Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2000-11-28
2003-07-22
Pryor, Alton N. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S256000, C424S405000
Reexamination Certificate
active
06596714
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable.
CROSS-REFERENCE TO RELATED APPLICATIONS
Not applicable.
BACKGROUND OF THE INVENTION
The present invention relates to a formulation for treating, controlling and preventing parasitic worm infestations and a method for making the formulation. More specifically, the present invention relates to a combination roundworm and tapeworm parasiticide for use in horses and household pets.
Several types of parasites, including cestodes, nematodes and obligate parasitic insects, particularly flies, commonly plague horses, dogs and cats. Cestodes are flatworms and include, for example, tapeworms, while nematodes are roundworms. Avermectins and milbemycins are nematocidal agents commonly used in the treatment and control of parasitic roundworm infestations in equines, including domestic horses, donkeys, mules and zebras, as well as in companion animals, namely cats and dogs. These agents are also effective against obligate parasitic flies. Contrary to popular belief among animal owners, however, these agents are ineffective against tapeworm infestations. Rather, tapeworm infestations must be controlled and treated by a cestocidal agent.
Studies have shown that misinformation about tapeworm treatment and control is common among horse owners. Many horse owners evidently believe that ivermectin, an avermectin used for treating and controlling roundworm infestations, is effective in controlling tapeworm infestations as well. This misinformation may account for a rise in the prevalence of certain tapeworms. A particular equine tapeworm whose prevalence is on the rise is
Anoplocephala perfoliata.
Tapeworms are pervasive parasites that appear to infect at least half of all mature horses. Post-mortem studies have shown that, in general, at least 50% of mature horses in many populations are infected with
A. perfoliata. A. perfoliata
is a type of tapeworm that can infect all types of equine animals. Adult
A. perfoliata
attach to the posterior regions of the equine intestinal tract. The highest concentration is in the cecal wall but a fair amount attach to the terminal ilium and ventral colon as well. The greatest concentration of
A. perfoliata
, and thus the greatest associated damage, occurs at the ileocecal junction.
A. perfoliata
infestation increases the incidence of spasmodic colon and ileal impaction in horses. Tapeworms also have been implicated as a cause of cecal and ileocecal intussusceptions in young horses. The latter conditions are potentially fatal and can be remedied only by complicated and expensive abdominal surgery.
There are only a few classes of drugs which are effective in the treatment, control and prevention of tapeworm infestations. Among these classes are praziquantel, pyrantel and morantel compounds. Parasiticidal formulations have been disclosed which contain praziquantel combined with a variety of roundworm controlling agents. One such formulation is disclosed in U.S. Pat. No. 5,824,653 to Beuvry et al. The compounds which result from these combinations, however, may be dangerous as praziquantel has been shown to be toxic at levels other than low dosages. Additionally, praziquantel purportedly is bitter to taste making it unpalatable and thus undesirable in ingestable formulations, for example, pastes.
Pyrantel and morantel compounds are currently believed by those skilled in the art to offer an inadequate substitute to praziquantel in the treatment and control of tapeworm infestations. Pyrantel salts generally either are only partially effective against tapeworms at their label dosages (e.g., pyrantel pamoate) or must be administered in daily regimes (e.g., pyrantel tartrate). Further, pyrantel pamoate offers a low suspended solids content when in paste form, the highest percentage encountered being about 43.95% weight per weight (w/w). A paste with a low suspended solids content contains less active ingredient per unit than a paste with a higher suspended solids content. Therefore, a higher volume of paste must be delivered to the animal in order to achieve the same therapeutic effect.
Accordingly, there remains a need in the veterinary industry for a combination parasiticidal formulation containing both a cestocidal agent and an agent effective against nematodes and obligate parasitic flies that is less toxic than formulations containing praziquantel. Further, a palatable combination parasiticide is needed for administration in ingestable forms. The primary objective of this invention is to meet these needs.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide a parasiticidal formulation that contains at least one agent effective against nematodes and obligate parasitic flies and at least one agent effective against cestodes so as to broaden the formulation's spectrum of parasite protection.
It is another object of the present invention to provide a combination parasiticidal formulation containing at least one agent that is effective against nematodes and obligate parasitic flies and at least one agent that is effective against cestodes which is less toxic than prior formulations which include praziquantel.
A further object of the present invention is to provide a palatable parasiticidal formulation that contains at least one agent that is effective against nematodes and obligate parasitic flies and at least one agent that is effective against cestodes which may be administered as a paste.
Still another object of the present invention is to provide a method of making a parasiticidal formulation that achieves the foregoing objects.
Yet another object of the present invention is to provide a method for administering a parasiticidal formulation that achieves the foregoing objects.
According to the present invention, the foregoing and other objects are achieved by a parasiticidal formulation that includes a mixture of an edible non-aqueous liquid, a thickening agent, an agent effective against nematodes and obligate parasitic flies and an agent effective against cestodes, wherein the cestocidal agent is pyrantel, morantel, any salt thereof, or any combination thereof. Preferably, the agent effective against nematodes and obligate parasitic flies is an avermectin, a milbemycin, a derivative thereof, or any combination thereof. Another aspect of the present invention is a method of making this parasiticidal formulation. This method includes mixing the above-mentioned components. A further aspect of the present invention is a method for administering the parasiticidal formulation of the present invention to an animal. This method of administration includes providing the parasiticidal formulation described above in the form of a paste and administering it to an animal for ingestion.
Additional objects of the invention, together with the advantages and novel features appurtenant thereto, will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned from the practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The parasiticidal formulation of the present invention is an effective ingestable formulation for the treatment and control of cestode, nematode and obligate parasitic fly infestations in equine and companion animals. Such animals include, but are not limited to, horses, donkeys, mules, zebras, dogs and cats. The formulation includes an edible, non-aqueous liquid, a thickening agent, an agent for treating and controlling roundworm and obligate parasitic fly infestations and a cestocidal agent for treating and controlling tapeworm infestations. This mixture provides a unique formulation in which the agent effective against nematodes and obligate parasitic flies is allowed to dissolve substantially into solution while the cestocidal agent remain
Phoenix Scientific, Inc.
Pryor Alton N.
Stinson Morrison & Hecker LLP
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