New Excipient for Moisture Activated Dry Granulation Process:
Spress® B818 Pregelatinized Starch NF
Pharmaceutical and nutraceutical ingredients continue to evolve as the need for new tablets, capsules and granules grows. These excipients are essential to deliver drugs, vitamins and herbal supplements. Many of the active ingredients are manufactured in powder form and do not have the flow or compression properties required for producing tablets or capsules. If the active ingredient is a small percentage of the formulation, direct compression can be used to make the tablets. This is the simplest method and the least costly in production time and energy. However, if the active ingredient is a large percentage of the tablet or capsule, the powders will not produce a viable dosage form. Thus, the need exists for turning these powders into flowable granules using a granulation process.
Traditional granulation processes include high shear granulation, fluid-bed granulation, continuous granulation, and roller compaction. All of these processes are excellent ways to produce quality granules for tableting or capsule filling, but they require significant production time. Now, a new alternative option for granulation exists - Moisture Activated Dry Granulation.
Moisture Activated Dry Granulation (MADG) is an efficient, cost-effective granulating process that does not require a drying step. In the MADG process, the Active Pharmaceutical Ingredient (API) is dry blended with a binder or combination of binders in a typical high-shear granulator. A limited amount of moisture is then added to granulate the powder mixture, but not over-wet it. Next, an absorbent excipient is added to evenly distribute the moisture and “dry” the granulation. Last, if the formulation requires a lubricant or disintegrant, it is added to the blend. Limited or no sizing is required in this process because the particles are small and uniform.
Historically, the MADG process has not been used to its full advantage due to the lack of excipients designed for the absorption step of the process. Grain Processing Corporation has developed an absorbent starch called Spress® B818 Pregelatinized Corn Starch NF for this process.
Grain Processing Corporation will be exhibiting at both SupplySide West in Las Vegas, NV, on October 21–22, 2010 and at AAPS in New Orleans, LA, on November 15–17, 2010. We invite you to stop by our booth to learn more about the MADG process and Spress® B818 Pregelatinized Corn Starch NF, as well as our MALTRIN® maltodextrins used as binders in the MADG process.
Please contact us for more information on the MADG process, Spress® B818, or if you would like to receive a copy of our White Paper on this subject.
MALTRIN® and Spress® are registered trademarks of Grain Processing Corporation.