M200
Introduction to M200 Benefits
In many cases of direct compression process, Microcrystalline Cellulose M102 and Dicalcium Phosphate (DCP) are used together commonly in many formulations. A formula with DCP presents better flowability and will increase overall density of the product and performs smoothly in high speed tableting process. The drawback of DCP, however, is its poor compressibility compared with MCC and other filler/binders. If the compressibility of the API is poor already, then DCP may not be a good choice in formulation. Although high density and coarser particle size can increase flowability of the blend, it is easier to cause separation of other ingredients during the tableting process. It is also reported in literatures that the stability of some APIs can possibly be affected by DCP. This makes many formulators searching for ways not to include DCP in the formulation.
Microcrystalline Cellulose M200 is the coarsest MCC grade, allowing it to provide superior flowability in formulations, but still retains good compressibility compared with other types of excipients. The superior properties make it easier for M200 to replace DCP in combination with M102 in the formulation. The change requires little adjustments in production that will improve tablet properties. M200 is a very stable raw material that rarely affects other ingredients which minimizes the risks of stability test failures.
M200 is one of the best excipients for direct compression process. The good flowability and tableting property can support your formulations in various conditions. In some cases where API and other excipients cannot provide adequate flowability, M200 would be the ideal solution.
We replaced DCP + M102 with M200 in the application of Amlodipine tablets in the following research.
From the result, even though F2 performs better in tablet hardness, the weight variation is higher due to insufficient flowability. F3 is similar to F1 in tablet weight variation, but the tablet hardness of F3 is evidently better than F1.
