Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – 3,10-dihydroxy-2-naphthacene carboxamide or derivative doai
Reexamination Certificate
1999-12-06
2002-11-12
Levy, Neil S. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
3,10-dihydroxy-2-naphthacene carboxamide or derivative doai
C514S352000, C514S974000, C424S405000, C424S406000
Reexamination Certificate
active
06479473
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATION
This application is a 35 USC §371 filing of PCT/GB97/01222, filed May 6, 1997, the entire contents of which is incorporated herein by reference.
FIELD OF THE INVENTION
This invention relates to administration of antimicrobials primarily in the field of veterinary medicine. The desirability of minimising administration activities in veterinary medicine is particularly acute for several reasons. Obviously the subject of treatment in veterinary medicine cannot be counselled nor cooperate in the treatment process. Therefore in addition to therapeutic considerations there arise disadvantages including the labour involved in catching and handling the animal and the stress it suffers arising from the treatment. One way of addressing these difficulties is to provide long-acting formulations so that each separate act of administration has a longer effect before a further treatment is called for.
BACKGROUND OF THE INVENTION
Long acting or single treatment antimicrobials have been available for some time now in veterinary medicine.
The long acting basis of such products can result from a combination of both the inherent nature of the drug or drug form used and the formulation in which it is administered. Their benefits over conventional repeat treatment products may include: reduced stress to the sick animal, in that it does not have to be caught and restrained on a daily basis in order to receive treatment, reduced work load for the farmer/veterinarian again because there are no repeat treatments and increased efficacy in treating clinical conditions in that drug levels are continuously present over a prolonged period.
However one of the problems with long acting formulations of antimicrobials is that they may cause irritation at the site of administration and also that high levels of antimicrobial can be found at the sites of administration for a long time.
A further difficulty with long acting or single treatment products can be that they may not give as high blood levels immediately following administration as do the repeat treatment products. Whilst this may not affect the overall level of efficacy of the product it may result in a slower initial rate of recovery which can in some cases lead to the increased rate of long term damage to affected tissues and organs. An alternative explanation for the cause of tissue/organ damage is that it results as a consequence of the animals own inflammatory response to infection. As well as causing damage to tissue this inflammatory process may also reduce the diffusion of antimicrobial to the site of infection/inflammation. One means of preventing this from happening is to administer an anti-inflammatory drug. Such a drug on its own will reduce the inflammatory response but will not reduce the incidence of bacterial infection and so it is also necessary to administer an antimicrobial. One such product containing both an anti-inflammatory drug and an antimicrobial is commercially available, namely, Finabiotic, Schering-Plough Animal Health, however, use of this product requires daily treatments in order to be effective.
SUMMARY OF THE INVENTION
Accordingly it is an object of the present invention to obviate or mitigate the aforesaid disadvantages by providing a long-acting or single treatment formulation which has both antimicrobial and anti-inflammatory effect.
According to this invention there is provided a veterinary product comprising an antimicrobial and an anti-inflammatory agent in intimate admixture wherein the antimicrobial is selected from the group consisting of long-acting antimicrobials or depot antimicrobial formulations.
The product is preferably provided as a single dosage in a pharmaceutically permissible “ready for use” container such as a multi use vial or as a disposable syringe, or in packaging (e.g. blister packaging) containing a selected number of discrete dosage formulations for a prescribed period of treatment, each formulation being contained in a multi use vial or in an ampoule or disposable dispensing device adapted for parenteral use or any other suitable physiologically acceptable carrier or vehicle.
Further according to the present invention there is provided a method of producing an improved veterinary product comprising bringing a selected amount of a long acting antimicrobial into intimate admixture with a pre-determined amount of an anti-inflammatory agent and preparing the admixture for parenteral administration. Preferably the amounts of antimicrobial and anti-inflammatory agent are calculated to provide dosage amounts for a single treatment.
Advantageously this invention provides a veterinary product which on administration produces reduced irritation at the site of administration and reduced levels of antimicrobial found at the sites of administration over a period of time.
REFERENCES:
patent: WO 96/01634 (1996-01-01), None
Lockwood, P.W. et al., “Flunixin-Meglumin als Zusatz zur antibiotischen Therapie: Die Wirksamkeit bei der Behandlung der enzootischen Pneumonie des Rindes unter den Bedingungen eines amerikanischen Feedlots,”Tierärztliche Umschau, 52:127-131 (1997).
Dherty, M.L., et al., “Isolation ofMycoplasma bovisfrom a calf imported into the Republic of Ireland,”Veterinary Record,135:259-260 (1994).
Kopcha, M. et al., “Experimental uses of flunixin meglumine and phenylbutazone in food-producing animals,”J. Am.Vet. Med.. Assoc.,194:45-49 (1989).
Verhoeff, J. et al., “Flunixin meglumine in calves with natural bovine respiratory syncytial virus infection,”Veterinary Record,118:14-16 (1986).
Orr Neil
Patterson Alan
Clement, Esq. Candace J.
Heslin Rothenberg Farley and Mesiti P.C.
Norbrook Laboratories Ltd.
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