Iguratimod osmotic pump controlled slow-release preparation

A technology of controlled release and osmotic pump, applied in the field of medicine, to achieve stable blood drug concentration, lasting and constant drug release rate, and good correlation between in vitro and in vivo

Inactive Publication Date: 2009-10-28
JIANGSU SIMCERE PHARMACEUTICAL R & D CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The iguratimod preparations currently researched and developed and applied for use are all ordinary tablets, which need to be taken twice a day

Method used

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  • Iguratimod osmotic pump controlled slow-release preparation
  • Iguratimod osmotic pump controlled slow-release preparation
  • Iguratimod osmotic pump controlled slow-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] prescription:

[0035] Drug-containing layer (calculated by weight percentage of drug-containing layer)

[0036] Alamode 31.25%

[0037] Polyoxyethylene 62.5%

[0038] appropriate amount of lemon yellow

[0039] Sodium Lauryl Sulfate 4.38%

[0040] Magnesium Stearate 1%

[0041] 5% PVA ethanol solution appropriate amount

[0042] Booster layer (calculated by weight percentage of booster layer)

[0043] Polyoxyethylene 62.5%

[0044] Sodium Chloride 25%

[0045] Hydroxypropyl Methyl Cellulose 3.12%

[0046] Polyvinylpyrrolidone k30 6.25%

[0047] Iron oxide red amount

[0048] Magnesium Stearate 1%

[0049] 8% PVA ethanol solution appropriate amount

[0050] Controlled release film (by weight percentage of tablet core)

[0051] Cellulose acetate 7.92%

[0052] Polyethylene glycol 4000 0.264%

[0053] Acetone: water appropriate amount

[0054] Protective layer: (by weight percentage of coated tablet)

[0055] Opadry Gastric Coating Premix 2%

[0056] Appro...

Embodiment 2

[0059] prescription:

[0060] Drug-containing layer (calculated by weight percentage of drug-containing layer)

[0061] Alamode 31.25%

[0062] Polyoxyethylene 62.5%

[0063] appropriate amount of lemon yellow

[0064] Sodium Lauryl Sulfate 4.38%

[0065] Magnesium Stearate 1%

[0066] 5% PVA ethanol solution appropriate amount

[0067] Booster layer (calculated by weight percentage of booster layer)

[0068] Polyoxyethylene 62.5%

[0069] Sodium Chloride 25%

[0070] Hydroxypropyl Methyl Cellulose 3.12%

[0071] Polyvinylpyrrolidone k30 6.25%

[0072] Iron oxide red amount

[0073] Magnesium Stearate 1%

[0074] 8% PVA ethanol solution appropriate amount

[0075] Controlled release film (by weight percentage of tablet core)

[0076] Cellulose acetate 10.68%

[0077] Polyethylene glycol 4000 0.356%

[0078] Acetone: water appropriate amount

[0079] Protective layer: (by weight percentage of coated tablet)

[0080] Opadry Gastric Coating Premix 2%

[0081] Ap...

Embodiment 3

[0084] prescription:

[0085] Drug-containing layer (calculated by weight percentage of drug-containing layer)

[0086] Alamode 31.25%

[0087] Polyoxyethylene 62.5%

[0088] appropriate amount of lemon yellow

[0089] Sodium Lauryl Sulfate 4.38%

[0090] Magnesium Stearate 1%

[0091] 5% PVA ethanol solution appropriate amount

[0092] Booster layer (calculated by weight percentage of booster layer)

[0093] Polyoxyethylene 62.5%

[0094] Sodium Chloride 25%

[0095] Hydroxypropyl Methyl Cellulose 3.12%

[0096] Polyvinylpyrrolidone k30 6.25%

[0097] Iron oxide red amount

[0098] Magnesium Stearate 1%

[0099] 8% PVA ethanol solution appropriate amount

[0100] Controlled release film (by weight percentage of tablet core)

[0101] Cellulose acetate 13.8%

[0102] Macrogol 4000 0.46%

[0103] Acetone: water appropriate amount

[0104] Protective layer: (by weight percentage of coated tablet)

[0105] Opadry Gastric Coating Premix 2%

[0106] Appropriate amo...

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Abstract

The invention relates to a slow-release control preparation containing iguratimod and a preparation method thereof. The slow-release control preparation is an osmotic pump type double-layer tablet using osmotic pressure of an osmotic pump as main release power. The preparation consists of a double-layer tablet core, a semi-permeable membrane and a release pore, and contains high molecular materials with slow-release control function such as polyoxyethylene, cellulose acetate and the like. Compared with the common tablet, the preparation has more durable release performance and more stable blood concentration, and only needs to be taken once every day. The preparation provides better medicament selection for the treatment of rheumatoid arthritis, and reduces the risk of adverse reaction possibly caused by the fluctuation of the iguratimod blood concentration. The preparation is orally-taken slow-release control preparation, and has stable and controllable quality; and the prescription and preparation processes are reliable and feasible, and are suitable for industrialized production.

Description

technical field [0001] The invention belongs to the technical field of medicine. To be precise, it is an oral osmotic pump controlled sustained-release preparation containing iguratimod for treating diseases such as rheumatoid arthritis and a preparation method thereof. Background technique [0002] Iguratimod chemical name: N-[3-(formamido)-4-oxo-6-phenoxy-4H-1-benzopyran-7-yl]-methanesulfonamide; [0003] Chemical Structure: [0004] [0005] Molecular formula: C 17 h 14 N 2 o 6 S molecular weight: 374.37 [0006] Iguratimod is clinically intended to treat diseases such as rheumatoid arthritis. At present, there are about 355 million people with arthritis in the world. In Asia, one out of every six people suffers from arthritis, the world's number one disabling disease, at some point in their life. Arthritis patients in mainland China have More than 100 million. Existing animal pharmacodynamic tests and human clinical trials have shown that iguratimod has good ...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/352A61P19/04
Inventor 李晓强彭涛许向阳刘春晖
Owner JIANGSU SIMCERE PHARMACEUTICAL R & D CO LTD
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