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IbD PU Deliverable 3.1 The two steps involved in MADG are: 1) agglomeration when the granulating fluid activates the binder, and 2) moisture redistribution when the moisture absorbents (e.g. microcrystalline cellulose and silicon dioxide) absorb the excess moisture – this result in relatively dry granules. Therefore, one the advantages of MADG is the elimination of the expensive drying step. Due to the very little water used, the process does not lead to larger lumps formation. Other advantages of MADG include: increased particle size, better flow and compressibility, wide applicability, less energy input, and suitability for scale-up to continuous process. This method however, cannot be used for the production of moisture-sensitive and/or hygroscopic drugs. Thermal adhesion granulation (TAG) Thermal adhesion granulation (TAG) technique is similar to MADG, in exception that the process uses both water and solvent as the granulating liquid instead of solely water as in MADG. In addition, TAG uses heat to facilitate the agglomeration – the formulation mixture is heated to a temperature range of 30 - 130oC under tumble rotation. Due to the low initial moisture content, all of the water is evaporated during this step, therefore eliminating the drying step. The granules are then cooled and sieved for further processing. The process is relatively simple with its low moisture and binder content in a closed unit. It is used to prepare highly compressible materials, good particle size and flowability granules, as well as high tensile strength granules that could be directly compressed into tablets with adequate hardness and low friability. This technique however, requires high energy inputs and extra equipment for heat generation and regulation (Yeh and Yeh, 2004; Lin et al., 2008). Melt granulation Melt granulation (also known as thermoplastic granulation) is a technique that employs meltable binders that melts at a temperature range of 50 - 90oC. The granulation is complete once the agglomerated powder is cooled and hence, solidification of the molten binders. The introduction of the binders can either be by solid form (in-situ melting method) or by molten form (spray-on method). Melt granulation is useful for heat-sensitive materials. The discounting of organic or aqueous solvents eliminates the capture and recycling process. The technique also excludes the wetting and drying process, making the entire process less energy- and time-intensive. The relatively high temperature in the in-situ melting method however, could cause degradation and/or oxidative instability of the ingredients, especially 81PDF Image | Solids handling for intensified process technology
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