Dispersible pharmaceutical composition for treatment of mastitis and otic disorders

A composition and drug technology, applied in the field of infectious diseases of organs, can solve unsolved problems such as long-term chemical and/or physical stability problems, and achieve improved resuspensibility, improved physical stability, and prevention of ear diseases. Effect

Inactive Publication Date: 2006-04-19
PHARMACIA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0046] Although the documents cited above disclose many compositions for the treatment of mastitis or for the treatment of ear diseases, none of them address the long-term chemical and / or physical stability problems caused by packaging compositions in oxygen-permeable containers, wherein the combination substances including pharmaceutically active drugs and / or excipients susceptible to oxidative degradation

Method used

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  • Dispersible pharmaceutical composition for treatment of mastitis and otic disorders
  • Dispersible pharmaceutical composition for treatment of mastitis and otic disorders
  • Dispersible pharmaceutical composition for treatment of mastitis and otic disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0186] A suspension for administration by intramammary infusion is prepared having the following composition:

[0187] Ceftiofur hydrochloride (micronized 12.5mg / ml

[0188] Labrafil TM M-1944CS 50mg / ml

[0189] Microcrystalline Wax NF 70mg / ml

[0190] Cottonseed Oil NF Sufficient

[0191] About 27% of the total amount of microcrystalline wax and cottonseed oil is placed in a kettle and heated to 85-98° C. while stirring. Heat the remaining cottonseed oil to 85-98°C with stirring in the preparation vessel. After the microcrystalline wax is completely melted, transfer the microcrystalline wax / cottonseed oil mixture from the kettle to the preparation vessel containing the cottonseed oil and mix thoroughly. After the resulting mixture has cooled to 38-45°C, add Labrafil to the preparation vessel with stirring TM M-1944CS, obtained excipients. Then add ceftiofur hydrochloride to the excipient and stir to obtain a uniform suspension. The suspension was sieved and packaged...

Embodiment 2

[0196] A suspension for administration by intramammary infusion is prepared having the following composition:

[0197] Ceftiofur hydrochloride (micronized) 12.5mg / ml

[0198] Labrafil TM M-1944CS 50mg / ml

[0199] Microcrystalline Wax NF 100mg / ml

[0200] Cottonseed Oil NF Sufficient

[0201] Heat the microcrystalline wax and cottonseed oil to 85-98°C with stirring in the preparation vessel. After the microcrystalline wax is completely melted, cool the mixture to 38-45°C, then add Labrafil with stirring TM M-1944CS into the preparation container to obtain excipients. Add ceftiofur hydrochloride to the resulting excipient and stir to obtain a homogeneous suspension. The suspension was sieved and packaged into 12 ml high density polyethylene syringes for mastitis. Finally, the packaged product is sterilized by gamma rays at a dose of 25-40 kGy.

[0202] The interfacial tension of the above suspension was determined by using 39°C deionized water titration technique compa...

Embodiment 3

[0206] A suspension for administration by intramammary infusion is prepared having the following composition:

[0207] Ceftiofur hydrochloride (micronized) 12.5mg / ml

[0208] Labrafil TM M-1944CS 200mg / ml

[0209] Microcrystalline Wax NF 100mg / ml

[0210] Cottonseed Oil NF Sufficient

[0211] Heat the microcrystalline wax and cottonseed oil to 85-98°C with stirring in the preparation vessel. After the microcrystalline wax is completely melted, the mixture is cooled to 38-45°C, and then Labrafil is added under stirring TM M-1944CS into the preparation container to obtain excipients. Then add ceftiofur hydrochloride to the resulting excipient and stir to obtain a homogeneous suspension. The suspension was sieved and packaged into 12 ml high density polyethylene syringes for mastitis. Finally, the packaged product is sterilized by gamma rays at a dose of 25-40 kGy.

[0212] The interfacial tension of the above suspension was determined by titration with deionized water ...

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PUM

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Abstract

A method is provided for treatment of an infective condition in a fluid-containing organ having a natural exterior orifice, such as the udder of a milk producing animal or an ear. The method comprises administering an antibacterial agent to the organ via the exterior orifice and administering in combination therapy with the antibacterial agent a second agent that is an anti-inflammatory agent, an analgesic and / or an antipyretic. The antibacterial agent and, optionally, the second agent, are administered as a pharmaceutical composition further comprising a vehicle that comprises an amphipathic oil that is water dispersible and ethanol insoluble, microcrystalline wax and a pharmaceutically acceptable non-aqueous carrier. Also provided is such a composition comprising the antibacterial agent and the second agent. The composition is readily dispersible in the fluid of the fluid-containing organ.

Description

field of invention [0001] The present invention relates to a method of treating infectious diseases of fluid-containing organs having a natural exterior orifice, such as the udder or ear of a dairy animal. The invention also relates to a dispersible pharmaceutical composition suitable for infusion into said organ according to the method of the invention, and a process for its preparation. Background of the invention [0002] Mastitis is inflammation of the mammary glands of a milk-producing animal such as a cow, most often caused by a bacterial infection. Bacteria entering the teat ducts of animals cause acute clinical or subclinical mastitis. More than 135 organisms have been shown to be causative agents of bovine mastitis. The three major classes of pathogens are Gram-positive cocci, Gram-negative bacilli, and Gram-positive bacilli. Hygiene, environmental factors, and metabolic disturbances due to high milk production combine to create favorable conditions for the devel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/44A61K45/06A61K9/00A61K47/06A61K47/14
CPCA61K47/06A61K9/0046A61K9/0041A61K47/44A61K47/14A61K45/06A61P25/04A61P27/16A61P29/00A61P31/04A61P9/00A61K31/47A61K31/382A61K31/352
Inventor 南希·J·布里滕约翰·W·伯恩斯约翰·W·哈尔伯格尼基·A·沃尔德伦杰弗里·L·沃茨
Owner PHARMACIA CORP
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