Actimed Laboratories, Inc.

Baxter International Inc.

Baxter Healthcare Sa

Em Diagnostic Systems, Inc.

John K McGeehan

Larry Richard Brown

Wai T Law

Sonal R Doshi

Terrence L Scott

Julia E Rashba-Step

Gerhard Ertingshausen

Uri Piran

Vered Bisker-Leib

Debra Lafreniere

Ed O'Connell

Timothy B Meluch

Eugene Mehr

The present invention relates to compositions of methods of making and compositions small compositions of particles of an active agent. In accordance with the method of production, the active agent is dissolved in an aqueous or aqueous-miscible solvent containing a dissolved phase-separation enhancing agent (PSEA) to form a solution in a single liquid phase. The solution is subjected to a liquid-solid phase separation to cause the active agent to form small spherical that are substantially amorphous or non-crystalline and are injectable through fine gauge needles at high concentrations. The invention has special application for higher molecular weight proteins.

Protein microspheres having injectable properties at high concentrations

Methods for processing microparticles involve providing a composition comprising a plurality of solid microparticles and at least one non-volatile material, providing a non-solvent, and exposing the composition to the non-solvent to remove at least a portion of the non-volatile material from the composition while retaining at least the microparticles.

Methods of processing compositions containing microparticles

The present invention is related to a method for preparing small spherical particles of an active agent by providing a solution in a single liquid phase. The single liquid phase comprises an active agent, a phase separation enhancing agent, and a first solvent. A phase change is induced at a controlled rate in the solution to cause a liquid-solid phase separation of the active agent and to form a solid phase and a liquid phase. The solid phase comprises solid small spherical particles of the active agent. The liquid phase comprises the phase separation enhancing agent and the solvent. The small spherical particles are substantially spherical and having a size from about 0.01 &#x3bc;m to about 200 &#x3bc;m.

Methods for fabrication, uses and compositions of small spherical particles prepared by controlled phase separation

Red blood cells are removed from whole blood or a fraction thereof by agglutinating whole blood with a mixture of a free agglutinating agent and nucleating particles having agglutinating agent intimately associated therewith to form clusters of red blood cells. High molecular weight polyethylene glycol may be added further to enhance agglutination. The clusters of red blood cells are much larger than the size of individual red blood cells, so that the clusters can easily be filtered through a porous medium. The plasma, which is substantially free of red blood cells, is further passed through a filter that optionally contains an additional agglutinating agent. Flow-delay additives may be provided to retain the fluid sample in contact with a reagent for a predetermined time.

Apparatus for red blood cell separation

Red blood cells are removed from whole blood or a fraction thereof by contacting whole blood with a combination of an agglutinating agent and nucleating particles to form clusters of red blood cells. High molecular weight polyethylene glycol may be added further to enhance agglutination. The clusters of red blood cells are much larger than the size of individual red blood cells, so that the clusters can easily be filtered through a porous medium. The plasma which is substantially free of red blood cells is further passed through a filter that optionally contains an additional agglutinating agent. Flow-delay means may be provided to return the fluid sample in contact with a regard for a predetermined time.

Red blood cells are removed from whole blood or a fraction thereof by contacting whole blood with a combination of an agglutinating agent and nucleating particles to form clusters of red blood cells. High molecular weight polyethylene glycol may be added further to enhance agglutination. The clusters of red blood cells are much larger than the size of individual red blood cells, so that the clusters can easily be filtered through a porous medium. The plasma which is substantially free of red blood cells is further passed through a filter that optionally contains an additional agglutinating agent.

Method and apparatus for red blood cell separation

A quantitative test device is manufactured using a feedback loop which allows one to modify continuously the dimensions of a reading scale printed on the device. The quantitative test device is manufactured by attaching the critical component of a two-component dye system to minute particles such as microcrystalline cellulose, silica, or latex, which particles are suspended in a solution of a polymeric binder. Additional non-immobilized components of the reaction system of the test device are optionally added to the polymer solution. The suspension of dyed particles in polymer solution is applied to a fabric as a coating, using conventional coating machines, to obtain a homogeneous distribution of immobilized dye throughout the fabric. The device includes a measurement zone which is made from a film support made of a material having a lower melting point than the filter cloth fabric used in the measurement zone was used. By using a lower melting point material for the support film, impulse heat sealing is controlled to a degree such that the lower melting point support is made to melt and extrude through the mesh of the fabric on either side of a channel, forming a seal along the sides of the channel.

Manufacturing process for sample initiated assay device

An analytical device for fluid samples includes a fluid sample well means connected to a sample initiation area in such a fashion that the assay will not commence unless sufficient sample is introduced into the sample well means to conduct the assay. Once sufficient sample has been deposited into the sample well means, the sample flows into an initiation area and the assay commences.

Method and device for metering of fluid samples and detection of

A completely water-soluble, solid, labile biochemical-containing diagnostic reagent is prepared without the need of a lyophilization step, by spraying, preferably by a fluidized bed process, an aqueous solution of labile biochemical, e.g., an enzyme, onto small particles, e.g., lower than 20 mesh, of an inert, completely water-soluble solid bulking agent, e.g., mannitol; drying the resultant labile biochemical-coated bulking agent to the desired dryness; and then forming resultant dried labile biochemical-coated bulking agent into a tablet suitable for a diagnostic test reagent, said tablet having a predetermined rate of dissolution.

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Woodbury, NJ, United States of America

John K McGeehan