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Cysteine for physiological injection

A cysteine, physiological technology, applied in the field of cysteine ​​for physiological injection, can solve problems such as easy oxidation or dimerization, instability of cysteine ​​solution, etc.

Active Publication Date: 2012-07-11
CORNELL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the effective concentration of physiological cysteine ​​solution is unstable, easy to oxidize or dimerize

Method used

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  • Cysteine for physiological injection
  • Cysteine for physiological injection
  • Cysteine for physiological injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0285] Embodiment 1: the production of physiological cysteine ​​solution

[0286] This example illustrates the desired composition, pH range and storage conditions of a physiological solution of cysteine.

[0287] To develop stable cysteine ​​formulations for physiological administration, several factors need to be considered. First, cysteine ​​hydrochloride solutions at concentrations of 50 mg / ml or above in 0.9% saline have a very low natural pH - about pH 0.8 to pH 1.0. Second, administering a cysteine ​​solution with a pH value of 4.0-5.0 can avoid vascular irritation or damage caused by cysteine ​​administration. Third, the basic form of cysteine ​​is insoluble at concentrations above 50 mg / ml and is generally considered too dilute for convenient administration to patients. In contrast, solutions containing 150-200 mg / ml or more cysteine ​​are more convenient for intravenous administration.

[0288] This example illustrates which types of cysteine ​​formulations can be...

Embodiment 2

[0344] Example 2: Cysteine ​​Precipitation When Solutions Are Exposed to Air

[0345] This example shows that exposing a low pH cysteine ​​solution to air during neutralization will result in the precipitation of cysteine. In this example, the formation of particulate matter was detected after the L-cysteine ​​hydrochloride monohydrate preparation was mixed with Tris neutralizing reagent.

[0346] Materials and methods

[0347] The following materials and equipment were used:

[0348] 1. Tris, 99.9%, ultra-pure grade, batch number 17120CH

[0349] 2. L-cysteine ​​hydrochloride monohydrate, Sigma Aldrich, R&D production grade, lot number 087K0707611

[0350] 3. Anhydrous sodium acetate, JT Baker, ACS grade, lot number B31151

[0351] 4. L-Ascorbic acid, Sigma Aldrich, ultra-pure grade, lot number 106K0053

[0352] 5. Calcium disodium salt of EDTA, hydrate, 98% purity, Aldrich lot number 01929KH

[0353] 6. Glacial acetic acid, Mallinckrodt, USP grade, lot number E40005

...

Embodiment 3

[0411] Example 3: Preliminary Cysteine ​​Toxicological Study

[0412] This example describes toxicology studies conducted in accordance with FDA guidelines.

[0413] Toxicological tests of L-cysteine ​​were performed in rats, dogs and monkeys. Monkeys have been used routinely for several years and monkeys have been used for several years to evaluate the effects of different neuromuscular blocking agents and reversal of neuromuscular blockade with different doses of cysteine. Give conscious rats 750mg / kg L-cysteine ​​by intravenous injection, and give conscious dogs 400mg / kg by intravenous injection. The neuromuscular blocking agent CW002, which is the R-trans, R-trans isomer of the compound shown below, was administered intravenously to anesthetized dogs at 200 mg / kg.

[0414]

[0415] Anesthetized dogs were awakened and sacrificed 2 days or 2 weeks later.

[0416] No animals exhibited clinical, biochemical, or histological evidence of organ toxicity. No toxic effects w...

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Abstract

This application describes methods of making and using physiological cysteine solutions useful for reversing a neuromuscular blockade caused by a cysteine-reversible neuromuscular blockade agent, that overcomes problems of cysteine precipitation and dimerization.

Description

[0001] This application claims priority to US Provisional Patent Application (Application No. 61 / 235,191), filed August 19, 2009, and PCT Application, filed March 17, 2010 (Application No. PCT / US2010 / 000796). The entire contents of each application are hereby incorporated by reference. [0002] This application is also related to U.S. Application No. 11 / 951,114, filed December 5, 2007; U.S. Application No. 10 / 975,197, filed October 28, 2004; PCT Application No. 60 / 515,048, filed October 28, 2004; and U.S. Provisional Patent Application No. 61 / 160,915, filed March 19, 2009, for PCT Application PCT / US2004 / 035869, The contents of these applications are hereby incorporated by reference in their entirety. Background of the invention [0003] In some surgical procedures, neuromuscular blocking agents must be used. However, when neuromuscular blocking agents do work, they can completely paralyze the patient. Therefore, the use of neuromuscular blocking agents is limited to situati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/198A61K38/06A61K9/00A61P21/00
CPCA61K31/375A61K47/22A61K9/06A61K31/198A61K9/0019A61P21/00A61K2300/00
Inventor J·J·萨瓦雷塞P·M·黑特
Owner CORNELL UNIVERSITY
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