Does anyone have any experience with, or any ideas regarding the following problem:
When a mixture of 1-3 triflouromethyphenyl piperazine, 1-benzylpiperazine, and one of the following binder/lubricant combinations the following results were found.
With a binder combination of Dextrose (DiPac), and appropriate amounts of Mg Sterate And Steric acid, after pressing the tablets they appeared in every way to be sound; however, after one week storage in an amber glass bottle the tablets became encrusted in a oily brown layer, the inside of the tablet remained sound.
The same results were obtained with a Lactose (SuperTab) binder mixed with appropriate amounts of the beforementioned lubricants. The browning process seemed to take slightly longer.
Again the same actives and lubricants were mixed with a Microcrystalline cellulose Binder (ProSolv)the tablets upon compaction had a yellowed color to them, after 5 days storage, no browning has occured, but the yellowing has covereed most of the tablet.
The above binders were again tried with the exception of steric acid, the die faces stuck up with the mixture, as would be expected, but it was within tolerance. The results of this test are 4 days along, and appear to be less brown, but that could jus be due to the differance in observation.
The above binders were again pressed into tablets; however in this case BZP was deleted from the mixture and the ratio of TFMPP increased. In this case within 3 days the tablets with the sugar based binders were completely oily, brown, gross. This tests unfortunately was not done with the MCC binder.
Hopefully someone can add some insight to this problem. It would be much appreciated.
Thanks,
Saint Cyril