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Phosphate-binding chitosan and uses thereof

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Phosphate-binding chitosan and uses thereof


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.
Related Terms: Hyperphosphatemia

Browse recent Cypress Pharmaceutical, Inc. patents - Madison, MS, US
Inventors: Robert L. Lewis, Charles E. Day
USPTO Applicaton #: #20120277183 - Class: 514 55 (USPTO) - 11/01/12 - Class 514 
Drug, Bio-affecting And Body Treating Compositions > Designated Organic Active Ingredient Containing (doai) >O-glycoside >Polysaccharide >Chitin Or Derivative

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The Patent Description & Claims data below is from USPTO Patent Application 20120277183, Phosphate-binding chitosan and uses thereof.

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BACKGROUND OF THE INVENTION

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.

Patients with end-stage renal disease may be advised to eat a diet low in phosphate. However, phosphate is present at some level in almost all the foods we eat. For this reason, phosphate binders were developed. Phosphate binders are compounds taken orally and which act in the gastrointestinal tract to bind phosphate and keep it from being absorbed. Phosphate binders are generally taken with each meal. Phosphate binders known in the art include, for example, various salts of aluminum and calcium, as well as some chemically synthesized crosslinked polymers. 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.

SUMMARY

OF THE INVENTION

The present invention provides a safe and effective phosphate binder derived from a natural polymer. In particular, the present invention provides, inter alia, phosphate-binding chitosan, compositions containing phosphate-binding chitosan, and methods for treating hyperphosphatemia using chitosan.

In one aspect, the present invention provides a method for removing phosphate from a subject (e.g., a mammalian subject). The method includes administering to the subject a therapeutically effective amount of chitosan. In some embodiments, the therapeutically effective amount of chitosan is administered orally.

In some embodiments, the subject is in need of treatment for hyperphosphatemia. In some embodiments, the subject is in need of treatment for chronic kidney disease and/or end-stage renal disease. In some embodiments, the subject is in need of treatment for one or more disorders of phosphate metabolism and/or impaired phosphate transport function.

In some embodiments, the therapeutically effective amount ranges from about 0.1 to about 10 grams of chitosan per dose. In some embodiments, the therapeutically effective amount ranges from about 0.5 to about 50 grams of chitosan per day.

In some embodiments, chitosan suitable for the invention binds at least about 30 mg phosphate per gram. In some embodiments, the chitosan binds at least about 60 mg phosphate per gram. In some embodiments, the chitosan binds at least about 90 mg phosphate per gram. In some embodiments, the chitosan binds at least about 120 mg phosphate per gram. In some embodiments, the chitosan binds at least about 150 mg phosphate per gram. In some embodiments, the chitosan binds at least about 180 mg phosphate per gram.

In some embodiments, chitosan suitable for the invention is administered in a form of a plurality of particles. In some embodiments, the plurality of particles have a mean volume particle size less than about 100 cubic microns. In some embodiments, the plurality of particles have a median volume particle size less than about 100 cubic microns.

In some embodiments, the plurality of particles include one or more particles having a roundness greater than about 10. In some embodiments, at least about 0.3% of the plurality of particles have a roundness greater than 10. As used herein, “roundness” refers to a measurement describing the shape of a particle. As used in this application, roundness is defined by the following equation:

Roundness=(Perimeter2)/(4*pi*area)

Roundness is typically measured using a digital image of a population of spheres and Image Pro Plus. Circular objects have a roundness=1.

In another aspect, the present invention provides a method for treating hyperphosphatemia. The method includes administering to a subject in need of treatment for hyperphosphatemia a composition comprising chitosan. In some embodiments, the subject is in need of treatment for chronic kidney disease and/or end-stage renal disease. In some embodiments, the subject is in need of treatment for one or more disorders of phosphate metabolism and/or impaired phosphate transport function.

In some embodiments, the composition of the invention includes a therapeutically effective amount of chitosan. In some embodiments, the therapeutically effective amount is from about 0.1 to about 10 grams chitosan per dose. In some embodiments, the therapeutically effective amount is from about 0.5 to about 50 grams chitosan per day.

In some embodiments, chitosan suitable for the invention binds at least about 30 mg phosphate per gram. In some embodiments, the chitosan binds at least about 60 mg phosphate per gram. In some embodiments, the chitosan binds at least about 90 mg phosphate per gram. In some embodiments, the chitosan binds at least about 120 mg phosphate per gram. In some embodiments, the chitosan binds at least about 150 mg phosphate per gram. In some embodiments, the chitosan binds at least about 180 mg phosphate per gram.

In some embodiments, chitosan suitable for the invention is present in a form of a plurality of particles. In some embodiments, the plurality of particles have a mean volume particle size less than about 100 cubic microns. In some embodiments, the plurality of particles have a median volume particle size less than about 100 cubic microns. In some embodiments, the plurality of particles include one or more particles having a roundness greater than about 10. In some embodiments, at least about 0.3% of the plurality of particles have a roundness greater than 10.

In some embodiments, the composition suitable for the invention is administered orally. In some embodiments, the composition is a nutritional supplement. In some embodiments, the composition is administered three times daily with meals.

In some embodiments, the composition further includes a carrier. In some embodiments, the carrier suitable for the invention is selected from the group consisting of a starch, a gum, an alginate, a silicate, dextrose, gelatin, lactose, mannitol, sorbitol, sucrose, tragacanth, cellulose, methyl cellulose, microcrystalline cellulose, a methylhydroxybenzoate, a propylhydroxybenzoate, polyvinylpyrrolidone and talc. In some embodiments, the composition is in a form of a cachet, a hard gelatin capsule, a soft gelatin capsule, an elixir, a lozenge, a pill, a powder, a sachet, a sterile packaged powder, a suspension, a syrup, or a tablet.

In yet another aspect, the present invention provides a composition suitable for treating hyperphosphatemia containing a therapeutically effective amount of chitosan. In some embodiments, the hyperphosphatemia is associated with chronic kidney disease and/or end-stage renal disease. In some embodiments, the hyperphosphatemia is associated with one or more disorders of phosphate metabolism and/or impaired phosphate transport function.

In some embodiments, the therapeutically effective amount is from about 0.1 to about 10 grams chitosan per dose. In some embodiments, the therapeutically effective amount is from about 0.5 to about 50 grams chitosan per day.

In some embodiments, chitosan suitable for the invention binds at least about 30 mg phosphate per gram. In some embodiments, the chitosan binds at least about 60 mg phosphate per gram. In some embodiments, the chitosan binds at least about 90 mg phosphate per gram. In some embodiments, the chitosan binds at least about 120 mg phosphate per gram. In some embodiments, the chitosan binds at least about 150 mg phosphate per gram. In some embodiments, the chitosan binds at least about 180 mg phosphate per gram.

In some embodiments, chitosan suitable for the invention is present in a form of a plurality of particles. In some embodiments, the plurality of particles have a mean volume particle size less than about 100 cubic microns. In some embodiments, the plurality of particles have a median volume particle size less than about 100 cubic microns.

In some embodiments, the plurality of particles include one or more particles having a roundness greater than about 10. In some embodiments, at least about 0.3% of the plurality of particles have a roundness greater than 10.

In some embodiments, the composition is suitable for oral administration. In some embodiments, the composition is a nutritional supplement.



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stats Patent Info
Application #
US 20120277183 A1
Publish Date
11/01/2012
Document #
File Date
04/20/2014
USPTO Class
Other USPTO Classes
International Class
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Hyperphosphatemia


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