Title of Invention	A PROCESS FOR PRODUCING METAL EMBEDDED CONTAINER
Abstract	A PROCESS FOR PRODUCING METAL EMBEDDED CONTAINER

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) COMPLETE SPECIFICATION [See section 10] A PROCESS FOR PRODUCING METAL EMBEDDED CONTAINER; SCITECH CENTRE, A COMPANY INCORPORATED UNDER SECTION 25 OF THE COMPANIES ACT, 1956, WHOSE ADDRESS IS 7, PRABHAT NAGAR, JOGESHWARI (WEST), MUMBAI - 400 102, MAHARASHTRA, INDIA; THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES AND ASCERTAINS THE NATURE OF THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFOr TECHNICAL FIELD This invention relates to a system for providing valuable atmosphere sensitive material / metals in a form, free of environmental and/or other contamination / degradation for effective delivery along with drug / food products. In particular films / foils of said material / metallic micro nutrients are embedded in containers / packs / capsules to carry said valuable metal / micro nutrients free of contamination / degradation. Industries such as the agro-chemical, food and drugs / pharmaceuticals are required to deliver controlled quantities or dosage of nutrients, drugs and other constituents through formulations that must be maintained in a stable form ideally up to the point of action. Atmosphere sensitive materials or materials that are not mutually compatible are required to be put into formulation in a manner to retain their effectiveness. Standard texts such as the 3 volumes of "Pharmaceutical Dosage forms edited by H.B. Liberman and L. Lachman (Marcel Dekker Inc. 1980), The Theory and Practice of Industrial Pharmacy by L. Lachman, H. A. Liberman and J. L. Kanig (Varghese Publishing House 1987), Microencapsulation and related drug processes by P. B. Deasy (Marcel Dekker Inc. 1984) describe methods such as selective coating of materials, erecting barriers, microencapsulation, selective pelletisation etc., used for manufacture of commercially viable products. These methods described in the prior art do provide solutions to the protection of atmosphere sensitive materials and/or materials that are mutually noncompatible in formulations for diverse applications. It is well established that biological systems such as humans, animals, plants need controlled levels of metals such as silver, gold, zinc etc as micronutrients for their routine biological processes. These are normally obtained through the diet. However there are occasions when these are to be supplemented from outside either in their metallic form or in the form of their compounds that are compatible with the biological system. The form in which they are to be supplied are very specific and often for best results they are to be supplied in the form of their metals in their non-oxidised state. The applications of these are widespread in the drugs and pharmaceutical and agrochemical and food industry. Most of the prior art described are either cumbersome to handle small quantities as required by the formulations or are not amenable to selective manoeuvrings when it comes to handling atmosphere sensitive metals such as silver In the formulations. OBJECTS OF THE INVENTION The object of the present invention is to provide solution to the long felt need of creating cost effective protective barriers for atmosphere sensitive metals like silver so that they remain protected from other ingredients of the formulation until delivery. Yet another object of the present invention is to produce metal streaked soluble containers that are attractive to consumers yet retaining their functional characteristic of protecting the atmosphere sensitive metal in the formulation. Thus according to an aspect of the present invention there is a system for providing atmosphere sensitive materials / metals in a form substantially free from environmental and/or other contamination / degradation, comprising said material / metal as films / foils embedded in a selective media preferably soluble outer body of containers / packs / capsules and the like used for containing food / medicinal substances. Preferably, in accordance with an embodiment the system can comprise of soluble capsule containers having embedded with the said valuable materials / metals / micronutrients as soluble films for effective and selective delivery of the metal micro nutrients as required as drug / food supplement. The capsule container media can be the conventional gelatine based soluble capsules. Importantly, it is possible by way of the above disclosed system to deliver at controlled levels such valuable metals such as silver, gold, zinc etc., as micro nutrients required in drug / pharmaceutical preparations, agrochemical, cosmeceuticals, nutraceuticals and food industry substantially / free of any environmental and/or other contamination / degradation. However it is already well known in the art to employ HPMC and starch for manufacturing containers such as capsules. The conventional gelatine can also be replaced by any of the following or any combination of some or all of them; Ethyle cellulose, carboxy methyl cellulose, hydroxy propyl methyl cellulose, polyvinyl alcohol, methacrylic acid copolymers, starch, gums like tragacanth, guargum, acacia and the like. which is followed by the addition of additives like preservatives, plasticizers, colourants, sweeteners & flavouring agents and the like and consequently adjusting the viscosity of the gelatine solution by adding warm water which is followed by de-aeration and the de-aerated gelatine solution with the additives are being transferred to "cap & body" dipping tank known in the art wherein further conventional steps are employed for manufacturing capsules. Such capsules consist of bodies & caps. In accordance with another aspect of the present invention there is provided a process for the manufacture of the system for providing atmosphere sensitive materials free from environmental contamination / degradation such as films of said material / metals embedded in capsule / container body for food / drug delivery comprising; providing the material / metal to be embedded in pure form such as foils / films of desired thickness; providing the media for embedding the material, in solution with or without the additives and obtaining a transparent clear solution; adding the material / metal as foil / film to said solution with or without additional plasticizers; de-aerating the solution; and obtaining the container / capsules with said soluble films of valuable material / metal embedded substantially free of environmental and/or other contamination / degradation following conventional container / capsule manufacturing process. While adding metal as foil / film to a solution material e.g. gelatine it is immaterial whether one adds metal film / foil to the clear material (gelatine) solution or alternatively material (gelatine) solution is added to a tank containing the metal foils. In accordance with a preferred aspect of the present invention the process of manufacture of the container such as capsule having the metal embedded, comprise the following steps : i. Pure Silver metal is made into foils of thickness ranging from 0.01 micron to 0.5 micron preferably 0.05 micron to 0.3 micron. ii. Addition level of silver films of about 0.01% w/w to about 5% w/w preferably between 0.1 to 2% w/w. iii. Making of gelatine solution of about 25% to about 40% w/v in water. iv. Addition of preservatives at this stage. V. Heating of the whole mass with stirring to melt the gelatine to form a transparent solution. This solution is filtered to remove any extraneous matter and transferred to the gelatine holding tanks. vi. Addition of the silver films to the gelatine solution as such or in slurry form. To prevent any lump formation stirring for not less than 30 minutes is done. Gelatine solution temperature is maintained in the range of about 40°C to about 65°C preferably in the range of 45 to 55°C. vii. Adjustment of the viscosity of the gelatine solution by addition of desired quantity of warm water. viii. Addition of natural or synthetic plasticizer in the gelatine solution may be necessary under some conditions. Further at this stage colourants, flavouring agents, plasticizers, sweeteners, are optionally added. ix. De-aeration of the solution prior to taking it for capsule formation. X. Transferring of the solution to the "cap and body" dipping tank. The temperature of the dipping tank is maintained at about 45°C to about 55°C preferably between 46 to 52°C. xi. Dipping of the capsule-making pin moulds into the gelatine solution. The pins are then withdrawn, turned and pushed Inside the drying zone. Capsule pins with gelatine on it travel through a drying zone of temperature about 22°C to about 30°C preferably between 24°C to 28°C. During this time the gelatine is set on the pins and dried. xii. Mechanical removal of the capsules from the pins. xiii. The capsules are cut into required length mechanically, joined cap and body and kept for aeration at 20°C to 30°C, preferably 24°C to 28°C for 60 minutes to 200 minutes. The moisture of the capsules is generally between 12% to 18% w/w. The metallic film could be silver or gold or any other metal. The process will now be described with a set of non-limiting examples. Example 1. 165 g. of gelatine was weighed in a beaker, 335 g. of deminaralised water was added. The mass was heated on a water bath at 50°C to 60°C with constant stirring so that the gelatine dissolves completely. 672 mg. of Silver foil was added directly into the gelatine solution and stirred well. The entire mass was de-aerated at 50°C for one hour. Capsule molding pins cap and body were hand dipped and dried in the capsule drying zone. After drying the capsules were removed from the pins. Example 2. 60 Kg. batch was prepared using silver leaves. 120 g. of the silver leaves were weighed and collected in a lubricated polybag. This was transferred into a plastic container. 1 litre of demineralised water was added in the container and silver leaves were soaked and mixed in the water. This mix was added into 60 Kg. of 33.3% w/v transparent gelatine solution. The whole mass was stirred for 30 minutes and then de-aerated for 1 hr. This gelatine solution with silver foil pieces suspended uniformly was transferred into cap and body gelatine tanks for dip molding trials. Moulding pins were dipped in the capsule making machine withdrawn with the gelatine and turned upside and passed through the capsules drying zone of temperature 20 to 30°C and relative humidity of 40% to 50%. During this the gelatine was set on the pins and dried to give the moisture content of 15% w/w. Silver content at addition stage ranges from 0.01% w/w to 2% w/w preferably 0.05% to 1% w/w of the gelatine solution. After molding and drying, silver content in each capsule ranges from 0.1% to 5% w/w of the finished capsules. An example of a sample capsule prepared by this process is illustrated in figure 1 which accompanied the provisional specification. The dispersed silver particles shape is irregular and the size varies from 23 microns to 1049 microns as observed under microscope. The capsules prepared by this process had moisture content of about 14% w/w and disintegration time of 2.59 minutes. The capsules prepared by the method of this invention can be used for drug formulations, food products, agro chemicals. We (;laim : 1. A process for producing acontainer consisting of its body &. cap wherein metals are embedded in pure form in the walls of the container comprising the steps of: (a) preparing an aqueous solution of the base material; (b) incorporating in the solution resulting from step (a) Jhe ^ desired metals with specified thickness, size and other desired parameters and stirring the resultant mixture for preventing lumping. (c) optionally adding additives such as natural or synthetic plasticizers, preservatives, colourants, sweeteners & surfactants in the resultant solution of step (b). (d) de-aerating the resultant product of ste^ (c). (e) manufacturing the containers from the resultant product of step (d) by a conventional process of dipping container making pin moulds into the product of step (d) followed by conventional steps of withdrawing the pins from the solution, drying the solution coated pins and mechanically removing the dried coating, as container from the pins. (f) drying the containers for controlling the moisture content of the manufactured container. 2. A process as claimed in claim 1 wherein the container is a capsule. 10 3. A process as claimed in claim 1 wherein the soluble material used for manufacturing the container is either an edible matter or a biofriendly matter; 4. A process as claimed in Claim 3 wherein the edible matter is being used for the manufacture of food and/or drugs; 5. A process as claimed in Claim 3 wherein the biofriendly soluble matter is being employed for manufacturing a soluble container for containing agrochemicals, pharmaceuticals, cosmeceuticals, nutraceuticals and the like; 6. A process as claimed in Claim 4 or 5 wherein the matter is gelatine or any conventional matter known in the art; 7. A process as claimed in Claim 1 wherein the metal is selected from the group silver, gold, zinc or any other valuable metal preferably silver. 8. A process as claimed in Claim 7 wherein the valuable metal is used at controlled level just to meet the needs of the humans, animals and plants. 9. A process as claimed in Claim 1 wherein the metals being used is in the form of foils / films; 10. A process as claimed in Claim 9 wherein the metal is selected from the group silver, gold or valuable metals which is of thickness ranging from 0.01 micron to 0.5 micron preferably in the range of 0.05 micron to 0.3 micron and film employed in the range of 0.01% w/w to about 5% w/w Preferably in the range of 0.1% to 2% \NI\N of the gelatine solution which is made up of 25% to 40% w/v in water and such solution is prepared by melting gelatine by heating the whole mass with stirring to make a transparent 11 gelatine by heating the whole mass with stirring to make a transparent solution and the solution is filtered to remove any extraneous matter; add silver foils / films to the resultant filtered solution, further resultant solution is being stirred for not less than 30 minutes to prevent lump formation and the resultant gelatine solution temperature is maintained in the range of about 40 degree to 65 degree C; Preferably in the range of 45 to 55 degree C and further adding warm water to adjust the viscosity of the gelatine solution and subsequently adding plasticizer if necessary and then de-aerating the solution and transferring the de-aerated solution to cap and body dipping tank wherein the temperature of the dipping tank is maintained at about 45 degree C to 55 degree C preferably between 46 to 52 degree C and then capsules are being manufactured from this solution by using conventional capsule making pin moulds and also conventional method using such moulds; 11. A process as claimed in Claim 10 wherein the manufactured capsule contains moisture between 12% to 18% w/w. 12. A soluble container manufactured by a process as claimed in Claim 1 wherein metals in pure form are embedded in its wall and therefore such metals are neither exposed to atmospheric oxygen or any other reactive gas of the atmosphere nor also exposed to the contents of such containers. 13. A soluble container as claimed in Claim 12 wherein it is a capsule; 14. A container as claimed in Claim 13 wherein material of construction of the container is either an edible matter or biofriendly matter; 12 15. A container as claimed in Claim 14 wherein it is made of gelatine; 16. A container as claimed in Claim 13 wherein the metal is selected from the group silver, gold, zinc or any other valuable metal preferably silver; 17. A container as claimed in Claim 13 wherein the valuable metal is used at a level just to meet the needs of the humans, animals and plants; 18. A container as claimed in Claim 13 wherein the metal is used in the form of foils or films; 19. A container as claimed in Claim 16 wherein the silver content is in the range of 0.1 to 5% of the finished product; 20. A container as claimed in Claim 19 wherein the silver particle shape is irregular and the size varies from 23 microns to 1049 microns and the moisture content is in the range of 10-12% w/w and disintegration time of 2-6 minutes in water as per pharmacopoeia! method . 21. A process for manufacturing a container substantially as described in the specification and also in the examples disclosed in the specification; 22. A capsule manufactured by a process substantially as described in the specification and also in the examples. ;th Dated this 5"" day of September, 2001, 13

Documents:

850-mum-2001-cancelled pages(5-4-2006).pdf

850-mum-2001-claims(granted)-(5-4-2006).doc

850-mum-2001-claims(granted)-(5-4-2006).pdf

850-mum-2001-correspondence(5-4-2006).pdf

850-mum-2001-correspondence(ipo)-(9-1-2006).pdf

850-mum-2001-drawing(3-10-2002).pdf

850-mum-2001-form 1(5-4-2006).pdf

850-mum-2001-form 1(5-9-2001).pdf

850-mum-2001-form 13(5-4-2006).pdf

850-mum-2001-form 18(24-8-2005).pdf

850-mum-2001-form 2(granted)-(5-4-2006).doc

850-mum-2001-form 2(granted)-(5-4-2006).pdf

850-mum-2001-form 3(5-9-2001).pdf

850-mum-2001-form 4(3-9-2002).pdf

850-mum-2001-power of authority(3-10-2002).pdf

850-mum-2001-power of authority(5-9-2001).pdf

abstract1.jpg