Patent ID: 7939106

Claim:
A process for the preparation of a rapidly disintegrating solid dosage form of fenofibrate capable of forming a stable suspension without irreversible particle aggregation, particle agglomeration, or particle growth, comprising the steps of: a) preparing an aqueous homogeneous suspension including primary particles of fenofibrate in the presence of one or more surface stabilizing agents, of which at least one is a phospholipid, or a combination of one or more surface stabilizing agents and one or more phospholipids, wherein the concentration of the phospholipid in the aqueous homogeneous suspension ranges from about 0.1% w/w to about 90% w/w; b) subjecting the aqueous suspension to a particle fragmentation process to form a homogeneous aqueous suspension of micron and submicron fenofibrate particles, wherein the mean volume weighted particle size of the fenofibrate particles in the suspension ranges between about 0.05 and about 10 micrometers; c) admixing the homogenous suspension of step b) with at least two rapidly dispersible matrix-forming agents, said at least two rapidly dispersible matrix-forming agents, being present in an amount of between 0.1% w/w and 90% w/w of the aqueous suspension, said amount permitting a dried solid form of said suspension, upon reconstitution in an aqueous environment, to revert to a suspension having no more than about 20% by weight of particle aggregation or agglomeration compared with the amount of aggregation or agglomeration of particles comprising a pre-dried suspension; d) drying the admixture to produce a solid having surface stabilized fenofibrate particles dispersed and embedded throughout a support matrix formed by the matrix-forming agents, wherein the support matrix dissolves or substantially disperses in a rapid disintegration time of less than 2 minutes upon contact between the solid and aqueous environment resulting in a release of the surface stabilized fenofibrate particles into the aqueous environment as a suspension; and further wherein, after contact between the solid and the aqueous environment, the resulting suspension comprises no more than about 20% by weight of aggregated or agglomerated fenofibrate primary particles; e) course milling and blending the solid with one or more pharmaceutically acceptable excipients to produce a dried powder; and f) forming the solid or dried powder into a solid dosage form of fenofibrate drug.