During manufacture of oral solid dose tablets that employs a dry granulation step including roller compaction, are API and excipients both usually added to the compactor or just API? Or does it depend on the product?
Dry granulation is process forming particles or granules from dry powder or powder blend without adding liquid. Here instead of wet granulation, the powder blend is compacted under high pressure to form sheets, or ribbons, which are then milled into granules later on to form granules for subsequence process i.e. blending, filling/ compression and coating based on product requirements, In roll compacter, both API and excipient prepare slug, ribbons or sheet where moisture sensitive molecule also create agglomerate along with maintain integrity and stability. It’s always subjective for selection how many portions of API and excipients added in roll compactor, few molecule where granulation properties achieve without adding excipients.
Main selection rational for excipients in dry granulation are how equilibrium, moisture maintain for solid dosage form and granule partial size of active in granule which needed for compression/ filling(slug/Tapping) along with blending, lubrication.
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