Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2000-04-06
2002-11-26
Peselev, Elli (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
Reexamination Certificate
active
06486128
ABSTRACT:
BACKGROUND OF THE INVENTION
The control of sea lice (
Lepeophtheirus salmonis
and
Caligus elongatus
) infestations in commercial salmon farming operations is still largely dependent on the use of chemical treatments (Roth M., Richards R. & Sommerville C. (1993) “Current Practices In The Chemotherapeutic Control of Sea Lice Infestations: A Review”
Journal of Fish Diseases
(16(1): 1-26). Outbreaks of these ectoparasitic copepods are currently treated by immersion bath treatments, with the organophosphates dichlorvos (Aquagard® Novartis) and Azamethiphos (Salmosan® Novartis), or hydrogen peroxide (Salartect® Brenntag, Paramove® Solvay-Interox) or the synthetic pyrethoids, cypermethrin (Excis® Vericore) and deltamethrin (Alphamax® Alpharma). Bath procedures are very labor intensive, costly and cause considerable stress to fish. Further, such treatments may not be feasible on exposed sites and during adverse weather conditions.
With the exception of cypermethrin, (Jakobsen P. J. & Holm J. C. (1990) “Promising Test With New Compound Against Salmon Lice”
Norsk Fiskeoppdrett.
January, 16-18), bath treatments are only effective against pre-adult and adult stages of sea lice, allowing chalimus stages to survive and continue the cycle of infestation. Treatments are therefore indicated only when populations reach the pre-adult and adult phases, and thus must be repeated frequently for effective control. Resistance to the organophosphate dichlorvos has been identified in some populations of sea lice (Jones M. W., Sommerville C. S. & Wootten, R. (1992) “Reduced Sensitivity of the Salmon Louse,
Lepeophtheirus salmonis,
to the Organophosphate Dichlorvos”
Journal of Fish Diseases
15:197-202). Hydrogen peroxide may cause damage to the gills and its use is restricted in summer owing to its toxicity at higher water temperatures (Thomassen J. M. (1993) “Hydrogen peroxide as a Delousing Agent for Atlantic Salmon” In:
Pathogens of Wild and Farmed Salmon: Sea Lice
(ed. by G. Boxshall & D. Defaye) Ellis Horwood Ltd. London).
A treatment that is effective against all parasitic stages of sea lice and other parasites which could be administered in feed, to avoid the disadvantages associated with bath applications, would be beneficial to the salmon industry. In-feed treatment allows medication during adverse weather conditions and on exposed sites and will permit simultaneous medication of all cages on a site and all sites in a loch system or single bay, thus reducing any cross infestation that may occur during the several days necessary to apply bath treatments to all cages on a site. The in-feed treatments currently available are the insect growth regulators, diflubenzuron (Lepsidon® Ewos) and teflubenzuron (Calicide® Nutreco) (Erdal J. I. (1997) “New Drug Treatment Hits Sea Lice When They are Most Vulnerable”.
Fish Farming International
vol.24, No.2). Their mode of action is the inhibition of chitin synthesis (Horst M. N. & Walker A. N. (1996) “Biochemical Effects of Diflubenzuron on Chitin Synthesis in the Post-molt blue crab” (
Callinectes sapidus
)
Journal of Crustacean Biology.
15: 401-408) and activity is therefore restricted to the moulting stages of sea lice.
The avermectins, produced by the culture of
Streptomyces avermilitis,
have highly potent anthelmintic and insecticidal properties. A chemically modified derivative, ivermectin (22,23-dihydroavermectin B
1
) was developed as a broad spectrum anti-parasitic for cattle, sheep, horses and pigs (Sutherland I. H. (1990) “Veterinary Use of Ivermectin”
Acta Leidensia
59: 211-216) and has been marketed world-wide since 1981. Ivermectin has also been extensively used in the treatment of several human parasitoses (Ottesen E. A. & Campbell W. C. (1994) “Ivermectin in Human Medicine”
Journal of Antimicrobial Chemotherapy.
34(2): 195-203). Following the recognition of organophosphate resistance in sea lice (Jones M. W., Sommerville C. S. & Wootten, R. (1992) “Reduced Sensitivity of the Salmon Louse,
Lepeophtheirus salmonis,
to the Organophosphate Dichlorvos”
Journal of Fish Diseases
15:197-202), ivermectin was considered as an alternative therapy. In addition to its novel mode of action, a further advantage lay in its application as an in-feed medication. Although ivermectin has not received regulatory approval for use in salmon, it may be prescribed in the United Kingdom by veterinarians under the cascade procedure (Anonymous (1998)
Amelia
No.8 Veterinary Medicines Directorate. Woodham Lane, Newhaw, Addlestone, Surrey KT15 3NB), where authorised products fail to provide effective control of sea lice infestations. The use of ivermectin over several years has indicated that it exercises some control at the commonly adopted dose rate of 25 &mgr;g kg
−1
biomass twice weekly (Rae G. H. (1996) “Guidelines for the Use of Ivermectin Pre-Mix for Pigs to Treat Farmed Salmon For Sea Lice” Scottish Salmon Growers Association pamphlet). However, ivermectin has been found to be toxic at levels greater than 25 &mgr;g kg
−1
biomass twice weekly (S. C. Johnson, et al., “Toxicity and Pathological Effects of Orally Administered Ivermectin In Atlantic, Chinook, and Coho Salmon and Steelhead Trout,”
Diseases of Aquatic Organisms.
Vol. 17: 107-112 (1993).
Emamectin (4″-deoxy-4″ epimethylaminoavermectin B,) has been recently used for treating edible plant crops (Leibee G. L., Jansson, R. K., Nuessly, G & Taylor J. L. (1995) “Efficacy of Emamectin Benzoate and
Bacillus thuringensis
at Controlling Diamondback Moth (Lepidoptera: Plutellidae) Populations On Cabbage in Florida”
Florida Entomologist.
78(1): 82-96).
SUMMARY OF THE INVENTION
This invention provides a method of eliminating, reducing, or preventing parasites in a fish population, comprising feeding emamectin or a salt thereof to said fish population at a daily dose of 25 &mgr;g to 400 &mgr;g per kg of fish biomass per day for a period of 3-14 days.
In a further aspect, a kit for preparing a medicated fish feed for eliminating, reducing or preventing parasites in a fish population is provided, comprising a supply of emamectin or a salt thereof and printed instructions for feeding the emamectin or emamectin salt at a daily dose of 25 &mgr;g to 400 &mgr;g per kg of fish biomass per day for a period of 3-14 days.
REFERENCES:
patent: 5288710 (1994-02-01), Cvetovich
patent: 5399717 (1995-03-01), Cvetovich et al.
patent: 5962499 (1999-10-01), Meinke et al.
patent: 5977029 (1999-11-01), Fischer et al.
patent: WO 92 08352 (1992-05-01), None
I.H. Sutherland, “Veterinary Use of Ivermectin,”Acta Leidensia, vol. 59, Nos. 1 and 2, pp. 211-216 (1990).
M.W. Jones et al., “Reduced sensitivity of the salmon louse,Lepeophtheirus salmonis, to the organophosphate dichlorvos,”Journal of Fish Diseases, vol. 15, pp. 197-202 (1992).
M. Roth et al., “Current practices in the chemotherapeutic control of sea lice infestations in aquaculture: a review,”Journal of Fish Diseases, vol. 16, pp. 1-26 (1993).
J.M. Thomassen, “Hydrogen peroxide as a delousing agent for Atlantic salmon,”Pathogens of Wild and Farmed Salmon: Sea Lice, pp. 290-295 (1993).
S.C. Johnson et al., “Toxicity and pathological effects of orally administered ivermectin in Atlantic, chinook, and coho salmon and steelhead trout,”Diseases of Aquatic Organisms, vol. 17, pp. 107-112 (1993).
E.A. Ottesen et al., “Ivermectin in human medicine,”Journal of Antimicrobial Chemotheraphy, vol. 34, pp 195-203 (1994).
G.L. Leibee et al., “Efficacy of Emamectin Benzoate andBacillus Thuringiensisat Controlling Diamondback Moth (Lepidoptera:Plutellidae) Populations on Cabbage in Florida,”Florida Entomologist, vol. 78, No. 1, pp. 82-96 (1995).
M.N. Horst et al., “Biochemical Effects of Diflubenzuron on Chitin Synthesis in the Postmolt Blue Crab Callinectes Sapidus,”Journal of Crustacean Biology, vol. 15, No. 3, pp. 401-408 (1995).
J.I. Eral, “New drug treatment hits sealice when they are most vulnerable,”Fish Farming International, vol. 24, No. 2 (1997).
J. Stone et al., “The efficacy of emamectin benzoate as an oral treatment of sea liceLe
Huq Abu S.
Shao Zezhi J.
Varma Kanwal J.
Lee William Y.
Mann Arthur
Peselev Elli
Salkeld Pamela G.
Schering-Plough Veterinary Corporation
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