Reducing dust and improving granule and tablet quality in the roller compaction process

Abstract

The dramatic reduction of non-compacted material during roller compaction and an important improvement of the granule and tablet qualities were obtained by a controlled wetting process before the roller compaction. The continuity of the roller compaction process was maintained by using a continuous fluid bed system. Due to a controlled water addition, a better binder distribution was obtained than when using micronised dry binders. When dry compacting poorly water soluble hydrochlorothiazide mixtures, the resultant dissolution rate was not influenced by the HPMC binder viscosity. When moistened blends were compacted, the resultant dissolution rate decreased with increasing HPMC binder viscosity. The roller compaction pressure had almost no influence on the drug dissolution rate. The addition of disintegrants did not improve the dissolution rate. When a fraction of the filler α-lactose monohydrate was replaced by microcrystalline cellulose, the dissolution rate increased with an increasing microcrystalline cellulose fraction. With the addition of 0.5% Tween® 80 to a formulation containing 25% microcrystalline cellulose and 50% α-lactose monohydrate, the dissolution rate increased and an immediate release tablet formulation was obtained. The presence of microcrystalline cellulose also improved the processing and avoided lump formation.