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Dispersible formulation of an anti-inflammatory agent

An anti-inflammatory agent, dispersive technology, applied in the direction of anti-inflammatory agents, medical preparations containing active ingredients, diseases, etc., can solve the problem of providing chemical and/or physical stability without instructions

Inactive Publication Date: 2006-09-06
PHARMACIA & UPJOHN CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0046] Although the above-cited documents disclose many compositions for treating mastitis or treating ear diseases, there is no indication of providing long-term chemical and / or physical stability of compositions packaged in oxygen-permeable containers if the Compositions comprising pharmaceutically active agents and / or excipients susceptible to oxidative degradation

Method used

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  • Dispersible formulation of an anti-inflammatory agent
  • Dispersible formulation of an anti-inflammatory agent
  • Dispersible formulation of an anti-inflammatory agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0158] A suspension was prepared for administration by intramammary infusion with the following composition:

[0159] Parecoxib Free Acid 100mg / ml

[0160] Labrafil TM M-1944CS 50mg / ml

[0161] Microcrystalline Wax NF 70mg / ml

[0162] Appropriate amount of cottonseed oil NF

[0163] Mix about 27% of the total amount of microcrystalline wax and cottonseed oil in a pot and heat to 85-98°C. The remaining cottonseed oil was mixed and heated to 85-98°C in the manufacturing tank. After the microcrystalline wax is completely melted, transfer the microcrystalline wax / cottonseed oil mixture in the pan to the preparation bath containing the cottonseed oil and mix well. The resulting mixture was cooled to 38-45°C, and the Labrafil TM M-1944CS is added to the preparation tank and mixed to form the carrier. Parecoxib is then added to the vehicle and the resulting composition mixed to form a homogeneous suspension. The suspension was filtered and filled into 12ml high density polyet...

Embodiment 3

[0173] A suspension was prepared for administration by otic infusion with the following composition:

[0174] Rofecoxib 25mg / ml

[0175] Labrafil TM M-1980CS 500mg / ml

[0176] Microcrystalline Wax NF 0.10mg / ml

[0177] Propyl gallate 1.0mg / ml

[0178] Mineral oil amount

[0179] Mix about 27% of the total amount of microcrystalline wax and mineral oil in a pot and heat to 85-98°C. Mix the remaining mineral oil in the preparation tank and heat it to 85-98°C. After the microcrystalline wax is completely melted, transfer the microcrystalline wax / mineral oil mixture in the pan to the preparation bath containing the mineral oil and mix well. The resulting mixture was cooled to 38-45°C, and the Labrafil TM Mix M-1980CS into the preparation pool. Propyl gallate is mixed and added to the preparation tank to form the carrier. Rofecoxib is added to the resulting vehicle and mixed to form a homogeneous suspension. The suspension was filtered and filled into 20ml polypropylene...

Embodiment 4

[0182] A suspension was prepared for administration by intramammary infusion with the following composition:

[0183] Deracoxib 300mg / ml

[0184] Labrafil TM M-1944CS 50mg / ml

[0185] Microcrystalline Wax NF 70mg / ml

[0186] Appropriate amount of cottonseed oil NF

[0187] Mix about 27% of the total amount of microcrystalline wax and cottonseed oil in a pot and heat to 85-98°C. Mix and heat the remaining cottonseed oil in the preparation tank to 85-98°C. After the microcrystalline wax is completely melted, transfer the microcrystalline wax / cottonseed oil mixture in the pan to the preparation bath containing the cottonseed oil and mix well. The resulting mixture was cooled to 38-45°C, and the Labrafil TM M-1944CS is mixed and added to the preparation tank to form the carrier. Deracoxib is then added to the resulting vehicle and mixed to form a homogeneous suspension. The suspension was filtered and filled into 12ml high density polyethylene mastitis syringes. The pac...

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PUM

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Abstract

A method is provided for treatment and / or prevention of an inflammatory condition in a fluid-containing organ having a natural exterior orifice, such as lthe udder of a milk-producing animal or an ear of a subject. The invention also relates to a dispersible pharmaceutical composition suitable for infusion into the organ according to the method of the invention, and a process for preparing such a composition.

Description

field of invention [0001] The present invention relates to methods of treating and / or preventing inflammatory diseases in organs containing fluid and having a natural external opening, such as the udder of a lactating animal or the ear of a subject. The invention also relates to dispersible pharmaceutical compositions suitable for infusion into the organ according to the methods of the invention, and methods of preparing such compositions. Background of the invention [0002] Mastitis is an inflammation of the mammary glands of a milk producing animal such as a cow, most commonly caused by a bacterial infection. Bacteria enter the animal's teat ducts and can cause acute, clinical, or subclinical mastitis. More than 135 organisms have been shown to be causative agents of bovine mastitis. The three main classes of pathogens are Gram-positive cocci, Gram-negative bacilli, and Gram-positive bacilli. Hygiene, environmental factors, and metabolic disturbances resulting from hig...

Claims

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Application Information

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IPC IPC(8): A61K31/415A61K31/167A61K31/545A61K31/546A61K9/00A61P27/16A61P15/14A61K31/00A61K47/44
CPCA61K31/00A61K47/44A61K31/545A61K31/167A61K31/546A61K9/0019A61K31/415A61P15/14A61P25/00A61P25/04A61P27/16A61P29/00A61P31/04A61P35/00A61P43/00
Inventor 南希·J·布里滕尼基·A·沃尔德伦杰弗里·L·沃茨约翰·W·哈尔伯格约翰·W·伯恩斯第二
Owner PHARMACIA & UPJOHN CO
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