BACKGROUND OF THE INVENTION
The present invention pertains to pharmaceutical packaging, and, in particular, to a packaging for a receptacle loadable into an inhaler and containing a pharmaceutical powder for inhalation.
One manner of introducing a pharmaceutical into a patient is by a pulmonary administration, during which the pharmaceutical is inhaled by the patient through use of an inhaler. For example, the pharmaceutical may be provided in the form of an inhalable powder filled within an interior volume of a receptacle, such as a thin walled, semi-rigid capsule. After dropping the capsule into an inhalation chamber of an inhaler, and then operating the inhaler to open the capsule, such as by piercing, to allow the powder to escape from the capsule interior volume into the inhalation chamber, the user can inhale the pharmaceutical from that chamber, typically through a chamber-capping mouthpiece or nosepiece of the inhaler. After use, the spent or substantially powder-free capsule then can be removed from the inhaler and discarded.
One well known method of packaging capsules is the use of thermoformed blister packs. To place one of such pack's capsules into an inhaler, a user may peel back a cover of a blister and remove the capsule from that blister. On occasion, a patient may need to repeat this process with capsules in additional blisters for a proper dose. To remove a capsule from the blister, some patients may try to pick the capsule out using a finger and thumb. This technique may be difficult to accomplish as there may be little space between the capsule and the walls of the blister. Alternatively, a patient may improvise with an instrument, such as a nail file or a spoon, to try and remove the capsule from the blister, or the patient might simply dump the capsule out of the blister into her hand. However, these methods also have shortcomings, as the capsule may be lightweight and easily mishandled, and further some patients may be reluctant to touch the capsule with bare hands for fear of, for example, dirtying the capsule.
Thus, it would be desirable to provide a receptacle packaging that can overcome one or more of these and other shortcomings of the prior art.
BRIEF SUMMARY OF THE INVENTION
In one form thereof, the present invention provides for a packaging for a unit dosage form or pharmaceutical preparation, wherein the packaging possesses a well characterized shape that permits the preparation to be easily and completely removed from the well by scooping with a delivery device, such as a device having a mouth that is essentially cylindrical.
In one form thereof, the present invention provides a packaging for an inhaler receptacle, the receptacle having a shell body enclosing an interior hollow filled with a powdered pharmaceutical that may pass from the hollow when the body is pierced or otherwise opened by operation of an inhaler loaded with the receptacle for pharmaceutical administration, the packaging including a base having a surface defining a well that accommodates the receptacle, and a cover for the well to maintain sterility of the receptacle within the well, which cover is at least partially removable from over the well to allow access to the receptacle. The well-defining surface includes a first region and a differently shaped second region, which first region is shaped to support the receptacle in alignment within the well, which second region accommodates a first end of the receptacle aligned in the well and has a mouth geometry or portion enlarged from the first region to allow a portion of an inhaler to be inserted therein to receive the first end of the receptacle for scooping the receptacle into the inhaler from the well.
One advantage of the present invention is that a packaging may be provided which allows a user to load an inhaler (or other delivery device) with a pharmaceutical powder-filled receptacle (or other unit dosage form) without manually touching that receptacle.
Another advantage of the present invention is that a packaging may be provided that has blisters from which receptacles can be easily removed without making the overall packaging undesirably larger, which larger size might thereby waste valuable space in the overall packaging.
Another advantage of the present invention is that a packaging may be provided a blister shaped to permit an inhaler end to be inserted therein, whereby a receptacle he blister may be scooped directly into an inhalation chamber of the inhaler.
Yet another advantage of the present invention is that a packaging may be provided that receptacle within a blister of that packaging to be dragged or scooped out therefrom.
BRIEF DESCRIPTION OF THE DRAWINGS
The above-mentioned and other advantages and objects of this invention, and the manner of attaining them, will become more apparent, and the invention itself will be better understood, by reference to the following description of embodiments of the invention taken in conjucntion with the accompanying drawings, wherein:
FIG. 1 is a top perspective view of a first embodiment of a receptacle packaging of the present invention;
FIG. 2 is a bottom perspective view of the receptacle packaging of FIG. 1, wherein receptacles within the packaging wells are not shown to facilitate illustration;
FIG. 3 is a top perspective view of a section of the receptacle packaging of FIG. 1 shown separate from the remainder of that packaging, which packaging section is shown with its sterility-maintaining cover partially peeled away to expose a portion of a single receptacle housed therein, the outline of which receptacle being shown in dashed lines;
FIG. 4 is a top view of the base of the receptacle packaging of FIG. 3, wherein the sterility-maintaining cover that has been peeled off completely from the base is not shown, and wherein the housed receptacle is also shown;
FIG. 5 is a top perspective view of the base of FIG. 4, wherein the receptacle is not shown;
FIG. 6 is a longitudinal cross-sectional view of the base and receptacle, taken along line 6-6 of FIG. 4;
FIG. 7 is a transverse cross-sectional view, taken along line 7-7 of FIG. 4;
FIG. 8 is a transverse cross-sectional view, taken along line 8-8 of FIG. 4;
FIG. 9 is a view similar to the view of FIG. 6, wherein an end of an abstractly shown inhaler is shown inserted into the base well at an initial stage of scooping the receptacle therefrom;
FIG. 10 is a side view similar to the view of FIG. 9 at an intermediate stage of the inhaler scooping the receptacle from the packaging;
FIG. 11 is a view similar to the view of FIG. 9 after the receptacle has been scooped from the packaging into the inhaler;
FIG. 12 is a top perspective view of a second embodiment of the present invention;
FIG. 13 is a longitudinal cross-sectional view of the base and receptacle, taken along line 13-13 of FIG. 12;
FIG. 14 is a top perspective view of a section of the receptacle packaging of FIG. 12 shown separate from the remainder of that packaging; and
FIG. 15 is a latitudinal cross-sectional view of the base and receptacle, taken along line 15-15 of FIG. 12.
Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent an embodiment of the present invention, the drawings are not necessarily to scale, and certain features may be exaggerated or omitted in some of the drawings in order to better illustrate and explain the present invention.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to FIG. 1, there is shown a first embodiment of an inhaler receptacle packaging of the present invention. Any directional references in this detailed description with respect to FIG. 1 or any of the other Figures, such as up or down, or top or bottom, are intended for convenience of description, and by itself does not limit the present invention or any of its components to any particular positional or spatial orientation.
The receptacle packaging, generally designated 20, holds a plurality of distinct receptacles, each maintained in sterility separate from the others. Each receptacle may be separately loaded into an inhaler to allow pulmonary delivery of the contents thereof. Packaging 20 may be scored, as shown at 22, to allow, for example, a user or manufacturer to divide packaging 20 into two or more, up to the plurality, such as eight, ten or more, of smaller receptacle packagings. As will be described in more detail below with respect to FIG. 12, scoring 22 is done in a manner so that when one of the smaller receptacle packagings is opened, an adjacent receptacle packaging is not inadvertently opened as well. An informational panel 21, identifying the contents of the receptacles and allowing for a user to note the date opened, is provided, but does not itself house an additional receptacle(s). FIG. 1 also shows an indicator 101 that may be used by a patient to associate a particular dose with a point of time for consumption of that dose. Indicator 101 is suitable for use by a patient as a tracking or recording tool to keep track of taking a dose at the right time. In the embodiment shown in FIG. 1, indicator 101 comprises three circles that enable a patient to track taking the dose by meal (breakfast/lunch/dinner) or by time of day (morning/noon/night). As an example, a patient can fill in one circle at each meal to track taking the dose. As another example, a patient can punch out one circle at each meal to track taking the dose. Indicator 101 is also suitable for use by a patient as a planning tool, to enable a patient to “kit up” the dosages needed for a particular time period, such as a work day. As an example, a patient could fill in or mark a circle on one of the smaller receptacle packagings as noon or lunch, and separate that packaging from packaging 20, and take that single packaging along with them for the work day, rather than having to take along the entire packaging 20. As would be apparent to one skilled in the art, indicator 101 could take other forms, such as in the form of squares, in the form of letters “B,” “L,” and “D” to indicate breakfast, lunch, and dinner, or any other marking that would assist a patient in associating a particular dose with a point in time for consumption of that dose.
With additional reference now to FIGS. 3-8, one such smaller receptacle packaging 20′ that holds a single receptacle is shown. Packaging 20′ is representative of all such packagings formed together to provide the receptacle holding capacity of packaging 20 of FIG. 1. Packaging 20′ includes a base 24 with a receptacle-containing well 26, and a cover 28 connected to the upper surface 29 of base 24, such as with an adhesive, continuously around well 26. Cover 28 completely covers well 26 to maintain the sterility of a receptacle, generally designated 60, within the well.
Receptacle 60 is shown as a capsule having a thin-walled shell formed by body member 63 and cap member 67. Body member 63 has generally cylindrical side walls 64 that terminate in a rounded, closed end 65. Cap member 67 has generally cylindrical side walls 69 and a rounded, closed end 71, which cap member during manufacture fits over an open end of body member 63 and is maintained thereat in a suitable fashion known in the art, such as via an annular snap fit. The otherwise hollow, interior volume 73 formed by cap member 67 and body member 63 being together is filled during receptacle manufacture with a powder, generally indicated at 75, suitable for inhalation by a user. Powder 75 includes the pharmaceutical material desired to be delivered pulmonarily, including the active ingredient and typically one or more excipients. The shown orientation of the receptacle within the Figures is merely illustrative and not intended to imply a necessary orientation.
Cap member 67 and body member 63 are made of any suitable material that allows for an opening of one or both such members, such as via a piercing element forming one, two or more holes therein, or such as the two members being pulled apart, or such as one or both of the members being sliced apart, within the inhaler during inhaler use. Such opening allows powder 75 to pass from interior volume 73 as appropriate. For example, the capsule shell may be made of a gelatin, hydroxy propyl methyl cellulose (HPMC), cellulose, water soluble polysaccharides (e.g., pullulan) or gelatin/PEG, as is known in the art. One suitable fillable capsule is available from Qualicaps of Whitsett, N.C., and is known as Posilok® capsule.
Other forms of receptacles may be used with the packaging of the present invention. For example, instead of the capsule-shape receptacle shown, the receptacles may be differently shaped, such as less elongated or rounded, or differently formed, such as being a film-covered containment well.
Base 24 is shown in FIGS. 3-8 separate from cover 28. Base 24 is manufactured with a one-piece construction from a plastic, such as a thermoformed plastic, with the well 26 being provided, generally speaking, as a blister. Plastic blister pack designs are well known and allow for the provision of, in a relatively inexpensive fashion, a lightweight, flexible and possibly transparent base having enough rigidity to provide a desired level of protection for the receptacle. In alternate embodiments within the scope of the invention, one or more other materials may be used to provide the base, including a more substantial or thicker base having recesses molded or formed therein to provide the receptacle well. For example, one may use cold form aluminum technology to produce a suitable base.
Upper surface 29 of base 24 is generally planar and includes a protruding peel tab 30 to facilitate the gripping and subsequent removal of cover 28. Well 26 is formed of a contoured surface particularly adapted for the periphery of the receptacle to be housed therein as well as the intended scoop or drag removal of the receptacle. Well 26 is shown as having a depth sufficient to fit the entire height of receptacle 60, as well as to provide a slight headroom above the receptacle to account for variations in manufacture, thereby allowing cover 28 to lie flat over the well. Other well depths, including lesser depths provided the cover account for the protrusion of the receptacle above the upper surface, may be employed within the scope of the invention.
The contoured surface forming well 26 slopes downward at a distal end to provide an end face or receptacle stop surface 31 that is generally upright. This surface can vary from exactly vertical while providing its stopping function, such as possibly including an undercut, or such as including a draft angle of about 5° to about 1° (e.g., about 4°, 3°, or 2°) from vertical to facilitate manufacture. As used herein, distal and proximal refer to locations relative to the positioning of an inhaler when inserted into the inhaler-accommodating geometry of the well described more fully below for scoop removal of the receptacle, wherein, for example, proximal end of the well refers to the location at which the inhaler is to be inserted, and distal end of the well refers to the end of the well farthest away from such proximal end. Receptacle stop surface 31 is for abutting contact with receptacle 60 when the receptacle may be pushed distally by the inhaler during removal of the receptacle from well 26.
In the embodiment shown in FIG. 5, immediately adjacent the distal end, the contoured well surface includes an optional surface 33 that slopes slightly downward from the upper surface 29, which surface 33 transitions to a surface 34 that juts inward sufficiently to provide ribs that maintain the alignment of the receptacle within well 26. The angling of surface 29 facilitates automatic receptacle loading during manufacture. In one embodiment, an angle about 30° and 60° or more from horizontal can be adopted. Surface 34 can be characterized by ribs which extend about a third of the longitudinal length of well 26, and are shown as being continuous in form. In alternate embodiments, different aligning members may be provided, such as longitudinally discontinuous members that may comprise a plurality of ribs or tabs on either side, or on one of the sides of the well or can be omitted entirely.
Also shown in FIG. 5 is an inhaler stop surface 51. Inhaler stop surface 51 is a multi-planed surface beyond which the inhaler cannot be pushed further distally into well 26. Inhaler stop surface 51 is sloped, thereby facilitating the movement or scooping of receptacle 60 from well 26 into the inhaler. Inhaler stop surface 51 is formed in the region where well 26 transitions from wider to narrower, at approximately two-thirds of the longitudinal length measured from the proximal end to the distal end of well 26.
In the embodiments depicted in FIGS. 12-15, the surface 33 has been omitted, as well as ribs on surface 34.
Surface 34 defines a distal cavity region 36 in which receptacle 60 is designed to closely fit, although usually not in a friction or press fit manner. However, such a press fit is within the scope of the invention. Receptacle 60 rests on a bottom well surface 37 below cavity region 36 and extends proximally therefrom. If the radius of curvature of the transition from receptacle stop surface 31 to bottom surface 37 is substantially greater than that of the receptacle end, it faces, the receptacle 60 may be pushed out of the packaging 20 when the inhaler 90 attempts to scoop the receptacle. Preferably, the ratio of the radius of curvature of the transition to the radius of curvature of the receptacle is less than 1.3, preferably less than or equal to 1. The embodiments depicted in FIG. 6, for example, illustrate a packaging 20 wherein the transition from receptacle stop surface 31 to bottom surface 37 has a radius of curvature that is less than a curvature of the receptacle end it faces. The embodiments depicted in FIGS. 12-15, for example, illustrate a packaging 20 wherein the transition from receptacle stop surface 31 to bottom surface 37 has a radius of curvature that is greater than a curvature of the receptacle end it faces. In the latter embodiment, the radius of curvature of the transition is 4.23 mm for a receptacle having an end radius of curvature of 3.5 mm.
The proximal end of well 26 includes a mouth portion or scoop geometry, generally designated 40. Mouth portion 40 is enlarged in width from that of cavity region 36 and is sized and shaped in conjunction with the inhaler or device intended to be utilized with the receptacle housed within packaging 20′. For an inhaler having a substantially cylindrical exterior periphery around its inhalation chamber as shown in FIGS. 9-11, the end of which periphery may be inserted into well 26 to scoop the receptacle 60 from that well, mouth portion 40 of the well-defining surface may be smoothly rounded with a curved leading edge 41 at upper surface 29. The enlarged width of mouth portion 40 provides a lateral spacing from the sides of aligned receptacle 60 which allows the inhaler to readily insert around the receptacle during scooping, and thus a proximal section of the receptacle that is not disposed between surfaces 34 is in greater lateral spaced relationship with the contoured surface of the well 26 than the lateral spaced relationship of the receptacle distal section with surfaces 34. Thus, the width of the mouth portion 40 will exceed the diameter or width of the inhaler, which in turn exceeds the diameter or width of the receptacle 60. Further, the width of the mouth portion 40 will exceed the diameter or width of the well 26 between surfaces 34. In the embodiments depicted in FIGS. 12-15, the width of the mouth portion 40 at the upper surface 29 is shown to be between 10 and 20 mm or more, e.g., 13.00 mm, while the width of the well 26 between surfaces 34 can be between 8 and 12 mm, such as 9.03 mm. In adapting the exemplified embodiment to larger packagings, the ratio of the mouth portion 40 to surface 29 can be between 1 and 1.5; and the ratio of the width well 26 to receptacle 34 can be between 1 and 1.5. Other scoop geometries than that shown herein may be substituted within the scope of the invention, especially if different inhaler configurations are to be utilized.
In the embodiment depicted in FIGS. 5-11, the mouth portion 40 slopes downward from leading edge 41 as a convex upper region 43 that transitions at a point of inflection 45 into a concave lower region 47. In the embodiment depicted in FIGS. 12-15, the concave lower region 47 extends to the leading edge 41 at the surface 29. The slope should be sufficient to permit the easy introduction of the inhaler into the mouth portion 40. In the embodiment depicted in these figures, the slope can be between 30° and 60° from vertical.
The bottom of concave portion 47 blends into the bottom surface 49 of the proximal portion of well 26. At least one of bottom surface 49 and/or 37 supports receptacle 60. In one embodiment, the bottom surface 49 is at the same depth from upper surface 29 as is well bottom surface 37. In another embodiment, the bottom surface 49 is at a depth from the upper surface 29 slightly below the depth of well bottom surface 37.
The radius of curvature of concave portion 47 at the proximal end of the well is larger than that of the capsule proximal end. For example, the radius of curvature of the lower region 47 depicted in FIGS. 12-15 can be about twice the radius of curvature of the receptacle (between 6 and 9 mm (e.g., 6.36 mm) and between about 3 and 4 mm (e.g., 3.5 mm) respectively). This curvature allows a user to drag a receptacle 60 from well 26 in the proximal direction if inhaler scooping is not desired, as during such dragging the receptacle ramps up concave portion 47 and then convex portion 43 when moved in that direction. This ramping feature that allows capsule dragging may be provided with other ramp geometries, such as a planar, inclined end face, or may be omitted altogether, within the scope of the invention.
In the shown embodiment, because the mouth portion 40 continues distally until the point at which surfaces 34 are provided, well 26 has somewhat of a mushroom shape at a depth or height at which the tops of ribs 34 are disposed. The mouth portion 40 and well 36 preferably meet and transition in at least one transitional surface, e.g. surface 39 (e.g. a plane or concave, relative to the mouth portion), shown in FIG. 13. The transition surface 39 (from well bottom surface 37 to upper surface 29) is preferably sloped away from the mouth portion 40. In FIG. 13, the slope shown is between about 30 to 60° from vertical. And, as the inwardly jutting ribs on surface 34 may not extend upward to top of well 26, and more particularly to the upper surface 29 of the base, well 26 can present a bullet shaped design at upper surface 29, in which the proximal end forms a more rounded profile of the bullet.
Cover 28 may be formed and attached to the base in a variety of manners known in the art. For example, cover 28 may be made of any known material, or combination of materials, and designed to provide for a suitable ease of removal while thwarting unintended access. Suitable materials known in the art include paper, foil, or a plastic sheet, and including combinations thereof. While the embodiment of FIG. 3 illustrates cover 28 as being of a lift and peel type material, wherein such peelable cover can be entirely removed to expose the complete longitudinal length and width of well 26, in alternate embodiments, as long as receptacle 60 is sufficiently exposable within well 26 to allow access by the inhaler through mouth portion 40, other cover techniques may be provided. For example, even a cover having a first peelable portion made of a backing paper, and a second portion of frangible foil that can be separately broken and peeled back from over the well after the first peelable portion has been removed, may be employed within the scope of the invention.
An alternate embodiment of the packaging of the present invention is illustrated in FIG. 12. Packaging 120 shown in FIG. 12 includes scoring 122 that allows packaging 120 to be separated into a plurality of smaller receptacle packagings, such as the receptacle packaging shown in FIG. 14. In the embodiment of FIG. 12, cover 28 includes a fused or sealed region that forms a halo around well 26. The sealed region is illustrated in FIG. 12 by the knurled, diamond-shaped pattern, which is referred to herein as seal or sealed region 128. Seal 128 is formed, for example, by heat sealing or fusing that region of cover 28 to upper surface 29 of base 24. Seal 128 assists in keeping cover 28 in place, and keeping receptacle 60 within packaging 120. As can be seen in FIG. 12, cover 28 includes an unsealed border 129 that surrounds seal 128 between seal 128 and scoring 122. Unsealed border 129 provides a breakaway region that allows cover 28 to be peeled back or otherwise separated from upper surface 29 of base 24 in the manner illustrated, for example, in FIG. 3. There is more resistance to separating cover 28 from upper surface 29 of base 24 in sealed region 128 than in unsealed border 129, but sealed region 128 is preferably designed to be peeled back or otherwise separated from upper surface 29 by a user. In the embodiment shown in FIG. 12, there is more resistance in sealed region 128 toward the distal end given the increasing sealed surface area as cover 28 is peeled back or otherwise separated beginning at the proximal end toward the distal end of well 26. Unsealed border 129 provides a region adjacent scoring 122 that is easily removable to prevent peeling off or separating the cover of an adjacent packaging. As cover 28 is peeled back or otherwise separated from one of the smaller receptacle packagings of packaging 120, cover 28 will readily separate in unsealed border 129, and, with scoring 122, only cover 28 for the one receptacle packaging will be peeled back. Alternatively, if sealed region 128 extends all the way to scoring 122, removing cover 28 from one of the smaller receptacle packagings of packaging 120 could well result in peeling back or separating cover 28 from an adjacent receptacle packaging, exposing a receptacle to unsterile conditions before it is ready for use. Unsealed border 129 helps ensure that opening one receptacle packaging will not inadvertently open an adjacent receptacle packaging.
Receptacle packaging 20′ is shown in FIGS. 9-11 in use with an inhaler abstractly shown in pertinent part at 90. Various inhaler designs are known in the art, including that disclosed in U.S. Pat. No. 6,732,732, which is incorporated herein by reference and which may be used as inhaler 90. However, the overall construction of the inhaler is not material to understanding the present invention. The pertinent aspect of the inhaler is that it has a part that can be inserted into mouth portion 40 to scoop out receptacle 60. This inhaler part, as is the case with inhaler 90 abstractly shown herein, will preferably include the loading opening of the inhalation chamber, but need not be so configured.
With packaging 20′ oriented such that cover 28 does not face downward, and preferably such that base 24 is horizontally disposed, a user may first peel back or otherwise remove cover 28 to expose at least a portion of receptacle 60. It will be appreciated that cover 28 may be fully removed before receptacle scooping, as receptacle stop surface 31 at the distal end of well 26 will serve as a backstop for receptacle 60 during inhaler insertion, which backstop could otherwise be furnished by the cover being only partially removed.
Inhaler 90 can then be manipulated to move in a downward and distal direction such that that inhaler tip 96 will first enter and typically slide along mouth portion 40. Tip 96 includes a central hole that opens directly to the inhalation chamber 94 of inhaler 90, which chamber is formed by an interior wall 95 of inhaler body 92. As inhaler 90 continues to be so moved, tip 96 slides under the rounded end of receptacle 60 as such end inserts into the central hole of the tip, and then the receptacle is cammed upward by engagement with interior wall 95 so as to continue to enter chamber 94. As inhaler 90 is continued to be manipulated by the user to move generally distally, and as shown in FIG. 10, receptacle 60 inserts farther into the inhalation chamber, and may tip upward slightly relative to well 26. During this inhaler movement, receptacle stop surface 31 provides a stop against which the receptacle can abut to prevent the receptacle from slipping out of well 26. It will be appreciated that this relative motion of the inhaler 92 and the base 24 represented in FIG. 9-11 may be achieved either by moving inhaler 90 relative to a stationary packaging, or by holding the inhaler stationary while moving the packaging relative thereto, or by a combination of both. Although FIG. 11 depicts the packaging being inclined, it should be appreciated that inclining the packaging is helpful, but not necessary, for successfully removing the capsule from the packaging with the inhaler.
After inhaler 90 and/or base 24 has been moved sufficiently to cause receptacle 60 to move into inhaler chamber 94, for example as shown in FIG. 11, such that the receptacle will not fall out if the inhaler is longitudinally horizontal or at a more upright angle, the inhaler can then be distanced from the packaging 20′, assembled to cap the inhalation chamber, and utilized in a normal course. The spent capsule, after removal from the inhaler, can be discarded, as opposed to placed back into the blister for subsequent disposal. Subsequent use of the inhaler with other capsule packaging 20′ may be performed until the capsule receptacle packaging 20 is fully exhausted.
While this invention has been shown and described as having preferred designs, the present invention may be modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.
Patent Application
20070131576
