MXPA05005402A

MXPA05005402A - Dry powder inhaler.

Info

Publication number: MXPA05005402A
Application number: MXPA05005402A
Authority: MX
Inventors: Ashwin Bhujanga Rao
Original assignee: Sun Pharmaceutical Ind Ltd
Priority date: 2002-11-20
Filing date: 2003-11-20
Publication date: 2005-08-03
Also published as: WO2004045487A2; AU2003302078A1; BR0316428A; CA2506866A1; WO2004045487A3

Abstract

The present invention provides a dry powder inhaler for administering medicaments in solid finely divided form to patients, wherein the dry powder inhaler is in the form of a disk inhaler comprising a disk shaped rotatable support (11) and an annular blister pack (1) containing at least 30 blister medicament units.

Description

DRY POWDER INHALER FIELD OF THE INVENTION The present invention relates to a dry powder inhaler for delivering to a patient, by oral inhalation, drugs in the form of finely divided solids. The present invention provides a compact, easy to carry and use dry powder inhaler having a means for dispensing a large number of doses of the medicament.

BACKGROUND OF THE INVENTION Dry powder inhalers are known in the prior art. Many of the dry powder inhalers are known and marketed. Some of the dry powder inhalers sold in the market and described in the prior art include: "Spinhaler" (the revolving inhaler of US Patent No. 5,239,991), "Rotahaler" (the revolving inhaler of the patents of U.S. No. 4,210,140 and 4,206,758), "Turbuhaler" (the turbulent inhaler of U.S. Patent Nos. 4,524,769, 4,907,583 and 4,668,218) and "Diskhaler" (the disc inhaler of US Pat. No. 4,811,731 and 5,035,237), among many others. In the art, information is found on dry powder inhalers and on the formulations used therein, for example, in textbooks such as "Particulate Interactions in Dry Powder Foxmulations for Inhalations" by Xian Zeng, Gary Martin and C ristopher Marriott. U.S. Patent Nos. 4,811,731 (assigned to Glaxo Group Limited) and 5,035,237 relate to a class of dry powder inhaler of the 'Diskhaler' type to administer to patients medicaments in the form of finely divided solids, where the dry powder inhaler is constituted by a housing, a tray mounted in the housing, which can move between the first and second positions with respect to the housing, a rotating support disc supplied in the tray and adapted to receive a carrier provided in the medication container. To open the container in a route leading to a mouth piece of inhalation, hereinafter referred to as an inhalation nozzle, a piston is put into operation so as to penetrate a container put in register with the plunger. This device uses a pack or pack of ampoules having 8 bubbles or ampoules in a single row of ampoules and, thus, can only accept one pack or pack of medicine containing only 8 doses. To dispatch two medications, they teach the use of a pair of identical inhalation devices placed back to back, which can be very bulky. Many of the commercially available dry powder inhalers can only contain a few units of medication, since otherwise they would be very bulky. It is necessary for the patient to take the bulky unit with him to administer the medication at the moment he needs it. In the case of dry powder inhalers in the form of inhaler discs or "Diskhalers", so called because they use a disc-shaped blister pack, which is mounted on a disc-shaped rotating holder, we have found that When you put more than 30 units of medicine in ampoules in the ampoules in the shape of a disc, you get a larger and more voluminous inhaler.

OBJECT OF THE INVENTION The object of the invention is to provide a compact, easy-to-carry and use dry powder inhaler having a means for dispensing a large number of doses of medicament.

HIS FIELD OF INVENTION The present invention provides a dry powder inhaler for administering to patients medicaments in the form of finely divided solids, whereby the dry powder inhaler takes the form of a disk-shaped inhaler or "Diskhaler" which contains a disc-shaped rotating holder and an annular package of ampoules containing at least 30 units of medicament in ampoule. More specifically, the present invention provides a dry powder inhaler for administering to patients medicaments in the form of finely divided solids, containing: (a) a lower unit; (b) a rotating support provided in the lower unit; (c) an annular blister pack mounted on the rotating holder, wherein the annular blister pack contains a plurality of medicament units in ampoule disposed in two concentric rings of ampule drug units; (d) an upper cover having a movable sliding piercing bolt unit, the movable sliding piercing bolt unit contains a piercing bolt and means for: (i) locating the unit in a first position to register the piercing bolt with the units of medicament in ampule of the first concentric ring to open or break, successively, the units of medicament in ampoule; (ii) preventing the unit from moving from the first position until the units of medicament in the ampoule of the first concentric ring are exhausted; (iii) after which, locate the unit in a second position to register the piercing bolt with the drug units in ampoule of the second concentric ring and break, successively, the medicine units in ampoule; (e) an air intake means, through which air can be infused into the dry powder inhaler and an air outlet means, through which the patient can inhale, thereby bringing the medication from a respiratory unit. Medicine in perforated ampoule will be dragged by the air flow produced by the patient. Optionally, a means is also provided in the dry powder inhaler of the invention to prevent the movable slider pin unit from moving out of the second position until the ampule vial units of the second concentric ring have been exhausted. .

DETAILED DESCRIPTION OF THE INVENTION The dry powder inhaler of the present invention is illustrated by the modalities described below.

BRIEF DESCRIPTION OF THE DRAWINGS Many aspects of the invention may be better understood by reference to the following drawings. The components of the drawings are not necessarily to scale, instead emphasis will be placed on clearly illustrating the principles of the present invention. Furthermore, in the drawings, like reference numbers designate corresponding parts in the various views. Figures 1A, IB, 1C, ID, 1E and 1F are the top, bottom, section A-A, top isometric, bottom isometric and side view, respectively, of the annular ring package of ampoules containing 30 + 30 doses of medicament. Figures 2A and 2B show the unit of the dry powder inhaler. Figures 3 are the exploded view of the dry powder inhaler. Figures 4A, 4B and 4C are the cross-sectional views of the dry powder inhaler. Figures 5A, 5B, 5C and 5D are variants of the fluted formation of the turbulence elements in the conduit connecting the air inlet orifice with the air outlet orifice of the nozzle.

Figures 6a and 6B show the position of the drilling pin slider for drilling the drug units in ampoule 0 to 30 of the first ring. Figures 6C and 6D show the position of the drilling pin slider for drilling the drug units in ampoule 31 to 60 of the second ring. Figures 7 ?, 7B, 7C, 7D and 7E show the immobilization positions of the drilling pin slide relative to the blister pack. Figure 7A shows the blister pack in the position where the ampoule number 1 drug unit will be punctured. Figure 7B shows the blister packet indexed in the number 2 medication unit. Figure 7C shows the blister pack when it has reached the 30th ampoule unit of the first ring. Figure 7D shows the position of the piercing bolt slide with respect to the blister pack when the ampule number 31 medication unit is ready to be punctured. Figure 7E shows the blister package indexed in medication unit number 32. Figures 8A, 8B and 8C are, respectively, the top isometric, bottom isometric and side isometric views of the drilling pin slide unit. Figures 9A and 9B show, respectively, the positions of the slide in the upper cover for the position 0-30 and the position 0-31. Figure 10? shows the exploded view of the rotating support and the lower unit. Figures 10B and 10C are views in horizontal section and in vertical section, respectively, showing the unidirectional ratchet unit of the rotating support with respect to the lower unit. Figure 11 shows the top views of a preferred embodiment of the inhaler of the present invention; Figures 12 and 13 show the internal views of the preferred embodiment of Figure 11. Figure 14 shows the top view of the annular package of ampoules of type '16 +16 in line '. Figure 15 shows the top view of the ring blister package of type '16 +16 stepped '. Figure 16 shows the top view of the annular gasket of type '32 +32 in line 'blisters. Figure 17 shows the top view of the ring blister package of type '32 +32 stepped '. The figures only represent embodiments of the present invention. The sole intention of the embodiments is to illustrate the present invention. The different parts of the dry powder inhaler of these embodiments are marked in Figures 1 to 17 and these marks are described below.

Figure 1 1: ring blister packaging 2: blister pack numbering 3: circular holes in the ring blister pack for the alignment pin: rectangular holes in the ring blister pack for the alignment pin 5: notch on the blister blister pack for the slide immobilizer bolt 6: first ring of the plurality of drug units in ampule of the annular package of ampoules 7: second ring of the plurality of drug units in ampoule of the annular package of ampoules Figure 2 8: nozzle cover 9: upper cover 10: lower unit 11: rotating support that will receive the annular blister pack 12: direction of movement of the rotating support in the counterclockwise direction 13: entry hole air 14: cutting on the top cover for the cantilever movement of the piercing bolt 15: movable sliding bolt drilling unit 16: counter window that will show the drug unit number to be consumed 17: unidirectional movement of the slide piercing bolt unit 18: position of the slide piercing bolt unit that will pierce the medicine units in ampoule of the first annular ring blister ring 19: position of the sliding piercing pin unit that will pierce the ampule-shaped medicine units in the second annular ring blister ring Figure 3 1: annular blister pack 3: circular holes in the annular blister pack for alignment pin 4: rectangular holes in the annular blister pack for alignment pin 8: nozzle cover 9: top cover 10: lower unit 11: rotating support that will receive the annular blister pack 13: air inlet hole 15: movable slider bolt unit 20: slot in the upper cover for the movement of the slider bolt unit 21: nozzle 22: medicament orifice for the medicament unit of the first annular ring ampoule ring 23: medicament orifice for the medicament unit of the second annular ring ampoule ring 24: ratchet on the lower unit for the unidirectional rotation of the rotating holder 25: circular alignment pins on the rotating support that will fit into the annular package of blisters 26: alignment pins Rectangular in the rotating support that will fit in the annular package of blisters Figure 4 13: air inlet orifice 15: movable sliding piercing bolt unit 22: medicament orifice for the medicament unit of the first annular ring ampoule ring 23: medicament orifice for the medicament unit of the second ring of the medicament annular blister pack 27: duct connecting the air inlet hole to the air outlet hole of the nozzle 28: air flow to the nozzle, which passes through duct 29: medicament that fell inside the duct 30: unidirectional movement of the slide drilling bolt unit 31: drilling bolt 32: sliding bolt immobilizer Figure 6 14: Cutting on the top cover for the cantilever movement of the piercing bolt 15: movable sliding piercing bolt unit 31: piercing bolt 32: slide immobilizer bolt 33: position of the slide piercing bolt unit that will pierce the ampule medicine units of the first annular ring ampoule ring 34: non-return position of the piercing bolt unit slider to pierce the ampule-shaped medicine units in the second annular ring ring of ampoules 35: position marker on slide 36: medicament that fell into the conduit from the first annular ring ring of ampoules 37: medicament that fell into the conduit from the second annular ring blister ring Figure 7 1: annular blister pack 3: circular holes in the annular blister pack for alignment pin 4: rectangular holes in the annular blister pack for alignment pin 5: notch in blister pack for immobilizer pin of slide 15: movable sliding piercing bolt unit 16: counter window that will show the medicine unit number to be consumed 32: slide immobilizer bolt 33: position of the slide piercing bolt unit that will pierce the medicine units in ampoule of the first ring of the annular gasket ampoules 3: non-return position of the slide-piercing bolt unit for piercing the ampule-shaped medicine units of the second ring of the ampoule ring package 38: indexing direction of the ampoule ring package 39: numbered medicament units in the package annular of blisters Figure 8 31: piercing bolt 32: slide immobilizer bolt 35: position mark on slide 40: ratchet arm of slide bolt unit for non-return movement 41: cover of the movement slot of the unit of bolt hole driller on the upper deck Figure 9 9: upper cover 14: cutting on the upper cover for the cantilever movement of the piercing bolt 33: position of the sliding piercing bolt unit that will pierce the ampule medicine units of the first ring of the ampoule ring package 34: non-return position of the slide piercing bolt unit for piercing the ampule medication units of the second annular ring blister ring 42: immobilization of the non-return ratchet of the sliding piercing bolt unit in the upper cover Figure 10 10: lower unit 11: rotating support that will receive the annular blister pack 12: direction of movement of the rotary support in the counterclockwise direction 13: air inlet hole 24: ratchet in the lower unit for the unidirectional rotation of the swivel bracket 43: ratchet arm on the swivel bracket 44: cavity in the swivel bracket for the ratchet arm Figure 12 45: retainer ring in the swivel bracket to prevent movement of the slide piercing bolt unit from the first ring to the second ring of the ampoule ring pack 46: removable cover over the conduit connecting the air inlet hole with the air outlet hole of the nozzle 47: locking lock in the lower unit to prevent movement of the rotating holder when the medicine unit in blister ready to be punctured has not been perforated Figure 13 48: spline design of spiral design in the conduit connecting the air inlet orifice with the nozzle air outlet orifice In one embodiment of the present invention, a dry powder inhaler is provided, the compact view of which is illustrated in Figures 2 ?, 2B and 3. The dry powder inhaler for administering to patients medicaments in the form of finely divided solids contains major parts, namely, a lower unit (10) with a nozzle (21), rotating support ( 11) of the blister pack, an annular blister pack (01) designed to admit a plurality of medicament units in ampoule, top cover (09) containing a movable or sliding slider pin (15) with a pin perforator or plunger (31) for penetrating a medicament unit into an ampoule which is in register therewith, hereinafter referred to as a slider or slider bolt unit and illustrated in Figures 4a, 6B , 8 and 9. The slide piercing bolt unit has a means that contains a slide immobilizer bolt (32), a piercing bolt (31) and an optional ratchet lever (40). The annular blister pack (01) has a plurality of ampule medicine units containing the specified amount of medicament. A plurality of ampule medicine units is disposed in two concentric rings in the blister pack. As described herein, different numbers of ampule medicine units, different configurations of the two rings of the ampoule pack and different diameters of the ampoule pack are possible. Figures 1A to 1F present an annular blister pack used in a preferred embodiment of the invention, wherein the annular ring blister pack contains 30 + 30 medication units in the first and second concentric rings, where the drug units in the first and in the second ring they are in an arrangement or arrangement in line as shown in the figures. In one embodiment, the first ring (06) and the second ring (07) contain, each one, 30 units of medicine in ampule in line with each other and the external diameter of the ampoule pack is 67.5 mm. Each vial of the blister pack has a number (02) that indicates the number of the unit of medicine to be consumed. The number of the medicine unit in the blister pack or a suitable visible element in the blister pack or in the rotating holder may be red in the region of the medicine units in ampoule 50 to 60 to indicate to the patient that Only the last ten doses remain in the blister pack. In the blister pack (03 and 04, respectively) circular and rectangular holes are also provided to be associated with the alignment pins of the rotating support to achieve the precise alignment of the blister pack with the rotating support, which prevent any undesirable movement of the blister. blister during the dispensing of the medicine and allow the ampoule to be perforated in the center allowing reproducible dosages to be obtained. The blister pack has a notch (05), into which the slide locking pin (32) fits to facilitate the smooth change of the piercing pin of the first concentric ring to the second concentric ring of the blister pack when the drug units of the First concentric ring are finished, as described below.

The movable sliding piercing bolt unit is placed in a first position (see Figures 6A, 6B, 7A and 9A) to register the piercing bolt with the medicament units in ampule of the first concentric ring in order to open or breaking, successively, the medication units and the slide immobilizer bolt (32) abutting the annular blister pack prevents it from moving from the first position (see Figure 7A) until the ampule medicine units of the first The concentric ring has been terminated, after which it is placed in a second position when the slide locking bolt (32) moves inwardly and upward in an inclined plane on the upper cover to engage with the notch (05) of the blister pack (see Figures 7C and 7D), to register the piercing bolt with the drug units in ampoule of the second concentric ring and to break, successively, the aces of medication (see Figures 6C, 6D, 7E and 9B). The ratchet arm (40) prevents the slide immobilizer bolt unit from moving from the second position until the medicament units in the ampule of the second concentric ring are exhausted (see Figures 8A and 9B). It should be noted that the resource of the ratchet arm is optional and that not all designs may need it. In those embodiments in which the inhaler has a robust design, the ratchet arm is not an essential element. In these embodiments, the register slider bolt unit in register with the ampoule medication units of the second annular ampoule ring ring can not be easily returned to the first ring of the ampoule packing, this is due to the lower degree of freedom of movement of the slider bolt unit due both to this type of design of the slider bolt unit and to the operational friction forces. In a preferred embodiment, the first concentric ring is the outer ring and the second concentric ring is the inner ring of the blister pack. The external and internal terms refer to the direction when there is movement of the boundary towards the center of the blister pack. Figure 7? illustrates the indexing address (38) of the ampoule packet having numbered medicament units (39) in ampoule. The lower unit (10) contains a nozzle (21) and a nozzle cover (08). The rotary support (11) is mounted on the tray of the lower unit, which contains an air inlet hole (13) and a ratchet (24) (see Figures 3, 10A and 10C) for unidirectional rotation of the support of the package of blisters mounted. The lower unit also contains the drug orifice (22 and 23) through which the medicament of the ampoule or open or perforated medicament unit of the first ring or of the second ring of the ampoule pack is emptied into the connecting conduit. the air inlet hole with the air outlet hole of the nozzle. When not in use, the nozzle is covered by the nozzle cover. As illustrated in Fiqras 4A to 4C, the air inlet orifice is connected to a conduit (27) and the air flow (28) created by inhaling the patient drags the medicament (29) into the patient's respiratory tract. , thanks to the air outlet means of the nozzle. In the illustrated embodiment, the angle of the air inlet orifice conduit may be 45 ° to 135 °. It is preferred that the angle is greater than 90 °. The angle used in the preferred embodiment is 106.5 °. In the above embodiment of the present invention, the ampule medicine units are located between the air inlet orifice and the mouthpiece. In alternate embodiments, the air inlet orifices are located between the two rings of drug units in an ampoule or between the ampoule medication unit and the nozzle or outlet opening. The wall of the conduit leading to the air outlet orifice may take several configurations of the fluted formations of the turbulence elements. The function of the striated formation is to make turbulent the current of air that drags the medicine. The formation can take the form of protuberances or projections in various ways, for example, spiral, single or multiple ribs, linear, helical, circular, conical, wedged, rectangular and the like. The formation can also take the form of depressions or hollows of various shapes, for example, spiral, linear, helical, circular, conical, wedge, rectangular and the like. Figures 5? at 5D show different configurations of the fluted formations of the turbulence elements in the wall of the conduit connecting the air inlet orifice with the air outlet orifice of the nozzle. The rotary support (11) contains a plurality of circular orifices or depressions along the circumference of the disc, arranged in two concentric rings, corresponding to the units of ampule-filled ampoule medicine to receive the units of medicament in ampule of the annular package of ampoules. The rotating holder can have elevations / projections, called alignment pins, which can fit into the corresponding holes of the blister pack, so that the blister pack is aligned with the rotating holder and register the vial with the pin perforator, these last actions performed with full precision. The shape of the alignment pins can be circular (25) or rectangular (26). The rotary support has a means for unidirectional movement, which contains a ratchet arm (43) to associate it with the ratchet (24) of the lower unit, as can be seen in Figures 10A to 10C. The cavity (44) of the swivel bracket allows the ratchet arm (43) to flex outwardly to remove the ratchet lock (24) from rotation and then flexes back to the next available pawl (24) to immobilize it in the next position. The suitable registration of the ratchet arm of the support with the pawl (24) of the lower unit makes it possible to lock or immobilize the rotary support in its position and the shape of the ratchet and the ratchet arm only allow unidirectional movement of the support in the opposite direction to the clock hands. Hence, the direction of movement of the rotating support is counterclockwise (12), as can be seen in Figures 2A and 10A. When the patient moves the rotating support in the direction of the indexing or indexing, the 'click' sound will indicate that the next blister pack ampule is in the proper registration position with the piercing pin. Alternatively, a spring mechanism can be used for the rotary movement of the rotating support. On top of the blister pack is the top cover (09). As can be seen in Figures 2? and 6A, in the upper cover there is provided a numerical indexing means that takes the form of a counter window (16), whose objective is to show the number appearing on the annular blister pack and show the number of the unit of medication in ampoule to be used. A cut (14) is also provided in the upper cover for the cantilever movement of the piercing bolt. The counter window is linked with the slide drilling unit, as shown in Figures 8 and 9. The movement of the counter window together with the slide unit can be seen in Figure 7. In Figure 7A, the Counter window shows the number one when the piercing pin unit is in register with the first ampoule of the first ring of the blister pack. Figures 7B and 7C show in the counter window the numerical advance as the rotary support advances. Figure 7D shows the counter window showing the number 31 corresponding to the first ampoule medicine unit of the second ring of the blister pack. The counter window can only show the number of the medicine unit in ampoule that is in register with the piercer and slider unit or it can show the numbers of the medicine units in ampoule both in the first ring and in the second ring of the blister pack with which the drilling and sliding bolt unit is in register. The counter window and numbering means are designed to make it easier for the patient to see the number of the medicine unit in ampoule of the blister pack, which is going to be administered. The further advance of the number in the counter window together with the piercing pin unit can be seen in Figure 7E. Also provided is a slide (15) having a position marker (35), whose function is to shift the position of the piercing bolt of the first ring of the blister pack to the second ring thereof. The slide can only move in one direction (17) and can be positioned in such a way that the piercing bolt is initially in a position (18) to pierce the first ring of the blister pack and then in a position (19) to pierce the second ring of the blister pack. In the upper cover there is a groove (20) for the movement of the slide together with the piercing bolt. As can be seen in Figure 8A, the slide contains a slide immobilizer bolt (32), a ratchet arm (40) for delivery without return and a perforator bolt (31) positioned at an angle, so as to puncture the blister in the center, and a cover (41) for the slot. As illustrated in Figure 4A, after the medicine units in ampule 1 to 31 of the first ring of the blister pack have been consumed, the slider moves in a unidirectional way (30) to bring it to the position in which they will be punctured. the ampule medicine units with numbers 31 to 60 of the second ring of the blister pack. Figures 6A and 6B illustrate the position (33) of the piercing pin slide unit ready to pierce the ampule medicine units having the numbers 1 to 30 of the first ring of the blister pack, starting with the drug unit at blister number 1. After piercing the blister unit, the medication drops (36) into the conduit of the first ring of the blister pack. Figures 6C and 6D illustrate the position (34) of the piercing bolt slider unit ready to pierce ampule medication units having numbers 31 to 60 of the second ampoule packing ring, starting with the medicament unit in blister number 31. Once the mobile pin and slider unit moves to the position of the second ring, it is in a non-return position (34) due to the immobilization effected by the ratchet arm (40) provided in the unit. of a movable sliding piercing bolt with a ratchet lock (42) provided in the upper cover of the dry powder inhaler, as can be seen in Figure 9B. After piercing the blister unit, the drug falls (37) into the conduit of the second ring of the blister pack. During the operation, the patient loads or places the blister pack into the dry powder inhaler. The counter window (16) of the slide bolt will show that the number 1 vial of the first ring is in position with the piercing bolt, as illustrated in Figure 7A. The patient removes the cap from the mouthpiece, holds it inside the mouth, presses the cut on the upper cover (14) to lower the piercing pin and pierce the ampoule and inhale. When the upper cover is pressed, the perforating bolt is angled down on the ampoule, so that the associated bleb is perforated at the center of the bottom. The above places the entire dose of the medicament in a reproducible form in the conduit and passes it to the mouthpiece of the dry powder inhaler. When the patient inhales, the air enters through the air inlet hole (13) and exits through the mouthpiece, along with the medication carried by it. For the displacement towards the next ampule, the user moves the rotary support (11) in a counterclockwise direction until he hears the "click" sound. This operation continues until the 30th ampoule is reached and drilled. In this position, the slide locking pin (32) moves inwardly and upwardly along an inclined plane on the upper cover and engages with the notch (5) of the blister pack. To move to the second ring of medicine units in blister, the patient has to slide the slide in the allowed direction (30), so that the slide immobilizer bolt moves inward and upward on an inclined plane together with the notch. When the above is carried out, the piercing bolt is placed in register with the first ampoule unit with medicament of the second ring of medicine units in ampoule of the annular ampoule packing and the ratchet arm (40) of the piercing pin unit of The mobile slide is firmly immobilized against the ratchet lock (42) of the upper cover of the inhaler to prevent any further movement. Additionally, the slide can not be retracted now due to the immobilization by the ratchet arm and the ratchet lock, so as to avoid any movement of non-return of the slide back to the first ring. In alternate modalities, in which there is no ratchet arm, the slide piercing bolt unit does not return to the first ring due to both the lower freedom of movement of the slide unit and the friction forces. The piercing bolt can now move along the second ring of ampule medicine units, from doses 31 to 60. Figures 11, 12 and 13 illustrate a preferred embodiment of the dry powder inhaler of the present invention. In the inhaler of this mode, the rotary support also has a retainer ring (45). This retainer ring functions as a means to prevent the slide piercing bolt unit from moving from the first ring of ampule drug units to the second ring of ampule ampule drug unit units until all units have been consumed of medicine in ampoule of the first ring of the blister pack. In addition to the retainer ring (45) present in the rotating holder, as shown in Figure 12A, the slide piercing bolt unit also has a projecting projection on the rotating support and only touches the retainer ring when the Slider bolt unit is in the first annular ring blister ring (not shown). The slide piercing bolt unit can only move along the first ring to consume the ampule medicine units along the first ring of the blister pack, but can not move towards the second ring, because the ring of Retainer hinders the projection provided in the slide piercing bolt unit. The movable sliding piercing bolt unit can only be moved from the first ring of ampule medicine units to the second ring of ampule medicine units when all the medicine units in ampoule of the first ring and the projection provided in the unit have been consumed. of the slide piercing bolt encounters an interruption or discontinuity in the retainer ring, which coincides with the notch provided in the blister pack, so as to allow the projection provided in the movable slide bolt unit to move inwardly and upwards on an inclined plane in the upper cover, beyond the retaining ring while at the same time the sliding locking bolt of the sliding bolt unit also moves inwards and upwards on the inclined plane of the upper cover to engage with the notch, so that the piercing bolt is now in register with the first unit of Ampoule medication of the second ring of the ampoule ring package. Now, the projection of the slider bolt unit, due to its peculiar settlement along the inclined plane of the upper cover, no longer hinders the retainer ring and, hence, the rotating support can move freely towards forward along the second ring of the annular package of ampoules to perforate the ampule medicine units and can be administered. There is also a removable cover on the duct connecting the air intake orifice with the air outlet orifice of the nozzle (46), as can be seen in Figure 12b. This cover can be disassembled to clean the duct and the nozzle. A means is also provided in the lower unit to prevent movement of the rotary holder when the ampule ready medication unit has not been pierced. The supplied means is a locking latch (47), which is formed by three bolts placed in the lower unit, as shown in Figures 12A and 12B. In Figure 12A two of these bolts can be seen. A bolt (not shown) engages with the holes of the rotating support from below. Another pin is activated by the toothing of the periphery of the rotating support. The third bolt is activated by the top cover when the consumer presses the piercing bolt unit to administer a blister unit. When the blister unit is not yet drilled, a locking latch bolt engages from below with the swivel bracket and prevents it from moving forward. When the blister medication unit is punctured and the piercing pin unit is pressed together with the upper cover, the locking latch is activated, whereby the lower bolt releases itself from the rotating support and can now move forward . While the rotating support is moving, the toothing of the outer periphery of the rotary support activates the lower bolt, whereby the rotary support is again immobilized and is unable to move or advance. The inhaler of this mode has the preferred spiral configuration (48) of the fluted formation of the turbulence elements in the conduit connecting the air inlet orifice with the air outlet orifice of the nozzle, as can be seen in the Figures 13A and 13B. In an alternate embodiment, a spring unit combined with the retainer ring and with the projection provided in the slide piercing bolt unit projecting into the rotating support is used. In a preferred embodiment, the blister pack has 30 units of medicament in ampoule in the first ring and 30 units of medicament in ampoule in the second ring of the annular package of ampoules, aligned with each other (referred to as 30 + 30 in line) and The outside diameter of the ampoule pack is 67.5 mm. In the blister packaging, different configurations of the two rings of the blister pack are possible, as well as different number of ampule medicine units and both possibilities may be included within the scope of the invention. The thirty ampule drug units of the first ring and the thirty ampule drug units of the second ring may be staggered or misaligned with each other (referred to as 30 + 30 staggered). Some other blister pack configurations that may be used in the present invention include 16 ampoule medicine units in each of the first and second concentric rings of the blister pack, which are or are aligned with each other (referred to as 16 + 16 in line) or they may be staggered or misaligned (called 16 + 16 staggered); or 32 units of ampoule medication in each of the first and second concentric rings of the blister pack, which are either aligned with each other (referred to as 32 + 32 in line) or are staggered or misaligned with each other (referred to as 32+) 32 staggered). Figure 14 illustrates one embodiment of a blister pack having 16 ampoule drug units in each of the first and second concentric rings of the blister pack, which are aligned or in line with each other. The various specifications for the dimensions are provided in the figure. The symbol 0 indicates the diameter in mm, while the rest of the numbers are the lengths in mm. Thus, the external diameter of the blister pack is 60 mm and the internal diameter is 27 mm. The diameter of the ampoules of the first ring and of the second ring is 5 mm in each case. Figure 15 illustrates another embodiment of a blister pack that in each of. The first and second concentric rings of the blister pack have 16 ampoule units of medicine, which are staggered or misaligned with each other. Figure 16 illustrates another embodiment of a blister pack that in each of the first and second concentric rings of the blister pack has 32 blister drug units, which are aligned or in line with each other. Figure 17 illustrates yet another embodiment of a blister pack that in each of the first and second concentric rings of the blister pack has 32 blister drug units, which are staggered or misaligned with each other. In all Figures 14 to 17, the symbol 0 indicates the diameter in mm, while the rest of the numbers are the lengths in mm. In one embodiment, the dry powder inhaler of the invention is disposable and has to be replaced by a new device when all of the ampoule ring ampoule medicine units have been finished. In another embodiment, the dry powder inhaler of the invention is reusable and the annular blister pack in which the two drug unit rings in ampule have been consumed can be replaced with a new annular blister pack with two unit rings of medication in ampoule. In this embodiment, there is no ratchet arm in the slide piercing bolt unit for non-retractable locking of the slide piercing bolt unit when it enters the second annular ring blister ring. When all of the ampoule medication units of the second ring of the blister pack have been consumed, the slide piercing pin unit is pulled back towards the position of the first outer ring in order to register with the first unit of medicament. in ampoule of the first ring of the new annular blister pack. In one embodiment of the invention, an additional air inlet hole is present, located in the slide piercing bolt unit, leading to the perforated ampule medication unit. This hole is located around the piercing bolt and leads to the medicine unit in a perforated ampule and into the medicine hole. In an alternate embodiment, the main air inlet port (13) of the top cover is not present and only the air inlet hole located in the slider bolt unit is present. The air inlet port of the slide piercing bolt unit serves to directly draw the medication that still remains in the ampoule medication unit and offer the patient greater availability of medication. In all the above embodiments, any or all of the components of the dry powder inhaler may become photoluminescent in order to achieve that the patient has access to the inhaler even in the dark. The various components of the dry powder inhaler can be transparent or translucent to facilitate the visibility of used or unused ampule medicine units. A "soft touch" material can also be incorporated in any of the components of the dry powder inhaler., preferably, on the sides of the device, where the patient holds the dry powder inhaler to administer a dose. The "soft touch" material used can be a TPE (thermoplastic elastomer) with a Shore hardness of approximately between 30 and 50. As already mentioned above, the medicament doses of the number 50 to approximately the number 60 in the ampoule packing It can be red to remind the patient of the upcoming termination of the blister pack dose. The annular blister pack used in the dry powder inhaler of the invention can be made from any suitable material known in the art. Usually, the film forming the ampoule can be made of polyvinyl chloride (PVC), PVC coated with polyvinylidene chloride (PVDC), films of PVC / Chlorotxifluoroethylene (CTFE), polypropylene (PP), polystyrene (PS), laminated polyamide oriented (OPA) / aluminum / PVC and the like. Typically, the cap or cover material used in the blister pack may be aluminum foil or its combination with paper and / or polyester (PET) and the like. Without deviating from the nature and scope of the invention, several modifications to the invention can be thought of, as described in the foregoing description. For example, the dry powder inhaler can be made of inert metal or reinforced plastics and synthetic polymeric material. The mouthpiece of the dry powder inhaler can be made of any moldable or shaped plastic and can have a suitable size and shape. The dry powder inhaler may, optionally, have secondary air inlet ports located in the upper or lower parts or sides of the nozzle to achieve the optimum balance between the fraction of fine particles of the drug available to the patient and the resistance of the device, to be therapeutically effective, as well as of convenient use for the patient. Although the invention has been described in terms of particular embodiments and applications, anyone with ordinary skill in the art can, in light of these teachings, generate additional embodiments and modifications without departing from the spirit or exceeding the scope of the claimed invention. It should be emphasized that the above described embodiments of the present invention, in particular, of any "preferred" embodiments, are only possible examples of the invention of implementations, only set forth for the clear understanding of the principles of the invention. Accordingly, it will be understood that the drawings and descriptions provided herein are presented by way of example only to facilitate understanding of the invention and will not be construed to limit the scope thereof.

Claims

CLAIMS: 1. A dry powder inhaler for administering to the patient medications in the form of finely divided solids, where the dry powder inhaler takes the form of a disk inhaler or diskhaler containing a rotating disk-shaped holder and a annular blister pack containing ampule drug units, wherein the annular blister pack contains a plurality of medicaments in ampules arranged in two concentric rings of ampule drug units.
2. A dry powder inhaler according to claim 1, having at least 30 units of medicament in ampoule.
3. A dry powder inhaler according to claim 2, having 60 units of medicament in ampoule.
4. A dry powder inhaler for administering to patients medicaments in the form of finely divided solids, inhaler comprising: (a) a lower unit; (b) a rotating support provided in the lower unit; (c) an annular blister pack mounted on the rotating holder, wherein the annular blister pack contains a plurality of medicament units in ampoule disposed in two concentric rings of ampule drug units; (d) an upper cover having a movable sliding piercing bolt unit, the movable sliding piercing bolt unit contains a piercing bolt and means for: (i) locating the unit in a first position to register the piercing bolt with the units of medicament in ampule of the first concentric ring to open or break, successively, the units of medicament in ampoule; (ii) preventing the unit from moving from the first position until the units of medicament in the ampoule of the first concentric ring are exhausted; (iii) after which, locate the unit in a second position to register the piercing bolt with the drug units in ampoule of the second concentric ring and break, successively, the medicine units in ampoule; (e) an air intake means, through which air can be infused into the dry powder inhaler and an air outlet means, through which the patient can inhale, thereby bringing the medication from a respiratory unit. Medicine in perforated ampoule will be dragged by the air flow produced by the patient.
5. A dry powder inhaler according to claim 4, wherein a means is provided to prevent the movable slider pin unit from moving from the second position until the ampule drug units of the second concentric ring have been exhausted.
6. A dry powder inhaler according to claim 5, wherein the means for preventing the unit from moving from the second position until the ampoule medicament units of the second concentric ring have been exhausted is a ratchet arm provided in the unit. of bolt drilling of sliding.
A dry powder inhaler according to claim 4, wherein a means for unidirectional movement of the rotating support is provided, means comprising a ratchet arm on the rotary support and a ratchet on the lower unit.
A dry powder inhaler according to claim 4, wherein the rotating holder has alignment pins to facilitate alignment of the annular blister pack with the rotating holder.
A dry powder inhaler according to claim 8, wherein the annular blister pack is provided with holes for associating them with the alignment pins of the rotating support.
10. A dry powder inhaler according to claim 4, wherein the means of the movable sliding piercing bolt unit is as follows: (a) to place the unit in a first position and register the piercing bolt with the medicine units in blister of the first concentric ring to break successively the units of medicament and to prevent the unit from moving from the first position until the blister medicament units of the first concentric ring have been exhausted, a slide immobilizer bolt is provided which bumps with the ring blister packaging; (b) to place the unit in a second position and register the piercing bolt with the medicament units in ampoule of the second concentric ring and to break successively the medication units, a notch is provided in the annular package of ampoules and an inclined plane in the upper cover, so that the sliding immobilizer bolt can move inwards and upwards on an inclined plane.
11. A dry powder inhaler according to claim 4, wherein to place the movable sliding piercing bolt unit in a first position in order to register the piercing bolt with the medicament units in ampoule of the first concentric ring to break , successively, the medication units; to prevent the unit from moving from the first position until the blister medicament units of the first concentric ring have been consumed, a projection moving in an inclined plane is provided in the slide piercing bolt unit along the upper cover and a retainer ring on the rotating support.
12. A dry powder inhaler according to claim 4, wherein the inhaler has a means to prevent movement of the rotary holder when the ampule ready medication unit has not been pierced.
13. A dry powder inhaler according to claim 12, wherein the means for preventing movement of the rotary holder when the ampule ready medication unit has not been perforated, contains a locking latch in the lower unit of the powder inhaler dry.
A dry powder inhaler according to claim 4, wherein a numerical indexing means is provided consisting of a counter window located on the top cover and numbers on the annular blister pack.
15. A dry powder inhaler according to claim 4, wherein the air inlet means is connected to the air outlet means by means of a duct.
16. A dry powder inhaler according to claim 15, wherein the conduit has fluted elements of turbulence on its walls.
17. A dry powder inhaler according to claim 16, wherein the fluted formations in the walls of the conduit have a spiral configuration.
18. A dry powder inhaler according to claim 4, wherein there is an air inlet orifice located in the slide piercing bolt unit, leading to the perforated ampule medication unit.