WO2022079744A1 - Produit pour administration orale, procédé de production dudit produit et composition dudit produit - Google Patents

Produit pour administration orale, procédé de production dudit produit et composition dudit produit Download PDF

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Publication number
WO2022079744A1
WO2022079744A1 PCT/IT2021/050291 IT2021050291W WO2022079744A1 WO 2022079744 A1 WO2022079744 A1 WO 2022079744A1 IT 2021050291 W IT2021050291 W IT 2021050291W WO 2022079744 A1 WO2022079744 A1 WO 2022079744A1
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WO
WIPO (PCT)
Prior art keywords
powder composition
compression
product
wrapping
oral administration
Prior art date
Application number
PCT/IT2021/050291
Other languages
English (en)
Inventor
Fiorenzo Draghetti
Original Assignee
I.M.A Industria Macchine Automatiche S.P.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by I.M.A Industria Macchine Automatiche S.P.A. filed Critical I.M.A Industria Macchine Automatiche S.P.A.
Publication of WO2022079744A1 publication Critical patent/WO2022079744A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B13/00—Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10—Chemical features of tobacco products or tobacco substitutes
    • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/465—Nicotine; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Definitions

  • the present invention concerns a product for oral administration, a method to produce such product as well as the composition of the latter. More specifically, the product for oral administration is of the type that is wrapped in a non-edible wrapping and is configured to be left for a long time in the mouth of the user, whose saliva provides to extract the active ingredient.
  • Tobacco-based products for oral use are known, which are to be consumed simply by leaving them in the mouth, rather than by smoking them. In this way, nicotine is taken without suffering the harmful effects caused by the combustion of tobacco, as instead happens in traditional smoking articles.
  • the snus is also made available in the form of single-dose products wrapped in a closed wrapping of material permeable to saliva, but not edible, in order to prevent the tobacco powder from spreading in the mouth.
  • a single-dose product of the state of the art is shown in fig. 1A, which shows the closed wrapping containing the tobacco powder, and the loose tobacco powder contained inside it.
  • a typical example of the material with which the wrapping can be made provides a filter paper similar to the material that is usually used for tea bags.
  • the saliva reaches the tobacco powder contained therein and extracts its active ingredients, in particular nicotine, by suction.
  • the product needs to be left in the mouth, more precisely between the lip and - - the gum, for a duration that can vary according to taste, ranging from a few minutes to several hours. It should be noted that neither the tobacco nor the wrapping are ingested by the consumer.
  • One disadvantage of known single-dose products lies in their standard sizes. Typically, one of these single-dose products has a length of the order of 2.5 cm, a width of the order of 1 cm and a height of the order of half a centimeter.
  • Another disadvantage, directly related to the sizes of the single-dose products, is linked to their packaging inside a secondary packaging, typically consisting of plastic boxes, comprising a predefined number of single-dose products, for example twenty or twenty-five.
  • the plastic boxes which are generally circular in shape, need to have a diameter of the order of 7 cm or more, each box having a weight in plastic of almost 20g. This leads to a considerable consumption of plastic material. Furthermore, due to the rectangular shape of the single-dose products, a considerable part of the internal volume of the box remains unoccupied.
  • tobacco-based oral products have been developed in which the single-dose packages to be left in the user’s mouth do not contain powder, but a product configured as a tablet.
  • This type of product is described, for example, by the international patent applications published with the publication number n. WO 2008/140372 Al and W02009/068279 Al.
  • one purpose of the present invention is to provide a composition that can be used to produce a product for oral administration which is configured as a substitute for the traditional or new generation smoking articles currently available on the market.
  • Another purpose of the present invention is to provide a product for oral administration that the consumer does not perceive as uncomfortable to leave in his/her mouth due to its bulk and/or the prolonged period of time it remains in the mouth.
  • Another purpose of the invention is to provide a product for oral administration the secondary packaging of which requires a smaller quantity of plastic than the products for oral administration of the state of the art.
  • Another purpose of the invention is to provide a product for oral administration that is capable of releasing its own active or gustatory ingredients quickly and effectively.
  • Another purpose is to perfect a method to produce the product for oral administration as above.
  • Another purpose is to perfect a method to produce the product for oral administration that allows to achieve the high productivity typical of an industrial process and which is, at the same time, simple to implement.
  • Another purpose is to provide a method to produce the product for oral administration which requires less frequent maintenance and cleaning interventions than the methods known in the state of the art.
  • a compressed tablet comprising a composition containing nicotine, and a lubricating substance.
  • the lubricating substance is preferably at a concentration comprised between 0.1% and 5% by weight with respect to the total weight of the composition.
  • the tablet according to the present invention must not be excessively compressed, such as a tablet of the orosoluble or orodispersible type.
  • the nicotine-containing powder is not meant to be ingested, but to release substances with determinate properties. If the tablet were too compressed, there would be a risk of not having the gradual release effect of the active ingredient by suction, typical of this kind of oral products.
  • the compressed tablet according to the present invention preferably has irregular edges or corners, even visible to the naked eye, due to the degree of porosity that characterizes it mentioned above.
  • the tablets known in the state of art, in particular in the pharmaceutical or food sector are completely compressed, with a negligible degree of porosity and with substantially regular, straight and smooth edges.
  • the tablet compression allows to have a single-dose product for oral administration that has smaller sizes than the “snus” products included in the state of the art. They are therefore less uncomfortable and awkward to keep in the mouth than those known in the state of the art.
  • Another advantage deriving from the fact that the compressed tablets have reduced sizes lies in the fact that their packaging inside the secondary packaging determines a lower consumption of plastic. Furthermore, thanks to the fact that the tablets are compressed and have the desired shapes and sizes, it is possible to significantly optimize the disposition of the oral products inside the secondary packaging.
  • a product for oral administration comprising the compressed tablet as above packaged in a closed wrapping made of a liquid permeable material, preferably not edible.
  • the liquid permeable material allows the passage of liquids, such as for example saliva, both from the outside to the inside of the wrapping and also from the inside to the outside of the wrapping.
  • the liquid permeable material can be a filter material.
  • the compressed tablet enclosed in the closed wrapping is at least partly crumbled. More preferably, the compressed tablet, inside the wrapping of liquid permeable material, has one or more fractures in correspondence with respective one or more points of a lateral edge thereof. These fractures define preferential trigger zones for the subsequent complete disintegration of the tablet, which is thus further facilitated. This determines a greater effectiveness of the saliva’s action, and therefore a faster dispersion of the active ingredient in the mouth.
  • a method to prepare a product for oral administration comprising a composition containing nicotine.
  • the method provides to dose a predetermined quantity of a loose powder composition containing nicotine in order to form a dose, to compress the dose so as to obtain a compressed tablet, and to package the compressed tablet individually in a wrapping of filter material, preferably not edible.
  • the wrapping is closed so as to enclose the compressed tablet and not let it escape.
  • the method also comprises, after the compression, a sub-step that provides to crush the compressed tablet so as to have the compressed tablet at least partly crumbled in the wrapping.
  • the compression step as above is advantageously carried out in a suitable compression unit, comprising one or more compression seatings and as many compression members.
  • the packaging step is performed after the compression step, that is, after the tablet has been compressed. By doing so, the use of the powder, and the dirt it generates, is limited to the compression unit only.
  • the packaging step provides to feed, or more precisely to “spray”, by means of a flow of air, doses of powder inside the packaging material made of filter material able to form the closed wrapping.
  • spraying powder on the packaging material as occurs in the state of the art, the particles of powder pass through the pores of the packaging material, spreading freely in many zones of the machine adjacent to the packaging zone, creating dirt and accumulation of powder which have to be removed in order to maintain the correct functionality of the machine.
  • Feeding the compressed tablets instead of the loose powder allows to prevent the escape of powder from the package being formed, and therefore dirtying the zone adjacent to the packaging zone, thus significantly limiting maintenance and cleaning interventions compared to the methods known in the state of the art.
  • the product thus obtained comprising the compressed tablet packaged in the wrapping of liquid permeable material, is advantageously packaged in a secondary packaging, preferably of the box-shaped type, made with plastic materials.
  • the liquid permeable material with which the wrapping is made is supplied in the form of a sheet or film.
  • the method provides, before the step of compressing the powder composition as above, a lubrication step so that the composition does not stick to the walls of the compression seatings and/or to the compression members.
  • the lubrication step provides to lubricate the powder composition by spraying a compound with lubricating properties on it.
  • the lubrication step can provide the lubrication of the compression seatings by introducing a lubricating liquid inside them.
  • it can also be provided to apply on the walls of the compression seating and/or on the compression member a coating of non-adherent material, such as for example Teflon, at least on the parts that come into contact with the powder to be compressed.
  • the method can provide, after the dosage step, a step of verifying the weight of the doses. More preferably, the weight verification step is performed during the compression step.
  • a load cell connected to the compression station can be provided.
  • the compression step is preceded by a step of pre-compressing the loose powder composition.
  • the partial crushing of the compressed tablets inside their closed wrapping occurs during the packaging step.
  • the one or more fractures are created in correspondence with the respective one or more points of its lateral edge.
  • a step of humidifying the compressed tablets for example implemented by spraying water or a suitable aqueous solution.
  • the humidifying step can be performed before, during or after the step of packaging the compressed tablet inside its packaging wrapping.
  • the humidifying liquid for example water
  • the humidifying step can be provided before or after the partial crushing of the compressed tablet.
  • an oral composition which can be used as a substitute product for cigarettes or other smoking articles.
  • the composition comprises nicotine and a lubricating substance, such as for example magnesium stearate, present in a concentration comprised between 0.1% and 5% by weight, with respect to the total weight of the composition.
  • a lubricating substance such as for example magnesium stearate
  • the composition is in the form of a powder. More advantageously, the powder is obtained by crushing tobacco leaves and treating them with aqueous steam in order to humidify the powder obtained.
  • - figs. 1A, IB and 1C are plan views, respectively, of an oral product of the state of the art, an oral product according to a first variant of the invention, and an oral product according to a second variant of the invention, in which the respective doses of powder composition comprised in each of the products are also visible, in the case of figs. IB and 1C these doses already being in the form of a compressed tablet;
  • - fig. 2 is an enlarged view of a detail of the compressed tablet shown in fig. IB;
  • FIG. 3 is a schematic front view of a method to prepare an oral product in accordance with the teachings of the present invention.
  • FIG. 4A, 4B and 4C are schematic views of an operating sequence which show successive steps comprised in the method according to the present invention.
  • - fig. 5 is an enlarged view of a detail of fig. 3.
  • the product for oral administration 10 also referred to hereafter only as “product” for the sake of brevity, comprises a powder composition containing nicotine, which in particular is compressed in order to form a tablet, and a wrapping 12 in which the composition 11 is enclosed.
  • reference number 11 indicates the compressed tablet, also referred to simply as “tablet” for the sake of brevity, of which two different embodiments can be seen in the lower part of figs. IB and 1C.
  • the compressed tablet 11 containing nicotine is intended to be used as a substitute for products for smoking articles, such as cigars, cigarettes and suchlike, so as to allow a consumer to take the nicotine without suffering the damage resulting from the combustion of tobacco in the cigarette.
  • the compressed tablet 11 consists of a humidified tobacco powder.
  • the humidified powder is obtained in a known manner, that is, by crushing and/or grinding tobacco, preferably fresh tobacco.
  • the powder obtained is then humidified in a known manner, for example by means of a treatment with water vapor.
  • composition also advantageously comprises excipients and/or additives which can improve its properties, for example the organoleptic properties or mechanical properties of the powder.
  • the composition comprises a lubricant, in a proportion preferably comprised between 0.1% and 5% by weight with respect to the total weight of the composition, more preferably between 0.5% and 4.5%, in order to facilitate its processing during the production of the oral product, as will be better explained below.
  • a suitable lubricating product is magnesium stearate.
  • the excipients and/or additives present in the composition are suitable for food use and can be ingested, in the event they are extracted from the saliva together with the nicotine, during the normal consumption of the oral product.
  • the wrapping 12 is made of a liquid permeable material, for example a filter material, in particular a material able to allow the passage of the saliva.
  • a filter material in particular a material able to allow the passage of the saliva.
  • the saliva can penetrate inside the wrapping 12 and come into contact with the compressed tablet 11 to extract the active ingredients of interest, in particular nicotine.
  • Saliva can also escape from the wrapping 12, taking the active ingredients extracted from the tablet 11 with it.
  • filtering material that the wrapping 12 can be made of is filter paper, of the type used for making tea bags.
  • the wrapping 12 is a flexible wrapping, also called “pouch”.
  • the compression of the powder composition allows to reduce its volume, by reducing the volume occupied by the air present inside the powder, that is, the intra-particle and inter-particle spaces inside the powder.
  • the compressed tablet 11 with a cylindrical shape has a diameter of the order of 1 cm.
  • the wrapping 12 can have a length of just under 2 cm, a width slightly greater than 1 cm and a height of the order of half a centimeter.
  • the tablet has a substantially rectangular parallelepiped shape with sizes of a few millimeters, for example 16 x 6 x 5, which respectively indicate the length, width and height of the tablet.
  • the corresponding wrapping 12 can have a length of the order of 2 cm, a width of the order of 7 mm and a height of the order of half a centimeter.
  • the sizes of the oral product 10 are smaller than the oral products of the state of the art.
  • the oral product 10 according to the invention can have an overall volume approximately halved with respect to the volume of known oral products.
  • the compression is not such as to remove every amount of air from the inside of the compressed tablet 11, such as for example for orosoluble tablets.
  • the degree of porosity of the tablet 11 can occur after a variable period of time following its insertion in the mouth. For example, a rapid disintegration of the tablet can be provided in order to have a fast and intense release of the substances. On the other hand, a longer and more widespread disintegration over time can also be provided in order to have a more gradual and lasting release of the substances.
  • the degree of porosity can be calculated using the formula 1 -(tablet density/true density), where the expression “tablet density” indicates the density of the tablet, while the expression “true density” indicates the density of the particles that make up the powder composition.
  • the tablet 11 which preferably has the shape of a solid with two opposite transverse surfaces and at least one lateral surface that connects the two transverse surfaces, has sharp edges 13 which have an irregular shape (fig. 2).
  • the tablet 11 has edges 13 with a globally linear shape but with an alternation of full and empty segments, visible to the naked eye, indicative of the porous structure of the tablet 11.
  • the compressed tablet 11 is partly crushed inside the wrapping 12, even before coming into contact with saliva. Providing that the tablet is already partly crushed allows to facilitate and accelerate the total disintegration of the tablet 11 after it comes into contact with saliva.
  • the oral product 10 as above can be produced by means of a production line 100 schematically shown in fig. 3.
  • the production line 100 comprises a station 110 for dosing the loose powder composition, indicated with reference number 11 A.
  • the dosing station 110 which preferably comprises a hopper 111, is in particular configured to feed predetermined doses of loose powder 11 A toward the following compression station 120.
  • the compression station 120 can for example comprise at least one compression member 121 and at least one corresponding compression seating 122, in which the compression member 121 engages, equipped with a bottom wall 122 A (fig. 3).
  • the compression member 121 can be configured as a punch or a plunger, the extremal surface 121 A of which comes into contact with the loose powder 11A disposed in the compression seating 122 so as to compress it against the bottom wall 122 A.
  • a controlled force is applied to the punch 121 so as to perform a desired compression of the powder, according to requirements.
  • load cells not shown, to be connected to the compression station 120, suitable to measure the forces applied to compress the powder composition 11A and/or to measure the weight of the latter before compression.
  • the line 100 Downstream of the compression station 120, the line 100 comprises a primary packaging zone 130 configured to wrap the compressed tablets 11 produced in the compression station 120 in their wrapping 12 of filter material.
  • the primary packaging zone 130 is of the so-called “flowpack” type, and comprises a station 131 for feeding at least one film 12A of liquid permeable material, in correspondence with which the film 12A is fed by a reel 12B thereof.
  • the station 131 for feeding the film 12A is followed by a longitudinal closure station 132, in correspondence with which the film 12A is wound around the tablets 11 fed in succession in a direction of feed A, and closed in the longitudinal direction by means of a longitudinal closure member 132 A, which is preferably driven against an abutment member 132B thereof so as to operate the longitudinal closure (fig. 3).
  • transverse closure station 133 In succession, in the direction of feed A, downstream of the longitudinal closure member 132A there is a transverse closure station 133, configured to close the film 12A of liquid permeable material transversely with respect to the direction of feed A.
  • the transverse closure station 133 is suitably provided with two closing members 133 A, 133B, each located on one respective side with respect to the succession of tablets 11 and which cooperate with each other so as to operate the closure of the film 12 A.
  • the two transverse closure members 133 A, 133B are of the counter-rotating type, but it is also possible to provide, alternatively, elements which, for example, open and close according to a translation motion toward and away from the film 12 A.
  • the longitudinal and transverse closures as above are preferably carried out by sealing the film 12A of liquid permeable material.
  • the closing members 132A, 132B, 133 A, 133B are, of course, suitable sealing members of the type commonly used in the automatic product packaging sector.
  • the primary packaging zone 130 also comprises a cutting station 134 disposed downstream of the transverse closure station 133 and provided with two opposite cutting members 134A, 134B, each disposed on one respective side of the film 12A and cooperating to cut the film 12A in correspondence with the transverse closures, so as to individually divide the wrappings 12.
  • Each cutting member 134A, 134B is equipped with a respective blade 134C (fig. 5).
  • the production line 100 also comprises a humidification device 140, located downstream of the compression station 120.
  • the humidification can occur by spraying liquid water, as schematically shown in fig. 3.
  • the humidification device 140 is located upstream of the primary packaging zone 130.
  • the humidification device 140 is configured to humidify the compressed tablets 11 at exit from the compression station 120.
  • the humidification device 140 is disposed inside the primary packaging zone 130, for example between the longitudinal closure station 132 and the transverse closure station 133, or between the transverse closure station 133 and the cutting station 134. Alternatively, it is possible to provide to place the humidification device 140 downstream of the primary packaging zone 130, that is, downstream of the cutting station 134.
  • the production line 100 comprises, downstream of the primary packaging station 130 with reference to the direction of feed A, a secondary packaging station 150 in correspondence with which the oral products 10 are packaged into a secondary packaging.
  • the secondary packaging provides to dispose the oral products 10 in a box 151 equipped with a corresponding lid 152. Both are fed separately and in succession into the secondary packaging station 150.
  • the secondary packaging station 150 is preferably located downstream of the humidification device 140.
  • the production line 100 also comprises a lubrication device 160 located in the vicinity of the compression station, so as to deliver a predetermined quantity of lubricant toward the powder composition before its compression occurs.
  • the lubrication device 160 comprises, for example, a delivery nozzle and is configured to spray the lubricant.
  • One possible example of a method to produce the oral product 10 in accordance with the invention is the following.
  • First a dosing step is provided, in which predetermined quantities of loose powder composition 11A are dosed, which are fed toward the compression station 120.
  • the compression step is performed, during which the doses of loose powder composition 11A are compressed in the compression seatings 122.
  • the compression occurs by driving the punch 121 so that it repeatedly hits the powder composition.
  • some embodiments of the method provide to carry out a lubrication step before the compression step.
  • the loose powder composition 11 A is prevented from adhering to the extremal surface 121 A of the punch 121 or to the bottom surface 122 A of the compression seating 122.
  • the lubrication step it can be provided to spray a liquid lubricant by means of the lubrication device 160 located in the vicinity of the compression station 120.
  • spraying the lubricant serves to lubricate the loose powder composition 11 A.
  • a liquid lubricating substance for example a solution of magnesium stearate
  • it can be provided to coat the extremal surface 121A of the punch 121 and/or the bottom wall 122A of the compression seating 122 with a film of non-stick material.
  • non-stick material can be, for example, Teflon or any other non-stick material suitable for use with food substances.
  • the step of coating the extremal surface 121 A of the punch 121 and the bottom wall 122 A of the compression seating 122 is performed in a step of assembly and set up of the production line 100.
  • the powder composition 11A can first undergo a precompression step, followed by a compression step.
  • the loose powder composition 11A is fed into the compression seating 122, where it occupies a first volume which, the lateral sizes of the seating 122 being equal, is identified by a first height Hl with respect to the bottom wall 122 A of the compression seating 122 (fig. 4A).
  • the loose powder composition 11A undergoes a pre-compression step, which provides to carry out a first slight compression on the powder, by means of the punch 121, with a predefined pre-compression force, advantageously smaller than the compression force that will be applied subsequently.
  • the step of pre-compressing the powder composition causes the latter to assume a second height H2, smaller than the first height Hl (fig. 4B).
  • a step of compressing the powder composition is carried out, in which the punch 121 compresses the powder composition already partly compressed during the pre-compression step, preferably by means of a compression force greater than the pre-compression force.
  • the powder composition reaches a third height H3 with respect to the bottom wall 122 A, inside the compression seating 122, which is smaller than the second height H2 (fig. 4C).
  • the compressed tablet 11 exits from the compression seating 122 in any way already known to the person of skill in the art, for example by expulsion or by falling. It should be noted that, after the compression step, the height of the compressed tablet 11 obtained increases slightly, stabilizing autonomously toward a value that can reach up to 50% of the first height Hl. This height increase is due to an elastic return intrinsically linked to the mechanical properties of the powder composition that has been compressed.
  • the method also provides to weigh the doses of powder composition fed into the compression seatings 122.
  • the weighing preferably occurs by measuring the compression force actually applied during the compression step, for example with the aid of a load cell (not shown in the drawings) connected to the compression station 120.
  • the compressed tablets 11 just produced are fed, preferably in succession and in line, toward the packaging zone 130 according to any mode known in the state of the art or which will be developed in the future.
  • the primary packaging step of the compressed tablets 11 allows to package them individually inside a wrapping 12 of liquid permeable material, for example a filter material, as explained above.
  • the primary packaging step provides a sub-step of partial crushing of the compressed tablet 11 after its wrapping 12 has been closed, that is, after the step of transverse closure of the tubular portion of film 12A of liquid permeable material.
  • This crushing can be performed, for example, by members for advancing the film 12 A, and/or by the cutting members 134A, 134B as shown in fig. 5. In this way, providing dedicated crushing means is prevented, so as to not complicate the production line.
  • these cutting members are preferably configured to operate the partial crushing of the tablet 11 at the moment of the cutting itself.
  • One example of how to achieve this configuration is to provide counter- rotating cutting members 134A, 134B with a circular body with a diameter such as to interfere with the oral product 10 being formed at the time of cutting (fig. 5). This interference can be due to a reciprocal distance between the surfaces of the two cutting members 134A, 134B that is smaller than the height H of the compressed tablet 11 at the time of cutting (fig. 5).
  • the difference in height must not be excessive, so as to effect only a partial crumbling of the tablet 11, preferably only in correspondence with a part of its edge 13.
  • the oral products 10 are automatically fed toward the secondary packaging station 150, where they are disposed inside a box 151.
  • the feed of the oral products 10 into the box 151 is controlled so as to feed a predetermined number of oral products 10 into the box 151. Once this predetermined number has been reached, a lid 152 is fed and applied onto the box 151 so as to close it.
  • the compressed tablet 11 is advantageously humidified, by means of the humidification device, during its feed toward the primary packaging station 130, during its feed into the primary packaging station 130, or during its feed toward the secondary packaging station 150. It is also possible to provide different steps of humidifying the compressed tablet 11.

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  • Chemical & Material Sciences (AREA)
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  • Medicinal Preparation (AREA)

Abstract

Un produit pour administration orale (10) comprend une composition de poudre (11A) contenant de la nicotine enfermée dans un emballage fermé (12) constitué d'un matériau perméable aux liquides. A son tour, dans une station d'emballage secondaire, le produit pour administration orale (10) est emballé à l'intérieur d'emballages en forme de boîte (151) qui peuvent être fermés au moyen de couvercles (152) correspondants. L'invention concerne également le procédé de production d'un tel produit pour une administration orale (10).
PCT/IT2021/050291 2020-10-12 2021-09-23 Produit pour administration orale, procédé de production dudit produit et composition dudit produit WO2022079744A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102020000023887A IT202000023887A1 (it) 2020-10-12 2020-10-12 Prodotto per somministrazione orale, procedimento per realizzare detto prodotto e sua composizione.
IT102020000023887 2020-10-12

Publications (1)

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WO2022079744A1 true WO2022079744A1 (fr) 2022-04-21

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IT (1) IT202000023887A1 (fr)
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008140372A1 (fr) * 2007-05-16 2008-11-20 Mcneil Ab Formulation nicotinique orale enrobée, tamponnée aux acides aminés
WO2009068279A1 (fr) * 2007-11-28 2009-06-04 Philip Morris Products S.A. Produit du tabac comprimé sans fumée pour la consommation orale
US20100021540A1 (en) * 2008-02-28 2010-01-28 Abbott Laboratories Tablets and Preparation Thereof
US20150157620A1 (en) * 2012-07-30 2015-06-11 Pierre Fabre Medicament Lozenges with multiple release kinetics for active ingredients
US9986756B2 (en) * 2012-01-20 2018-06-05 Altria Client Services Llc Exhausted-tobacco oral product

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008140372A1 (fr) * 2007-05-16 2008-11-20 Mcneil Ab Formulation nicotinique orale enrobée, tamponnée aux acides aminés
WO2009068279A1 (fr) * 2007-11-28 2009-06-04 Philip Morris Products S.A. Produit du tabac comprimé sans fumée pour la consommation orale
US20100021540A1 (en) * 2008-02-28 2010-01-28 Abbott Laboratories Tablets and Preparation Thereof
US9986756B2 (en) * 2012-01-20 2018-06-05 Altria Client Services Llc Exhausted-tobacco oral product
US20150157620A1 (en) * 2012-07-30 2015-06-11 Pierre Fabre Medicament Lozenges with multiple release kinetics for active ingredients

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Publication number Publication date
IT202000023887A1 (it) 2022-04-12

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