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Formulations comprising ceftiofur and ketoprofen or ceftiofur and benzyl alcohol

A technology of ceftiofur, preparation, applied in the field of preparation containing ceftiofur and ketoprofen or ceftiofur and benzyl alcohol

Active Publication Date: 2012-02-01
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, to the applicant's knowledge, at the time of filing this application, there has not been a suitably effective formulation comprising the active agents of ceftiofur and ketoprofen

Method used

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  • Formulations comprising ceftiofur and ketoprofen or ceftiofur and benzyl alcohol
  • Formulations comprising ceftiofur and ketoprofen or ceftiofur and benzyl alcohol
  • Formulations comprising ceftiofur and ketoprofen or ceftiofur and benzyl alcohol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] Effect of benzyl alcohol on physical properties of Ceftiofur HCl oily suspension.

[0136] Table 1

[0137] Laboratory batches were prepared with and without 1% benzyl alcohol.

[0138]

[0139] The following observations were made: formulations with benzyl alcohol separated greater on standing in 100 mL laboratory rectangular vials compared to batches without benzyl alcohol. This result is surprising and unexpected.

[0140] Initial observations revealed day 4 separation in 100 mL laboratory rectangular vials. The sedimentation volume (F) is the equilibrium volume of the sediment (V u ) and the total volume of the suspension (V 0 )The ratio. Thus, F=V u / V 0 . The F-value (typically in the range of approximately 0 to 1) increases as the volume of suspension occupied by the precipitate appears to increase. In a system where F=0.75, for example, 75% of the total volume in the vessel is apparently occupied by loose, porous flocs forming the precipitate. When ...

Embodiment 2

[0167] A batch of ceftiofur containing benzyl alcohol is Comparison of RTUs

[0168] Ceftiofur formulations (Lots E-H, respectively) were prepared with 0, 1.0, 2.0, and 3.0% benzyl alcohol, and their physical properties were comparable to those prepared by Pfizer RTU sterile suspension (ceftiofur hydrochloride) was compared, which did not contain benzyl alcohol. The settling volume standing in a 100 mL graduated cylinder was measured. Sedimentation volume (%) = [(volume of sediment x 100) / (total volume)] and the results are summarized in Table 8.

[0169] Table 8

[0170] Sedimentation volume (%) = (volume of sediment x 100) / total volume)

[0171]

[0172] NR = not recorded

[0173] The viscosity was measured in a Brookfield LV 2 at 100 rpm and the results are summarized in Table 9.

[0174] Table 9

[0175] Viscosity

[0176] lot E

Lot F

batch G

batch H

Benzyl alcohol

0％

1％

2％

3％

129cps

136cps

...

Embodiment 3

[0189] Development of a combination Ceftiofur HCl and Ketoprofen oily suspension

[0190] The following outlines the development of a stable, easily resuspendable combination Ceftiofur HCl and Ketoprofen oily suspension for injection comprising 5.0% w / v ceftiofur and 15.0% ceftiofur w / v ketoprofen suitable for intramuscular and subcutaneous injection. The desired formulation contained 5.0% ceftiofur HCL and excipients; PHOSPHOLIPON 90H, sorbitan monooleate, propylene glycol and benzyl alcohol in a refined cottonseed oil vehicle. Attempt to incorporate ethanol as an excipient in the original ceftiofur HCL injection formulation.

[0191] Formulation 1

[0192] Intent: To compare the addition of various concentrations of benzyl alcohol and ethanol. NB - Ketoprofen Free.

[0193] The sub-batches had the following amounts of benzyl alcohol and ethanol:

[0194] 1: 15% benzyl alcohol / 0% ethanol

[0195] 2: 10% benzyl alcohol / 0% ethanol

[0196] 3: 0% benzyl alcohol / 0% ethanol...

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Abstract

The present invention relates to veterinary or pharmaceutical formulations which may comprise ceftiofur, ketoprofen, benzyl alcohol, or effective combinations thereof. The formulations of the present invention may include a wetting or dispersing agent, a preservative, a flocculating agent or resuspendability enhancer, and / or a biocompatible oil vehicle. This invention also provides for, inter alia, formulations for the treating, controlling and preventing of respiratory disorders, particularly bovine respiratory disease (BRD), in warm-blooded animals, such as livestock,. This invention further provides for methods of increasing the resuspendability of an oily formulation which may comprise the addition.

Description

[0001] Cross-references with related applications [0002] This application claims the benefit of US Provisional Application Serial No. 61 / 119,764, filed December 4, 2008, and US Provisional Application Serial No. 61 / 116,031, filed November 19, 2008, the disclosures of which are incorporated herein by reference. All incorporated. Field of Invention [0003] The present invention relates to improvements in the field of veterinary medical therapy and more particularly to improvements related to formulations that may contain ceftiofur, benzyl alcohol, ketoprofen, or combinations thereof. Background of the Invention [0004] Ceftiofur is a cephalosporin antibiotic administered to cattle and pigs to control bacterial infections of the respiratory tract. It is used in veterinary medicine as the sodium and hydrochloride salts. It is administered intramuscularly to cattle and pigs. It is also expected to be used as a crystalline free acid for intramuscular and subcutaneous admini...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K47/14A61K47/24A61K47/26A61K47/44A61K31/192A61K31/545
CPCA61K47/10A61K31/192A61K47/26A61K31/545A61K47/24A61K47/44A61K47/14A61K9/0019A61P11/00A61P29/00A61P31/00A61P31/04A61P43/00A61K9/10
Inventor M·拉扎克A·约翰逊J·戈斯瓦米A·阿瓦希
Owner BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC
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