Moisture-Activated Dry Granulation

In the pharmaceutical industry, the three most common granulation processes for solid dosage form production are wet granulation, dry granulation (roller compaction) and direct blending. Yet, despite being well-established techniques, each has its drawbacks.

Moisture-activated dry granulation (MADG) was developed in response to the difficulties experienced with wet granulation, in terms of endpoint, drying and milling, and offers an efficient, cost-effective granulating process that does not require a drying step. The old adage that “time is money” has never rung truer. Manufacturers are increasingly aware of processing steps, production costs, safety issues and time-to-market, not withstanding the absolute requirement for quality and reliability. In tablet manufacture, direct compression has always been the traditional first choice, followed by granulation, which adds time and cost to the process (and formula).

A growing, but not as yet widely adopted process, is moisture-activated dry granulation (MADG): as minimal moisture is needed in this specialty granulation process, no drying time is required, significantly shortening the processing time. It’s a simple and innovative process in which granules are created with water and a granulating binder, as in wet granulation, but are not heat dried or milled, which also helps to minimise endpoint sensitivity. Plus, it works in situations when wet granulation or dry compression won’t (such as water- or heat-sensitive products). And, along with reduced steps, the equipment required is the same as that used in traditional wet granulation – which is what most manufacturing sites are equipped with – so mass implementation would be relatively easy to achieve.