M105

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Introduction to M105 Benefits

Microcrystalline Cellulose M105 presents the finest particle size among all MCC grades. During tableting process, the large surface area of the fine M105 particle contributes to the increase of bonding areas between the particles to provide excellent compressibility and tablet hardness.

The Benefits of M105 are Listed Below:

  • It is especially suitable for APIs with high crystallinity in direct compression. Normally, API with high crystallinity has poor compressibility, thus, adding M105 in formulation can improve the performance of tablet hardness.
  • It can be used together with excipients with poor compressibility, such as Dibasic Calcium Phosphate to increase tablet hardness.
  • M105 in formulation provides better mouth feel for chewable tablet products because of its finer particle size. In contrast to other sugar excipients, M105 provides better compressibility without compromising the taste of the product.
  • M105 is particularly suitable in dry granulation compared with other types of MCC. In general, powder compressibility decreases after granulation because of the increase of granule size and the reduction of powder plastic deformation. It has been proven in literature that the higher the pressure we use during dry granulation process, the more significant the decrease of granule compressibility. M105 can enhance compressibility of the powder mixture and make it easier to produce ribbons and granules with appropriate sizes and maintain good compressibility of the granules at the same time. With the advantages of M105, formulators can optimize formulations quickly to make manufacturing processes smoother, and even lower the usage of excipients in formulations to cut down material costs.
We use Valsartan as a drug mode to demonstrate the advantages of M105 in dry granulation process. In the example, M101 in F1 and F2 represent traditional MCC grade used in dry granulation process. The two formulations which contain M101 are made into granules with suitable sizes, but with broader particle size distribution that could cause lower yield rate after the sieving process. In Formulation 3 (F3), we replace M101 with M105 and reduce the pressure from 3000psi to 1500psi but are still able to make coarser granules with better tablet strength. In Formulation 4 (F4), we increase the usage of Valsartan from 45.7% to 60.4% and reduce the usage of M105 from 40% to 25% to downsize the tablet to 250mg instead of the previous 350mg tablet size in F1, F2 and F3. Despite the alterations in F4, tablet strength still exceeds F1 and F2 under the same pressure. From the result, it shows that F3 and F4 have similar dissolution rate compared with the control groups, which indicates that the excellent compressibility of M105 in granule and tablet formulation through dry granulation process does not affect API dissolution. From the example, using M105 in dry granulation process can improve granule quality, provide extra flexibility for formulation design, and reduce equipment loading. The superior performance of M105 is an ideal binder when it comes to designing a recipe using the dry granulation process.