Directly-compressible naproxen or naproxen sodium compositions
AssigneeSyntex Pharmaceuticals International Ltd.
InventorsRoy Kuramoto, Zakauddin T. Chowhan, Ranal O. Pendleton, Hafez Hafezzadeh
Life of this patent
Estimating the term…
Abstract
The present invention relates to directly-compressible naproxen or naproxen sodium compositions comprising spray-dried naproxen or naproxen sodium. The present invention further relates the processes for preparing the directly-compressible naproxen or naproxen sodium compositions, to aqueous mixtures containing naproxen or sodium naproxen suitable for spray-drying and useful in the processes for preparing the directly-compressible compositions, to naproxen or naproxen sodium tablets prepared from the directly-compressible compositions, and to the processes for preparing the naproxen or naproxen sodium tablets.
Claims45
A directly-compressible naproxen composition consisting essentially of 90 to 97% spray-dried naproxen, 0.5 to 1.5% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0% lubricant.
A directly-compressible naproxen sodium composition consisting essentially of 80 to 90% spray-dried naproxen sodium, 6.0 to 8.0% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0% lubricant.
A process for preparing a naproxen sodium tablet, which process comprises:
- (1) spray drying an aqueous mixture-containing 20 to 70% solids, the solids consisting essentially of 85.11 to 100% naproxen sodium, optionally binder in an amount less than or equal to 6.97% and optionally disintegrating agent in an amount less than or equal to 6.97%, to obtain a spray-dried naproxen sodium composition with a free moisture content that does not exceed 9.09%;
- (2) combining the spray-dried naproxen sodium composition with sufficient amounts of water and dry excipients to obtain a directly-compressible naproxen sodium composition comprising 80 to 90% spray-dried naproxen sodium, 6.0 to 8.0% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0% lubricant;
- and
- (3) compressing the directly-compressible composition into a tablet.
A process for preparing a directly-compressible naproxen sodium composition, which process comprises:
- (1) spray drying an aqueous mixture containing 20 to 70% solids, the solids consisting essentially of 85.11 to 100% naproxen sodium, optionally binder in an amount less than or equal to 6.97% and optionally disintegrating agent in an amount less than or equal to 6.97%, to obtain a spray-dried naproxen sodium composition with a free moisture content that does not exceed 9.09%;
- and
- (2) combining the spray-dried naproxen sodium composition with sufficient amounts of water and dry excipients to obtain a directly-compressible naproxen sodium composition consisting essentially of 80 to 90% spray-dried naproxen sodium, 6.0 to 8.0% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0 % lubricant.
An aqueous mixture suitable for spray drying to obtain a spray-dried naproxen composition, the mixture containing 20 to 70% solids, the solids consisting essentially of 90.46 to 100% naproxen, optionally binder in an amount less than or equal to 6.25%, and optionally disintegrating agent in an amount less than or equal to 6.25%.
An aqueous mixture suitable for spray drying to obtain a spray-dried naproxen sodium composition, the mixture containing 20 to 70% solids, the solids consisting essentially of 85.11 to 100% naproxen sodium, optionally binder in an amount less than or equal to 6.97%, and optionally disintegrating agent in an amount less than or equal to 6.97%.
A spray-dried naproxen composition suitable to combine with dry excipients to obtain a directly-compressible naproxen composition, the spray-dried composition consisting essentially of 90 to 100% naproxen, free moisture content that does not exceed 1.63%, optionally binder in an amount less than or equal 6.25% and optionally disintegrating agent in an amount less than or equal 6.25%.
A spray-dried naproxen sodium composition suitable to combine with dry excipients to obtain a directly-compressible naproxen sodium composition, the spray-dried composition consisting essentially of 80 to 100% naproxen sodium, free moisture content that does not exceed 9.09%, optionally binder in an amount less than or equal to 6.97% and optionally disintegrating agent in an amount less than or equal to 6.97%.
A process for preparing a naproxen tablet, which process comprises:
- (1) combining a spray-dried naproxen composition consisting essentially of 90 to 100% naproxen, free moisture content that does not exceed 1.63%, optionally binder in an amount less than or equal to 6.25%, and optionally disintegrating agent in an amount less than or equal to 6.25% with sufficient amounts of water and dry excipients to obtain a directly-compressible naproxen composition consisting essentially of 90 to 97% spray-dried naproxen, 0.5 to 1.5% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0% lubricant;
- and
- (2) compressing the directly-compressible composition into a tablet.
A process for preparing a spray-dried naproxen sodium composition suitable to combine with dry excipients to obtain a directly-compressible naproxen sodium composition, which process comprises:
- (1) spray drying an aqueous mixture containing 20 to 70% solids, the solids consisting essentially of 85.11 to 100% naproxen sodium, optionally binder in an amount less than or equal 6.97% and optionally disintegrating agent in an amount less than or equal 6.97%, to obtain a spray-dried naproxen sodium composition with a free moisture content that does not exceed 9.09%.
A naproxen tablet consisting essentially of to 97% spray-dried naproxen, 0.5 to 1.5% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0% lubricant.
A naproxen sodium tablet consisting essentially of 80 to 90% spray-dried naproxen sodium, 6.0 to 8.0% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0% lubricant.
A process for preparing a naproxen tablet, which process comprises:
- (1) spray drying an aqueous mixture containing 20 to 70% solids, the solids consisting essentially of 90.46 to 100% naproxen, optionally binder in an amount less than or equal to 6.25% and optionally disintegrating agent in an amount less than or equal 6.25%, to obtain a spray-dried naproxen composition with a free moisture content that does not exceed 1.63%;
- (2) combining the spray-dried naproxen composition with sufficient amounts of water and dry excipients to obtain a directly-compressible naproxen comprising 90 to 97% spray-dried naproxen, 0.5 to 1.5% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0% lubricant;
- and
- (3) compressing the directly-compressible composition into a tablet.
A process for preparing a naproxen sodium tablet, which process comprises:
- (1) combining a spray-dried naproxen sodium composition consisting essentially of 80 to 100% naproxen sodium, free moisture content that does not exceed 9.09%, optionally binder in an amount less than or equal to 6.97%, and optionally disintegrating agent in an amount less than or equal to 6.97% with sufficient amounts of water and dry excipients to obtain a directly-compressible naproxen composition consisting essentially of 80 to 90% spray-dried naproxen sodium, 6.0 to 8.0% free moisture content, 1 to 6% binder, 1 to 6% disintegrating agent, and 0.1 to 2.0% lubricant;
- and
- (2) compressing the directly-compressible composition into a tablet.
Dependencies are inferred from the claim text.