The packaging material containing nicotine product

 

The invention relates to materials for packaging containing nicotine products. The material includes a polymer based on dimethyl-2,6-naphthalenecarboximides and/or monomers 2,6-naphthaleneboronic acid, such as polyethylenterephthalat PEN, or polytrimethylene PTN, or crystalline polymer complex polyester LCP-based hydroxybenzoic acid and hydroxynaphthoate acid. The material can be laminated to other polymer or metal foil. 2 C. and 14 C.p. f-crystals, 1 table.

The invention relates to materials for packaging containing nicotine products.

The prior art For many years tobacco Smoking was one of the most serious health problems worldwide. Smoking, as we now believe, is the main cause of, for example, high blood pressure and lung cancer. However, due to the narcotic nature of nicotine for smokers is extremely difficult to completely stop Smoking. An acceptable alternative to Smoking was the delivery of nicotine in other than Smoking, form, or fashion, for example in the form of a chewing gum containing as the active ingredient nicotine, for example, U.S. patent 3845217. Other PR is And 5543424, device, allowing you to inhale nicotine through the elongated tube, for example, U.S. patent 5501236, nicotine-containing nasal sprays, for example, U.S. patent 5656255, patches for the introduction of the nicotine transdermal by, for example, U.S. patent 4915950 etc.

The main condition that exists when packaging of medicines and food, is the requirement that the packaging protected the product from moisture and oxygen from the environment. Rarely the product itself causes some problems. On the other hand, nicotine is a very aggressive towards its environment and penetrates through most known materials. He is also very hygroscopic and, therefore, sensitive to moisture, and when it is exposed to oxygen or air, then brown. Because nicotine is toxic, and because the expected shelf life of products containing nicotine, is about two years, usually used in the field of packaging, packaging materials, for example polypropylene, polyethylene and polyvinyl chloride, therefore, cannot be used for packaging products that contain nicotine.

Known polymer which satisfies the requirements with respect to tightness of oxygen in the excitation copolymer, derived from Acrylonitrile and methyl methacrylate and a graft (graft-polymerization) to nitrile rubber main chain. Thanks copolymerization with methyl methacrylate polymer becomes softer and it can be processed. Barexavailable with any quantities of nitrile rubber, it is amorphous and at room temperature is a glassy polymer.

The temperature interval in which Barexcan be processed, is very narrow, it is difficult removal of layers during processing of the polymer, as it results in a large amount of waste. This is partially due to the fact that the elasticity Barexdepends on the temperature. In addition, to date, it has high cost. Use WagahTin impermeable to nicotine container is disclosed in U.S. patent 5501236.

The essence of the invention.

Thus, an object of the present invention is the provision of an alternative to Barexmaterial that has suitable from the point of view impermeable to briteney, thus, it is proposed alternative impermeable to nicotine packaging material for nikotinsoderzhaschie product that has the characteristics listed in the claims.

The material according to the present invention includes polyethylenterephthalat, polytrimethylene and/or liquid crystal polymer LCP and has excellent characteristics in terms of impermeability to oxygen, water and nicotine. With a temperature intervals polymers in accordance with the invention are suitable for processing and will have a reasonable price. The material according to the invention is known per se, however, were not known for its barrier properties for nicotine. Also not considered its use for the manufacture of packaging for products containing nicotine.

A detailed description of the invention the Packaging material in accordance with the invention is proposed in connection with the use of nicotine products for therapeutic treatment of patients with nicotine addiction. Examples of such products are chewing gum, sucking tablets, nasal sprays, nicotine patches and nicotine inhalers, selling che is bowenia to the stability of the product for them, are high. Expect the shelf life is two years, with no noticeable changes in the composition of the considered composition, concentration or dose. Specific intervals of allowed deviations installed in accordance with the requirements of relevant organizations such as the Food and Drug Administration, PDA, USA.

Chewing nicotine gum is usually present in the form of a complex with an insoluble cation-exchanger, dispersed in the gum base, in order to be stable. Tablets nicotine is usually present in the form of an inclusion complex. Only a small amount, if any, nicotine in contact with the packaging of chewing gum and tablets and, thus, the requirement for nicotine barrier for these products is below. The pH value for the chewing gum is usually slightly higher 4.

In natalem aerosol nicotine is present in the form of a liquid solution having a concentration of approximately 10 mg/ml and a pH value of approximately 7. Nasal aerosol placed in a glass vessel, inert in relation to the aggressiveness of nicotine. However, the nicotine solution, also comes into contact with the pads and the piston ustroystvami.imeet packaging. Here, the concentration depends on the pressure of the vapors of nicotine which changes depending on temperature. At room temperature the concentration of the patch is approximately 250 mg/ml In the patch and inhaler pH value is approximately at 9-10.

The number of factors is important when choosing packaging for nikotinsoderzhaschie products. Nicotine should not migrate through the packaging material and to evaporate from the system or uncontrollably to accumulate in the packing material. Nicotine should be protected from exposure to oxygen, because it is easily decomposed by contact with air or with oxygen. Products containing nicotine also get brown or yellow color, even when there are only small quantities of decomposition products, leading to cosmetic flaws long before you have exhausted all the limits of stability. Thus, it is extremely important to have good barrier to oxygen.

In addition to the above initial requirements nicotinic stability and low oxygen permeability and other factors that should be taken into account with respect to packaging materials for nikotinsoderzhaschie product is arier especially important for nasal aerosols, in which the loss of water has a strong influence on the concentration of the product. Characteristics of the water barrier is also important in other forms of distribution, because the water can have an effect on the penetrating characteristics of the polymer. Great discussion and requires the ability to process, as discussed large-scale production, in which even small problems can lead to large cost.

To find the packaging material for packaging nikotinsoderzhaschie product that meets the requirements listed above, the proposed two different types of polymers. The first of these materials is PEN, polyethylenterephthalat:PEN is a complex polyester based on dimethyl-2,6-pattendee.remotename or monomers 2,6-naphthaleneboronic acid. Dimethyl-2,6-naphthalene - dicarboxylate and monomers-2,6-naphthaleneboronic acid, for example, sold by the company Amoco under the trademark NDC and NDA-monomer, respectively. PEN is a semi-crystalline substance and is a glassy polymer at room temperature.

There are other polymers, such as PTN (polytrimethylene), which is based on the same monomers. PTN is the issue about the use of polymers, containing both substances and dimethyl-2,6-naphthalenyloxy or monomers 2,6-naphthaleneboronic acid.

PEN differs from PET (polyethylene terephthalate), which is another, usually more used polyester, the fact that the benzene ring in the PET molecule replaced by naphthalene in PEN. This makes the PEN more stringent than the structure of the PET and makes the PEN properties more suitable for the present invention than those of the PET.

Second nicotinereplacement polymer in accordance with the present invention is a complex of the polyester-based Liquid Crystal Polymer LCP. One example of such polymers is VectraTAnd 530 with the following structure:LCPs are a group of materials that have a characteristic molecular structure. LCP polymers consist of zhestkokrilih rod-like macromolecules that are straight by lining up one line when melting with the formation of idcourse patterns. Such specific structure leads to a significant improvement in mechanical properties compared with conventional polymers, and also gives a number of other exceptional properties. Monomers are hydroxybenzoic acid and hydroxy isA 530, filled with 30% mineral filler. LCP material has a dense structure due to its high crystallinity, is chemically resistant and has an extremely low degree of diffusion for oxygen and water.

According to the invention it was unexpectedly found that in addition to the above-mentioned barrier properties against water and oxygen, PEN, PTN and LCP also demonstrate remarkable barrier properties in relation to nicotine. Table 1 shows the comparison of the properties WagahT210, PEN and 14991 VectraA 530. For comparison, the polymer Isoplast 2530 (polyurethane having better barrier characteristics than other prioritary due to its high transition temperature in the glassy state), which has a high impermeability to nicotine.

Barexsold by the company British Petroleum, PEN firm Shell and Eastman, Vectracompany Ticona and Isoplast company of Dow.

The stability of these materials in relation to nicotine was investigated using the following tests for the study of sorption. The pieces individually, each of the investigated materials were placed in glass b is under the amount retained in each of the pieces of polymeric materials nicotine was extracted and analyzed using UV, HPLC (high performance liquid chromatography) and GC (gas chromatography). Values for Wagah 210 used as reference levels.

As explained above, PTN, sold through a Shell company, chemically very similar PEN. In the chemistry of polymers usually acts adopted the view that related to the chemical structure of the compounds have similar physical/chemical properties. Therefore, the above good results for PEN imply that PTN has good barrier properties against nicotine.

Not permeable to nicotine polymers PEN and PTN in accordance with the invention can be used by themselves in the form of films or can be combined with other impermeable materials when laminating to further improve the barrier characteristics of the packaging material. Suitable for laminating materials are metals, particularly aluminum, foil, and other polymers, such as polyacrylonitrile (CANCER), polyamide (PA) grades (PVDS) and fluorocarbon polymers, each of which are good barriers to oxygen and water are also suitable other polymeric materials, such as ethylenevinylacetate copolymer (EVOH) and polyvinyl who plasticine polymers, such as, for example, SurlynTfrom DuPont), polyethylene (PE) and polypropylene (PP), which are waterproof.

LSP station most suitable for use in the case of injection molding. PEN, PTN and LPS can be fused with other polymers such as PET. Such alloy may then be treated as a PET, but thanks to the introduction of the PEN, PTN and LPS alloy demonstrates the superior barrier properties compared to pure PET.

Hereinafter the invention will be described and illustrated on the following example. It should be noted that this example should not be construed as limiting the invention in any way.

Example 1.

Infinite plate with aluminum foil, which is not necessarily the one hand laminated with a thin layer of polymer, such as polyethylene or polypropyleneglycol, roll from the reel on which it is stored, and passed the applicator, which is on the other side of aluminum foil or laminated aluminum foil causes a continuous layer PEN, PTN or LPS with extrusion of the covering device. The thickness of the aluminum foil is in the range from 5 to 50 μm, preferably in the range of 8-20 μm. The amount of deposited polymer may varai was one and was essentially undamaged, whole. An acceptable thickness of the PEN, PTN and LPS is in the range of 1-100 μm, preferably 8-50 μm.

Later, the bags of plaster is made by dividing the laminate on two plates with the formation of the upper and lower parts of the bag. Consistently using a vacuum device nikotinsoderzhaschie patch is placed on one plate and placed on top of another plate. The end plates are clamped to each other by heating at the edges, with the formation of the bag.

In example 1, is not permeable to nicotine materials used for the manufacture of packaging that completely surrounds nikotinsoderzhaschie product. These materials also primenenii for partial encirclement of the product and/or for sealing the package nikotinsoderzhaschie product. PEN, PTN and LCP can also be taken in other areas where use BarexT. One such application is the sealing of polymeric tubes containing polymer liners with nicotine for nicotine inhaler, which is currently supplied by the company Pharmasia Up John that described in U.S. patent 5501236. The polymer tube can be made from materials in accordance with the present invention. These tubes can be made, Apanovich chewing gum or tablets and for sealing glass bulbs containing nicotine nasal sprays. Materials are also suitable for packaging, as dosage forms, such as pills and tablets, and the like, is poured directly into the packaging. Therefore, the packaging for special need is made in the form or forms, where the injected substance, which must be formed in the form of tablets, pills and the like, with the specified material, reaching its final form, is formed during solidification in the package. In each such package, for example, may be merged one or more tablets, pills and the like. After infusion of packaging can be sofalcone or something like that, to ensure the nicotine impermeable packaging for wityh tablets, pills and so on. If necessary, the packing material may be provided with an additional material, or a thin plate, so that the substance was poured, not stuck to the packaging material.

Claims

1. The packaging material containing nicotine product containing the polymer, based on dimethyl-2,6-naphthalenedisulfonate and/or monomers 2,6-naphthaleneboronic acid and representing polio contains the other(s) polymer(s), preferably, one or more, such as pan-PAN, polyamide-RA, grades-PVDC, fluoropolymers, ethylenevinylalcohol copolymer-EVOH, polyvinyl alcohol-PVA, ionomers, polyethylene PE, polypropylene PP and polyethylene terephthalate-PET.

3. Material according to any one of the preceding paragraphs, characterized in that it is laminated to one or more metallic and/or polymers(Oh)s foils(Oh)AMI.

4. The material on p. 3, characterized in that it is laminated with aluminum foil.

5. Material according to any one of the preceding paragraphs, characterized in that it is used for full circle, partial circle, and/or for sealing the package containing nicotine product.

6. Material according to any one of the preceding paragraphs, characterized in that it is used for packaging, which is supplied forms or their equivalent, where to pour the substance as solidification in the package is given its final shape and appearance.

7. The material on p. 6, characterized in that it is used for packaging, which lay directly tablets or pills.

8. Material according to any one of the preceding paragraphs, characterized in that it is used for packaging the patch for transdermal administration of nicotine, DL is nicotine or nicotine inhalers.

9. The packaging material containing nicotine product containing crystalline polymer complex polyester LCP-based hydroxybenzoic acid and hydroxynaphthoate acid.

10. The material on p. 9, characterized in that it further contains the other(s) polymer(s), preferably one or more, such as pan-PAN, polyamide-PA, grades-PVDC, fluoropolymers, ethylenevinylalcohol copolymer-EVOH, polyvinyl alcohol-PVA, ionomers, polyethylene PE, polypropylene PP and polyethylene terephthalate-PET.

11. Material according to any one of paragraphs. 9 and 10, characterized in that it is laminated to one or more metallic and/or polymers(Oh)s foils(Oh)AMI.

12. The material on p. 11, characterized in that it is laminated with aluminum foil.

13. Material according to any one of the preceding paragraphs, characterized in that it is used for full circle, partial circle, and/or for sealing the package containing nicotine product.

14. Material according to any one of the preceding paragraphs, characterized in that it is used for packaging, which is supplied forms or their equivalent, where to pour the substance as solidification in the package is given its final shape and appearance.

15. Material pogladyat tablets or pills.

16. Material according to any one of the preceding paragraphs, characterized in that it is used for packaging the patch for transdermal administration of nicotine, for nikotinsoderzhaschie chewing gum, for nikotinsoderzhaschie tablets, sprays for nasal administration of nicotine or nicotine inhalers.

 

Same patents:

The invention relates to a biodegradable complex polyesters, which are used to produce thermoplastic products

The invention relates to products made of polyester plastic, preferably polyethylene terephthalate (PET) having one or more layers of thermoplastic material with good barrier characteristics for gas applied directly to at least one of its surfaces, and new methods of making such articles

The invention relates to a multilayer plastic bottles, which are able to absorb oxygen sufficient to maintain full or almost full (depending on the requirements of the product) lack of oxygen in the tank to provide the required retention period contained in the bottle of the product in the store

The invention relates to a method of coating methods, extrusion on a metal surface
The invention relates to materials for the manufacture of containers and to containers on its basis intended for beverages and other food products, which can be applied by stamping circuit configuration and create the shape of the container by bending sheet

The invention relates to biodegradiruemym the copolymers and plastic products, including biodegradable copolymers

Composite material // 2214921
The invention relates to thermoplastic composite materials, in particular materials having a layer of acrylic resin

The invention relates to the field of packaging food products such as sweets, chocolate, candy, sugar or caramel, chewing gum, candy

The invention relates to a layered material consisting of at least two different polymeric materials that are directly connected to each other, where (A) is a thermoplastic polymer or thermoplastic polymer mixture containing at least one polar compound, at least one of the metals 1-5th main groups or 1-8-th side groups of the periodic system in the form of an extremely fine powder, and (B) is a polyurethane

The invention relates to the production of organo - and fiberglass to protect against thermal factors defeat an open flame and intense heat fluxes and can be used in the construction, automotive, chemical engineering, etc

The invention relates to the condensation copolymers, are able to absorb oxygen, which can be used for the manufacture of films, containers, packaging, bottles, etc

The invention relates to technology of textile finishing production, namely, to furnish heat-resistant materials for sewing special flame-retardant and oil service, giving them a high physico-mechanical properties

The invention relates to a method for production of a stretched multilayer breathable film that provides a barrier to microorganisms and a barrier to blood and body fluids, and the film itself

The invention relates to the field of macromolecular chemistry, more specifically to a method for producing a composite polymer pervaporation membranes, representing multiclone a product made of layers on the basis of polymers with different structures

The invention relates to the manufacture of heat-shrinkable casings, able to withstand high mechanical loads
Up!