Abstract
A dry powder inhaler for pulmonary or nasal use, comprising at least an inhaler body (201) and a cartridge (203) with a plurality of powder compartments (205) each including one dose of a drug. The body (201) has an opening (204) shaped for receiving the cartridge (203) and the plastic body recess (215) and the detent (218) to allow a controlled advancement and turning movement of the cartridge (203) relative to the body (201) for sequentially delivering each of the plurality of unit doses filled into the cartridge compartments (205). The inhaler construction is suitable for filling the plurality of unit doses into the compartments (205) with the cartridge (203) assembled into the body (201). The invention affords a large dose inhaler of single-use and low cost that improves industrial filling and manufacturing cost for the delivery of high dosages of inhaled medicines.
Claims
1. A dry powder inhaler suitable for pulmonary or nasal delivery, comprising an inhaler body and a cartridge the inhaler comprising: a. an inhaler body comprising a mouthpiece; an inhalation channel for providing fluid communication between the patient's mouth when engaged with the mouthpiece; a bottom channel inlet; side inlets for allowing direct air admission from atmosphere into the inhalation channel; an inhaler body opening (204) formed in the inhaler body and defined between opposing top and bottom walls and opposing side walls (226, 426, 626), said inhaler body opening having at least one end open by means of which the cartridge may be mounted into the opening; one or more plastic body protrusions for engaging and locking the cartridge once mounted in said inhaler body opening; one or more body rails in the said inhaler body opening shaped for receiving the cartridge and one or more body recesses and detents commonly adapted for movement of the cartridge relative to the body; and b. a cartridge comprising a plurality of powder compartments of tapered cylindrical or near-cylindrical shape formed therein for carrying a powder-based medicament; bottom walls that engage with the plastic body protrusions for engaging and locking the cartridge once mounted in said inhaler body opening; top walls that engage with the body rails; one or more cartridge protrusions that engage with the one or more plastic body recesses and detents provided in the body for allowing the movement of the cartridge in relation to the body from a storage position into an inhalation position, when the cartridge is mounted in the body opening shaped for receiving the cartridge; and a bottom inlet slit and top outlet hole; c. the cartridge further comprising a plurality of powder compartments turning and advancing in sequence inside the body from a storage position where there is no fluid air communication into the plurality of powder compartments, into an inhalation position, where there is sequential alignment and fluid air communication between the body bottom or the side inlets, each of the plurality of cartridge powder compartment bottom or side inlet slits, the cartridge top outlet and the mouthpiece channel; characterized in that the inhaler body and cartridge are assembled prior to powder filling into individual cartridge compartments and the said assembled inhaler comprises a body filling opening for filling the inhalation powder into the cartridge.
2. A dry powder inhaler of claim 1, characterized in that the assembled inhaler comprises a hinged or foldable lid in the inhaler body that allows the powder filling of the inhalation powder through the said body filling opening in the inhaler assembled configuration.
3. A dry powder inhaler of claim 1, characterized in that, during the powder filling, the cartridge is free to advance and turn unrestrained in relation to the body in said assembled inhaler configuration for filling a unit dose of the inhalation powder into each of the plurality of cartridge compartments.
4. A dry powder inhaler of any of the above claims, characterized in that, during powder filling, each of the plurality of cartridge compartments is sealed by close contact with the bottom walls in the body opening (204) shaped for receiving the cartridge.
5. A dry powder inhaler of any of the above claims, characterized in that the body hinged or foldable lid, once the last unit dose of powder has been filled into the plurality of cartridge compartments, is moved and snapped into and against the body, providing mechanical interference with the cartridge outlet and such said mechanical interference closes the inhaler body filling opening and provides sealing of the filled cartridge.
6. A dry powder inhaler of any of the above claims, characterized in that the body hinged or foldable lid, once moved or folded and snapped into and against the body, comprises at least one plastic body recess and detent engaging with at least one compartment protrusion comprised in each of the plurality of cartridge compartments for restraining and controlling the sequential advancement and turning travel of the cartridge in relation to the body between multiple initial positions, at which multiple positions each of the plurality of cartridge compartments is sealed, into a final position at which final position each of the plurality of cartridge compartments becomes aligned with the body inhalation channel, and the air inlets and the outlets included in the compartment are available for air admission and in communication with the body inhalation channel.
7. A dry powder inhaler of any of the above claims, characterized in that the body hinged or foldable lid, once moved and snapped into and against the body, comprises a detent between the cartridge and the body, once each cartridge movement is concluded.
8. A dry powder inhaler of any of the above claims, characterized in that the inhaler cartridge comprises at least one cartridge hand grip or holder, adapted for turning or advancing the cartridge in relation to the body.
9. A method to fill a dry powder inhaler, the inhaler comprising: a. an inhaler body comprising one or more body recesses and detents adapted for movement of the cartridge relative to the body; and b. a cartridge mounted in the inhaler body and comprising a plurality of powder compartments of tapered cylindrical or near-cylindrical shape formed therein for carrying a powder-based medicament; one or more cartridge protrusions that engage with the one or more plastic body recesses and detents provided in the body for allowing the movement of the cartridge in relation to the body from a storage position into an inhalation position; c. the cartridge further comprising a plurality of powder compartments turning and advancing in sequence inside the body from a storage position where there is no fluid air communication into the plurality of powder compartments, into an inhalation position where there is fluid air communication into the plurality of powder compartments; wherein the method comprising filling the plurality of drug doses in the assembled inhaler, through a filling opening in the body component, into each individual cartridge compartment, the cartridge compartment being advanced to the next drug compartment filling position until all cartridge compartments are filled and the hinged or foldable body lid is closed and snapped into and against the inhaler body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] FIGS. 1a to 1d show prior art inhalers;
[0039] FIGS. 2a and 2b show respectively a perspective and longitudinal sectional view of an inhaler body according to the invention;
[0040] FIGS. 3a and 3b show respectively a perspective and transversal sectional view of an inhaler cartridge according to the invention;
[0041] FIGS. 4a and 4b show respectively perspective and frontal views of additional aspects of an inhaler body according to the invention;
[0042] FIGS. 5a and 5b show perspective views of additional aspects of an inhaler cartridge according to the invention;
[0043] FIG. 6a shows a perspective view of an inhaler body according to FIG. 2 and an inhaler cartridge according to FIG. 3 in the disassembled configuration;
[0044] FIG. 6b shows a perspective view of an inhaler body according to FIG. 2 and an inhaler cartridge according to FIG. 3 following the assembly step, in the assembled configuration, with the hinged lid in the open position, making the device available for powder filling;
[0045] FIGS. 7a and 7 b show perspective views of another aspect of an inhaler body and an inhaler cartridge according to the invention respectively in the disassembled and assembled configurations;
[0046] FIGS. 8a to 8c show longitudinal sectional views of an inhaler according to the invention during powder filling into the plurality of powder compartments;
[0047] FIGS. 8d to 8f show longitudinal sectional views of an inhaler according to the invention following powder filling into the plurality of powder compartments, when the hinged lid has been moved into the closed position;
[0048] FIG. 9 shows a longitudinal sectional view of an inhaler according to FIG. 8, following powder filling and closing of the hinged lid, when the inhaler cartridge is in the storage position;
[0049] FIG. 10 shows a longitudinal sectional view of the inhaler according to FIG. 8, following powder filling and closing of the hinged lid, when the inhaler cartridge has been moved from the storage position into the inhalation position;
[0050] FIG. 11 shows an outline of the filling method.
DETAILED DESCRIPTION OF THE INVENTION
[0051] The invention will now be described on the basis of the drawings. It will be understood that the embodiments and aspects of the invention described herein are only examples and do not limit the protective scope of the claims in any way. The invention is defined by the claims and their equivalents. It will be understood that features of one aspect or embodiment of the invention can be combined with a feature of a different aspect or aspects and/or embodiments of the invention.
[0052] Referring to the drawings, numbered sequentially after the word “Fig.”, like numerals indicate like parts, and each of the embodiments or aspects is identified with series of numbers where the number of hundreds is the number of the embodiment or aspect (1xx to 7xx) and the equivalent feature in each of the embodiments or aspects has the same number xx.
[0053] Referring to the drawings in FIGS. 2a and 2b, there is shown an inhaler body 201 comprising a mouthpiece or nosepiece 202 for engaging with the patient's mouth or nose respectively, and an opening 204 for receiving an inhaler cartridge 203, such opening 204 including top 210 and bottom 211 walls, which are of cylindrical or near-cylindrical shape and absent of any sharp edges, side walls 226, and at least one body rail 212 for allowing a turning or pivoting movement of the cartridge 203 in relation to the body 201.
[0054] FIG. 2a illustrates the inhaler body 201 which comprises a powder filling opening 214 and an hinged or foldable lid 213, included in the top wall 210 of the body opening 204, injection moulded in the same material and moulding step as the body 201 itself. FIG. 2a further shows that the hinged or foldable lid 213 further includes at least one plastic body recess 215 shaped to be engageable with corresponding cartridge protrusions 217 in the cartridge 203, to provide the device of advancing and controlling the pivoting or turning motion of the cartridge 203 in relation to the body 201, including the detent 218 to provide a non-return between the cartridge 203 and the body 201, once said advancement is concluded.
[0055] FIG. 2a additionally shows that the bottom wall 211 of the body opening 204 includes at least one plastic body protrusion 219 engageable with the corresponding bottom wall 221 of the cartridge 203, which provides a snap type assembly and the mechanical locking between the body 201 and the cartridge 203 following said assembly.
[0056] FIG. 2b further illustrates the body top wall 210 and the hinged or foldable lid 213 have a snap-type assembly 216 to provide a snap type assembly and mechanical locking of the hinged or folded lid 213 into the body top wall 210 following said assembly. In addition, there is also shown an opening 224 into the bottom wall 211 of the opening 204 shaped to receive the cartridge 203 allowing air entry into said opening 204, in alignment with a mouthpiece channel 208.
[0057] Referring to the drawings in FIGS. 3a and 3b, there is shown the inhaler cartridge 203 comprising cylindrical or near-cylindrical cartridge top 220 and cartridge bottom 221 walls, absent of sharp edges, and a plurality of powder compartments 205, each with an inlet 206 and outlet 207, which is suitable for filling, storing and delivery inhaled powder formulations.
[0058] FIG. 3a further illustrates the inhaler cartridge 203 comprises at least one plastic cartridge protrusion 217 at the cartridge top wall 220 for each of the plurality of powder compartments 205, which are engageable with the corresponding body hinged lid plastic body recess 215 and the detent 218, to provide the device for advancing and controlling the pivoting or turning motion of the cartridge 203 within the body rail 212 in relation to the inhaler body 201, between multiple positions, including the non-return device to provide a non-return once said advancement is concluded.
[0059] FIG. 3b additionally illustrates that the inhaler cartridge 203 includes at least one hand grip 222 engageable with the patient's fingers to provide a turning device for turning the cartridge 203 in relation to the body 201 between multiple positions.
[0060] Referring to FIG. 4a, there is shown a second aspect of the inhaler body 301 where an hinged or foldable lid 313 with a plastic body recess 315 and a detent 318 form a device for controlling the advancement of the inhaler cartridge 203 and are integrated with the mouthpiece or nosepiece 302.
[0061] FIG. 4b shows a third aspect of the inhaler body 401 where a plastic body recess 415 and a detent 418 form the device for controlling the advancement of the cartridge and are integrated into the inhaler body side walls 426.
[0062] FIGS. 5a and 5b show a second aspect of the inhaler cartridge 503 where the cartridge protrusions 517 are located in the frontal wall of each of the powder compartments 505, engageable with the corresponding body protrusions (i.e. the plastic body recess 415 and the detent 418) of the third aspect of the inhaler body 401 shown in FIG. 4b, to provide the device for advancing and controlling the pivoting or turning motion of the cartridge 503 in relation to the body 401, between the multiple positions, by means of the actuation of the hand grip 522 by the patient's fingers.
[0063] Referring next to FIG. 6, there is shown the assembly of the inhaler comprised by the inhaler body 201 and the inhaler cartridge 203. FIG. 6a illustrates that, following manufacturing, the inhaler cartridge 203 is inserted into the inhaler body 201 through the opening 204. FIG. 6b shows that the snap type engagement between the plastic body protrusions 219 and the cartridge bottom wall 221 provides full mechanical locking between the inhaler body 201 and the inhaler cartridge 203 following the assembly step, while the engagement of the cartridge top wall 220 with the body rail 212 allows for free turning movement between the inhaler cartridge 203 and the inhaler body 201.
[0064] FIG. 6b further illustrates that, following assembly, each of the powder compartments 205 is available for filling with a powder unit dose through the body powder filling opening 214, since the body hinged or foldable lid 213 is in the opening position from the injection moulding process of the inhaler body 201, and the inhaler cartridge 203 is free to turn sequentially in relation to the inhaler body 201, without mechanical constraints.
[0065] FIG. 7a additionally shows the assembly of a second inhaler aspect comprised by the inhaler body 601 and the inhaler cartridge 603, where side air inlets 609 are included in each of the powder compartments 605 for additional, tangential air admission into the powder compartments 605 leading to the generation of the effective dispersive and aerosolization dynamics disclosed in the afore-mentioned Portuguese patent application PT103481. FIG. 7b illustrates that, following assembly, the side air inlets 625 comprised in the inhaler body side walls 626 allow for air admission into each of the powder compartments 605 through the compartment side air inlets 609, when said powder compartment 605 reaches the inhalation position aligned with the mouthpiece channel 608.
[0066] Referring next to FIG. 8, there is shown the filling of an inhaler. FIG. 8a illustrates the powder filling of a unit dose by conventional equipment into the first cartridge powder compartment 705 through the body powder filling opening 714 while the body lid 713 is in the opened position. FIG. 8b shows the turning of the inhaler cartridge 703 until the second powder compartment 705 is aligned with the body powder filling opening 714 and is available and ready to be filled. FIG. 8c then illustrates the powder filling of a second unit dose by conventional equipment into the second cartridge powder compartment 705 through the powder filling opening 714 while the body hinged lid 713 is in the open position.
[0067] FIGS. 8d to 8f show that, following filling of a unit dose into the last available cartridge powder compartment 705, the body lid 713 is moved or folded from the open position into the closed position and snapped into and against the body top wall 710 of the inhaler body 701, providing close mechanical contact and sealing interference with the outlet 707 of each of the cartridge powder compartments 705 and, together with the close contact and sealing interference of the body bottom wall 711 with the cartridge powder compartment bottom inlet 706, providing the full powder compartment 705 sealing to the powder unit dose, across all cartridge compartment storage positions.
[0068] FIG. 9 illustrates the inhaler when the patient removes the inhaler from the packaging and accesses the inhaler with the inhaler cartridge 705 in the storage position, where each of the plurality of the powder compartments 705 is sealed by the body bottom wall 711, the body top wall 710 and the closed body lid 713.
[0069] Referring next to FIG. 10, there is shown an inhaler when the patient engages with the cartridge hand grip 522 and turns to advance the first of the powder compartments 705 into the inhalation position. At this position, cartridge powder compartment bottom inlet 706 becomes aligned with the bottom wall opening 724, thus allowing air admission into the powder compartment 705, and the cartridge powder compartment outlet 707 becomes aligned with the mouthpiece channel 708, thus allowing fluid communication with the patient's airways and dispersion of the powder unit dose included in said powder compartment 705 through the patient's inspiratory effort.
[0070] FIG. 11 shows the outline of the method to fill the dry powder inhaler. In a first step S1, a first one of the drug doses are filled in the assembled inhaler through a filling opening 214; 314; 414; 71 in the body 213; 313; 413; 613; 713 into a first one of the individual cartridge compartments 205; 505; 605; 705. In step S2 the cartridge compartment 205; 505; 605; 705 is advanced to the next drug compartment filling position until in step S3 all of the cartridge compartments 205; 505; 605; 705 are filled. In step S4, the hinged or foldable body lid 213; 313; 413; 613; 713 is closed and the snapped in step S5 into and against the inhaler body (213; 313; 413; 613; 713).
