Abstract
The performance of 16 tablet breaking force testers was evaluated in terms of accuracy, reproducibility and repeatability. Three tablet formulations with different plastic or brittle deformation mechanisms and with target breaking forces of 50, 100 and 150 N were tested. Statistically significant diffecrences were observed between the estimated mean values of the investigated testers. The approximate accuracy measured as the percentage difference from the grand mean mostly lay in the interval ±10 %. The reproducibility expressed as the relative standard deviation between the testers estimated by the concept of components of variance was 5-7 % depending on the model tablet excipient. The standard deviation within testers (repeatability) was affected by the type of model formulation showing increasing variability with increasing brittleness of the compressed material. No specific effect of altering the speed of platens on the mean values or the variability was observed. It is concluded that, compared to other quality methodologies of solid dosage forms with a suspected variability, there is generally no reason to question the standard and performance of the breaking force testers used today in the pharmaceutical industry.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Pharmazeutische Industrie |
| Vol/bind | 67 |
| Udgave nummer | 1 |
| Sider (fra-til) | 109-115 |
| Antal sider | 7 |
| ISSN | 0031-711X |
| Status | Udgivet - 1 jan. 2005 |