DuraGran®, Reduce drug-layering production time and costs

ABSTRACT
Using our patented process, Frontida is able to reduce the amount of excipients and/or process steps used to build beads or controlled release granules.

For higher concentration doses, DuraGran® processing foregoes spheronization and extrusion steps typically used to create controlled release beads.

DuraGran® Patented Technology

Frontida’s DuraGran® process allows us to create controlled release beadlets / granules of uniform and narrow particle size range without the use of spheronization / extrusion equipment or the need to layer product onto a uniform sized sugar bead.

The patented process creates granules of more uniform particle size than a standard wet granulation process with easily modified process parameters that can be used to target a desired particle size. The technology can be applied to controlled release formulations and to create tastemasked, orally disintegrating tablet formulations.

The process modifies standard high-shear granulating and fluid bed process steps by adjusting process parameters in such a way that we can target a much narrower particle size range than can normally be achieved by a standard wet granulating process.

BENEFITS

The benefits of the patented process are a reduction in the number of process steps and time needed to create a defined granule particle size distribution range. Production costs, energy requirements and Quality Unit in-process monitoring can all be reduced by employing this technology.

More About DuraGran®

Our DuraGran® process can facilitate the creation of granules for the following applications:
Fast dissolve tablets (ODTs) where a small, durable taste-masked granule is desired.
- The DuraGran® process enables us to make a fine granule (less than 0.5mm) that contains very few superfines,
- The material is coated in a subsequent process with the appropriate taste masking material, combined with the appropriate flavored cushioning granulation and then compressed into tablets
As an alternative to the extrusion / spheronization process
- Larger granules can be formed and then coated in a subsequent process to provide the desired targeted release profile
- These granules would be suitable for direct filling into capsules or combining with a cushioning blend and compressed into tablets
Granules that can provide a unique product look
- Large colored granules in a white tablet with minimal color bleed into the white portions of the tablet
- These colored granules can be for appearance only, or formulated to provide a delayed release portion of the dose
Formulations with API loading as high as 90% or more
Any formulation requiring small durable granules that flow well

CONCLUSION

Frontida offers free consultation to companies that wish to evaluate whether their product concept may be suitable for this technology platform. We also conduct test batches to create DuraGran® materials that can be further evaluated for suitability. To set up a discussion and to learn more, please fill out our contact form.
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