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Dispersible pharmaceutical compositions

A kind of composition and medicine technology, applied in the field of compositions that can be easily dispersed in body fluids in the preparation of the composition, and can solve problems such as prolonged chemical and/or physical stability, long-term chemical and physical stability, etc.

Active Publication Date: 2006-01-11
ZOETIS SERVICE LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The use of oxygen-permeable packaging containers and delivery devices in anti-mastitis preparations and compositions for the treatment and prevention of ear infections is useful for long-term use of compositions containing ingredients such as active drugs or excipients that are susceptible to oxidative degradation. There are serious concerns about chemical and / or physical stability
[0056] Although the various references cited above disclose many compositions for the treatment of mastitis and other disease symptoms, none of them mentions that the compositions packaged in oxygen-permeable containers achieve prolonged chemical and and / or problems with physical stability, where the composition contains a pharmaceutically active substance that is susceptible to oxidative degradation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0174] A suspension having the following composition for treating and / or preventing mastitis in lactating cows by intramammary infusion was prepared.

[0175] Ceftiofur hydrochloride (micronized) 12.5mg / ml

[0176] Labrafil TM M-1944CS 50mg / ml

[0177] Microcrystalline Wax NF 70mg / ml

[0178] Cottonseed Oil NF q.s.

[0179] Mix the microcrystalline wax and about 27% of the total amount of cottonseed oil in a reaction kettle and heat to 85-98°C. The remaining cottonseed oil is mixed and heated to 85-98°C in the production tank. After the microcrystalline wax is completely melted, the microcrystalline wax / cottonseed oil mixture in the reaction kettle is transferred to the production tank containing cottonseed oil, and fully mixed. The resulting mixture is cooled to 38-45°C, mixed into the production tank and added to Labrafil TM M-1944CS, forming excipients. Ceftiofur hydrochloride is then added to the excipients, and the resulting composition is mixed to form a homogen...

Embodiment 2

[0182] A suspension having the following composition for treating and / or preventing mastitis in lactating cows by intramammary infusion was prepared.

[0183] Ceftiofur hydrochloride (micronized) 12.5mg / ml

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

[0185] Microcrystalline Wax NF 100mg / ml

[0186] Cottonseed Oil NF q.s.

[0187] The microcrystalline wax and cottonseed oil are mixed and heated to 85-98°C in the production tank. After the microcrystalline wax is completely melted, cool the mixture to 38-45°C, add Labrafil to the production tank TM M-1944CS. Ceftiofur hydrochloride is then added to the resulting vehicle and mixed to form a homogeneous suspension. The suspension was sieved and filled into a 12ml high-density polyethylene mastitis syringe. Finally, the packaged product is sterilized by gamma irradiation with a dose of 25-40 kGy.

[0188]The surface tension of the above suspension was determined by the drop volume method and compared with 100 mg / ml microcrystal...

Embodiment 3

[0190] A suspension having the following composition for treating and / or preventing mastitis in lactating cows by intramammary infusion was prepared.

[0191] Ceftiofur hydrochloride (micronized) 12.5mg / ml

[0192] Labrafil TM M-1944CS 200mg / ml

[0193] Microcrystalline Wax NF 100mg / ml

[0194] Cottonseed Oil NF q.s.

[0195] The microcrystalline wax and cottonseed oil are mixed and heated to 85-98°C in the production tank. After the microcrystalline wax is completely melted, cool the mixture to 38-45°C, add Labrafil to the production tank TM M-1944CS. Ceftiofur hydrochloride is then added to the resulting vehicle and mixed to form a homogeneous suspension. The suspension was sieved and filled into a 12ml high-density polyethylene mastitis syringe. Finally, the packaged product is sterilized by gamma irradiation with a dose of 25-40 kGy.

[0196] The surface tension of the above suspension was determined by the drop volume method and compared with 100 mg / ml microcryst...

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Abstract

A pharmaceutical composition is provided comprising a vehicle that comprises (a) an amphipathic oil that is water dispersible and ethanol insoluble, (b) microcrystalline wax, and (c) a pharmaceutically acceptable non-aqueous carrier; and having an antibacterial substance in an antibacterially effective amount stably dispersed in the vehicle. The composition is suitable for administration by intramammary infusion to a milk producing animal for treatment and / or prevention of mastitis or other diseases of the udder, as well as for otic administration for treatment and / or prevention of an ear infection.

Description

field of invention [0001] The present invention relates to a stable pharmaceutical composition containing an antibacterial agent, especially a composition which can be easily dispersed in body fluids. The invention also relates to a method for the preparation of said composition and a method for the treatment and / or prophylaxis of diseases caused by bacterial infections of fluid-containing organs such as udders or ears of milk-producing animals, said method comprising applying The composition is administered to a fluid-containing organ as described. Background of the invention [0002] Mastitis is an inflammation of the mammary glands of dairy animals such as cows, usually caused by a bacterial infection. Bacteria entering the teat ducts of animals can cause acute, clinical or subclinical mastitis. According to the literature, more than 135 organisms are considered to be the causative agents of bovine mastitis. The three main classes of pathogens are Gram-positive cocci, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/44A61K31/545A61K9/00A61K31/415A61K31/43A61K31/65A61K45/06A61K47/06
CPCA61K31/43A61K9/0041A61K31/545A61K47/44A61K47/06A61K31/65A61K45/06A61K31/415A61K9/0046A61P15/14A61P27/16A61P29/00A61P31/00A61P31/02A61P31/04A61P33/00A61K2300/00A61K9/10
Inventor N·J·布里顿N·A·沃尔德伦J·W·波恩斯
Owner ZOETIS SERVICE LLC