Other

Research Medical, Inc.

University of Utah Research Foundation

Baxter Research Medical, Inc.

Aesica Pharmaceuticals Limited

James C McRea

Wan S Kim

Seo Y Jeong

Robert J Todd

Gerald D Buckberg

Gaylen M Zentner

Mark S Williams

Christopher G Anderson

Norman T Smith

Udipi Shettigar

Yong Nian Xia

Catriona A Oare

Kirk Fowers

Stephen J Martin

Stephanie Poulsen

The invention relates to drug substance preparations, pharmaceutical compositions and dosage forms containing (R)-(&#x2212;)-2-(2-fluoro-4-biphenylyl) propionic acid as the active pharmaceutical ingredient, and limited amounts of specific product-related and process-related impurities.

Drug substance preparations, pharmaceutical compositions and dosage forms

Methods and apparatuses for salvaging blood from a patient are disclosed. A blood salvaging and/or blood processing circuit coupled to a cardiopulmonary bypass circuit, cardiotomy circuit, or directly to the patient comprises a hemocentrator for removing water, fluids, and low molecular weight solutes by ultrafiltration and a sorbent-containing plasma separator for removing a selected solute, such as heparin. A combination device for salvaging blood comprises a closed plasma chamber containing a plasma chamber solution, a hollow fiber plasma-separating membrane for receiving blood and permitting plasma to be transported therethrough into the plasma chamber solution and for refiltering the treated plasma back into the blood circuit, a selective sorbent for contacting the selected solute in the plasma and binding the selected solute, and an ultrafiltration membrane for removing water, fluids, and low molecular weight components from the plasma.

Salvage of autologous blood via selective membrane/sorption technologies

A polycationic system for the removal of polyanions from a fluid medium is formed by, first, activating a biocompatible hydroxylated support with an organic sulfonyl chloride, such as p-toluene-sulfonyl chloride, in the presence of a dialkylamino pyridine activation catalyst, such as 4-dimethylamino-pyridine (DMAP). The activated support is then reacted with a polymer having a polyamide backbone with pendent alkyl amine groups, such as poly-L-lysine (PLL), to form C--N bonds between an activated carbon from the hydroxylated polymer and an amine group from the polymeric polyamide. Finally, any unreacted activated sites on the hydroxylated polymer are capped or removed with an effective amount of capping agent such as a mercapto (--SH), hydroxy (--OH) or amino (--NH.sub.2) containing compound which reacts with the unreacted activated sites. The pendent alkyl amines on the polyamide backbone exist, at the appropriate pH, as polycations. The polyanion, such as heparin, is removed from fluids, such as blood plasma and whole blood, by bringing these fluids in contact with the polycationic system. The polyanion is bound to the polycation system by ionic attraction. The polyanion can then be released from the polycation system by treatment with a basic solution, thereby allowing the system to be reused.

Selective sorbent removal system using polycation activated substrates

A system for selective removal of certain components from plasma drawn from a patient comprises an extracorporeal blood circulation circuit and a cannula. The extracorporeal blood circulation circuit has an uptake line for transporting blood from the patient, a plasma separator, and a return line connected to the plasma separator for transporting selectively depleted blood from the plasma separator to the patient. The plasma separator is connected to the uptake line for receiving the blood, selectively removing plasma components (e.g., heparin) by separating plasma from whole blood and interfacing such plasma with an adsorption substrate, recombining depleted plasma, and reinfusing selectively depleted blood into the return line for transport to the patient. The cannula has an uptake conduit with an intake end and an exit end, and a return conduit, connected to the uptake conduit, with an outflow end and an entry end. The exit end is connected to the uptake line of the bypass circuit and the entry end is connected to the return line of the bypass circuit. Structure at the outflow end of the return conduit alters the direction of flow and directs selectively depleted blood being returned to the patient into the right atrium of the patient's heart when the intake end of the uptake conduit is disposed within the patient's inferior vena cava. An alternative cannula with washers may be inserted into a venous return cannula whereby recirculation and pooling of the selectively depleted blood is prevented.

Cannula apparatus and system for heparin removal from blood

This invention relates to a stylet for use with a retrograde cardioplegia catheter and its methods of use. The stylet includes a stylet rod, a handle on the proximal end of the stylet rod and a predetermined curve in the distal end of the stylet rod. The handle has a thumb rest on the proximal end and a one or two finger loops extending outward from the handle. An obturator is located on the distal end of the predetermined curve to impede blood flow through a tip of the cardioplegia catheter during insertion of the catheter. The invention also contemplates methods for using the stylet.

Removable stylet for retrograde cardioplegia catheter and methods for use

A system and method of achieving both convective and diffusive transport of plasma across a membrane accompanied by the selective removal of plasma components using sorbents followed by reinfusion of the purified plasma in a blood circulation system is achieved by pumping blood through a filter comprising a bundle of 'U' shaped hollow fibers immersed in a closed plasma chamber containing sorbents in an electrolyte solution. As blood flows through the entry arm, due to positive transmembrane pressure difference, plasma filtration into the plasma chamber occurs. The entering plasma causes an increase in the chamber pressure but does not exceed the pressure in the entry arm. The increase in chamber pressure exceeds the pressure in the exit arm of filter where the transmembrane pressure difference is negative and the direction of filtration reverses causing reverse filtration/reinfusion of plasma from the chamber into the blood in the exit arm. The phenomena of positive and reverse filtration from the hollow fiber filter establishes the circulation of plasma fluid in the plasma chamber. The plasma filtering through the entry arm, which corresponds to the arterial end of the system, passes through the plasma chamber solution containing the sorbents where plasma components get selectively depleted. The sorbents may be in any usable form which are not permeable to the filter. The purified plasma reenters the filter along the exit arm corresponding to the venous end where negative transmembrane pressure exists.

Plasma filter sorbent system for removal of components from blood

Synthesized succinyl and glutaryl glucosamines, p-(succinylamido)-phenyl-.alpha.-D-gluco- and mannopyranosides, p-(glutarylamido)-phenyl-.alpha.-D-gluco- and mannopyranosides and p-(isothiocyanotophenyl)-.alpha.-D-gluco- and mannopyranosides are reacted with insulin to form corresponding glycosylated insulins containing from 1 to 3 glycosyl groups per insulin molecule. The novel glycosylated insulins resist aggregation and show significant activity in depressing blood sugar levels.

Amido-phenyl-.alpha.-D-glucopyranoside derivatives

Synthesized succinyl and glutaryl glucosamines, p-(succinylamido)- phenyl-.alpha.-D-gluco- and mannopyranosides, p-(glutarylamido)-phenyl-.alpha.-D-gluco- and mannopyranosides and p-(isothiocyanotophenyl)-.alpha.-D-gluco- and mannopyranosides are reacted with insulin to form corresponding glycosylated insulins containing from 1 to 3 glycosyl groups per insulin molecule. The novel glycosylated insulins resist aggregation and show significant activity in depressing blood sugar levels.

Glycosylated insulin derivatives

Synthesized succinyl and glutaryl glucosamines, p-(succinylamido)-phenyl-.alpha.-D-gluco- and mannopyranosides, p-(glutarylamido)-phenyl-.alpha.-D-gluco- and mannopyranosides and p-(isothiocyanotophenyl)-.alpha.-D-gluco- and mannopyranosides are reacted with insulin to form corresponding glycosylated insulins containing from 1 to 3 glycosyl groups per insulin molecule. The novel glycosylated insulins resist aggregation and shown significant activity in depressing blood sugar levels.

Growing community of inventors

Salt Lake City, UT, United States of America

James C McRea