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Sustained release l-arginine formulations and methods of manufacture and use

A slow-release preparation, arginine technology, applied in the field of two-messenger cyclic GMP

Inactive Publication Date: 2006-02-08
PALMETTO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cytotoxic effects of NO may be largely independent of guanylate cyclase and cyclic GMP formation

Method used

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  • Sustained release l-arginine formulations and methods of manufacture and use
  • Sustained release l-arginine formulations and methods of manufacture and use
  • Sustained release l-arginine formulations and methods of manufacture and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0156] Example 1: Tablet Formulation 1

[0157] About 250 g of L-arginine was placed in the mixer and while it was slowly mixing at 100 RPM, 100 g of EUDRAGIT RS 30D low permeability methacrylic aqueous polymer dispersion (Rohm America, Piscataway, NJ) was added to form a wet mass . Pass the wet mass through a 18-20 mesh screen and allow to dry at 50°C for 24 hours. The resulting dry L-arginine granules (250 g) were dry blended with 84 g of METHOCEL K100M CR methylcellulose (The Dow Chemical Company, Danbury, CT) and 3 g of magnesium stearate to form a mixture. The resulting blend was compressed into tablets using a 7 / 16 arched punch.

Embodiment 2

[0158] Embodiment 2: Tablet formulation 2

[0159] 250g of L-arginine was placed in a mixer and while it was mixing slowly, 84g of METHOCEL K100M CR methylcellulose and 3g of magnesium stearate were added. The resulting blend was compressed into tablets using a 7 / 16 arched punch.

Embodiment 3

[0160] Embodiment 3: Capsule preparation 1

[0161] 250 g of L-arginine was placed in the mixer and while it was mixing slowly, 100 g of EUDRAGIT RS 30D low permeability methacrylic aqueous polymer dispersion was added to form a wet mass. Pass the wet mass through a 18-20 mesh screen and allow to dry at 50°C for 24 hours. The resulting dry L-arginine granules (250 g) were dry blended with 84 g of METHOCEL K100 M CR methylcellulose and 3 g of magnesium stearate to form a mixture. The resulting mixture is placed in 00 gel capsules.

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Abstract

The present invention provides methods and formulations for the treatment and prevention of cerebrovascular and cardiovascular diseases and disorders. The present invention is based at least in part on the discovery that administering to a subject a formulation comprising an agonist of endothelial nitric oxide synthase (eNOS), such as an HMG-CoA reductase inhibitor, and a formulation comprising a NO precursor, such as L-arginine The formulations are useful for treating or preventing cerebrovascular and / or cardiovascular diseases or disorders.

Description

[0001] related application [0002] This application claims U.S. Provisional Patent Application Serial No. 60 / 421,258, filed October 24, 2002, entitled "Methods and Compositions for Treating Cerebrovascular and Cardiovascular Diseases and Disorders," filed September 29, 2003, and entitled " Methods and Compositions for Treating Cerebrovascular and Cardiovascular Diseases and Disorders," U.S. Provisional Patent Application Serial No. 60 / 507,312, and filed October 17, 2003, entitled "Slow-Release L-Arginine Formulations and Their Production and Use Priority of U.S. Provisional Patent Application Serial No. 60 / XXX,XXX for "Methods", each of which is hereby incorporated by reference in its entirety in its entirety. Background of the invention [0003] A family of enzymes known as nitric oxide synthases (NOS) synthesize nitric oxide (NO) - an important biological second messenger - from L-arginine. NOS has several different isoforms, including constitutive NOS (cNOS) and inducible...

Claims

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Application Information

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IPC IPC(8): A61K9/22
Inventor E·S·龙
Owner PALMETTO PHARMA
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