Baxter International Inc.

Baxter Healthcare Sa

Nikkiso Company Limited

Dirk Faict

Francesco Peluso

Patrick R Balteau

Annick Duponchelle

Leo Martis

Jean-Pierre Hartman

Eric J Henaut

Vincent Houwaert

Paul-Andre Gollier

Jean-Luc Dewez

Ron Burke

Philippe Lambert

Tranaeus Anders

Robert W Childers

Paul F Emerson

Vital Eerlingen

Chi J Chen

Lisa Colleran

Christian Renaux

Anne Leyssens

Alain Segers

Isabelle Wilmet

Jose Divino

Jerome Colas

Jean-Paul Menneguerre

Paola Elisabettini

Fabian Somers

Michel Taminne

Robert Warren Childers

Paul Frederick Emerson

Marion Gericke

Bart Degreve

A container is provided comprising a body defined, at least in part, by a film, the body including at least one side seal, at least two chambers separated, at least in part, by a peelable seal, and the film including a sealant layer having a bimodal thermal behavior such that the side seal is a permanent seal and the peelable seal can, at least in part, be separated.

Containers and methods for manufacturing same

Stable single bicarbonate-based solutions are provided. The bicarbonate-based single solution of the present invention includes at least calcium and bicarbonate and is stored or packaged in a sterile manner within a container with a gas barrier. The single solutions of the present invention can remain stable for three months or more. In this regard, the stable and single bicarbonate-based solutions of the present invention can be readily and effectively used during medical therapy, such as dialysis therapy.

Stable bicarbonate-based solution in a single container

The present invention relates to stable pharmaceutical protein formulations that are stabilized using peptide stabilizers selected from the group consisting of Gly-Gly, Gly-Gly-Gly, Gly-Tyr, Gly-Phe, Gly-His, Gly-Asp, Gly-Ala, Ala-Gly, Ala-Ala, derivatives thereof and mixtures thereof. Furthermore, the present invention relates to stable pharmaceutical formulations comprising erythropoietin and peptide stabilizers selected from dipeptides, tripeptides, tetrapeptides, pentapeptides, and mixtures thereof. In addition to peptide stabilizers, the formulations may contain surfactants.

Stabilization of pharmaceutical protein formulations with small peptides

Bicarbonate containing solutions for use during medical treatment are provided. The bicarbonate containing solution of the present invention includes at least two separate components including a bicarbonate concentrate and an electrolyte concentrate which can be readily and sterilely mixed to form a ready-to-use formulation for patient administration, particularly as applied to the treatment of acute renal failure associated with critically ill patients in an intensive care setting.

Bicarbonate-based solutions for dialysis therapies

The present invention provides an improved dialysis solution. The improved dialysis solution provides for the use of specific polypeptides as an osmotic agent with an additional osmotic agent such as dextrose. To this end, the present invention provides, in an embodiment, a peritoneal dialysis solution comprising as osmotic agents approximately 0.25 to about 4.0% (w/v) polypeptides and approximately 0.5% to about 4.0% (w/v) dextrose. The polypeptides have well defined characteristics.

Peritoneal dialysis solutions with polypeptides

The present invention provides devices and methods for stabilizing bicarbonate-based solutions for peritoneal dialysis or hemofiltration. The bicarbonate-based solutions of the present invention are formulated and stored in at least two parts&mdash;an alkaline bicarbonate concentrate and an acidic concentrate. The alkaline bicarbonate concentrate is adjusted to have a pH of about 8.6 to 10.0. The acidic concentrate is adjusted to have a stable, acidic pH ranging from about 1.0 to 3.0. Upon mixing, although some variation in the pH of the mixed bicarbonate solution exists, the inventors have discovered that with the appropriate selection of the parameters of the concentrates, the pH of the mixed solution is always within an acceptable physiological range.

Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy

A system and a method are provided for admixing solutions. The system includes containers separately accessible by one or more pumps for mixture of the solutions in a container immediately before administration to a peritoneal cavity of a patient. Alternatively, the system and method allow for direct administration of the mixed solution to the peritoneal cavity of a patient without intermediate mixing thereof. The solutions may be mixed in predetermined ratios as input to the system prior to delivery.

System and method for providing sterile fluids for admixed solutions in

A container system for containing and preserving gas generating solutions such as bicarbonate-containing solutions is provided. The system includes an outer container or barrier that is gas impermeable. The system also includes an indicator for visually indicating when gas has been permitted to leak or escape from the outer container thereby changing the physical characteristics of the gas generating solution.

System for preserving and delivering gas-containing solutions

A multiple chamber container for mixing and administering a plurality of products. The container has at least two chambers separated by a seal line. A frangible connector is situated between the two chambers for mixing the products contained within the chambers as desired. Each chamber has at least one port for filling of product into the chamber. The ports are located on the same exterior side of the container such that the chambers can be filled without folding the bag and by using existing filling equipment.

Multiple chamber container

A method and device for stabilizing and storing bicarbonate solutions is provided. In an embodiment, a device is provided having a container and carbon-dioxide generating substances that include a solid material which upon contact with water generates carbon-dioxide gas. The device may be packaged together with the bicarbonate or in a separate overpouch. The present invention also provides a method for the stabilization of bicarbonate solutions utilizing a means that generates high pressure carbon dioxide.

Method for manufacturing and storing stable bicarbonate solutions

A peritoneal dialysis solution buffered with L-histidine to a pH of at least 6.5. An apparatus and method for utilizing the solution is also disclosed.

Histidine buffered peritoneal dialysis solution

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Assenede, Belgium

Dirk Faict