Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The present disclosure provides a sterilized medical system that includes an ultra high pressure sterilized glucose solution in a container. The sterile glucose solution may contain less than about 40 ppm total glucose degradation product. The glucose solution may be a ready-to-use infusion solution disposed in a single chamber container.

Abstract: Sterilized dialysis solutions containing glycosaminoglycan, for example Heparin, and methods of making and using same are provided. In an embodiment, the present invention provides different peritoneal dialysis solutions containing Heparin that are stable under sterilization conditions. For example, the solutions are designed to provide all-in-one, ready-to-use sterilized solutions for peritoneal dialysis.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Dialysis solutions and methods of manufacturing and using same are provided. The dialysis solution at least includes three solution parts that are separately stored and sterilized at an effective pH to promote the stabilization of the solution parts including a pH-sensitive solution part that has, for example, a pH-sensitive osmotic agent, such as a glucose polymer. The solution parts are admixed to form a ready-to-use solution with a physiologically acceptable pH.

Abstract: Dialysis solutions and methods of manufacturing and using same are provided. The dialysis solution at least includes three solution parts that are separately stored and sterilized at an effective pH to promote the stabilization of the solution parts including a pH-sensitive solution part that has, for example, a pH-sensitive osmotic agent, such as a glucose polymer. The solution parts are admixed to form a ready-to-use solution with a physiologically acceptable pH.

Abstract: 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.

Abstract: Methods for determining mixing accuracy are provided. The present invention includes methods for determining mixing accuracy with respect to mixing devices that are employed to mix a number of solutions, such as dialysis solutions. The mixing accuracy is evaluated based on a spectrophotometric analysis of a surrogate ingredient, such as a colorant, in the mixed solution. The colorant can be added to one of the original solutions prior to mixing.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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—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.

Abstract: 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.

Abstract: 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—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.

Abstract: 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.