At 20 min, generics released less than 60 %, while olanzapine Zydis® released 95 %. With the longer time point (90 min), selleck products they
reached 96–112 % release. Generic ODT formulations using loosely compressed tablets had relatively fast and/or MLN2238 ic50 coarse disintegration but slow dissolution. Olanzapine Zydis® (a freeze dried tablet) was the fastest disintegrating ODT formulation and exhibited the most effective dissolution curve of all the tablet strengths tested, regardless of potency. The investigated generic olanzapine ODT products required more than 30 s to dissolve even 10 % of the active ingredient when compared with olanzapine Zydis® ODT, which could release approximately 25 % in the same time period. Generic ODT products use different manufacturing platforms: direct compression; molded tablets; uncoated tablets; and some with pigment colorants.
Risperdal M-Tab® and olanzapine Zydis® tablets may have similar disintegration rates, but the Zydis® ODT dissolved at twice the speed (likely due to the differences in active ingredient solubility in artificial saliva). In our tests, the smaller mass of the 5-mg olanzapine ODTs may facilitate the observed shorter disintegration and dissolution times selleckchem versus the larger 20-mg tablets. Generic olanzapine ODT formulations incorporate water expansive polymers that appeared in the dispersion as a coarse insoluble residue, which may explain slow dissolution rates. After 5 min, some generic forms of olanzapine ODT almost match the dissolution rate of Zydis® but do not realize 100 % release. There are some limitations
of our experiments. The in vitro disintegration times may not be identical to in vivo disintegration times, and the small number of generic drug tablets available to the investigation did not permit statistical analysis. 5 Conclusions The in vitro artificial saliva disintegration and dissolution tests are a proxy for the disintegration process in a patient’s mouth. Tablet orodispersibles are consistently slower to disintegrate and release drug substance than lyophilized Thalidomide wafers. Compared with olanzapine Zydis® ODT, generic olanzapine ODT formulations of soft compressed tablets incorporate water expansive polymers that appeared in the dispersion as a coarse insoluble residue, which may explain their slow dissolution rates. Furthermore, in a direct comparison between risperidone ODT and olanzapine Zydis®, orodispersible drugs with similar manufacturing methods (lyophilization), it is evident that, even though disintegration rates are similar, the risperidone is not as soluble in artificial saliva as is olanzapine.