the mechanical drive. During testing, the motorised jaw drives forward pressing the tablet against the fixed jaw until such time as the tablet breaks, whereupon the motorised jaw retracts and the load required to break the tablet is recorded.
High hardness values may indicate, for example, increased disintegration times and reduced dissolution values. On the other hand, if hardness is too low then friability, and hence % defective, may well be too high. By exploiting the correlation between hardness, disintegration, dissolution, friability, percentage defective and weight variation, the various parameters can be manipulated to produce a dosage form with optimum characteristics.
Significant advances have been made in the field of tablet hardness testing in recent years. Copley Scientific offers a range of semi and fully automatic electronic testers incorporating these advances and varying in sophistication from simple hand-held units for use on the production floor to fully automatic units incorporating printout and data input/output facilities.
All Copley Hardness Testers feature:
- Simple, easy to use operation ensures that the number of operations required to perform a test is kept to a minimum
- Full supporting documentation (including full IQ/OQ/PQ qualification documentation where applicable)
Tablet Hardness Tester TH3
The Tablet Hardness Tester Model TH3 is a portable semi-automatic electronic tablet hardness tester with LCD display designed to accept tablets up to 30 mm in diameter – ideal for the tablet production area as a quick check as to compression force settings.
The tablet is placed on the test platform between the test jaw and the load cell plunger. A multi-turn low-friction hand-wheel similar to the type used on machine tools is used to apply load to the tablet until it fractures.
The resulting breaking force is displayed on the LCD display in either newtons (N), grams (g), pounds (lbs) or ounces (oz).
To test another tablet, simply press to zero the loads cell and proceed as above.
Two models are available, the TH3/200 having a range of 200 Newtons +/- 0.04N or the TH3/500 having a range of 500 Newtons +/- 0.1N respectively.
Tablet Hardness Tester TBF 1000
The Tablet Hardness Tester Model TBF 1000 combines the economy of a simple easy to use tester with the performance and accuracy of microprocessor controlled data collection.
Foremost in the design specification were those features that you, the user, identified as being essential to the “ideal” hardness tester.
You told us, for example, that the unit must be as compact as possible such that it could be used in the confines of the tablet press booth. So, we made it compact.
You told us that the unit should be simple to operate – the TBF 1000 employs just three touch sensitive keys located on the front panel to set up, perform a test and provide a print-out of the results.
At the same time, you asked for a number of advanced and sophisticated features – so we provided them plus a small QWERTY keyboard located in the base of the instrument to access them.
On completion of the test, the TBF 1000 automatically prints out the results and statistical analysis. Attach a balance and/or thickness gauge and the TBF 1000 will collect weight and thickness data as well.
- The TBF offers a choice of speed between 0.06 and 0.5 mm per second with a default setting at 0.1 mm per second.
- Measuring range of hardness: 0 ~ 500N (± 0.1N)
- Tablet diameter: up to 36 mm
- Results can be expressed in either kilograms-force (kgf), kiloponds (kp), newton (N) or pounds (lps)
- The TBF 1000 has a throughput of approx.5-8 tablets per minute dependent on the hardness and diameter of the tablets under test
- PC interface: RS 232 or USB
- Display: LCS screen
- Dimensions (WxDxH): 283x235x160 mm
The DIS 6000 has been designed as a direct response to this problem. With a footprint of just 650 x 450 x 640 mm (w x d x h), the DIS 6000 is one of the most compact dissolution testers available on the market today.
The Dissolution Tester DIS 8000 represents the very latest in tablet testing technology. CNC production techniques combined with modern microprocessor design guarantees the highest standards of performance and reliability.
The Testers have been specifically designed for use in the quality and production control of normal, plain coated and delayed release coated tablets and gelatin capsules in accordance with the specifications as laid down in European, United States and associated Pharmacopoeias.
Based on an original design by Roche, the friability tester has now become an accepted standard throughout the pharmaceutical industry for determining the resistance of uncoated tablets to the abrasion and shock experienced in manufacturing, packing and shipping operations.
Together with friability testing, the testing of a tablet’s hardness (or more correctly breaking force) plays a vital role in both product development and subsequent quality control.
The Delivered or Emitted Dose is the total amount of drug emitted from the inhaler device and hence available to the user.
