A method of manufacturing pieces of plaster for the transmission of influence through the skin

 

The invention relates to medicine, specifically to the continuous process of forming a piece of patch for percutaneous exposure, contains the following stages: a continuous supply of strip material containing layer permeable membrane, a continuous supply for clamping the surfaces with the first strip, the second strip formed of an impermeable material basis, the joint transmission of the first and second strips through the position of the filling and sealing, in which the material containing the active substance is injected between the bands and the formation of pockets of the first covering devices that close up of the band with each other in the longitudinal direction of the strips, and the second covering device, that close up of the band with each other in the transverse direction of the bands; the size of the pockets regulate through regulating provisions and/or frequency of the first covering device and/or by regulating the quantity of provisions and/or the frequency of the second covering device. The invention allows to obtain a large pocket to accommodate a large volume of gel. 17 C.p. f-crystals, 1 Il.

This invention relates to a method isrotating patch, which can be applied to the skin of a person, who wants to receive a certain dose of nicotine, when he was going to quit.

One particularly satisfactory form of piece of patch disclosed in the description of the patent in the United Kingdom 2232892, where he generally defined as a closed body for insertion through the skin of physiologically active substances, such body contains impermeable support membrane and a microporous or permeable membrane, which form between them a cavity, and mentioned physiologically active substance is inside said cavity in liquid form, these microporous or permeable membrane permeable to the aforementioned physiologically active substances and is in contact with him, and the liquid material, enclosed between the impermeable base membrane and a microporous or permeable membrane within said cavity, virtually no mobility through a viscous flowable gel, characterized in that: a) either the above-mentioned hydrophilic membrane, and the contents of the mentioned hydrophobic cavity; b) or the above-mentioned hydrophobic membrane, and the cavity contains a hydrophilic wetting agent; in the process ISOE is it a controlled velocity and the physiologically active substance is released from the microporous membrane with the speed which is virtually constant over a period of several hours.

Normally closed body in the form of a piece of plaster from one to the other hand has multiple layers, which may include: (i) remove and remove the protective layer, (ii) a layer of sticky substance, (iii) permeable membrane or membrane, (iv) a layer of gel containing the physiologically active substance (such as nicotine), and (v) a layer of impermeable material basis.

In practice, the first three (or more) layer can be applied in the form of pre-formed layered structure. Then you need to apply the active substance [layer (iv)] a layered structure [on the combination of layers (i)-(iii)] , and then hook the active substance in the proper place by providing a layer basics [layer (v)].

Usually, when a manufacturer of products of this type, submit materials horizontally and a certain amount of the active substance precipitated fixed intervals or positions along the layered structure, after which the substrate is installed in the proper position, so as to cover the active substance to the mounting substrate, for example, by compression, to a layered structure in the regions around the individual to whom, is Platania", for example, a process similar to the shown machine for packing goods bubble packs. If you need to change the volume of the tank, you must perform a significant refurbishments.

Taking into account the fact that the active substance is usually in the form of a gel, it can be estimated that there are serious problems in the treatment of the gel associated with providing appropriate quantity of gel through the clear intervals along the layered structure without allocation of gel into the environment. In addition, when it is desirable to change the amount of gel in order to change the amount of active substance in the piece of plaster, or change the area of contact of product with skin (assuming that the concentration of active substance in the gel remains the same), it may be difficult to change in the car when its work to achieve the desired effect.

There is already equipment to wrap such items as the so-called calling cards, which are cards for introduction into the phone mechanism, so that the user can use the phone for saving unused items held by electromagnetic means, LISCO to the second layer of material and parallel to it. Often one layer is transparent and the other opaque, and contains instructions and other information. Two layers of material to reduce and condense with each other through opposite pairs of sealing devices, such as hot wheels, which act on the opposite longitudinal edges of two strips of material, which brought with each other. In addition, the sealing mechanism intermittent acts in the transverse direction of contiguous layers, already connected along their opposite longitudinal edge areas, so it's pocket. When the formed pocket, a phone card or something like that served in the pocket, which still remains open along its top (fourth) edges. As soon as the card or other object properly placed in the pocket, and while both layers continue to move down, the fourth open edge of the pocket is closed, usually by the same horizontal sealing mechanism. In fact, the most efficient way to perform this operation in relation to the upper edge of the lower pocket is in its seal at the same time that you seal the bottom edge nearest the top of the pocket. Both sealing operation could same time, when is the seal, it is desirable to form the last transverse seal, and directly next during the process or at a later stage, the pockets can be separated from each other by cutting, or in the zone between the upper seal the bottom of the pocket and the lower seal the top of the pocket can be formed by lines of weakening, so the pockets still remain connected on the ends, but when the line attenuation, which can be easily performed gap.

To some extent, of such equipment may also be used to create pockets that contain other ingredients such as sugar or seasonings (for use in restaurants).

According to the first aspect of the present invention created a method of forming a piece of patch for percutaneous exposure, which contains the following stages: the flow from the first linear speed of the strip material containing the removed layer, adhesive layer and the permeable membrane; a feed with the same first linear velocity, at least one second strip formed of an impermeable material (material) basis, in a position of close proximity with the first strip, with erwou the position of the seal, which, at least, the opposite longitudinal edge zones of the strips are attached to each other, and, as an option to mount the intermediate zones of the strips along their lengths so as to form at least one elongated chamber; passing the first and second strips connected at least at their longitudinal edges, through the second position of the seal, on which the strips are sealed to each other in the transverse direction at intervals along the strip, due to what each camera becomes an open top pocket; the introduction of the liquid containing the active substance, in the newly formed pocket or pockets; sealing pockets along their previously left open edges so as to form a completely sealed pockets.

According to the second aspect of the present invention created a method for continuous formation of a piece of adhesive for percutaneous exposure, which contains the following stages:
a continuous supply of strip material containing layer permeable membrane;
a continuous supply of the second strip containing impermeable material basis, in the position of close proximity with the first band, and with their surfaces facing each other;
with Arial, contains the active substance is injected between the bars and through the first covering devices that close up of the band with each other in the longitudinal direction of the strips, and the second covering devices that close up of the band with each other in the transverse direction of the bands, form pockets;
the size of the pockets regulate through regulating provisions and/or frequency of operation of the first covering devices and/or throttling of the provisions and/or frequency of operation of the second covering device.

In the dispensing and shaping pieces of plaster synchronous/synchronous way it is a continuous process. This process differs from the technology bubble products, which is a function from one position to the other, and is not continuous.

Usually on the second covering the top, the previously exposed area of the pocket or pockets are sealed, and the sealing at the same time allows you to close the lower part of the pocket or pockets directly above the first mentioned pocket or pockets.

The method may also include phase separation is of ASI active substance, from adjacent pockets that are closer and further in the course of manufacture.

If you want to provide on one corner of the piece of tarpaulin tear the ear, then at this stage may be provided with the function "shear cut". In addition, at this stage, or directly after this stage can be performed other functions, such as registration, application of the relief and elimination of the bumps.

In addition, when two lanes initially bring with each other and sealed along their longitudinal edges, and when the gap between the sealing edge area provides one or more additional longitudinal seal, then you will create two or more pockets, it is desirable to separate these adjacent in the transverse direction pockets at the corresponding position, which is further along. This can be achieved, for example, by means of rollers acting on the opposite side of the United strips, at least one of the rollers has a cutting edge so as to separate adjacent pockets in the transverse direction.

Preferably, in the process according to the present invention was applied system for gas flushing, which can be provided by the base, that pocket, when he closed up, actually contains only the gel and the flushing gas, such as nitrogen. Alternatively, instead of using the inert flushing gas filling and sealing can be performed in a "vacuum".

Sealing adjacent strips can be carried out through opposite pairs covering devices (for example, the heated rollers), and the means by which the injected fluid (gel) containing the active substance may be in the form of a tube, the lower open end of which may be at a level that is significantly below the axis of rotation of these covering devices, and may be located at a level slightly above the level at which use cross-covering device, which alternately converge with each other to create a transverse seals along the strip through the desired intervals. It can be estimated that a careful synchronization of different parts that perform stage sealing and cutting, with current technology easily enables you to achieve this.

When it is desirable to increase the number of active substances with maintaining a constant concentration of active substance in the gel, it is obvious that you need the I one or more ways. If, for example, during the manufacture of pockets make three pockets that are next to each other, it is possible to reduce the number of pockets to two, which will increase the allowable width of each pocket. Do this by removing one of the pairs covering devices (for example, a heating roller) and adjust the location of the remaining pairs covering devices; in addition, remove one of the dispensing nozzles.

Alternatively, or in addition to this, adjust the run time of the transverse sealing to be performed over large intervals, resulting in a form more long pockets.

It is obvious that when the transverse sealing during the formation of the longer pockets perform with less frequency, it is also necessary that you made appropriate adjustment of the transverse cutting equipment, so that the cutting was still running along the seeding division one sealed pocket or row of pockets from the adjacent pocket or row of pockets.

Obviously, even if the amount of pocket change, you can continue feeding the first and second bands with the same linear velocity. In addition, there is no need to replace the two and the mandatory production. In other words, to obtain the pockets of different size can be used without adjustment of the same materials and some videos. In fact, a significant advantage of the present invention is that the desired change of the volume of the pocket does not need any modification to the components responsible for the submission of two original bands of the materials. The handling of such bands is performed with sufficient care, this provides a significant advantage to maintain a constant feed rate. This advantage is that the continuous process allows you to have on the material constant pressure/tension, which leads to less damage to or distortion of the finished product and to receive caressing eyes", and aesthetically more pleasing pocket than received intermittent way. Indeed, intermittent or inconsistent ways, such as according to which the work machine for sealing bubble packaging, in which the movement is performed according to the principle of start-stop, can cause damage due to the stretching of the material.

Relatively simply by means of the corresponding control equipment to ensure poperen the Oia longer or shorter pockets, and equally relatively easy when the same control equipment to ensure coordination of the components responsible for cross-cutting, without re-equipment of the machine.

Through experiments it was determined that the process according to the present invention can be used for the manufacture of small pockets measuring up to 2 cm2. It differs from known processes in which the smallest possible area of the pocket is at least 5 cm2.

The tube or tubes, or something similar that provides the injection of the gel containing the active substance into the pockets remain in the same position and produce respectively corresponding volume of gel in the pocket, is formed when a transversal seal, or immediately after its formation. Provided equipment for accurate dosing, which ensures that exactly the desired amount of gel is deposited in each pocket, and this equipment can be adjusted to compensate for the increase or reduction of requirements in relation to the volume of the pocket in a manner similar to the regulation of the time of actuation covering devices.

Preferably, the flow meters shall redient, introduced to it in the pocket actually in the vertical direction. However, alternatively, the materials may be fed through an essentially horizontal direction, while the liquid is injected in fact, in the vertical direction.

For a better understanding of the present invention and to show how it can effectively exercise will be made with reference to the example according to the attached drawing, which shows a perspective view of the method according to the present invention performed on the equipment with the appropriate device for implementing the method.

The drawing shows a drum 1 with the base material in the form of a strip 2, which is pulled together with the drum 1 and is passed around the tension roller 3, and then over a guide roller 4 and the other guide roller 5, and then in the lower direction. In a similar manner, but starting from the opposite side equipment, a drum 6 with a layered material (the aforementioned type), with a strip 7 of a material (for example, in the form of a layered structure), take off the drum 6 and pass around their own tension roller 8, and then around three guide rollers 9, 10 and 11, and further down in the zone "gap" 12, where it su is the IKI 13, 14 and 15, which carry sealing strips 2 and 7 at their opposite in the longitudinal direction of the edge zones 16 and 17, as well as in the Central zone 18, so that the area between the two strips 2 and 7 is divided into two pockets 19 and 20, which are open at the top and bottom ends. However, when these pockets 19 and 20 are moved down, they are faced with cross-covering system, intermittent, which contains two hot rod 21 and 22, which are usually separated from each other, but occasionally come with each other for the formation of the horizontal seals across the width moves in the lower direction of the strips 2 and 7, whereby the pockets 19 and 20 are sealed along their bottom edges, as well as their vertical edges. Not shown (for clarity) two tubes that protrude into the pockets 19 and 20, the lower end zone of the tubes are just over the hot rods 21 and 22. Near these two tubes are two smaller tube (also not shown), through which the inert gas (in particular, nitrogen) under pressure is introduced into the pockets 19 and 20, in order to provide an inert atmosphere within the metered fill your pockets by imposing certain doses of gel through the main tube in these pockets 19 and 20. When heated CTE is the PTO pockets 23 and 24. It is easy to see that the heating and sealing action of the rods 21 and 22 provides simultaneous sealing the bottom edges of the pockets 19 and 20 and the upper edges of the pockets 23 and 24. Also obviously, lanes 2 and 7, when they separated and when moved in conjunction with each other, then continuously move with the same linear velocity. For this reason, the terminals 21 and 22 when they are in lanes 2 and 7, are moved with the same speed as the strip, so that the smooth progress of these bands is not slowing down.

Below the pockets 23 and 24 show two other pockets 25 and 26, formed shortly before the creation of pockets 23 and 24. As shown in the drawing, the lower edge of the pockets 25 and 26 are exposed to devices 27 and 28 for cutting, which is cut in the transverse direction of the United lanes 2 and 7, in order to separate a pair of pockets 25 and 26 of the pair 29, are presented below in the form of pockets 30 and 31.

It is obvious that the complex equipment such as parentally mechanism can be applied to pull the strips 2 and 7 with a uniform velocity and for their submission to the covering system consisting of heated rollers 13, 14 and 15, with the same speed and bandwidth of the United lanes 2 and 7 If you require more long pockets, you only need to provide covering system 21, 22 for the same duration, but with large intervals, and the system 27, 28 for cutting with the appropriate long intervals. It is also clear that when equipped with three pairs 13, 14 and 15 of heated rollers covering system is provided by the manufacturer of the two pockets 19 and 20, and that by increasing or decreasing the number of pairs of heated rollers or other covering devices, you can increase or decrease the number of pockets formed close to each other.

Dosing through tubes (not shown) of the gel containing the active substance (e.g., nicotine), can be carried out by the perfect dosing equipment, which comes to the consumer market, such as equipment company ibar systems Limited.

Although the dosage of the gel through a tube into a pocket or pockets carried out in the form of discontinuous portions, the supply of inert gas through the connecting pipe or interconnecting pipe to provide the formed pocket or pockets inert atmosphere may be carried out continuously.

With appropriate control equipment can by tapping the edit button mesrine operation of sealing the heating components 21, 22 and components 27, 28 to be cut off in order to change the length of the pockets. There is no need for readjustment of the equipment. Therefore, the change in the value of the pockets may be effected without the necessity of replacement of any hardware components. All you need to do is change the location of the heating rollers 13, 14 and 15 and/or the frequency of operation of the system 21, 22 for sealing and systems 27, 28 to be cut off. If desired, the base material can be painted in body color or it will be left unpainted on the side which is facing outwards, when a piece of plaster put on the human body. At further stages during the process of individual pockets can be cut to ensure a "tear-off lug" "shear cut", while they individually can be Packed in their own individual wrapper or wrap groups, jointly collected in bags or other appropriate containers.


Claims

1. Method for continuous formation of a transdermal patch, comprising the following steps: a continuous supply with a linear speed of the strip material containing the removed layer, the adhesive layer is of the first strip of impermeable material (material) of the substrate facing each other with the surfaces in close proximity with the surface of the first strip, joint transmission of the first and second strips through the first position for sealing, which, at least, the opposite longitudinal edge zones of the strips are fixed to each other, in particular, with intermediate zones of the strips attached along their length to form at least one elongated chamber, joint transmission bands, joined at least along the longitudinal edges, through the second position for sealing, which strips fasten to each other in the transverse direction at intervals along the strips, whereby each camera becomes an open top pocket, the introduction of a liquid or gel containing the active substance, in the newly formed pocket or pockets, and the incorporation of pockets along their previously left open zones for the formation of a fully patched pockets.

2. The method according to p. 1, characterized in that the previously open area of the pocket or pockets are sealed at the second position for sealing, the seal sealing simultaneously closes the adjacent area of the pocket or pockets directly above in the course of the initially mentioned pocket or pockets.

3. The method according to p. 1 or 2, characterized in that it further includes the step of separating ku is containing the active substance, from adjacent pockets above and below along the tape patch.

4. The method according to any of the preceding paragraphs, characterized in that the phase separation cut additionally perform an operation “shear cut”.

5. The method according to any of the preceding paragraphs, characterized in that the two bands first reduce each other and sealed along their longitudinal edges, and separately or simultaneously create one or more additional longitudinal seal between the fittings and edge zones to create thus of two or more adjacent in the transverse direction pocket width of the bands.

6. The method according to p. 5, characterized in that adjacent in the transverse direction, the pockets are separated at the stage of cutting in the longitudinal direction by means of rollers, at least one of which has a cutting edge and which affect the opposite side of the United strips for separating adjacent in the transverse direction of the pockets.

7. The method according to any of the preceding paragraphs, characterized in that it further comprises the step of flushing gas, in which each pocket is washed gas before and/or during the step in which the injected liquid or gel.

8. The method according to p. 7, characterized in that atrivayut of tubes of small diameter directly into his pocket.

9. The method according to any of the preceding paragraphs, characterized in that the steps of filling and sealing carried out at a pressure below atmospheric pressure.

10. The method according to any of the preceding paragraphs, characterized in that the sealing adjacent strips shall be implemented by the opposite pairs of longitudinal or transverse covering devices.

11. The method according to p. 10, characterized in that the means through which the injected liquid or gel containing the active substance is performed in the form of a filling tube, which is inserted into each pocket.

12. The method according to p. 11, characterized in that the lower end of the filling tube set at a level that is significantly below the axis of rotation of the covering device.

13. The method according to p. 10 or 11, characterized in that the filling tube set at a level slightly above the level at which a cross-covering device.

14. The method according to any of paragraphs.10-13, characterized in that it further comprises the step of regulating the amount of pockets that run close to each other, by adding or removing one or more pairs of longitudinal covering devices and to control the location of the intermediate zadelyvanija size pockets through regulation time cross-covering devices, what change the length of the pockets.

16. The method according to any of the preceding paragraphs, characterized in that the pockets do not less than 2 cm2.

17. The method according to any of the preceding paragraphs, characterized in that the strip serves essentially in the vertical direction and the liquid or gel containing the active substance is injected into the pocket or pockets essentially in the vertical direction.

18. The method according to any of paragraphs.1-16, characterized in that the strip serves essentially in the horizontal direction, and the liquid or gel containing the active substance is injected into the pocket or pockets essentially in the vertical direction.

 

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EFFECT: low risk of traumatic complications.

5 cl, 2 dwg

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