Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Methods are provided for promoting the adsorption of an active agent to microparticles by modifying the structural properties of the active agent in order to facilitate favorable association to the microparticle.

An orally disintegrating dosage form of a proton pump inhibitor, methods for its production and use thereof are provided. The dosage form includes a plurality of pellets containing a proton pump inhibitor admixed with a disintegrant to afford rapid disintegration in the oral cavity after administration.

Disclosed in certain embodiments is an immediate release solid oral dosage form comprising a plurality of particles, each particle comprising: (i) a core comprising a first active agent; (ii) a coating comprising a second active agent layered over the core; and (iii) a material that is sensitive to acidic pH layered over the coated core; wherein the dosage form releases at least about 70% of the second active agent within 45 minutes as measured by in-vitro dissolution in a USP Apparatus 2 (paddle) at 50 rpm in 500 ml 0.1 N HCl at 37° C.

An optimized pharmaceutical formulation for the treatment of inflammatory diseases of the colon is disclosed, wherein the pharmaceutical formulation is a capsule containing pellets, which capsule is suitable for oral administration and delivers the active substance in a targeted manner to the site of action, namely the colon. This is achieved by a complex and multiple coating of pellets, which permit a modified release of active substance. The release of the active substance is at its maximum only in the colon, with at the same time low blood plasma levels. The results of the pharmaceutical tests concerning in vitro release are corroborated by the results in pharmaco-kinetic and clinical studies and the clinical efficacy demonstrated by these. The formulation according to the invention has a very good medicinal safety.

The present invention provides a method for preparing a bone protein preparation which contains for example growth factors. The present invention also provides a bone protein preparation obtained by the method and paste, putty, pellet, disc, block, granule, osteogenic device or pharmaceutical composition containing said bone protein preparation.

Improved spherical beads that may be used in producing pharmaceutically active pellets by depositing a pharmaceutically active agent on the surface of said spherical beads. The spherical beads includes a pharmaceutically acceptable carrier material, including: a) at least 60 wt. % of phosphoric acid calcium salt and b) up to 40 wt. % of organic material.

Greater than or equal to 90 wt % of the spherical beads have a particle size in the range of from 90 μm to 1200 μm. The spherical beads have: a bulk density of at least or more than 1000 g/l, a specific surface area of at most or less than 10 m.sup.2/g, and a hardness of at least or more than 600 g/mm.sup.2. Also included is a method for producing such spherical beads and to pharmaceutically active pellets being prepared by depositing a pharmaceutically active agent on the surface of the spherical beads.

A delivery device for an active agent comprises nanoparticles based on a biopolymer such as starch. The delivery device may also be in the form of an aptamer-biopolymer-active agent conjugate wherein the aptamer targets the device for the treatment of specific disorders. The nanoparticles may be made by applying a high shear force in the presence of a crosslinker. The particles may be predominantly in the range of 50-150 nm and form a colloidal dispersion of crosslinked hydrogel particles in water. The biopolymer may be functionalized. The aptamer may be conjugated directly to the cross-linked biopolymers. The active agent may be a drug useful for the treatment of cancer. The delivery device survives for a period of time in the body sufficient to allow for the sustained release of a drug and for the transportation and uptake of the conjugate into targeted cells. However, the biopolymer is biocompatible and resorbable.

The present invention discloses an extended release multi-particulate sprinkle composition comprising a plurality of discrete units, each discrete unit comprising quetiapine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.

Provided herein is a coated particle comprising: (i) a microparticle that comprises a pharmaceutically acceptable excipient and (ii) nanoparticles of a therapeutic agent, wherein the surface of the microparticle is coated with the nanoparticles. Also provided herein is a pharmaceutical composition comprising the coated particle. Furthermore, provided herein are methods of their preparation.