Phosphate-binding chitosan and uses thereof

a phosphate-binding chitosan and chitosan technology, applied in the field of phosphate-binding chitosan, can solve the problems of hyperphosphatemia, increased patient burden, and increased risk of kidney failure, and achieve the effect of safe and effective phosphate-binding chitosan

Inactive Publication Date: 2009-10-08
CYPRESS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Like other diseases for which there is no cure, chronic kidney disease takes an ever-increasing toll on patients who have it.
As the disease progresses, the kidney becomes less efficient at removing various ions from the blood.
This condition, known as hyperphosphatemia, carries with it many grave health risks.
For example, when serum phosphate and calcium levels are above a certain threshold, hardened deposits may form throughout the body, endangering circulation.
There are clinical circumstances in which the administration of aluminum or calcium salts is ill-advised.
In animal models, certain crosslinked polymers carry with them elevated risks of carcinogenesis.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Phosphate-Binding Assay

[0063]Phosphate concentrations were quantitated by the method of Lowry and Lopez, J. Biol. Chem., 162: 421-428. To determine phosphate binding to chitosan powder, 20 mg chitosan was weighed into a 12×75 mm glass tube. 3.0 ml of distilled water and 50 μl of 0.53M monobasic potassium phosphate were added. The tube was sealed with plastic wrap and placed on a Lab-Tek Aliquot mixer to mix for 1 hour at room temperature. The chitosan was then allowed to settle by gravity.

[0064]3.0 ml of acetate buffer (0.1N acetic acid, 0.025N sodium acetate) was added into a new clean, dry, and optically matched 12×75 mm glass tube. 50 μl of supernatant was taken from the chitosan tube as prepared above and mixed into the acetate buffer. Next, 0.30 ml of 1% ascorbic acid was added with mixing followed by 0.30 ml of 1% ammonium molybdate in 0.05N sulfuric acid with mixing. The absorbance at 700 nm was measured in a Spectronic 20 spectrophotometer 10 minutes after adding the molybda...

example 2

The Size and Shape of Chitosan Particles and Their Phosphate-Binding Abilities

[0070]Certain samples of chitosan were subjected to particle size and shape analysis using techniques known in the particle size measurement art. For example, samples of chitosan particles can be analyzed using a Nikon microscope and Image-Pro Plus.

[0071]To analyze a sample using Image-Pro Plus, the sample was first dispersed into a carrier fluid. It was then put under the microscope and the magnification was determined. In the Image-Pro Plus program, refining adjustments were made to get an optimal image with good contrast so that the program can distinguish the particles from the background. Typically, 100 images were then taken at random to get an unbiased result. Typically, at least 300 particles were needed to count in the 100 images.

[0072]Once the images were collected, a Macro was run on Image-Pro Plus to count the particles and calculate the specific statistics as needed (e.g., roundness, area or s...

example 3

Treatment of Hyperphosphatemia Using Chitosan

[0077]The following human patients suffering from hyperphosphatemia are treated with chitosan as described below.

[0078]Human patient No. 1 has a serum phosphorus concentration between about 5.5 and about 7.5 mg / dL and has not taken a phosphate binder prior to the treatment. A composition containing about 4 grams of chitosan sample I from Table 1 is orally administered three times daily with meals.

[0079]Human patient No. 2 has a serum phosphorus concentration between about 7.5 and about 9.0 mg / dL and has not taken a phosphate binder prior to the treatment. A composition containing about 6 grams of chitosan sample I from Table 1 is orally administered three times daily with meals.

[0080]Human patient No. 3 has a serum phosphorus concentration greater than about 9.0 mg / dL and has not taken a phosphate binder prior to the treatment. A composition containing about 8 grams of chitosan sample I from Table 1 is orally administered three times dail...

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Abstract

The present invention provides compositions and methods for removing phosphate from a subject using chitosan. The present invention also provides compositions and methods for treating hyperphosphatemia based on phosphate-binding chitosan.

Description

BACKGROUND OF THE INVENTION[0001]Like other diseases for which there is no cure, chronic kidney disease takes an ever-increasing toll on patients who have it. As the disease progresses, the kidney becomes less efficient at removing various ions from the blood. Among these ions is phosphate, which can form insoluble particles when combined with calcium. In end-stage renal disease, the final stage of chronic kidney disease, kidney function is so compromised that phosphate levels in the blood (serum) become markedly elevated. This condition, known as hyperphosphatemia, carries with it many grave health risks. For example, when serum phosphate and calcium levels are above a certain threshold, hardened deposits may form throughout the body, endangering circulation. It is therefore very important to control serum phosphate levels in patients with end-stage renal disease.[0002]Patients with end-stage renal disease may be advised to eat a diet low in phosphate. However, phosphate is present...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/722A61P13/00
CPCA23L1/056A61K31/722A61K9/20A23L29/275A61P13/00A61P13/12
Inventor LEWIS, ROBERT L.DAY, CHARLES E.
Owner CYPRESS PHARMA
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