AU2002332990B2

AU2002332990B2 - Dosage system & dosage vehicle therefor

Info

Publication number: AU2002332990B2
Application number: AU2002332990A
Authority: AU
Inventors: John Kohnke
Original assignee: Individual
Current assignee: Individual
Priority date: 2001-10-26
Filing date: 2002-10-25
Publication date: 2007-05-10
Anticipated expiration: 2022-10-25

Description

27 Mar. 2007 17:13 Wa l ington-Dummer Sydney No.9373 P. 4 1 DOSAGE SYSTEM DOSAGE VEHICLE THEREFOR The present invention relates to a dosage system and a t dosage vehicle therefor and, more particularly, to a vehicle and system particularly, although not exclusively, c00 adapted to the delivery of therapeutically effective and/or o nutritionally effective substances by oral ingestion for Oh animals.

ci ci O BACKGROUND It is known, for example in the case of humans, to provide vitamin supplements in tablet form.

However, when it comes to providing supplements to animals, particularly for example large animals such as horses, the sheer volume of supplement required to be effective teaches away from a simple pill-based approach.

In addition vitamin supplements have been constrained in the way they can be combined to provide targeted treatments.

It is an object of the present invention to address or ameliorate one or more of the abovementioned disadvantages.

BRIEF DESCRIPTION OF INVENTION Accordingly, in one broad form of the invention there is provided a method for delivery of predetermined quantities of predetermined selections of a therapeutically COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 271 Mar, 2007 17:13 Wall ington-Dummer Sydney No.9373 P. la or nutritionally effective substance over predetermined 0 time intervals into the body of an animal; said method Ct comprising: At a first location sorting a dosage vehicle ci according to an at least one primary characteristic; 0 At said first location selecting and mixing at a first mixing time one or more of said dosage vehicles ci Sin accordance with a predetermined selection and O predetermined quantity thereby to obtain a first dosage of a selection and quantity of said therapeutically or nutritionally effective substance specifically adapted for a predetermined target animal or target animal group; Transporting said first dosage to a second location; Selecting and mixing at a second mixing time said first dosage with a predetermined selection and predetermined quantity of feed material thereby to obtain a first feed mix; e) Administering said first feed mix to said target animal or target animal group at a first predetermined administration time which is at or around said second mixing time; Repeating steps and at predetermined repeat time intervals thereby to maintain a predetermined COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 27.Mar. 2007 17:14 Wal inston-Dummer Sydney No.9373 P. 6 lb therapy profile in said target animal or target animal 0 0 group over a predetermined therapy period.

ct Preferably the method further includes attributing at 00 least one sub-characteristic to an at least one dosage o vehicle.

ci en Preferably said at least one sub-characteristic is such ci o that it can be utilised to distinguish one dosage vehicle 0 from another on the basis said at least one primary characteristic.

Preferably said dosage vehicle is sorted according to said at least one sub-characteristic.

Preferably the method includes a second subcharacteristic.

Preferably said second sub-characteristic is selected from odour, density, size, volume, diameter, length.

Preferably said predetermined repeat time interval is 1 day.

Preferably said predetermined repeat time interval is day.

COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 7 M r 2 0 0 17 :14 Wallington-Dumme r Sydney No 9373 P. 7 Ic Preferably said predetermined therapy period is at least six months.

Preferably said approximately 3 Preferably said approximately 2 Preferably said approximately 1 predetermined therapy period is months.

predetermined therapy period is months.

predetermined therapy period is month.

Preferably a second dosage is administered in a subsequent predetermined therapy period, thereby to tailor therapy for said animal as a function of time.

Preferably said dosage vehicle is in the form of a predetermined quantity of a substance to be applied topically.

Preferably said dosage vehicle is in the form of a predetermined quantity of a solid, ingestible substance.

COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 27.Mar. 2007 17:14 Wa i nston-Dummer Sydney No.9373 P. 8 ld S Preferably said solid, ingestible dosage is in the form eC of a pellet, prill, beadlet, bead, granule, tablet, t caplet or flake.

00 Preferably said predetermined target animal is selected o from a dog, a pig, a cow or a fish.

Cc eC Preferably said predetermined target animal is a horse.

Preferably said predetermined target animal is a human.

According to another form of the present invention there is provided a system comprising means for carrying out the method as defined above.

Accordingly, in a further form of the invention there is provided a dosage system for delivery of predetermined quantities of predetermined selections of a therapeutically or nutritionally effective substance over predetermined COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 27 r. 2007 17:14 Wal inston-Dummer Sydney No.9373 P. 9 2 time intervals into the body of an animal; said dosage (C system comprising: c At a first location sorting a dosage vehicle OO according to an at least one primary ci characteristic; S(b) At said first location selecting and mixing at a O- first mixing time one or more of said dosage en vehicles in accordance with a predetermined ci 0 selection and predetermined quantity thereby to ci obtain a first dosage of a predetermined selection and predetermined quantity of said therapeutically or nutritionally effective substance specifically adapted for a predetermined target animal or target animal group; Transporting said first dosage to a second location; Selecting and mixing at a second mixing time said first dosage with a predetermined selection and predetermined quantity of feed material thereby to obtain a first feed mix.

administering said first feed mix to said target animal or target animal group at a first predetermined administration time which is at or around said second mixing time; COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 WO 03/034837 PCT/AU02/01448 3 repeating steps and at predetermined repeat time intervals thereby to maintain a predetermined therapy profile in said target animal or target animal group over a predetermined therapy period.

Preferably said system further includes attributing at least one sub-characteristic to an at least one dosage vehicle.

Preferably said at least one sub-characteristic is such that it can be utilized to distinguish one dosage vehicle from another on the basis of said at least one primary characteristic.

Preferably said system further includes a second subcharacteristic.

Preferably said predetermined repeat time interval is 1 day.

Preferably said predetermined repeat time interval is day.

Preferably said predetermined therapy period is at least six months.

Preferably said predetermined therapy period is approximately 3 months.

WO 03/034837 PCT/AU02/01448 4 Preferably said predetermined therapy period is approximately 2 months.

Preferably said predetermined therapy period is approximately 1 month.

Preferably said dosage vehicle is in the form of a predetermined quantity of a topical substance.

Preferably said solid, ingestible dosage is in the form of a pellet, prill, beadlet, bead, granule, tablet, caplet or flake.

Preferably said predetermined target animal is selected from a dog, a pig, a cow or a fish.

Preferably said predetermined target animal is a horse.

Preferably said predetermined target animal is a human.

In a further broad form of the invention there is provided a method for delivery of predetermined quantities of predetermined selections of a therapeutically or nutritionally effective substance over predetermined time intervals into the body of an animal; said method comprising: WO 03/034837 PCT/AU02/01448 At a first location sorting a dosage vehicle according to an at least one primary characteristic; At said first location selecting and mixing at a first mixing time one or more of said dosage vehicles in accordance with a predetermined selection and predetermined quantity thereby to obtain a first dosage of a predetermined selection and predetermined quantity of said therapeutically or nutritionally effective substance specifically adapted for a predetermined target animal or target animal group; Transporting said first dosage to a second location; Selecting and mixing at a second mixing time said first dosage with a predetermined selection and predetermined quantity of feed material thereby to obtain a first feed mix.

administering said first feed mix to said target animal or target animal group at a first predetermined administration time which is at or around said second mixing time; repeating steps and at predetermined repeat time intervals thereby to maintain a predetermined therapy profile in said target WO 03/034837 PCT/AU02/01448 6 animal or target animal group over a predetermined therapy period.

Preferably said method further includes attributing at least one sub-characteristic to an at least one dosage vehicle.

Preferably said dosage vehicle includes a second subcharacteristic.

Preferably said predetermined repeat time interval is 1 day.

Preferably said predetermined repeat time interval is day.

Preferably said predetermined therapy period is at least six months.

Preferably said predetermined therapy period is approximately 3 months.

Preferably said predetermined therapy period is approximately 2 months.

WO 03/034837 PCT/AU02/01448 7 Preferably said predetermined therapy period is approximately 1 month.

Preferably said predetermined target animal is a horse.

Preferably said predetermined target animal is a human.

In yet a further broad form of the invention there is provided a dosage vehicle for a dosage system, said dosage vehicle comprising a mass in the form of a mixture of dispersed portions of at least one active component in a substantially non-reactive separator material.

Preferably said mass is a compressed mass.

Preferably said mass is a compressed mass compressed by a cold compressing method.

WO 03/034837 PCT/AU02/01448 8 Preferably said substantially non-reactive separator material includes at least one active component.

Preferably said substantially non-reactive separator material is selected so that its concentration and composition is such that its at least one active component does not interfere with the uptake or other therapeutic or nutritional effect of said at least one active component in said dispersed portions.

Preferably said substantially non-reactive separator material is Calcium Carbonate.

Preferably said substantially non-reactive separator material is Dicalcium Phosphate.

Preferably the density of said substantially nonreactive separator material is selected so that dosage vehicles of said dosage system all have substantially the same mass irrespective of the composition of said at least one active component.

Preferably the distribution of said at least one active component within said substantially non-reactive separator material is arranged so as to substantially prevent chemical interaction between mechanically juxtaposed dosage vehicles.

Preferably said dosage vehicle is formed from a cold compression process.

Preferably said at least one active component is selected to provide said vehicle with a primary WO 03/034837 PCT/AU02/01448 9 characteristic pertinent to its therapeutic or nutritional effect.

Preferably the composition of said active component and said substantially non-reactive separator material is selected so as to impart at least a first subcharacteristic to said dosage vehicle.

Preferably said first sub-characteristic is a visual characteristic.

Preferably said at least a first sub-characteristic permits a user to distinguish one dosage vehicle from another in accordance with the primary characteristic of each dosage vehicle.

In yet a further broad form of the invention there is provided a dosage of therapeutically or nutritionally effective substance comprising a predetermined selection and predetermined quantity of one or more of the above dosage vehicles.

In yet a further broad form of the invention there is provided a treatment regime for a target animal comprising administering the dosage at predetermined repeat time intervals thereby to maintain a predetermined therapy profile in said animal over a predetermined therapy period.

Preferably said predetermined repeat time intended is 1 day.

Preferably said predetermined repeat time intended is day.

WO 03/034837 PCT/AU02/01448 Preferably said predetermined therapy period is at least six months.

Preferably said predetermined therapy period is approximately 3 months.

Preferably said predetermined period is approximately 2 months.

Preferably said predetermined period is approximately I month.

Preferably a second dosage is administered in a subsequent predetermined therapy period, thereby to target said animal as a function of time.

Preferably said predetermined target animal is a horse.

Preferably said predetermined target animal is a dog, a pig, a cow or a fish.

Preferably said predetermined target animal is a human.

WO 03/034837 PCT/AU02/01448 11 BRIEF DESCRIPTION OF DRAWINGS Embodiments of the present invention will now be described with reference to the accompanying drawings wherein: Fig. 1 is a block diagram of a dosage system in accordance with a first preferred embodiment of the present invention; Fig. 2 is a diagrammatic representation of dosage vehicles within separate groupings suitable for use with the system of Fig. 1; Fig. 3 is a diagrammatic representation of an individual dosage vehicle in accordance with an embodiment of the invention; Fig. 4 is an exemplary arrangement of a first dosage in accordance with an embodiment of the invention; Fig. 5 is an exemplary embodiment of a second dosage in accordance with an embodiment of the invention; Fig. 6 diagrammatically illustrates a treatment regime in accordance with an embodiment of the invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Initially, with reference to Fig. 1, there is illustrated a dosage system 10 in accordance with a first preferred embodiment of the present invention.

In this instance the dosage system 10 comprises five separate groupings of dosage vehicles 11.

WO 03/034837 PCT/AU02/01448 12 In this instance each dosage vehicle of each grouping is comprised of a specific therapeutically effective substance or combination of substances.

In this instance each dosage vehicle 11 is in the form of a compressed cylindrical food pellet termed a "pellet".

In this specification the term "pellet" refers to distinctive small compressed cylindrical food pellets, typically measuring within the range of 8-12mm in length and 2-3.5mm in diameter, formed in a cold-pressed pelleting machine. This method reduces heat damage to heat sensitive nutrients, such as vitamins. Heat damage is a problem in the steam pelleting process used to produce horse feeds.

"Pellets" have been developed to eliminate dust, sift out and food refusal often associated with powdered or granule supplements.

Each pellet is manufactured from high quality ingredients, containing specific nutrients with built-in antioxidants and natural preservative compounds to maintain nutrient potency. They resist crumbling and are formulated to be highly palatable to the target animal.

In this instance there are five grouping wherein first grouping 12 has a first primary characteristic 12A, second grouping 13 has a second primary characteristic 13A, third grouping 14 has third primary characteristic 14A, fourth grouping 15 has a fourth primary characteristic 15A and WO 03/034837 PCT/AU02/01448 13 fifth grouping 16 has fifth primary characteristic l6A as illustrated diagrammatically in Fig. 1.

Each of the primary characteristics 12A, 13A, 14A, 16A is distinct and separately identifiable one from the other, The primary characteristics define the collective therapeutic effect or other effect of the dosage vehicles 11 making up the respective grouping to which that primary characteristic attaches.

In addition to the primary characteristic each grouping 12, 13, 14, 15, 16 has associated with it at least one sub-characteristic l2B, 13B, 14B, l5B, 163 respectively (identified sub-characteristic in this instance in Fig.

1).

Each grouping can be further identified by further sub-characteristics as appropriate and relevant. In this instance, by way of example, each grouping can be further identified by sub-characteristic in Pig. 1.

In use, for the purpose of therapeutic application to animal 17 a predetermined portion of dosage vehicle 11 from each of the f ive groupings 12, 13, 14, 15, 16 is mixed together to prepare a dosage 18 comprising a predetermined selection of predetermined quantities of one or more of the groupings 12, 13, 14, 15, 16.

The dosage 18, in this instance, is prepared at the same location at which the individual dosage vehicles 11 are prepared and sorted initially according to sub- WO 03/034837 PCT/AU02/01448 14 characteristic The dosage 18 is then transported to a separate location at or near where administration is to take place.

At a time of first administration tl the dosage 18 is mixed into feed 22 and fed to animal 17 resulting in the ingestion of dosage 18.

A similar procedure can be followed to prepare a second dosage 18A for administration at time t2 and so on with a view to maintaining a predetermined therapy profile in the target animal 17 over a predetermined therapy period.

Fig. 2 illustrates particular examples of subcharacteristic suited to link the respective groupings to their primary characteristics 12A, 13A, 14A, 15A, 16A.

Tn this instance the sub-characteristic is based on colour thereby allowing a link to be made between the colour of the dosage vehicles 11 in a particular grouping with the primary (therapeutic) characteristic of that same grouping. So, for example, as illustrated in Fig. 2, first grouping 12 can be made up of pellets of white colour, the pellets containing calcium and mineral supplements as will be described by way of further example below.

Second grouping 13 can have sub-characteristic "a" defined as colour brown with the composition of the pellets comprising trace-minerals and choline.

WO 03/034837 PCT/AU02/01448 Similarly third grouping can have a sub-characteristic comprising a golden yellow colour which is associated with a vitamin composition. Fourth grouping 15 can have a sub-characteristic comprising a black colour signifying an iron supplement composition. Finally, in this instance, fifth grouping 16 can be identified by a sub-characteristic comprising a light tan colour signifying a pellet composition comprising live yeast culture.

Typically each grouping will contain a chemical composition which has a reasonably long shelf-life. In many instances, however, on associating or mixing dosage vehicles from different groupings the shelf-life, by virtue of the close mechanical association may in the prior art become reduced.

In the instance of the present invention, each dosage vehicle 11, in this instance in the form of a pellet 19 includes an array of active components 20 distributed throughout the pellet 19 within a substantially nonreactive separator material 21. Typically the separator material 21 can be a calcium based material. This arrangement ensures that pellets or dosage vehicles from different groupings and having different primary characteristics, even if closely mechanically associated will not allow the active components 21 to come into such close contact that unwanted reactions will take place prior to ingestion or administration.

WO 03/034837 PCT/AU02/01448 16 With reference to Figs. 4 and 5 the particular characteristics of the pellet construction described with reference to Fig. 3 allows pellets/dosage vehicles having different primary characteristics to be aggregated into close mechanical association. So, for example, Fig. 4 allows a dosage 22 to be formulated by aggregating equal portions of dosage vehicles 11 having five different primary characteristics, namely 20% of type 1 characteristic, 20% of type 2 characteristic, 20% of type 3 characteristic, 20% of type 4 characteristic and 20% of type 5 characteristic.

In addition the non-reactive separator material 21 in each pellet 19 is selected so that the weight of each pellet, irrespective of the active components 20 within each pellet is approximately the same for each pellet, irrespective of its primary characteristic 12A, 13A, 14A, 16A. A potential benefit of this characteristic is that the distribution of pellets 19 throughout dosage 22 does not vary over time.

Fig. 5 illustrates an alternative exemplary dosage 23 comprised, in this instance, of 20% of pellets 19 having a type 1 characteristic, 40% of pellets 19 having a type 2 characteristic an 40% of pellets having a type 3 characteristic.

It will be understood that different dosages such as dosage 23 and dosage 22 can be made up for targeting WO 03/034837 PCT/AU02/01448 17 specific animals and taking into account some specific characteristics of the animal such as, for example, age, its daily work schedule at that time and so on. Hence dosage 22 may be suitable for a given animal at one time in its life and under certain working conditions whilst dosage 23 might be more suited to that animal at a different time in its life or when the animal is working under different working conditions.

With reference to Fig. 6 there is illustrated in graphical form a "whole of life" treatment regime to which the dosage system 10 of the present invention is suited.

In this specific example the animal is a horse passing through a growth phase A, a racing/working phase B, a dressage phase C and a retirement phase D. In growth phase A the administration times TI, T2, T3 are specific to growth phase A and are hence denoted TIA, T2A, T3A (refer Fig. In growth phase A it may be that relevant proportions suited for that particular animal at that particular phase are best provided by dosage 22 of Fig. 4 whilst during the racing/working phase B the dosage 23 of Fig. 5 would be more appropriate administered at time intervals TIB, T2B, T3B Thus it will be observed that a highly targeted and animal specific treatment regime can be formulated via dosage system 10, but provided in a cost effective way with the initial production of pellets 19 or like dosage WO 03/034837 PCT/AU02/01448 18 vehicles 11 being performed in the appropriate manufacturing context and followed by the segregation of the various groupings 12, 13, 14, 15, 16 (refer Fig. 1) on the basis of sub-characteristics which are a function of the primary characteristics of the different dosage vehicles 11 being utilized to prepare targeted dosages 18 also at the manufacturing complex following which the dosages 18 can be delivered to the location of the target animal and administered in the manner generally described with reference to Fig. 1 and Fig. 6.

There will now follow specific examples of compositions and treatment regimes suited for application by way of the dosage system 10 as described above. The examples are directed at the instance where the target animal 17 is a horse. However, it will be understood that other target animals can be identified.

EXAMPLE 1 Target Animal Group: For racing, performance, equestrian, breeding and growing horses Concentrated Trace-Mineral and Vitamin Supplement for Horses The regime of this example represents a new concept in providing a supplement of trace-minerals and vitamins to make-up shortfalls in the common grain, chaff and hay rations fed to horses in training.

WO 03/034837 PCT/AU02/01448 19 The regime is formulated from two separate dosage vehicles blended in a 50:50 ratio to deliver a comprehensive range of nutrients to correct low or inadequate levels in the diet.

First Dosage Vehicle Brown Pellet:- The Major Trace-Minerals Provide all the essential trace-minerals to the latest supplementary levels recommended for racing and performance horses. An adequate intake of these nutrients is important to ensure optimum metabolic function, bone and tissue strength.

These trace-mineral pellets are formulated to maximise the uptake of the individual trace-minerals by a combination of "chelated" (protein complexed) organic forms and inorganic soluble sources of zinc, manganese, copper, iron and cobalt, as well as iodine, complemented by organic selenium and chromium in yeast complexes. In fact, CellvitalM contains three sources of iron to help ensure optimum uptake and utilisation of this important tracemineral in the diet of horses in training.

Second Dosage Vehicle Golden Yellow Pellet:- The Major Vitamins Contain a comprehensive range of all vitamins to avoid interaction with trace-minerals that can occur in "all-in one" powders and other bulky pelleted supplements.

WO 03/034837 PCT/AU02/01448 The dosage vehicle of this example provide optimum levels of Vitamin A to offset losses of this important vitamin following harvest and storage of feed, as well as Vitamin E in its most stable form. A full range of B group vitamins, including assured levels of those most commonly destroyed in feeds, helps to ensure optimum levels necessary for metabolic function. A supplementary level of choline, recognised as a B group vitamin, is included in the trace-mineral pellet formulation, because choline is well-known for its destructive effects leading to a loss of vitamin potency when mixed into an "all-in-one" powdered or liquid vitamin supplement.

The two dosage vehicles of this example provide a high potency, palatable trace-mineral and vitamin supplement formulated to correct low or inadequate levels in the common feeds fed to racing and other horses, thereby effectively meeting the increased needs of the equine athlete.

Active Ingredients per dose:- Each 40g daily dose of a 50/50 blend of the two dosage vehicles provides the following nutrients:- Essential Trace-Minerals (as proteinate (chelated) and inorganic forms for optimum bioactivity) zinc (Zn) 350mg Manganese (Mn) 350mg Copper (Cu) 160mg Iron (Fe) 350mg Cobalt (Co) 1.2mg WO 03/034837 PCT/AU02/01448 21 Iodine 2.3mg Selenium (as Selenium yeast Sel-Plex-507*)1.4mg Chromium (as chromium yeast Biochrome

M

Vitamin Co-factors Vitamin A 50,000iu Vitamin D3 5,000iu (125pg) Vitamin E 500iu (500mg) Vitamin K3 Vitamin B1 Vitamin B2 Niacin (Vitamin B3) 130mg Pantothenate (Vitamin BS) Vitamin B6 Vitamin B12 100p.g Folic acid Biotin 250xg Choline (in trace-mineral supplet

TM

300mg Each 40g of Cell-Vital M also contains Calcium (Ca) 3.6g Phosphorus 1.2g Trademark of Alltech Biotechnology Inc, Kentucky USA Because the two dosage vehicles contain nutrients in a concentrated form to make-up shortfalls in the ration, it is best to divide the full daily amount above 20g between the morning and evening feed to help ensure optimum uptake of nutrients, avoiding overloading of the absorption mechanism in the digestive tract.

The 50:50 blend of trace-mineral and vitamin pellets are highly palatable and well accepted by horses, even those considered to be suspicious eaters.

The daily dose ranges from 20g a day for horses in light work to 30g daily (as 2 x 15g doses) for horses in WO 03/034837 PCT/AU02/01448 22 pre-training, to 40g daily (2 x 20g doses) for horses that are in full race or upper level equestrian training.

Available in: 3.0 kg plastic bucket (75 x 40g doses) 15 kg plastic bucket (375 x40g doses) EXAMPLE 2 Target Animal Grouping: For Racing Performance Horses CONCENTRATED MINERAL, TRACE-MINERAL AND VITAMIN SUPPLEMENT FOR RACING AND PERFORMANCE HORSES The dosage is formulated as a high potency "all-inone" supplement to ensure that the demand for both major and micronutrients, which may be inadequate in the diet of horses in hard training and group level racing and upper level athletic performance, is satisfied.

The dosage of this example is composed of five separate types of pellets, each providing specific nutrients in a stable cold-pressed form to make up shortfalls in the grain, chaff and hay diets to meet the elevated metabolic activity associated with hard, fast or prolonged exercise.

First Dosage vehicle white Dosage Vehicles:- The Major Minerals Contain calcium, phosphorus and magnesium, with Vitamin A and D, as the major skeletal structural minerals WO 03/034837 PCT/AU02/01448 23 to help correct imbalanced and low levels in grain based diets, thus ensuring the maintenance of a strong musculoskeletal system.

Second Dosage Vehicle Brown Dosage Vehicle:- The Major Trace-Minerals Provide all the essential trace-minerals to correct low levels in racing diets, that could otherwise result in reduced musculo-skeletal strength and less than optimum supply of available trace-minerals including zinc, manganese, iron, iodine and copper essential for efficient metabolic function. Both selenium and chromium are included as bioactive organic bioplexes with yeast, which helps ensure optimum utilisation and tissue cell bioactivity.

Third Dosage Vehicle Golden Yellow Dosage Vehicles:- The Major Vitamins These fortify the diet with a comprehensive range of vitamins to correct low levels and loss of potency in feed during storage. Adequate levels of these important micronutrients are essential for metabolism, energy utilisation, liver function, the maintenance of the appetite and well-being of horses subjected to hard training and repeated upper level racing and competition.

WO 03/034837 PCT/AU02/01448 24 Fourth Dosage Vehicle Black Dosage Vehicles:- Three Forms of Iron Deliver an additional source of iron in 3 forms, with Vitamin C, Vitamin B12 and folic acid, which in conjunction with the trace-minerals and vitamins contained in the other pellets, help to correct inadequate dietary levels to meet the need for this important trace-mineral for optimum tissue enzyme and oxygen transport function in the blood and muscles.

Fifth Dosage Vehicle Red Dosage Vehicles:- Live Yeast Culture and Vitamin E These pellets complete the high potency nutritional package supplied by the regime of this example.

Based on a live yeast culture which is known to provide additional micronutrients and assist release of nutrients from grains and hay, these pellets also contain additional Vitamin E to meet upper level demands, as well as Vitamin C for stabled horses without access to pasture or green feed.

The regime of this example eliminates the need for separate supplements of calcium, iron, vitamin E and other vitamins that substantially increase the costs of feeding.

Its scientifically formulated cold-pressed pellets help ensure optimum nutrient potency even in this "all-in-one" supplement to the last dose in the container.

WO 03/034837 PCT/AU02/01448 Even the way that this regime is dosed is different.

Because of its high potency, it is recommended that it be provided as two half doses, one in the morning feed and the other in the evening feed, to ensure optimum uptake from the digestive system.

Where the regime of Example 1 is used as a routine supplement, the regime of Example 2 may be substituted for 2 days prior to, and for 2 days after, racing or hard competition.

The regime of Example 2 is formulated as a comprehensive mineral, trace-mineral and vitamin supplement with a bioactive live yeast culture to help correct dietary shortfalls thereby maintaining optimum metabolic and digestive function in upper level equine athletes.

However, because demand can change relative to the diet, additional supplementation of calcium and phosphorus, as well as a salt mix, may be required to ensure adequate levels of these important nutrients.

Active Ingredients per dosage:- Each 120g of dosage of Example 2, the standard recommended dose, divided between morning and afternoon feeds (2 x 60g doses each day), provides the following comprehensive range of nutrients in 5 separate pellets:- WO 03/034837 26 Major Minerals and Digestive Nutrients Calcium (Ca) Phosphorus (P) Magnesium (Mg) Live Cultured Yeast (as Yea-Saccl026T m Essential Trace-Minerals (as proteinate (chelated) and inorganic bioactivity) PCT/AU02/01448 11. 8g 4.1g 2 .8g 10. Og forms for optimum Zinc (Zn) Manganese (Mn) Copper (Cu) Iron (Fe) Cobalt (Co) Iodine (I) Selenium (as Selenium yeast Chromium (as chromium yeast 357mg 357mg 163mg 477mg 1.2mg 2.35mg Sel-Plex-50 *)1.4mg Biochrome"' 5.1mg Vitamin Co-factors Vitamin A (Retinol) 56,130iu (16.84mg) Vitamin D3 (Cholecalciferol) 5,613iu (140.3Xg) Vitamin E (dl-c-tocopherol) 1285iu (1285mg) Vitamin K3 (Menadione) 20.4mg Vitamin B1 (Thiamine) 40.8mg Vitamin B2 (Riboflavin) 51mg Niacin (Vitamin B3) 132.6mg Pantothenate (Vitamin B5) 51mg Vitamin B6 (Pyridoxine) 40.8mg Vitamin B12 (Cyanocobalamin) 222kg Folio acid 19.8mg Vitamin H (Biotin) 252kg Choline (contained in trace-mineral supplet T as choline chloride to avoid vitamin destruction during storage) Vitamin C (as sodium and calcium ascorbate for optimum stability and bioactivity) 300mg 1.03g *Trademark of Alltech Biotechnology Inc, Kentucky USA The pellets of Example 2 are formulated as 4 major supplements to correct dietary imbalances and inadequacies of calcium and phosphorus and magnesium thereby helping WO 03/034837 PCT/AU02/01448 27 to maintain musculoskeletal structure and metabolic activity; additional iron and Vitamin C for blood maintenance and metabolic function; Vitamin E for metabolic efficiency, as well as a comprehensive range of traceminerals and vitamins, including a live yeast culture, to meet the elevated needs of horses in hard training on grain and hay based diets.

A daily dose of the dosage of Example 2, by combining 4 major supplement groups in an innovative form to avoid nutrient interactions, saves both time and money compared to mixing 4 separate supplements into a feed.

Remember, This example is a highly concentrated nutritional supplement which should be given as two half doses per day to avoid overload of gut absorption sites of calcium, trace-minerals and vitamins. Additional calcium and phosphorus may be required in horses fed on high grain or high lucerne diets to counteract imbalanced intakes in these feeds. A supplement of salts should be provided relative to the work effort and duration, and climatic conditions.

The daily dose ranges from 100g (2 x 50g doses) for horses weighing 400-475kg, and 120g (3 x 60g doses) for horses weighing 475 to 550kg in hard race training or upper WO 03/034837 PCT/AU02/01448 28 level equestrian competition, including polo horses, eventing, endurance and showjumping horses.

Available in: 3.0 kg plastic buckets (25 x 120g doses) 15 kg plastic buckets (125 x 120g doses) EXAMPLE 3 Target Animal Group:- For growing and breeding horses Mineral, Trace-Mineral and Vitamin Supplement for Growing and Breeding Horses A comprehensive supplement containing three (3) separate dosage vehicles or pellets, combined in a scientifically blended ratio that meets the specific needs of growing and breeding horses.

First Dosage Vehicle White Dosage Vehicle:- The Major Minerals Contain calcium, phosphorus and magnesium, with Vitamin A and D to correct low, imbalanced or inadequate levels in diets, thereby helping to ensure optimum bone formation and development. The ratio of calcium to phosphorus at 2.7 calcium to 1.0 phosphorus is specially matched to meet critical mineral balance on both grass and legume based pastures, as well as diets supplemented with lucerne or meadow hay.

This combination ensures adequate phosphorus is available to maintain fertility in breeding mares, as well as the skeletal foundation of unborn foals in late-term WO 03/034837 PCT/AU02/01448 29 pregnant mares and avoid bone mineral imbalances and deficiencies in the diets of growing horses.

Second Dosage Vehicle Brown Dosage Vehicle:- The Major Trace-Minerals This innovative vehicle in the form of a pellet contains all the essential trace-minerals to make up dietary shortfalls, thereby helping to ensure sound bone and joint development focusing on targeted supplementation with the three trace-minerals most likely to be inadequate or imbalanced in the diet relative to the needs of growing horses zinc, manganese and copper, as well as iodine and selenium, for growth and assured fertility in breeding horses.

This pellet provides a combination of 'chelated' or protein complexed and soluble elemental trace-minerals to ensure optimum uptake and utilisation, and thereby assists in reducing the risk of bone and joint abnormalities in growing horses and unborn, late-term foals.

Third Dosage vehicle Golden Yellow Dosage Vehicle:- The Major Vitamins A full range of vitamins is compounded into a separate pellet to ensure that optimum stability of the individual vitamins is maintained by eliminating direct contact with destructive trace-minerals.

WO 03/034837 PCT/AU02/01448 The vitamin content helps to supplement the natural losses of vitamins in feeds during storage and processing, assuring optimum activity of the mineral and trace-mineral content where vitamin co-factors, such as Vitamin A, D, E and many B group vitamins, are vital for structural and metabolic function.

This regime is an innovative supplement that overcomes the problems of sift-out and powder loss from dry feeds fed out to paddocked horses.

Active Ingredients per doset- The dose rates of this example are relative to the ration blend and the specific needs related to the age and growth rate of foals, weanlings and yearlings, and the stage of pregnancy and lactation in broodmares. Dose rates are recommended on the expected mature weight that will be achieved in a growing horse, and the actual body weight of a mare or breeding stallion. For this reason, the dose rate ranges from 60 150 g daily, with the average dose rate being 105g daily.

105 grams 150 grams (weanlings 6mths mature to 500kg) Early lactation mare 500kg Major Minerals Calcium (Ca) 11.8g 16.9g Phosphorus 4.1g 5.9g Magnesium (Mg) 3.9g 5.6g Essential Trace-Minerals (as proteinate (chelated) and inorganic forms for optimum bioactivity) WO 03/034837 PCT/AU02/01448 31 Zinc (Zn) 312mg 446mg Manganese (Mn) 312mg 446mg Copper (Cu) 143mg 204.3mg Iron (Fe) 312mg 446mg Cobalt (Co) 1.07mg 1.53mg Iodine 2.05mg 2.93mg Selenium (as Selenium yeast Sel-Plex-50'*) 1.25mg 1.78mg Chromium 4.5mg 6.4mg Choline (as Chromium yeast Biochrome

TM

263mg 375mg Vitamin Co-factors Vitamin A (Retinol) 41,475iu (12.44mg) 59,250iu(17.78mg) Vitamin D3 (Cholecalciferol)4,147iu (103gg)5,925iu(148pg) Vitamin E (dl-a-tocopherol adsorbate)341iu (341mg)487iu Vitamin K3 (Menadione) 13.65mg 19.5mg Vitamin B1 (Thiamine) 27.3mg 39mg Vitamin B2 (Riboflavin) 34.13mg 48.76mg Niacin (Vitamin B3) 88.73mg 126.7mg Pantothenate (Vitamin B5) 34.13mg 48.76mg Vitamin B6 (Pyridoxine) 27.3mg 39mg Vitamin B12 (Cyanocobalamin) 68.25pg 97.5mg Folic acid 10.24mg 14.6mg Vitamin H (Biotin) 168g 240pg Trademark of Alltech Biotechnology Inc, Kentucky USA Available in: 3 kg plastic buckets (28 x 105g doses) kg plastic buckets (142 x 105g doses) EXAMPLE 4 Target Animal Group:- For Racing, Performance, Equestrian, Breeding and Growing Horses Calcium, Phosphorus, Magnesium and Trace-Minerals, with vitamin A and D, for Horses.

This regime is not an ordinary calcium supplement it is formulated to provide essential bone minerals, complemented by trace-minerals and Vitamin A and D to WO 03/034837 PCT/AU02/01448 32 ensure common dietary inadequacies and imbalances are corrected.

This dosage regime contains two pellets in a blend that helps overcome low or inadequate levels in grain based feeds, or low lucerne diets, fed to racing, performance and stud horses.

First Dosage Vehicle White Dosage Vehicle:- The Major Minerals Contain calcium, phosphorus and magnesium, with Vitamin A and D, to make up shortfalls in the feed, and provide adequate major minerals, especially calcium, thereby helping to maintain musculo-skeletal soundness in horses in hard training.

Second Dosage Vehicle Brown Dosage vehicle:- The Major Trace-Minerals Provide a scientifically formulated amount of essential trace-minerals, particularly zinc, manganese, copper and selenium that are low in many home-mixed diets due to widespread soil deficiencies and inherent imbalances in grains and hays.

A daily supplement of this dosage provides additional bone and joint minerals, as well as a wide range of essential trace-minerals shown to be necessary for adaptive bone modeling that strengthens the muscular-skeletal system WO 03/034837 PCT/AU02/01448 33 in response to increased load-bearing when horses are in a training program.

The dosage of this example is complementary to the dosage of Example 2 as a source of calcium and bone minerals to make-up shortfalls in the diets of racing and breeding horses.

This dosage is an innovative way of providing a highly palatable source of calcium and a "top-up" of traceminerals, which, as they are blended from two separate pellets, help reduce the risk of sift out and separation common with powdered calcium supplements mixed into feeds.

Horses relish the taste of the pellets of this regime as compared to bland calcium powders, further reducing sift-out.

This regime provides an amount of calcium, along with phosphorus, Vitamin A and Vitamin D that facilitates its uptake and blood balance, which can be absorbed efficiently.

This regime does not provide a large quantity of calcium in a single dose as contained in many calcium supplements formulated for high grain diets. This is because 90% of calcium is absorbed from the small intestine and when given once daily in large quantities of insoluble calcium carbonate, much of the calcium is not able to be WO 03/034837 PCT/AU02/01448 34 absorbed and is passed into the hindgut where it is not available, and eventually it passes into the droppings.

It is not the sheer amount of calcium that is supplied that is important, it's the balance between other minerals, including magnesium and phosphorus, and the need to avoid overload of excess beyond the absorption limit, that determines the efficiency of calcium uptake and balance between calcium and phosphorus in the horse's blood and body tissues. For this reason, it is recommended that it is given twice daily, mixed into the feed to help ensure more efficient and complete uptake and utilisation.

This regime is a balanced form, containing a 2.7-1.0 calcium to phosphorus ratio, as compared to 8:1. ratio in cheaper, limestone based supplements that are often also given at higher dosage rates. The inclusion of complementary levels of trace-minerals helps to avoid the risk of over-supply and imbalances that can occur when another supplement containing these nutrients and vitamins is added to the diet.

Active Ingredients per dose:- The average dose of this example ranges from 60-120 grams per day, given in equal doses divided between morning and evening feeds.

90g 120g (Light Work) (Medium Work) (Racing, Pre-Training) Calcium (Ca) 8.9g 13.4g 17.8g Phosphorus 3.3g 4.9g 6.6g WO 03/034837 PCT/AU02/01448 Magnesium (Mg) 3.05g 4.6g 6.1g This regime also contains: Zinc (Zn) 52.5mg 78.75mg 105mg Manganese (Mn) 52.5mg 78.75mg 105mg Copper (Cu) 24mg 36mg 48mg Iron (Fe) 52.5mg 78.75mg 105mg Cobalt (Co) 0.18mg 0.27mg 0.36mg Iodine 0.35mg 0.52mg 0.69mg Selenium (Se) 210g 315gg 420gg Chromium (Cr) 0.75mg 1.13mg Vitamin A (Retinol) 5,700iu 8550iu 11,400iu Vitamin D3 (Cholecalciferol)570iu 855iu 1140iu Available in: 3.5 kg plastic buckets (35-70 doses) kg plastic buckets (150-300 doses) EXAMPLE Target Animal Grouping: For Racing and Performance Horses IRON SUPPLEMENT FOR EQUINE ATHLETES This example is a new concept in the method of supplementing the trace-mineral iron when requirements in horses are elevated in excess of that naturally contained in, or available from digestion of feed.

The traditional hay and grain diets of horses in training contain from 1,500 1,800 mg of elemental iron in the daily ration. However only 15 17% of this iron is able to be absorbed or is 'bioavailable' to the average horse, particularly from dry, mature hays and grains.

The regime of this example is formulated as an innovative supplement containing three forms of iron, with complementary Vitamin C, Vitamin B12 and folic acid, WO 03/034837 PCT/AU02/01448 36 that is formulated to correct low or inadequate levels in the diet relative to a horse's specific daily requirement.

It is primarily a source of iron only, it is recommended to be used as a booster source of iron during the critical period prior to hard exercise or racing, when more iron is required by the metabolic enzymes and oxygen transport compounds in the muscles during periods of maximal oxygen uptake.

It is formulated for use in conjunction with the regime of Example 1 trace-mineral and vitamin supplement where it can be used to make up dietary shortfalls of iron in the range of essential trace-minerals and vitamins for hard working horses.

The pellets of this example contain three forms of iron: Iron protein bioplex a bioactive, organic form of iron that is carried on a protein iron-protein chelate) to facilitate its uptake from the small intestine.

Iron carbonyl a source of 98% pure iron in micronised form, which has been (98% iron) shown to be the most available form of supplementary iron for human and animal diets.

WO 03/034837 PCT/AU02/01448 37 Iron sulfate a well absorbed form of iron that provides a reservoir of (23% iron) elemental iron in the gut for more sustained release.

A matched amount of sodium and calcium ascorbate, as stable forms of Vitamin C, are included to facilitate the uptake of iron from the small intestine, complemented by Vitamin B12 and folic acid to assist in its utilisation.

Whey powder is used to provide a source of phospholipid compounds to help maintain the intestinal lining and minimise irritation by iron and other elemental mineral compounds.

Active Ingredients per dose: Each 20g of Cell Iron pellets, the mid range dose, provides the following nutrients: grams 20 grams 25 grams Iron (as Proteinate) 135mg 180mg 225mg Iron (as carbonyl) 29.4mg 39.2mg 49mg Iron (as sulfate) 75.6mg 100.8mg 126mg Total Iron (16mg/g) 240mg 320mg 400mg Also contains per dose: Sodium ascorbate 120mg 160mg 200mg Calcium ascorbate 120mg 160mg 200mg Cyanocobalamin (Vit. B12)240.g 320pg 400kg Folic acid 9mg 12mg whey powder containing 1500mg 2000mg 2500mg 13% crude protein and gut protective phospholipids WO 03/034837 PCT/AU02/01448 38 The label dose rates include recommendations for horses in pre-training, where additional iron may be beneficial to correct inadequate levels in the diet when red cell numbers increase in response to regular exercise.

The dose recommendations also take into account other sources of iron provided in the diet, such as by the addition of supplements of Example 1 (350mg iron/40g dose) or other supplements, so as to avoid excess amounts of iron that would be not fully absorbed or utilised.

Additional recommendations are provided for horses in advanced and full training in both cool and hot, humid climates. Iron is excreted in the sweat (23mg iron/Litre of sweat) of horses during hot weather. The basic hay and grain diet is unlikely to either provide this amount for the elevated needs of horses in training or allow the horse to replace daily losses when a horse sweats heavily under hot conditions.

The vehicles of this example comprise cold-pressed pellets, which are dust free, difficult to sift out and do not separate in the feed mix.

The pellet of this example can be mixed into the feed to provide an additional source of iron to supplement low or inadequate levels in the diet, prior to racing and hard exercise, or as a regular 3 day course of iron at 10-14 day intervals for horses in race training on grain and hay based diets.

WO 03/034837 PCT/AU02/01448 39 Available in: 1.2 kg plastic tubs (60 x 20g doses) kg plastic buckets (175 x 20g doses) EXAMPLE 6 Target Animal Groups Show and Pleasure Horses, Ponies and miniature Horses CALCIUM, TRACE-MINERAL AND VITAMIN SUPPLEMENT FOR ADULT SHOW MND PLEASUR E HORSES, PONIES AND MINIATURE HORSES This supplement formulated for the lightly worked show and pleasure horse that is economical, easy to use and makes up the shortfalls in pasture as well as in a hard feed ration.

This regime provides a comprehensive and high quaality range of minerals, trace -minerals and vitamins but in three separate small, palatable cold-pressed pellets.

First Dosage Vehicle White Coloured Pellets:- The major minerals Contain calcium, complemented by Vitamin A and D to assist its uptake and regulation, as well as phosphorus and magnesium the major minerals; to offset low levels in chaff and hay diets.

Second Dosage Vehicle Brown Pellets:- The major Trace-minerals Provide a wide range of essential t race-minerals5, many in protein bioplex (protein chelated) forms to maximise uptake, includling selenium and chromium yeasts to meet the WO 03/034837 PCT/AU02/01448 needs of light work, thereby providing additional traceminerals that help ensure optimum coat condition.

Third Dosage Vehicle Golden Yellow Pellets:- The Major Vitamins These pellets deliver a comprehensive package of essential vitamins often lost in dried and stored feeds making up shortfalls, thereby assisting metabolism, vitality and health.

The three separate dosage vehicles of this example help assure stability of the individual classes of nutrients, reducing the risk of inter-reaction, chemical binding and loss of potency of trace-minerals and vitamins during storage and use. They are palatable and a daily supplement can be given to horses at pasture, if necessary, off the hand without having to provide them with a 'hard' feed.

It is an innovative supplement that helps turn 'feed' into 'food' avoiding sifting out and dust common with powdered supplements.

Available in: 3 kg plastic buckets (60 x 50g doses for a 450-500kg horse) kg plastic buckets (300 x 50g doses for a 450-500kg horses) The number of doses in each pack for Ponies and Miniatures is relative to each individual animal's bodyweight.

WO 03/034837 PCT/AU02/01448 41 SUMMARY OF EXAMPLES In summary, important or significant. characteristics of the dosage systems of Examples 1 to 6 may be summarized as: 1. Individual solid dosage forms, including pellets, prills, beadlets, beads, granules, tablets or caplets contain nutritional and therapeutic substances that are separated to reduce inter-reaction between the compounds that could or can occur when they are mixed together in the one formulation, and then pressed or formed into a solid dosage form.

NB. Prills are a small ball-like dosage form, similar in appearance and size to the sugar coated '100's and 1000's' confectionary topping used on cakes, chocolate discs etc.

2. The individual solid dosage forms are blended in a scientifically formulated ratio to provide a targeted therapeutic dose or food supplement relative to the :0 specific needs of the animal or human to deliver medication or correct low or inadequate nutrient levels in the diet.

3. The individual solid dosage forms (not powder) can be identified by the natural colour of the ingredients or colour coded by the addition of food colourings to make them distinct and easily recognized in the blend WO 03/034837 PCT/AU02/01448 42 of the product formulated for a particular purpose, treatment or use.

4. The concept need not be restricted to an oral supplement or treatment, and may be used topically as a blended treatment for wounds etc, where the individual ingredients would not ordinarily be stable or maintain the activity, or would react chemically together, if they were mixed in the one formulation.

The concept of the examples is based on the separation of classes of nutrients, or even therapeutics, to prevent chemical interaction, as well as allowing these nutrients to be blended in varying ratios from bulk lots of the individual dosage forms to meet the specific needs of the animal.

For instance, trace-minerals, such as iron or copper react chemically with vitamins, such as Vitamin A, E and C to reduce their potency. In vitamin preparations, choline, classed as a B group vitamin, reacts chemically to destroy many other B group vitamins. However, it is not affected by trace-minerals, so it can be included in a separate trace-mineral mix to form solid doses. Even when in a dry powder form, destructive reactions can occur with those nutrients in close contact.

As previously described the dosage vehicles typically comprise a mass in the form of a mixture of dispersed WO 03/034837 PCT/AU02/01448 43 portions of at least one active component in a substantially non-reactive separator material.

However, in some instances, the non-reactive separator material may itself include an active component. A case in point is where the substantially non-reactive separator material is calcium. If there is too much calcium in certain formulations these reduce the uptake of active components such as iron, zinc, magnesium and manganese.

(It should also be noted that if there is too much zinc this can reduce the uptake of manganese).

In instances where calcium may reduce the uptake of such active components one can, for example, chose a less reactive carrier such as, for example, DiCalcium Phosphate as a substitute for Calcium Carbonate.

As a general rule one should always select concentration and type of the separator material so that any active component which it might contain does not interfere with the uptake or therapeutic effect of the active component or components in the dosage vehicle.

The above describes only some embodiments of the present invention and modifications, obvious to those skilled in the art, can be made thereto without departing from the scope and spirit of the present invention.

Claims

27.M r. 2007 17:14 Wa I ington-Dummer Sydne No .9373 P 44 CLAIMS 0 (N 1. A method for delivery of predetermined quantities of predetermined selections of a therapeutically or 00 nutritionally effective substance over predetermined time intervals into the body of an animal; said method 0 comprising: ON At a first location sorting a dosage vehicle en according to an at least one primary characteristic; S(b) At said first location selecting and mixing at a first mixing time one or more of said dosage vehicles in accordance with a predetermined selection and predetermined quantity thereby to obtain a first dosage of a selection and quantity of said therapeutically or nutritionally effective substance specifically adapted for a predetermined target animal or target animal group; Transporting said first dosage to a second location; Selecting and mixing at a second mixing time said first dosage with a predetermined selection and predetermined quantity of feed material thereby to obtain a first feed mix; e) Administering said first feed mix to said target animal or target animal group at a first predetermined administration time which is at or around said second mixing time; COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 27.kr, 2007 17:14 Wallinston-Dummer Sydney N o. 93 3 P I S) Repeating steps and at predetermined repeat time intervals thereby to maintain a predetermined Stherapy profile in said target animal or target animal 00 group over a predetermined therapy period. o 2. The method of Claim 1 further including attributing at least one sub-characteristic to an at least one dosage C vehicle. 3. The method of Claim 2 wherein said at least one sub- characteristic is such that it can be utilised to distinguish one dosage vehicle from another on the basis said at least one primary characteristic. 4. The method of Claim 2 or Claim 3 wherein said dosage vehicle is sorted according to said at least one sub- characteristic. The method of any one of Claims 2 to 4 including a second sub-characteristic. 6. The method of Claim 5 wherein said second sub- characteristic is selected from odour, density, size, volume, diameter, length. 7. The method of any one of Claims 1 to 6 wherein said COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 27.Mar, 2007 17:15 Wallinston-Dummer Sydney No.9373 P. 12 46 S predetermined repeat time interval is 1 day. S8. The method of any one of Claims 1 to 6 wherein said OO predetermined repeat time interval is 0.5 day. ci o 9- The method of any one of Claims 1 to 8 wherein said O predetermined therapy period is at least six months. Ci C o 10. The method of any one of Claims 1 to 8 wherein said predetermined therapy period is approximately 3 months. 11. The method of any one of Claims 1 to 8 wherein said predetermined therapy period is approximately 2 months. 12. The method of any one of Claims 1 to 8 wherein said predetermined therapy period is approximately 1 month. 13. The method of any one of Claims 1 to 12 wherein a second dosage is administered in a subsequent predetermined therapy period, thereby to tailor therapy for said animal as a function of time. 14. The method of any one of Claims 1 to 13 wherein said dosage vehicle is in the form of a predetermined quantity of a substance to be applied topically. COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27 27.M'r. 2007 17:15 Wallington-Dummer Sydney No,9373 P 13 47 8" 15. The method of any one of Claims 1 to 13 wherein said c-i dosage vehicle is in the form of a predetermined quantity tof a solid, ingestible substance. 00 16. The method of claim 15 wherein said solid, ingestible o dosage is in the form of a pellet, prill, beadlet, bead, Ogranule, tablet, caplet or flake. en en o17. The method of any one of Claims I to 16 wherein said predetermined target animal is selected from a dog, a pig, a cow or a fish. 18. The method of any one of Claims 1 to 16 wherein said predetermined target animal is a horse. 19. The method of any one of Claims I to 16 wherein said predetermined target animal is a human. A system comprising means for carrying out the method as defined in any one of Claims 1 to 19. 21. A method or system substantially as herein described with reference to the accompanying drawings. COMS ID No: SBMI-06774927 Received by IP Australia: Time 17:19 Date 2007-03-27