Patent ID: 7939105
Filing Date: 2011-05-10
Classification: A61K,A61P

Abstract:
1. A process for the preparation of a rapidly disintegrating solid dosage form capable of forming a stable suspension without irreversible particle aggregation, particle agglomeration, or particle growth, comprising the steps of: a) preparing an aqueous suspension including primary particles of a water insoluble or poorly water-soluble drug 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 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 particles, wherein the mean volume weighted particle size of the water-insoluble or poorly water-soluble drug 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 drug particles dispersed and embedded throughout a support matrix formed by the at least two matrix-forming bulking/releasing agents, or combination thereof, 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 drug 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 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 the drug.