Hi all, need your opinions. First some background, I work for a solid oral dosage pharma company making a bi-layer tablet. One layer is formulated to dissolve instantly and the other is formulated to dissolve slowly. In one formulation both layers contain active ingredient X and a second ingredient Y, and of course each layer contains different excipients.
My problem: manufacturing wants to granulate the instant dissolve portion of the tablet followed by granulating the longer acting portion of the tablet without a complete cleaning of the mixer. Currently, the mixer is cleaned thoroughly at the end of the run and then other granulations may be processed in the mixer. Now they say because the actives (X and Y) are the same in both types of granulation and the risk of the excipients being carried over into the finished product is nil (since the finished tablet contains all ingredients from both types of granulations), there is no need to do a thorough clean between the two types of granulations.
I think they are two seperate products and a thorough clean is necessary, regardless of the fact that all ingredients are found in the finished tablet.
Please give me your opinions.