Evaluation of disintegration testing of different fast dissolving tablets using the texture analyzer.
The in vitro disintegration behavior of fast dissolving systems manufactured by the main commercialized technologies was studied using the texture analyzer (TA) instrument. Quantitative parameters were employed to characterize the effect of the major test variables on the disintegration profiles. The average disintegration profiles of the products were compared using the test conditions that minimized these effects and at the same time mimicked the in vivo situation in the patient's mouth. The differences in the disintegration mechanisms of the fast dissolving systems were reflected in the shape of their disintegration profiles and in the parameters derived from the profiles. The differences were explained in relation to the technology and/or formulation characteristics involved in the manufacture of each product. The in vitro disintegration times obtained under the simulated in vivo conditions were correlated with the reported in vivo disintegration times.
el-Arini
Silvia Kocova
SK
Pharmaceutical Research & Development, Merck Frosst Canada and Co, Centre for Therapeutic Research, P.O. Box 1005, Pointe Claire-Dorval, QC, Canada H9R 3P8.
Clas
Sophie-Dorothée
SD
D006863:Hydrogen-Ion Concentration; D007700:Kinetics; D011312:Pressure; D015203:Reproducibility of Results; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature; D014815:Vitamins / Q000008:administration & dosage / Q000737:chemistry
D013607:Tablets; D014815:Vitamins