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Solid naproxen concentrates and related dosage forms

a naproxen concentrate and concentrate technology, applied in the direction of biocide, anhydride/acid/halide active ingredients, drug compositions, etc., can solve the problems of reducing the solubility of drugs, introducing unnecessary electrolytes, and unable to use formulating tablets or powder filled capsules. , it is impractical to use this approach with high-dose drugs, such as naproxen

Inactive Publication Date: 2011-03-03
PHARMA INT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These techniques provide solid salts with high water solubility; however, these techniques introduce unnecessary electrolytes or diminish the drug solubility in other commonly used, less hydrophilic solvents, such those used to manufacture soft gelatin capsules.
These methods, however, cannot be used in formulating tablets or powder filled capsules.
However, the need to use large amounts of cyclodextrin (which can reach up to 50% of the drug concentration) and the concern of cyclodextrin toxicity make it impractical to use this approach with a high-dose drug, such as naproxen.
However, nano-sized drug particles inherently are unstable and tend to aggregate to reduce the high surface energy generated during size reduction.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0053]This example demonstrates the preparation of a solid naproxen concentrate of the invention.

[0054]85.20 g of naproxen concentrate was prepared using the following ingredients.

IngredientAmount (g)Naproxen sodium, USP75.60Citric acid, USP9.60

[0055]Naproxen sodium was dry-mixed with citric acid in planetary (Hobart) mixer for 5 min. The blend was mixed with purified water (18.00 g) for 5 min, and the wet mass was dried at 45°±5° C. in a drying oven for 8 hours. Dried naproxen concentrate then was screened through # 30 mesh screen.

[0056]The resultant naproxen concentrate had final moisture content of 2.2% and bulk density of 0.41 g / mL.

example 2

[0057]This example demonstrates the preparation of a solid naproxen concentrate of the invention.

[0058]28.50 g of naproxen concentrate was prepared using the following ingredients.

IngredientAmount (g)Naproxen sodium, USP25.20Hydrochloric acid, NF3.50

[0059]Naproxen sodium was dry-mixed with citric acid in planetary (Hobart) mixer for 5 min. The blend was mixed with purified water (10.00 g) for 5 min, and the wet mass was dried at 45°±5° C. in a drying oven. Dried naproxen concentrate then was screened through # 30 mesh screen.

[0060]The resultant naproxen concentrate had final moisture content of 2.2% and bulk density of 0.41 g / mL.

example 3

[0061]This example demonstrates the preparation of a solid naproxen concentrate of the invention.

[0062]146.00 g of naproxen concentrate was prepared using the following ingredients.

IngredientAmount (g)Naproxen sodium, USP100.00Maleic acid (Hydroxysuccinic acid)46.00

[0063]Naproxen sodium was dry-mixed with maleic acid in planetary (Hobart) mixer for 5 min. The blend was mixed with purified water (28.00 g) for 5 min, and the wet mass was dried at 45°±5° C. in a drying oven. Dried naproxen concentrate then was screened through # 30 mesh screen.

[0064]The resultant naproxen concentrate had final moisture content of 1.82% and bulk density of 0.45 g / mL.

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Abstract

The invention provides a composition consisting essentially of a solid naproxen concentrate, wherein the solid naproxen concentrate comprises (a) a solid naproxen free acid and (b) a solid naproxen alkali salt, and wherein at least 90% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt, as well methods of producing such a solid naproxen concentrate.

Description

BACKGROUND OF THE INVENTION[0001]The success in treating most diseases mainly is governed by optimizing the rate of drug release and its delivery to the site of action. Diseases that cause pain are typical cases where the rate of drug release has a direct impact on patient health and patient quality of life. For example, while immediate drug release is required to treat fever, migraine headache, or acute dental pain, a controlled release of the same medicine would be a better choice for patients with chronic inflammatory diseases, such as rheumatoid arthritis and osteoarthritis.[0002]Naproxen, (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and d-2-(6-methoxy-2-naphthyl)propionic acid, is one of the most effective agents in the management of acute and chronic pain and inflammatory diseases. Pharmacologically, naproxen is classified as a non-steroidal anti-inflammatory drug (NSAID). Naproxen has powerful anti-inflammatory, analgesic, and antipyretic properties.[0003]Naproxen is used ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/48A61K31/192A61P29/00
CPCA61K9/1617A61K9/1688A61K9/4833A61K31/192A61K9/4866A61P29/00
Inventor HASSAN, EMADELDIN M.GUMUDAVELLI, SRIDHAR
Owner PHARMA INT INC
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