MATERIAL AND PROCESS FOR INCORPORATION OF LOW DOSAGE ACTIVE PHARMACEUTICAL INGREDIENTS AND USE THEREOF

摘要

A low dose API pharmaceutical tablet having excellent content uniformity is provided. The tablet is formed by spray coating a support excipient with the API. The resulting composition is suitable for direct compression tablet formulation without the need for an additional granulation step to uniformly coat the API onto the support excipient. The support excipient comprises microcrystalline cellulose, a binder and a disintegrant, and is formed by spraying a homogeneous slurry of the support excipient components.