MXPA97008179A - Assortment system for dust inhaler s - Google Patents

Abstract

The present invention relates to a storage system and powder assortment for a dry powder inhaler, characterized in that it comprises: a carrier, a bubble shell on the carrier, a shear layer fixed around the perimeter of the bubble shell and a tongue pivotally fixed to the carrier and fixed to the stress layer cut

Description

ASSORTMENT SYSTEM FOR DRY POWDER INHALER BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The field of the invention comprises dry powder storage devices and systems for powdered drugs. Several drugs in a dry powder mixture form can be inhaled directly into the lungs, through the lungs and nose. Inhalation allows the drug does not pass through the digestive system and can eliminate the need for other techniques of drug application of more intervention, for example, hypodermic injections, etc. Direct inhalation may allow smaller doses of drug to be used to achieve the same desired results as the same orally administered drug. In other cases, inhalation can help avoid undesirable side effects. To provide direct inhalation of a powder drug, several dry powder inhalers have been used. These dry powder inhalers typically provide dry powder from a bulk tank, capsule or bubble pack, for inhalation by the patient. To seal the powdered drug from the environment (to reduce cake formation, contamination, etc.), individual discrete sealed dose containers, such as bubbles, are preferred. However, although various storage devices and assortment of dry powder in bubbles have been used, several disadvantages remain. For example, the bubble must be strong enough to provide good sealing against the environment, but also to be able to reliably release the drug powder when used by the patient. In addition, to provide better precise doses, virtually the drug powder must be released from the bubble into the inhalation device, of course, without letting any of the bubble or container material mix with or flow along with the drug powder. . As inhaled drugs, such as asthma drugs, storage and drug assortment materials can be used very frequently; Advantageously, the device must be compact, inexpensive and easy to manufacture and use. Accordingly, an object of the invention is to provide an improved dry powder storage and assortment system for use with an inhaler.

BRIEF DESCRIPTION OF THE INVENTION For these purposes, a storage device and dry powder assortment preferably includes a disk having radially separated metal thin film bubbles containing a drug powder. The bubbles are advantageously sealed on a layer of shearing stress of the underlying metal foil. In the preferred embodiment, the shear layer is attached to a carrier disk. Cutting tabs are advantageously joined on the shear layer, below each bubble, with a space separating the tabs of the disk. In preferred use, an actuator pushes on the tongue, pressing or peeling off the shear layer of the bubble, and releasing the dry powder content from the bubble. The bubble can also preferably be formed of a brittle material with a marked line usually centrally located, so that the bubble is opened when it is engaged by an actuator, to release the powder drug content from the bubble.

BRIEF DESCRIPTION OF THE DIBU30S Other objects and aspects of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings. However, the drawings are provided for purposes of illustration only and are not intended to limit the scope of invention. In the drawings, where similar reference characters denote similar elements throughout the various views: Figure 1 is a perspective view of a dry powder inhaler; Figure la is a perspective view of the advance knob of the inhaler of Figure 1; Figure Ib is a plan view of the inhaler of figure 1; the figure is a schematically illustrated partial sectional view of the inhaler of figure 1; Figure 2 is a perspective view of a drug carrying disc having external tabs; Figure 3 is a perspective view of an alternative carrier disk, having internal disk tabs, - Figure 4 is another embodiment of a disk carrier having tabs contained within the disk; Figure 5 is an enlarged partial section view taken along the line 5-5 of Figure 2; Figure 5A is a top view thereof; Figure 5B is an exploded sectional view taken along line 5B-5B of Figure A; Figure 5C is a bottom view thereof; Figure 6 is a side elevational view thereof, immediately before opening the bubble; Figure 7 is a side elevation view thereof, immediately after the bubble has been opened by shear stress; Figure 8 is a sectional view of the carrier disc of Figure 2 installed within a first mode of dry powder inhaler; Figure 9 is a sectional view of the disc carrier of Figure 2 installed inside a dry powder inhaler of the second embodiment; Figure 10 is a perspective view of an alternate disk carrier having circumferentially marked bubbles that burst open on angled plates; Figure 11 is an alternative disc carrier embodiment having bubbles that open radially bursting marked on flat plates; FIGURE LIA is a perspective view of the underside of the disk carrier of FIGURE 11; Figure 12 is another embodiment of a disk carrier having circumferentially bursting open bubbles marked on flat plates; Figure 13 is a vieta fragment is a tornado section along line 13-13 of Figure 10; Figure 14 is a side elevational view of the bubble of Figure 13, immediately before opening; Figure 15 is seen in side elevation thereof, which shows the bubble immediately after opening; and Figure 16 is a perspective view of a peeling direct release carrier.

DETAILED DESCRIPTION OF THE DRAWINGS Turning now to the detail of the drawings, as shown in Figure 1, a dry powder inhaler 20 has a nozzle 22 which is covered by a lid 24 when not in use. A knob 26 on the top of the inhaler 20 can be used to advance individual drug doses to supply them through the nozzle 22. Referring to FIGS. 1, Ib and LE, a bubble opening mechanism 38 includes a button central 28 located on a spring 44 on an oscillator arm 40. The oscillating arm 40 has a lever end 42 for pushing on an inner tongue 32 on a carrier disc 34 to apply shear stress or open by peeling a bubble 36. carrier disk 34 and bubble 36 are further illustrated in Figures 2-5. Figure 2 shows a carrier disc 46 which has external tabs 48 which extend from radially spaced bubbles 36 supported on a carrier disk 60. Figure 3 better illustrates the carrier disk 34 shown in Figure 1, which has tabs. 32. FIG. 4 shows another embodiment of reciprocating carrier disk having tabs contained within the profile of the disk 50. Pin holes 52 for shear stress extend from the disk 50 and during use, the pins in an inhaler device extend through the holes 52 to push against a tongue contained within the disc 50, to shear open the bubbles 36. The carrier discs 34, 46 and 50 may include an indicator / pulse slot 72. Turning to FIG. 5 that illustrates a tongue carrier disk design, a bubble cora 54 is located on a shear layer 56. The perimeter of the bubble cora 54 is sealed advantageously with heat to the shear layer 56 as shown in Figures 5 and 5a. Drug powder 62 is contained between the bubble corall 54 and the shear layer 56. A tab 48 extends below the shear layer 56, below the bubble coil 54. The tongue 48 is separated from the disk carrier 60 by a space 64 all around it, except for the hinge line 68 (Figure 7). The hinge line 68 can optionally be provided as an indented area. A stress concentrator 70 can be similarly included as an option to provide a point or tooth on the disc carrier 60 at the innermost site of the space 64, just inside where the bubble cora and the stress layer meet. cutting. The stress concentrator can help initiate the shear / shear action by peeling the shear layer. The bubble shell 54 and the shear layer 56 are preferably thin sheets of metal, e.g., aluminum. The disc carrier 60 and the tongue 48 are preferably injection molded or die cut plastic. The shear layer 56 adheres to the disc carrier 60 and the tongue 48 with an adhesive 49, and spans the space 64, as shown in Figures 5B and 5C. Figures 6 and 7 illustrate the operation of the disc carrier 60 within an inhaler. As shown in Figure 6, the disk 60 rests on support 84 located just inside the space 64. The bubble 36 is located on a guide wall 86. As shown in Figures 6 and 7, an actuator 80 pushes on the tongue 48 which, acting as a lever, causes the shear layer 56 (forming the lower surface of the bubble 36) to be pressed and peeled off from the bubble shell 54, thereby opening the bubble. The powder 62 contained within the bubble 36 falls freely from the bubble 36 and the disc 60, into a conduit in the inhaler. The tongue 48 rotates pivotally around the hinge point 68. As this occurs, the heat seal 58 remains intact, with the opening of the bubble 36 provided by peeling off the shear layer 56. Referring to FIG. Figure 8, a dry powder inhaler 100 has a housing 102, a nozzle 104 and an impeller 108 inside a mixing chamber 106. A battery-driven motor 110 rotates the impeller 104. As the bubble 36 is opened by stress cutting, as shown in Figures 6 and 7, the bubble powder 36 falls into the mixing chamber 106, mixed with air, and can be extracted and inhaled by the patient. Figure 9 shows an alternative inhaler modality having a nozzle 104 centrally located. Figures 10-16 illustrate bubbles that open by bursting, instead of opening by tearing or peeling. As shown in Figure 10, a burst bubble carrier disc 130 has a plurality of burst bubbles 132 on angled plates 138. Plates 136 and bubbles 132 have a circumferential score of 134. Figure 12 shows a similar embodiment, but with the flat plates in the plane of the disc rather than at an angle. Figure 11 shows an alternative embodiment having flat plates 144, with a radial mark 142 on plates 140 and bubbles. Figure Ia best illustrates radially marked bubbles 148 on radially marked flat plates 144. The marked or weakened section of plates 144 and bubbles 142 preferably are centrally located on each bubble 148. As shown in Figure 13,? N carrier disk 130 of bursting bubbles has a fragile bubble shell 132 fixed by a heat seal 58, at the bubble shell perimeter, to a lid material 150. The lid material 150 in turn is attached to a plate 136. shell 132 of bubbles has a marked or weak point 134 at its center. Correspondingly, the plate 136 has a mark aligned with the mark 134 on the bubble shell 132. The bubble cora 132 is advantageously made of a fragile plastic or metal material. The lid material 150 is preferably metal (e.g., aluminum foil), while the plate 136 is preferably a hard plastic injection molded or die cut, as is the center section of the bearer disk During use, as shown in Figures 14 and 15, a plunger or actuator 160, having a wide flat blade shape with an angled point 166 is urged downward on the mark 134 on the plate 136 which is supported. on its sides by supports 164 (part of the inhaler). As the actuator is driven towards the bubble, the bubble cracks or burst, as shown in Figure 15, releasing the powder 62. The bubbles shown in Figures 5 and 13 can also be provided in strip form, more than In the form of a disc, as shown in Figure 16. Therefore, although several modalities have been shown and described, it should be appreciated that much more modifications can be made, without departing from the spirit and scope of the present invention.

Claims (11)

NOVELTY OF THE INVENTION CLAIMS

1. - A storage and powder assortment system for a dry powder inhaler comprising: a carrier; A bubble shell on the carrier; a layer of shear stress fixed around the perimeter of the bubble shell; and a tongue pivotally fixed to the carrier and fixed to the shear layer.

2. The system according to claim 1, further characterized in that the carrier is a disk.

3. The system according to claim 1, further characterized in that it comprises a plurality of bubble armor and because the carrier is a strip.

4. The system according to claim 1, further characterized in that the shear layer comprises a thin layer metal sheet.

5. The system according to claim 1, further characterized in that the bubble shell comprises a single-layer metallic thin sheet. 6.- The system in accordance with the claim 1, further characterized in that the bubble shell extends over the carrier. 7.- The system in accordance with the claim 1, further characterized in that it comprises a space separating the carrier disk from the tongue on all sides, except in a hinge line which forms a bridge over the space. 8. The system according to claim 2, further characterized in that it comprises: a central opening in the disk; a plurality of shear tabs projecting radially from the central opening, each shear tab having a circumferential edge spaced apart from the carrier disk through a space, and with each shear tab pivotally connected to the carrier disk in a line of hinge along one side of the tongue; with the shear force layer overlapping, fixing to and connecting the carrier disk and the shear tabs; and a bubble layer which overlaps and is fixed to the shear layer, the bubble layer including a plurality of bubble armor each forming a space containing dust between the shear layer and the bubble armor, and with a shell of bubbles formed substantially on each tongue. 9. The system according to claim 8, further characterized in that it comprises a shear force concentrator at the circumferential edge of the tongue, opposite the hinge line. 10. The storage and powder drug storage system according to claim 8, further characterized in that it comprises sealing with heat around a perimeter of substantially each bubble shell, fixing the bubble layer to the stress layer. cutting. 11. An assortment method of a drug dose comprising the steps of: providing an inhaler having an accommodation and a carrier disk with a tongue and an actuator inside the housing, said carrier disk having a bubble which includes a shear layer containing a dose of drug; advancing the carrier disk on the housing to a position in alignment with the actuator in the housing; moving the actuator to engage and move a tongue on the carrier disc; pivoting the tab pivotally through the actuator and applying shear stress to the shear layer that seals the drug dose within the bubble on the carrier disk; and let the dose of drug fall from the bubble into the inhaler housing.