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EP0255404A1 Expired / Lapsed EP ⏱️ 0.0 years remaining

Sustained release ibuprofen formulation

Assignee: APS Research Ltd
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Filing: 1987-07-31
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Granted: —
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Expires: 2007-07-31
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Abstract

Abstract The present invention provides a sustained release α-4-(2-methylpropyl)benzene acetic acid (Ibuprofen) formulation comprising sufficient granules to provide a predetermined dose or number of doses of Ibuprofen, each granule having a diameter between 0.5 and 2.0 mm and comprising: a) a core containing l00 parts of Ibuprofen and from l0 to 70 parts of a microcrystalline cellulose; and b) a coating covering substantially the whole surface of the core and comprising l00 parts of a water insoluble but water swellable acrylic polymer and 20 to 70 parts of a water-soluble hydroxylated cellulose derivative, the weight of the coating being from 5 to 20% of the weight of the core.

Inventors

  • 👤 Brian William Barry
  • 👤 Peter York
  • 👤 Bryan Arthur Mulley

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-05 03:31
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/185; A61K31/19; A61K9/00; A61K9/14; A61K9/16; A61K9/1605; A61K9/1629; A61K9/1652; A61K9/48; A61K9/50; A61K9/5005; A61K9/5021; A61K9/5026; A61K9/5036; A61K9/5042; A61K9/5047; A61P; A61P25/00; A61P25/04; A61P29/00

Claims Analysis

Total Claims: 11
Claim 1
Independent Claim 104 words
A sustained release α-methyl-4-(2-methylpro­pyl)benzene acetic acid (Ibuprofen) formulation comprising sufficient granules to provide a predetermined dose or number of doses of Ibuprofen, each granule having a diameter between 0.5 and 2.0 mm and comprising: a) a core containing l00 parts of Ibuprofen and from l0 to 70 parts of a microcrystalline cellulose; and b) a coating covering substantially the whole surface of the core and comprising l00 parts of a water insoluble but water swellable acrylic polymer and 20 to 70 parts of a water-soluble hydroxylated cellulose derivative, the weight of the coating being from 5 to 20% of the weight of the core.
Claim 2
Dependent Claim 104 words
A sustained release α-methyl-4-(2-methylpro­pyl)benzene acetic acid (Ibuprofen) formulation comprising sufficient granules to provide a predetermined dose or number of doses of Ibuprofen, each granule having a diameter between 0.5 and 2.0 mm and comprising: a) a core containing l00 parts of Ibuprofen and from l0 to 70 parts of a microcrystalline cellulose; and b) a coating covering substantially the whole surface of the core and comprising l00 parts of a water insoluble but water swellable acrylic polymer and 20 to 70 parts of a water-soluble hydroxylated cellulose derivative, the weight of the coating being from 5 to 20% of the weight of the core.
Claim 3
Dependent Claim 50 words
The formulation of claim l, which is a 24 hour formulation, wherein the granule diameter is between l.5 and 2.0 mm, the coating contains 25 to 35 parts of the water soluble hydroxylated cellulose derivative, and the weight of the coating is approximately 20% of the weight of the core.
Claim 4
Dependent Claim 52 words
The formulation of claim l, which is a l2 hour formulation, wherein the granule diameter is between 0.7 and l.2 mm, the coating contains 25 to 35 parts of the water soluble hydroxylated cellulose derivative, and the weight of the coating is between 8 and l2% of the weight of the core.
Claim 5
Dependent Claim 23 words
The formulation of any one of claims l to 3, wherein the core contains between l5 and 20 parts of the microcrystalline cellulose.
Claim 6
Dependent Claim 22 words
The formulation of any one of claims l to 4, wherein the coating comprises about 30 parts of the hydroxylated cellulose derivative.
Claim 7
Dependent Claim 37 words
The formulation of any one of claims l to 5, wherein the hydroxylated cellulose derivative is hydroxypropyl methycellulose having a degree of substitution of 28 to 30% of methoxy groups and 7 to l2% of hydroxy groups.
Claim 8
Dependent Claim 16 words
The formulation of any one of claims l to 6, wherein the acrylic polymer is neutral.
Claim 9
Dependent Claim 18 words
The formulation of any one of claims l to 7, wherein the granules are contained in a capsule.
Claim 10
Dependent Claim 55 words
A process for producing a formulation according to any one of claims l to 8 comprising: 1. mixing the Ibuprofen with the microcrystalline cellulose; 2. forming the mixture into particles; 3. forming a solution of the hydroxylated cellulose derivative and the acrylic polymer; and 4. coating the particles using the solution to form the granules.
Claim 11
Dependent Claim 13 words
l0. The process of claim 9, wherein the granules are sieved after formation.

References Cited (Backward Citations)

EP0172014A2 Cited
EP0194838A2 Cited
DE3620631A1 Cited

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