GB2150437A - Roll-on application of veterinary agents - Google Patents

Abstract

A roll-on applicator is used veterinarily to apply veterinary agents such as medicaments, (e.g. analgesics, anti-inflammatories) insecticides and ectoparaciticides to the skin of an animal.

Description

SPECIFICATION Roll-on application of veterinary agents Background of the invention A large variety of agents are applied topically to animals for the treatment of various undesirable conditions. Among these, topical fluid formulations of antiinflammatory, analgetic, insecticidal and ectoparasiticidal agents are widely known and used because of their high degree of effectiveness. For example, dimethyl sulphoxide is an antiinflammatory and analgetic agent which is effective topically because of its rapid skin penetrating ability. Cypermethrin is a widely used topically applied insecticidal and ectoparasiticidal agent for controlling infestations of fleas, lice, ticks and other insects. Cypermethrin based veterinary products have been used in animal washes, rinses, shampoos, and flea collars.Dimethyl sulphoxide is available in liquid and gel forms which are poured or rubbed onto the animal. However as application methods, washes, shampoos, gels and pour-ons all involve several disadvantages. First, it is nearly impossible for the person applying the medicament to avoid contact with the product; hands, eyes, face, etc. are likely to be contaminated, and cannot necessarily be washed off before the product has penetrated the skin or caused some irritation to the skin or eyes. Dimethylsulphoxide, for example, penetrates the skin and spreads through the human circulatory system almost immediately after contact with the skin, and is detected by the presence of a garlic-like taste in the mouth. Second, these application methods are relatively difficult and time consuming.Thirdly, much of the product is wasted because these methods of application require a large excess of medicament in order to assure adequate treatment.

A new type of veterinary product is needed which overcomes the disadvantages of currently available topical veterinary agents. The present invention provides a delivery system and method of applying topically effective fluid veterinary agents which protects the person applying the product by avoiding contact with the agent, and provides a much easier and less wasteful way of applying the agent.

Summary ofthe invention The invention provides a new delivery system for delivering veterinary agents to animals, which comprises (a) a topically effective fluid veterinary agent which is contained in (b) a reservoir having roll-on applicator means for applying the fluid to the animal.

Brief description of drawing Figure 1 presents a cross-section of one example of a roll-on type applicator bottle and cap suitable for use in the present invention. The drawing is discussed in detail herein below.

Detailed description of the invention The reservoir and roll-on dispensing means of the present invention can be any presently known or subsequently developed container having a roll-on type oriface which permits dispensing of fluids by rolling the applicator on the desired surface to which the fluid is to be applied. As used herein, the term "fluid" is intended to refer to both liquids and low-viscosity gels. The reservoir and applicator must be formed of materials which are compatible with the liquid medicament and stable when filled. Examples of such materials are thermoplastic synthetic resins such as high polypropylene, polyethylene, and nylon, as well as various natural and synthetic rubbers. A preferred system is a high density polyethylene (HDPE) bottle and cap with a polyvinyl chloride (PVC) or polycarbonate applicator ball.Any configuration of the reservoir and roll-on applicator which is compatible with the liquid medicament contained therein can be used in the present invention.

For example, a reservoir and applicator suitable for the practice of this invention are shown in Figure I. The depicted device comprises a plastic ball (1) which can freely rotate and is surrounded by housing (2) held by holder ring (10) in reservoir (11). A small part ofthe outer face of the ball is surrounded by the holder ring and a larger part of the ball face is surrounded by the housing. Thehousing is provided with a hole (6) and a number of projections (4) are provided on the inner face of the housing to fix the position of the ball relative to the holder ring. The height of the projections on the lower part of the housing is greater than that of the projections on the upper part of the housing. In the figure, (5) is the neck of the reservoir, (7) is the cap, (11) is the reservoir, and (8) and (9) are screws.The gap between the surface of the ball and the holder ring can be held substantially constant, and the application of a liquid medicament can be made at a uniform rate by contacting and rotating the ball at the point of application, independent of the pressure to the ball. As the height of the lower projections is higher than that of the upper projections, the gap between the surface of the ball and the lower inner face of the housing is useful for storing the fluid medicament. The rate of application of medicament can be controlled by changing the height of the projections, i.e. the magnitude of the gap, according to the viscosity and other properties of the fluid medicament to be applied. For the application of a more viscous fluid, the gap should be increased. The cap prevents drying of the ball surface during storage.

The topically effective veterinary fluid agent may be any fluid agent which provides advantages when it is applied to external surfaces of an animal. These include, but are not limited to, anti-inflammatory agents, insecticidal and ectoparasiticidal agents, topical anesthetics, and antibiotics.

In addition to the active agent(s), the fluid agent will contain a solvent or carrier for the active agent, and may contain other pharmaceutically acceptable additives, such as gelling agents, pH balancers, stabilizers, and preservatives. These agents are well known to those skilled in the art. A particularly useful gelling agent is Carbopol 934. However, other gelling agents known to those skilled in the art may be used.

The present invention is particularly useful for topical application to animals, particularly but not exclusively dogs and horses, of antiinflammatory medicaments such as dimethyl sulphoxide (D.M.S.O.) and various corticosteroids such as cortisone and flumethasone. For example, in practicing the method of the present invention, the drug delivery system reservoir may contain dimethyl sulphoxide, medical grade, with or without a corticosteroid such as flumethasone, a gelling agent such as one of the commercially available carbopols which is neutralized with an alkali hydroxide or an organic amine, and a chelating agent such as disodium edetate.

The present invention is also useful as a means of applying insecticides to animals, particularly but not exclusively to cats and dogs. Insecticides which can be topically applied with a roll-on applicator according to the method of this invention include, but are not limited to cypermethrine and other natural or synthetic pyretheroids or organo phosphorous compounds, such as permethrin, deltamethrin, cyhalothrin, and malathion. The active agent is dissolved in a non-irritating pharmaceutically compatible solvent such as triethylene glycol, ethylene digol or butyl digol, which may also contain a synergist such as piperonyl butoxide. The preferred insecticide is cypermethrin, with piperonyl butoxide as an optional synergist. The preferred solventforthese drugs is ethylene digol.

Because of the efficiency of administration achieved by roll-on application, the concentration of active agent in the fluid formulation will be the same as or less than that in currently known topical fluid formulations. The particular concentration can be readily chosen by those skilled in the art. An effective roll-on formulation of cypermethrin and piperonyl butoxide for controlling fleas in dogs and cats would contain 5 to 30 ms/ml cypermethrin and 5 to 30 mg/ml piperonyl butoxide. An effective concentration of dimethyl sulphoxide in a roll-on formulation for treating acute traumatic inflammation in dogs and horses would contain about 75 to 95 mgiml D.M.S.O.

The effective dose range is dependent on the particular active ingredient as well as on the nature and degree of the condition being treated, but such dose ranges are readily determined by those skilled in the art.

Thus, for example, a 90mg/ml D.M.S.O. gel should be applied to the skin over the affected area of the animal two to three times daily, dependent upon the individual condition and response. An insecticidal formulation containing 10 mg!ml cypermethrin and 20 mg/ml piperonyl butoxide should be applied at the rate of a few strokes to the groin, base of tail, or neck area once or twice a week.

The presently claimed roll-on method of applying topically effective agents to animals differs from other known methods such as pour-ons, shampoos, rinses, etc., in that application of agent can be substantially more directed and controlled. Hence, the fluid agent can be rolled onto the precise area which it is desirable to treat. For example, an insecticidal agent for the control of fleas on dogs and cats is applied with one or two strokes of the roll-on applicator ball to the groin, over the base of the tail or around the neck of the animal.

When the animal is heavily infested with fleas, the application may be placed on two or three of these sites.

An anti-inflammatory medicament is rolled directly over the affected area of the animal.

This invention is further illustrated by, but not limited to, the following examples.

Example 1 A formulation is prepared having the following composition: Dimethyl sulphoxide, medical grade 900 mg Carbopol 934 4 mg Disodium edetate 0.2 mg NaOH titrated to produce pH 5.7 Deionized water to produce 1 gram.

100 grams of the above formulation are placed in a high density polyethylene roll-on type bottle which has a PVC applicator ball.

Example 2 An insecticidal roll-on formulation having the following composition was prepared.

Cypermethrin 20 mg Piperonyl butoxide 20 mg Butyl digol to produce 1 gram.

100 ml of the above formulation were placed in a conventional high density polyethylene roll-on type bottle with cap, having a PVC applicator ball.

Example 3 An insecticidal roll-on formulation was prepared having the following composition.

Cypermethrin 10 mg Piperonyl butoxide 20 mg Ethylene digol to produce 1 gram.

100 ml of the above formulation were placed in a conventional high density polyethylene roll-on type bottle with cap, having a PVC applicator ball.

Claims (12)

1. A delivery system for delivering veterinary treatment to animals, which comprises: (a) a topically effective fluid veterinary agent which is contained in (b) a reservoir having roll-on applicator means for applying the fluid to the animal.

2. The delivery system of claim 1 in which the topically effective fluid is an antiinflammatory and/or analgetic agent.

3. The delivery system of claim 2 in which the fluid is a pharmaceutically acceptable fluid formulation of dimethyl sulphoxide.

4. The delivery system of claim 3 in which the fluid is a pharmaceutically acceptable gel containing about 900 mg/gram dimethyl sulphoxide.

5. The delivery system of claim 1 in which the topically effective fluid is an insecticidal and/or ectoparasiticidal agent.

6. The delivery system of claim 5 in which the fluid is a topically effective fluid formulation of cypermethrin and piperonyl butoxide.

7. The delivery system of claim 6 in which the topically effective fluid formulation contains about 10-20 mgigram cypermethrin, and 20 mg/gram piperonyl butoxide.

8. A method of controlling ectoparasites and/or insects on an animal, which comprises applying to a topically effective ectoparasiticidal and/or insecticidal fluid by contacting the desired area or areas of the substrate with a roll-on dispensing means having a reservoir which houses the said fluid and permits the flow of the said fluid to a roll-on ball-type applicator which is wetted thereby.

9. A method according to claim 8 wherein the said fluid is a topically acceptable fluid formulation of cypermethrin and piperonyl butoxide.

10. A method according to claim 9 wherein the topically acceptable fluid formulation contains about 10-20 mg/gram cypermethrin and 20 mgigram piperonyl butoxide.

11. A drug delivery system substantially as described herein.

12. A method of controlling parasites and/or insects substantially as described herein.