Nebulizer disposable

 

(57) Abstract:

Usage: the invention relates to medicine and can be used in inhalers. The inventive nebulizer disposable comprises a tubular casing forming a flow path of air, open at both ends, with one end forms an air intake 4 and the other end forms vozduhovyvoda hole 5. The casing includes a compartment 3 for storing inhalable powder pharmaceutical drug. The compartment 3 is located close to the intake 4 and covered with a thin foil 6, which gives the Department of airtightness. The foil can be removed from the compartment from the outside of the casing, and the specified casing attached form with narrowing 9, adjacent powder compartment 3 so that the narrowing of the inhalation was turbulent air flow, which raises the powder from the compartment 3 and mixes the powder with the air flow. 13 C.p. f-crystals, 7 Il.

The invention relates to driven the breath inhaler, having, in General, a tubular shape and having two ends, with one end forms the air intake, and the other end of the vent hole, and the inhaler contains a powder pharmaceutical pre the of, driven by respiration are described, for example in WO 89/01348, US-A-4265236, and EP-A-0404454.

In EP-A-0404454 describes the inhaler one time use, driven by the breath of the containing chamber for powder pharmaceutical drug, with the specified camera provide with air intake and exhaust hole. The air intake and vostokovedenie hole closed by a common cover. The powder is placed in a relatively large chamber, which means that the powder will not necessarily be located in the place in which the air flow is the most effective.

In US-A-4265236 describes a tubular nebulizer disposable, driven by the breath containing a flexible tube, the ends of which are normally sealed is inserted into each other. This type of seal will not necessarily water resistant. In addition, there is the risk that a certain amount of the powder may fall out of the inhaler when the ends of the tube disconnected.

In WO 89/01348, in a variant embodiment, representing most interest here, describes a tubular nebulizer disposable, which is sealed at both ends with the break-away covers. A single dose is alatore, there is a risk that some of the powder will be lost when the inhaler is open.

The present invention is the task of creating a nebulizer disposable, in which the dose of the powder of a pharmaceutical product can be installed accurately and in which powder of a pharmaceutical product may be stored at ensuring an airtight seal and moisture resistance. Dose transmitted using different samples of the same inhaler, should be generally constant. Finally, the inhaler should be prepared to use and simple to use and also simple and cheap to manufacture.

This task is achieved in that the inhaler one time use has characteristics that are described in the main claim. Advantageous variants of the embodiment described in the dependent claims.

In Fig.1 shows a perspective view of the inhaler in accordance with the present invention; Fig.2 perspective view of the inhaler in accordance with Fig.1, but showing the two main parts of the inhaler in a disassembled state, and Fig.3, A-C different stages of opening of the powder division is the preferable embodiment of the narrowing of the adjacent powder compartment.

A preferred variant of the present invention described in Fig.1 4. In Fig. 1 shows a fully assembled inhaler is ready for use. As you can see, the inhaler consists of two elongated main parts, the upper part 1, which is made from a molded sheet of plastic material, and the lower part 2, preferably made from laminated plastic aluminum foil. The upper part 1 has a-shaped, essentially rectangular in shape. The width of the top part several times greater than the height. The lower portion is generally flat, and thus, these two parts form a tubular casing, restricting air channel or flow path of the air intake 4 and exhaust 5 hole. The spherical portion of the grooves or recesses 3, indicated by the dashed line, is placed close to the reciever 4. The recess 3 forms a powder compartment covered with tape 6, which preferably are made of aluminum foil, also laminated plastic. The recess 3 may also be provided with one or more small apertures 24 in the bottom. The hole or holes 24 occurrences must be sufficiently high to allow the entry of air is through the opening (s).

As shown, the end portion of the tape 6, covering the recess 3, have between the recess 3 and the reciever 4. The ribbon attached to the lower part 2 around the powder compartment through relatively weak weld joint 22 (Fig. 2). The end of the tape is attached by means of a relatively large and, thus, a stronger weld joint, front office, as you can see, set the airflow direction. The free portion of the tape 6 are bent back over the recess 3 and released to the outside through the air intake 4. In this particular variant embodiment of the free portion of the tape guide and support the two conical projections 7 and 8, extending in a downward direction on the upper part 1. The free portion of the tape may be bent in a loop under the bottom part 2 and is attached to the lower portion around the recess 3 with a relatively weak weld joint, thus sealing the hole 24 and the recess 3. The tape should be long enough to extend after the recess 3, forming, thus, the lug 25, which serves as a grip for opening the tape.

The narrowing of the flow path in the form of a protrusion 9, oriented perpendicularly relative to norwescap limit at each end of the support 10.

In addition, the nebulizer provide devices for deaggregation after the powder compartment, as seen in the direction of the intended direction of air flow through the inhaler. These fixtures to deaggregate contain a number of inclined flat surfaces that are oriented at an angle of approximately 30owith respect to the longitudinal direction of the inhaler, and it was determined that the most efficient angle of the flat surface relative to the direction of flow of air to break up the agglomerates of the powder is, the angle is approximately equal to 30o. Since the air flow will be to some extent deviate flat surface, the flow direction will not be the same as the longitudinal direction, and the above angle was selected as the best compromise. However, this angle may vary in the range between 30 and 50owhen the preferred range of 25 30o.

The flat surface of the Orient, in General, perpendicular relative to the bottom part 2, or at least as perpendicular as possible with the method of manufacturing an inhaler. A flat surface is positioned so that their projections in the plane of the cross section with recreates, to ensure that any large particles or agglomerates entrained in the air stream will hit at least one such surface.

In a preferred variant embodiment of the flat surfaces 12, 13, 14, 15 and 16 are placed on the ends up of the technological chain of the two pairs of recesses 17, 18, 19 and 20 formed in the side surfaces of the upper part 1 and at the end up the processing chain of the Central recess 21 located between the said indentation forming an island in the flow path. The ends down the processing chain of these recesses and the recesses converge in the direction of air flow and have a smooth, rounded shape for good aerodynamic parameters without any areas where you could settle the powder carried by a stream of air.

In Fig.2 two main parts of the inhaler shown separated. In addition to the parts shown in Fig.1, a powder compartment 3 is shown open, and the tape 6 is pulled out through the air intake. Form (dashed line) of a welded joint 22 may be visible on the ribbon 6 and around the powder compartment 3. As you can see, the shape of the welded connection is selected to be on the perimeter of quadratini tape from the bottom 2 will be facilitated, since wresting action will be on the front and the back corner. Because the weld that holds the inner end of the tape is wide and sturdy, the user, through increased resistance you feel when the unit is open.

In Fig.3, A-C shows various stages of opening of the powder compartment 3 by pulling the tape 6, exposing thereby the powder 23. In Fig.3, A shows the tape 6 is attached around the recess 3 on the bottom side of the bottom, thus closing the opening 24, leaving the eye of the gap 25.

The view from the end shown in Fig.4 more clearly illustrates the relationship between the top 1, bottom 2, and the powder compartment 3, tape 6, the conical projections 7, 8, the protrusion 9 and the supports 10.

When the inhaler should be used, inhaler is held more or less horizontally with the flat half 2 facing down. Free horses of the tape 6 is pulled through the eyelets 25, exposing, thereby, the hole 23 and the powder in the powder compartment 3. Two conical protrusion 7 and 8 will hold the tape 6 flat against the bottom part 2 and, thus, to prevent the tape to block the narrowing of the powder before the division of the military air flow through the inhaler will be very turbulent in the area of narrowing and powder pharmaceutical drug will rise from the powder compartment and mixed with the air flow. Any particles stuck to the tape, can also be entrained with the air flow as part of the tape, first covering the powder Department, will also be laid directly on the flow path. By puckane air in the lower part of the recess 3, a through hole 24 will engage with the lower pressure at the bottom of the recess, which can prevent the lifting of the powder from the hollows.

The tests showed that the dose leaving the typical powder compartment (e.g., 0.5 mg), located at the narrowing, with an area of approximately 10 to 12 mm2will remain essentially constant when the air velocity varying from 30 l/min 60 l/min

Filled with powder, the air will then flow from narrowing to the devices for deaggregation. The angle of the inclined surfaces will cause that lighter particles, i.e. particles within the respirable range, less than 6 microns, will be rejected from the surface without sticking to it and, therefore, will mainly follow the air stream, while the heavier particles and agglomerates will hit about it and to deviate from flat surfaces and in this case to split into smaller dasticity showed what percentage of particles within the respirable range in the inhaled dose will remain essentially constant when the air flow rate of 30 l/min 60 l/min

What dose inhaled particles remains constant in a wide range of air flows, is important to minimize differences between patients with different abilities to inhalation.

It should be noted that the tubular shape of the inhaler makes it possible to install a rubber ball or similar object over the reciever. With it, the powder can be discharged from the inhaler into the throat of the patient in synchronism with the respiration of the patient with the help of the assistant, if the patient will not be able to use the inhaler on their own.

As mentioned above, the lower part 2 of the inhaler, as well as the tape 6 is preferably made of aluminum foil laminated to or coated with an appropriate plastic. Aluminum will ensure the desired protection from moisture, while plastic will ensure that the tape can be welded to the bottom and the fact that the lower part can be welded to the top. The lower part can consist, for example of aluminum foil, having a thickness of 45 μm, which on one side pona, which has a thickness of 60 μm. The upper part is preferably made of polypropylene with a thickness of 300 or 400 μm. The upper part may be transparent so that the user can see, is blown if the dose of the powder compartment. The tape may be made of a layered material having a polyester having the effect of "exfoliation", aluminum and the layer containing the polymer blend of polybutylene and polypropylene.

The choice of material of the inhaler must comply with applicable drug drug. The above materials selected, keeping in view the specific drug (budesonide), these materials are more readily release the drug.

A certain composition of the powder pharmaceutical drug is completely optional, and the powder may contain, for example pure active substance, a mixture of different active substances or mixture of active substances (active substances) with adjuvant (adjuvants). It should be noted that the amount of drug selection greatly expands due to moisture-proof protective shell of a drug in a powder compartment.

The inhaler can be made as Abramovich offices. If the recesses should be provided with through-holes, they also form at this stage. Deepening fill drugs, whose vertices are called scraper, which will guarantee essentially the same amount of different doses. Then laminated plastic and aluminum foil are welded over the holes and around the indentation on the outer side of the bottom.

After that, the lower part of the weld to the upper parts and the strip is cut to the formation of a separate inhalers, which are ready for packaging and use. The upper part is formed from sheets of plastic. When the molding operation, attention must be paid to ensure that the side walls of the upper part were possible, perpendicular to the top side to ensure air flow, which is more uniform throughout the cross section of the inhaler. Features supports 10 is to prevent the protrusion, forming a constriction, a distorted during the welding process.

The invention is, of course, can have many modifications within the scope of the attached claims.

Thus, the protrusion 9, education is on the powder. In Fig.5 7 illustrates several examples of this.

In Fig.5 shows how the projection 9 may be provided with a small Central hole 26 on the powder compartment 3. When the patient takes a breath through the inhaler, additional air will be directed more or less perpendicular down to the powder compartment, thus increasing the turbulent effects in the vicinity of the powder compartment.

In Fig. 6 and 7 shows two alternative embodiments in which the protrusion is provided by the edge 27 and 28, respectively oriented along the longitudinal length of the ledge, and which will also send some amount of air flow more directly into the powder compartment.

However, these variants of the embodiment will require a higher degree of precision to obtain the desired effect than the above-described variant embodiments and therefore will be more difficult to produce.

The protrusion 9, which forms a constriction, is illustrated as having a trapezoidal cross section and as straight in longitudinal section. However, it should be noted that narrowing can have a number of forms within the scope of the attached claims.rich it's not the main axis parallel to the direction of air flow, or you may have a different shape. You can also have multiple recesses, for example, if you want to increase the dose accurately in a known manner. As described above, the powder compartment can be made without holes (holes) 24. In addition, to seal the recess 3 with respect to the openings (holes) 24 can be used two separate tape.

The protrusions 7 and 8 can be given a shape that is different from the conical and which may be such that the protrusions were sent much of the air flow more directly over the powder compartment. They can also be integrated with the supports 10.

Tape 6 can also be adapted so that it could be completely removed from the lower part 2. In this case, the protrusions 7 and 8 is not necessary, at least not for direction or support tape.

Fixtures for deaggregation can be performed other than in the form of flat surfaces oriented at an angle of approximately 20 to 50orelative to the direction of air flow. This angle can also be changed outside of this range and the surface need not be flat.

The material at the bottom and the ribbon does not need moderatory can be processed so to obtain these properties.

It is also clear that you can do the inhaler in one piece, which doused or fold after the implementation of the respective molding.

1. Nebulizer disposable driven breathing, containing a hollow casing forming a flow path of air, open at both ends, with one end forms the air intake, and the other end forms a vent hole, and the casing contains a storage compartment for inhalable powder pharmaceutical preparation, characterized in that the storage compartment of the inhaled powder is close to the reciever and covered with a thin foil, which gives the Department the tightness, the foil is placed with the possibility of its removal from the casing, and the casing is moulded into the form of a constriction adjacent to the powder compartment, so in order to narrow inhalation formed turbulent air flow to catch up powder from the Department and mixing it with air flow.

2. Inhaler under item 1, characterized in that the deepest part of the Department is connected with the ambient air through one or more through holes.

3. Inhaler on p. 1, distinguished by the s, containing a powder compartment, made in the form of recesses when the two halves are joined along their longitudinal sides.

4. Inhaler on p. 3, characterized in that the upper half is made of a thin sheet, preferably made of plastic.

5. Inhaler on p. 4, characterized in that the constriction is made in the form of recesses in the upper half of the casing, and the recess is oriented transversely relative to the direction of air flow and is located above the powder compartment.

6. The inhaler according to any one of paragraphs.3 to 5, characterized in that the lower half is made of an aluminum foil laminated with plastic.

7. The inhaler according to any one of paragraphs.1 to 6, characterized in that a thin foil made in the form of a tape having one free end extending from the intake, and the tape is attached to the lower half of the casing around the edges of the powder compartment through relatively weak welded joints.

8. Inhaler on p. 7, characterized in that the free end of the tape is bent from the air intake under the lower half of the casing.

9. Inhaler on p. 8, characterized in that the welded joint is made in a processing chain points duoplant for exposure of the powder.

10. The inhaler according to any one of paragraphs.7 to 9, characterized in that the upper half of the casing between the powder compartment and the intake made the tabs extending down to hold the tape, the tape is not blocking the air flow.

11. The inhaler according to any one of paragraphs.1 to 10, characterized in that between the powder compartment and vent hole in the flow path of the air posted by fit for deaggregation.

12. Inhaler on p. 11, characterized in that the device for deaggregation contain a flat surface oriented at an angle in the range of 20 to 50 degrees to the airflow direction and approximately perpendicular to the plane of the lower half casing, while adaptations are made so that they completely cover the cross-section of the casing to form along the air flow.

13. Inhaler under item 12, characterized in that the flat surface is oriented at an angle in the range of 25 35o.

14. Inhaler on p. 13, characterized in that the flat surface is oriented at an angle 30o.

 

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