AU2003266441A2 - Dustless Veterinary Medicament, therapeutic drug or nutritional product and method for making same - Google Patents
Dustless Veterinary Medicament, therapeutic drug or nutritional product and method for making same Download PDFInfo
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- AU2003266441A2 AU2003266441A2 AU2003266441A AU2003266441A AU2003266441A2 AU 2003266441 A2 AU2003266441 A2 AU 2003266441A2 AU 2003266441 A AU2003266441 A AU 2003266441A AU 2003266441 A AU2003266441 A AU 2003266441A AU 2003266441 A2 AU2003266441 A2 AU 2003266441A2
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- water
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- granulated
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Description
Regulation 3.2
AUSTRALIA
Patents Act 1990 (Provisional Specification No: 2002953322) STANDARD
SPECIFICATION
For the invention entitled "Dustless medicament, therapeutic drug or nutritional product and methods for making same" The invention is described in the following statement: P:\OPERU PN\257560 sp c.doc-13/1202 -1- VETERINARY MEDICAMENT, THERAPEUTIC DRUG OR NUTRITIONAL PRODUCT AND METHOD FOR MAKING SAME This invention relates to veterinary medicaments, therapeutic drugs and nutritional products, and more particularly, but not exclusively, to veterinary medicaments, therapeutic drugs and nutritional products for administering to animals in an aqueous solution.
There exists a problem in the administering of water-soluble veterinary medicaments, therapeutic drugs and nutritional products to animals, as follows. The active principals of such products are often supplied in a powder or micronised powder form.
Examples of such active principals include Amoxycillin Trihydrate, Tylosin Tartrate, Tiamulin, and Lincomycin. Owing to the chemical/physical characteristics and, in particular the granulometric characteristics and physical structure of such fine powders, the products are prone to the release of substantial quantities of fine particles of respirable dust during handling. Moreover, such products may contain chemicals or the like which are hazardous or toxic if inhaled by a handler, and thus it is highly desirable to eliminate or at least reduce the likelihood of inhalation of same. The problem is exacerbated by the tendency of some such substances to crumble when handled.
For example, in a rural farm environment, during the process of weighing, packing and administering such products to the drinking water of animals, particularly in windy weather, the products are prone to the release of substantial quantities of toxic respirable dust. As a result, such products may create severe occupational health and safety problems for those handling the products and for those working within the immediate or nearby environment.
The applicant has determined that one way of reducing the likelihood of inhalation of such veterinary medicaments, therapeutic drugs and nutritional products is to reduce the tendency of the substances to form as dust. This approach also addresses the related problem of expensive veterinary medicaments, therapeutic drugs and nutritional products being lost in windy conditions, which problem in turn leads to the further problems such as P OPERUPM U2I75(AI p-p.doc-13112A)2 -2the inaccurate dosage to livestock.
It has been previously proposed to provide a blend with low-dustiness characteristics for use in fodder production and/or for livestock feeding by adding an active principal and surfactants to a carrier substance. However, such processes are limited to fodder and feed products, as the active principal must be combined with a carrier meal, flour or bran to reduce the dustiness.
Preferred embodiments of the present invention seek to provide a water-soluble granulated medicament, therapeutic drug or nutritional product for administering to animals in an aqueous solution in which the water-soluble granulated medicament, therapeutic drug or nutritional product itself has improved resistance to forming as dust during handling.
In accordance with the present invention, there is provided a water-soluble granulated product for administering to animals in an aqueous solution, said product comprising: a water-soluble granulated material at least 95% by weight of which has a size of between 50 microns and 3000 microns, and a water-soluble coating applied to granules of the granulated material for reducing the tendency of the material to form as dust.
Preferably, said water-soluble granulated product is a medicament, therapeutic drug or nutritional product.
Preferably, said water-soluble coating comprises between 0.1% and 10% by weight of the coated granules.
Preferably, said water-soluble coating includes water-miscible and/or waterdispersible additives.
P;UPERJPNU587560 pw spav-13/12M -3- Preferably, said material is pure active principal of said water-soluble granulated medicament, therapeutic drug or nutritional product.
Preferably, the water-soluble granulated product is administered to the animals in their drinking water.
Preferably, at least 95% by weight of the granulated material has a granule size of greater than 100 microns.
Preferably, at least 95% by weight of the granulated material has a granule size of greater than 200 microns.
Preferably, at least 95% by weight of the granulated material has a granule size of greater than 300 microns.
In accordance with another aspect of the invention, there is provided a method for producing a water-soluble granulated product for administering to animals in an aqueous solution, said method including the steps of: granulating a water-soluble material into granules at least 95% by weight of which have a size of between 50 microns and 3000 microns, and applying a water-soluble coating to said granules for reducing the tendency of the material to form as dust.
Preferably, said water-soluble granulated product is a medicament, therapeutic drug or nutritional product.
Preferably, in said step of applying a water-soluble coating the coating is applied such that it comprises between 0.1% and 10% by weight of the coated granules.
Preferably, said water-soluble coating includes water-miscible and/or water-dispersible additives.
Preferably, said method further includes the step of selecting the granules such that greater than 95% by weight of the granulated material has a granule size of greater than 100 microns.
Preferably, said method further includes the step of selecting the granules such that greater than 95% by weight of the granulated material has a granule size of greater than 200 microns.
Preferably, said method further includes the step of selecting the granules such that greater than 95% by weight of the granulated material has a granule size of greater than 300 microns.
Preferably, said material is pure active principal or blend of pure active principals of said water-soluble granulated medicament, therapeutic drug or nutritional product.
Preferably, the water-soluble granulated medicament, therapeutic drug or nutritional product is for administering to the animals in their drinking water.
Preferred embodiments of the present invention will now be described, by way of examples only.
In one preferred embodiment of the present invention, there is provided a method for producing a water-soluble granulated veterinary medication, veterinary therapeutic, livestock drug, or nutritional product wherein the active principal is granulated according to a particular granulometric specification. The "active principal/s" are the active ingredients of the water-soluble granulated veterinary medication, veterinary therapeutic, livestock drug, or nutritional product. Because of this granulation, the quantity of respirable particles is practically reduced to nil. The granular active principal is then coated with a water-soluble coating, which water-soluble coating may include one or both of a water-miscible additive and/or a water-dispersible additive. VVhen dry, this coating binds and seals the granule and inhibits its ability to emit dust during handling, while still enabling the product to be readily soluble in water. In particular, the coating serves to bind the material of each granule together to prevent the granules from breaking up into smaller particles, such as dust particles. In this way, the size of each of the granules is maintained better during packaging, storage and shipping, and the tendency of the material to form as dust is greatly reduced.
Examples of suitable water soluble coatings include lauryl sulphates including sodium lauryl ether sulphate and lauryl ethoxy sulphates, polyethylene glycols including polyethylene glycol glycerol riccinoleate, non ionic surfactants including esters of propylene glycols and esters of poly oxy ethylene (POE) including POE ethylene nonyl phenyl ether, POE ethylene octyl phenyl ether, POE sorbitan mono stearate, POE sorbitan mono oleate, POE sorbitan monolaurate, POE sorbitan mono palmitate, POE ethylene castor oil ether and POE ethylene sorbitan mono oleate, esters of mono and di-glycerides and tri glycerides, POE ethylated castor oil, mono and di-ethanolamides, quarternary and amphoterics, ethoxy sulphates, alkyl benzene sulphonic acids, lauryl, cetyl and stearyl alcohols, polyoxy propylene and polyoxy ethylene glycols, glycerol and glycerine.
In a first step of a method of producing a water-soluble granulated medicament, therapeutic drug or nutritional product according to one preferred embodiment of the present invention, the active principal is granulated to specific granulometric requirements to a mesh size between 50 microns and 3000 microns (depending on the particular medicament, drug or nutritional product and its physical limitations). In a second step of the method, the granules of the active principal are coated by way of a ribbon blender or equivalent mixer used for blending powdered or granulated products. In this process, the water-soluble coating and any water-miscible and/or water-dispersible additives are incorporated into the product through a micronised spraying process. Each product may require different water-soluble coatings (incorporating different water-miscible and/or water-dispersible agents) according to the chemical characteristics of the product concerned, as some coatings may form undesirable chemical reactions and alter the material being coated, ie the coating should be compatible with and unreactive to the active principal.
With particular regard to the first step of granulation, in the preferred embodiment, the manufacturer of the granulated material is supplied with a granulometric specification for the water-soluble veterinary medication, veterinary therapeutic drug or nutritional product, which may vary according to the specific product being manufactured and the method of manufacture of the pure substance on which the material is based. According to the described embodiment, the material may be manufactured as a slurry, and then sprayed as fine droplets into a drying chamber. The particle size is regulated by the size of the droplets. The actives may also be produced using a different P:OPER\PN\258735(60 pr-v spc.doc-l13/A22 -6process depending on the chemical used.
The material is collected and is passed through a customized sieving process to remove particles below 50 microns, and a varying percentage below 300 microns. In one particular form of the invention, the granules are passed through the sieve and are selected such that less than 5% of the finished product is made up of particles of less than 300 microns in size and such that no particles may exceed 3000 microns in size. The steps of granulating the material and coating the granulated material are distinct such that these steps may be performed at different premises; this flexibility may be of benefit to the producer of the final product.
In the step of coating the granulated material, the mixer to be used is cleaned and prepared by steam cleaning after which the granulated veterinary medication, therapeutic drug or nutritional product is added. A water-soluble coating, which may include one or both of a water-miscible and/or a water-dispersible additive, is prepared and formulated to meet the specific requirements of the product being treated. This coating is placed in liquid form in a spraying reservoir and is sprayed as a micronised mist over the granules while operating the mixer until the supply is exhausted. The mixer is operated during this process to provide a relatively uniform distribution of the coating on the granules, and thus a homogeneous finished product. On completion of the mixing process, which in the particular embodiment being described averages 8 minutes in duration, the mixer is stopped and the coated product is held stationary for approximately 2 minutes to allow for at least partial drying of the coating. The finished product may then be transferred into holding bins for analysis and packaging.
The spraying is carried out by means of compressed air atomizer nozzles for pressurized liquids.
The complexity of the combination of the water-soluble coating with any watermiscible and/or water-dispersible additives is matched to the chemical characteristics of the material being coated.
P:\OPERUPN\2587560 prov spe.doc-13/12/02 -7- The method described involves no blending of carriers/meals or flours or ingredients other than the pure materials to be coated (ie. the active principal/s) and the water soluble coating (including any additives) employed. It is intended purely as a method of producing a water-soluble product in a safe-to-handle form, and with a reduced tendency to emit respirable dust particles.
The following two examples of products according to the present invention, and produced according to the method of the present invention, have been included to further clarify the nature of the invention and the advantages it procures.
Example 1 Tylosin Tartrate BPV is manufactured generally as a fine powder or as a compacted uncoated granule the mesh size of which varies from 0.02 microns to 200 microns. The material to be coated was manufactured and supplied to the granulometric specification of less than 5% passing through a 200-micron sieve and 100% passing through a 600-micron sieve. Five hundred kilos of this uncoated material was added to a ribbon mixer and a spray tank was filled with 6 kilos Polyethylene Glycol 400 and 5 kilos of Glycerol. The mixer was engaged and the liquids sprayed until the tank was exhausted. The mixer continued mixing for a total of 8 minutes. After a resting period where the product was allowed to sit for 2 minutes the product was packed off.
The coated product was tested for dust emission using the EU approved test equipment, the Stauber Heubach Dust Meter Type 2. The results were: 0.4mg/filter an equivalent to 4mg/m 3 air. This result is well within the limits set by the Australian NOHSC for atmospheric contaminants of 10mg/m air.
A sample of Tylosin Tartrate BPV in its normal granulometry was obtained from the same manufacturer and was tested using the identical Stauber Heubach Dust Meter Type 2. The results of the test on this untreated product were 29.8mg/filter, or 29.8 times the limit set by the Australian NOHSC for atmospheric contaminants of 10mg/m 3 air. As such, it was concluded that the method employed in accordance with the present invention P:\OPERRUPNU5875601 pm spe.doc-13/12112 -8effectively inhibited the ability of the active principal, Tylosin Tartrate BPV, to emit respirable dust during handling and thus provided a safer working environment for the handlers of the product.
Example 2 Amoxicillin Trihydrate BP is manufactured generally as a micronised powder. The product was manufactured and supplied to the granulometric specification of less than 2% passing through a 200 micron sieve, 50% passing through a 400 micron sieve and 100% passing through a 600 micron sieve. Five hundred kilos of the uncoated product was added to a ribbon mixer and the spray tank was filled with 8 kilos of Polyethylene Glycol 200 and 2 kilos of Ectoeric 20, (or Polyoxyethylene sorbitan mono-oleate). The mixer was engaged and the liquids sprayed until the tank was exhausted. The mixer continued mixing for a total of 8 minutes. After a resting period in which the product was allowed to sit for 2 minutes, the product was packed off.
The product was tested for dust emission using the Stauber Heubach Dust Meter Type 2. The results were: 0.3mg/filter an equivalent to 3mg/m 3 air. This result is well within the limits set by the Australian NOHSC for atmospheric contaminants of 10mg/m 3 air.
A sample of Amoxycillin Trihydrate BP in its normal granulometry and untreated was obtained from the same manufacturer and tested using the identical Stauber Heubach Dust Meter Type 2. The results of the test on this untreated product gave 3mg/filter, or 3 times the limit set by the Australian NOHSC for atmospheric contaminants of 10mg/m 3 air). As such, once more it was concluded that the method employed in accordance with the present invention effectively inhibited the ability of the active principal, Amoxycillin Trihydrate BP, to emit respirable dust during handling and thus provided a safer working environment for the handlers of the product.
Preferred embodiments have been described by way of example only and modifications are possible within the scope of the invention.
9 Throughout this specification, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated step or integer or group of steps or integers but not the exclusion of any other step or integer or group of steps or integers.
Claims (22)
1. A water-soluble granulated product for administering to animals in an aqueous solution, said product comprising: a water-soluble granulated material at least 95% by weight of which has a size of between 50 microns and 3000 microns, and a water-soluble coating applied to granules of the granulated material for reducing the tendency of the material to form a dust during handling.
2. The water-soluble granulated product as claimed in claim 1 wherein the water-soluble coating comprises between 0.1% and 10% by weight of the coated granules.
3. The water-soluble granulated product as claimed in claim 1 or 2 wherein at least 95% by weight of the granulated material has granule size of greater than 100 microns.
4. The water-soluble granulated product as claimed in any one of claims 1 to 3 wherein at least 95% by weight of the granulated material has a granule size of greater than 200 microns.
The water-soluble granulated product as claimed in any one of claims 1 to 4 wherein at least 95% by weight of the granulated material has a granule size of greater than 300 microns.
6. The water-soluble granulated product as claimed in any one of claims 1 to wherein the water soluble coating is selected from one or more of the group consisting of lauryl sulphates including sodium lauryl ether sulphate and lauryl ethoxy sulphates, polyethylene glycols including polyethylene glycol glycerol riccinoleate, non ionic surfactants including esters of propylene glycols and esters of poly oxy ethylene (POE) including POE ethylene nonyl phenyl ether, POE ethylene octyl phenyl ether, POE sorbitan mono stearate, POE sorbitan mono oleate, POE sorbitan monolaurate, POE sorbitan mono palmitate, POE ethylene castor oil ether and POE ethylene sorbitan mono oleate, esters of mono and di- glycerides and tri glycerides, POE ethylated castor oil, mono and di- ethanolamides, quarternary and amphoterics, ethoxy sulphates, alkyl benzene sulphonic acids, lauryl, cetyl and stearyl alcohols, polyoxy propylene and polyoxy ethylene glycols, glycerol and glycerine.
7. The water-soluble granulated product as claimed in any one of claims 1 to 6 wherein the water-soluble coating comprises a mixture of polyethylene glycol and glycerol or a mixture of polyethylene glycol and polyoxyethylene sorbitan mono-oleate.
8. The water-soluble granulated product as claimed in any one of claims 1 to 7 wherein the water-soluble coating includes water-miscible and/or water- dispersible additives.
9. The water-soluble granulated product as claimed in any one of claims 1 to 8 wherein the said water-soluble granulated product is a medicament, therapeutic drug or nutritional product.
10. The water-soluble granulated product as claimed in claim 9 wherein the water-soluble granulated material is pure active principal or a blend of pure active principals of the medicament, therapeutic drug or nutritional product.
11. The water-soluble granulated product as claimed in any one of claims 1 to wherein the granulated product is for administering to animals in their drinking water.
12. A method for producing a water-soluble granulated product for administering to animals in an aqueous solution, said method including the steps of: granulating a water-soluble material into granules at least 95% by weight of which have a size of between 50 microns and 3000 microns, and applying a water-soluble coating to said granules for reducing the tendency of the material to form as dust during handling.
13. The method as claimed in claim 12 wherein the water-soluble coating is applied to the granulated water-soluble material such that the water-soluble coating comprises between 0.1% and 10% by weight of the coated granules.
14. The method as claimed in claim 12 or 13 further including the step of selecting the granules such that greater than 95% by weight of the granulated material has a granule size of greater than 100 microns.
The method as claimed in any one of claims 12 to 14 further including the step of selecting the granules such that greater than 95% by weight of the granulated material has a granule size of greater than 200 microns.
16. The method as claimed in any one of claims 12 to 15 further including the step of selecting the granules such that greater than 95% by weight of the granulated material has a granule size of greater than 300 microns.
17. The method as claimed in any one of claims 12 to 16 wherein the water soluble coating is selected from one or more of the group consisting of lauryl sulphates including sodium lauryl ether sulphate and lauryl ethoxy sulphates, polyethylene glycols including polyethylene glycol glycerol riccinoleate, non ionic surfactants including esters of propylene glycols and esters of poly oxy ethylene (POE) including POE ethylene nonyl phenyl ether, POE ethylene octyl phenyl ether, POE sorbitan mono stearate, POE sorbitan mono oleate, POE sorbitan monolaurate, POE sorbitan mono palmitate, POE ethylene castor oil ether and POE ethylene sorbitan mono oleate, esters of mono and di-glycerides and tri glycerides, POE ethylated castor oil, mono and di-ethanolamides, quarternary and amphoterics, ethoxy sulphates, alkyl benzene sulphonic acids, lauryl, cetyl and stearyl alcohols, polyoxy propylene and polyoxy ethylene glycols, glycerol and glycerine.
18. The method as claimed in any one of claims 12 to 17 wherein the water soluble coating comprises a mixture of polyethylene glycol and glycerol or a mixture of polyethylene glycol and polyoxyethylene sorbitan mono-oleate.
19. The method as claimed in any one of claims 12 to 18 wherein the water- soluble coating includes water-miscible and/or water-dispersible additives.
The method as claimed in any one of claims 12 to 19 wherein the granulated product is a medicament, therapeutic'drug or nutritional product.
21. The method as claimed in claim 20 wherein the water-soluble granulated material is pure active principal or a blend of pure active principals of the medicament, therapeutic drug or nutritional product.
22. The method as claimed in any one of claims 12 to 21 wherein the granulated product is for administering to the animals in their drinking water. DATED this 20th day of July 2004 ALAN DOUGLAS JOHN LYONS AND KARYN PATRICIA LYONS WATERMARK PATENT TRADE MARK ATTORNEYS 290 BURWOOD ROAD HAWTHORN VICTORIA 3122 AUSTRALIA P23815AU00 KJS/JPFNRH
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2003266441A AU2003266441A1 (en) | 2002-12-13 | 2003-12-04 | Dustless Veterinary Medicament, therapeutic drug or nutritional product and method for making same |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2002953322A AU2002953322A0 (en) | 2002-12-13 | 2002-12-13 | Veterinary medicament, therapeutic drug or nutritional product and method for making same |
| AU2002953322 | 2002-12-13 | ||
| AU2003266441A AU2003266441A1 (en) | 2002-12-13 | 2003-12-04 | Dustless Veterinary Medicament, therapeutic drug or nutritional product and method for making same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2003266441A2 true AU2003266441A2 (en) | 2004-07-08 |
| AU2003266441A1 AU2003266441A1 (en) | 2004-07-08 |
Family
ID=34314584
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2003266441A Abandoned AU2003266441A1 (en) | 2002-12-13 | 2003-12-04 | Dustless Veterinary Medicament, therapeutic drug or nutritional product and method for making same |
Country Status (1)
| Country | Link |
|---|---|
| AU (1) | AU2003266441A1 (en) |
-
2003
- 2003-12-04 AU AU2003266441A patent/AU2003266441A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| AU2003266441A1 (en) | 2004-07-08 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| DA3 | Amendments made section 104 |
Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT(S) FILED 21 JUL 2004 |
|
| MK4 | Application lapsed section 142(2)(d) - no continuation fee paid for the application |