PARTICLES OF SPHERICALLY AGGLOMERATED LACTOSE FOR DIRECT COMPRESSION AND METHOD OF PREPARATION THEREOF

摘要

Many active pharmaceutical ingredients are not directly compressible, therefore addition of pharmaceutical excipients is necessary. Fillers are essential pharmaceutical excipients, among which sugars are commonly employed, especially lactose. It is required that such substances have good flowability and compressibility. The present invention enables a simple and industry applicable production of particles of spherically agglomerated lactose that have suitable flow properties, excellent compression characteristics and reduce or prevent occurrence of segregation in mixture for production of solid dosage forms. They are porous spherical agglomerates. Particles of spherically agglomerated lactose comprise prism-like primary particles that are radially arranged and form a bigger agglomerate structure. Particles of spherically agglomerated lactose have suitable size, are highly breakable, have relatively high specific surface area and enable production of tablets with high tensile strength.