Language selection

Search

Patent 2626708 Summary

Third-party information liability

Some of the information on this Web page has been provided by external sources. The Government of Canada is not responsible for the accuracy, reliability or currency of the information supplied by external sources. Users wishing to rely upon this information should consult directly with the source of the information. Content provided by external sources is not subject to official languages, privacy and accessibility requirements.

Claims and Abstract availability

Any discrepancies in the text and image of the Claims and Abstract are due to differing posting times. Text of the Claims and Abstract are posted:

  • At the time the application is open to public inspection;
  • At the time of issue of the patent (grant).
(12) Patent Application: (11) CA 2626708
(54) English Title: RECEPTACLE PACKAGING WITH INHALER-ACCOMMODATING GEOMETRY
(54) French Title: EMBALLAGE DE RECEPTACLE AVEC GEOMETRIE ACCUEILLANT UN INHALATEUR
Status: Deemed Abandoned and Beyond the Period of Reinstatement - Pending Response to Notice of Disregarded Communication
Bibliographic Data
(51) International Patent Classification (IPC):
  • B65D 75/34 (2006.01)
  • B65D 83/04 (2006.01)
  • B65D 85/42 (2006.01)
(72) Inventors :
  • EHLING, PETER (United States of America)
  • HUNDLEY, WILLIAM M., II (United States of America)
  • JACOBY, ETHAN (United States of America)
  • MONSON, RODNEY HAL (United States of America)
(73) Owners :
  • ALKERMES, INC.
(71) Applicants :
  • ALKERMES, INC. (United States of America)
(74) Agent: SMART & BIGGAR LP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2006-11-06
(87) Open to Public Inspection: 2007-05-31
Examination requested: 2009-04-17
Availability of licence: N/A
Dedicated to the Public: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2006/043310
(87) International Publication Number: US2006043310
(85) National Entry: 2008-04-21

(30) Application Priority Data:
Application No. Country/Territory Date
60/733,764 (United States of America) 2005-11-07

Abstracts

English Abstract


A packaging (20) for a receptacle loadable into an inhaler for pulmonary
delivery of the contents of the receptacle. The packaging includes a base (24)
and a cover (28), which base has a surface defining (26) a well that
accommodates the receptacle. The well-defining surface includes a first region
and a differently shaped second region, which first surface region is shaped
to support the receptacle in alignment within the well, and which second
surface region accommodates a first end of the receptacle aligned in the well
and has a mouth geometry enlarged from the first surface 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.


French Abstract

La présente invention concerne un emballage destiné à un réceptacle pouvant être chargé dans un inhalateur pour libérer dans les poumons le contenu du réceptacle. L'emballage comprend une base et un couvercle, la base ayant une surface définissant un puits qui accueille le réceptacle. La surface définissant le puits comprend une première région et une seconde région de forme différente. La première région de surface est formée pour soutenir le réceptacle aligné avec le puits, et la seconde région de surface accueille une première extrémité du réceptacle aligné avec le puits et présente une géométrie buccale agrandie à partir de la première région de surface pour permettre qu'une partie d'un inhalateur soit insérée dans celle-ci pour recevoir la première extrémité du réceptacle pour vider le réceptacle dans l'inhalateur à partir du puits.

Claims

Note: Claims are shown in the official language in which they were submitted.


CLAIMS
WE CLAIM:
1. A packaging for a unit dosage form, said packaging comprising:
a base having a well-defining surface that defines a well that accommodates
the
unit dosage form;
a cover for said well, said cover being at least partially removable to allow
access
to the unit dosage form;
wherein said well-defining surface includes a first surface region and a
differently
shaped second surface region, said first surface region shaped to support the
unit dosage
form in alignment within the well, said second surface region accommodating a
first end
of the receptacle aligned in the well and having a mouth geometry enlarged
from said
first surface region to allow a portion of a delivery device to be inserted
therein to receive
the first end of the unit dosage form for scooping into the delivery device
from said well.
2. 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, said packaging
comprising:
a base having a well-defining surface that defines a well that accommodates
the
receptacle;
a cover for said well to maintain sterility of the receptacle within said
well, said
cover being at least partially removable to allow access to the receptacle;
wherein said well-defining surface includes a first region and a differently
shaped
second region, said first region shaped to support the receptacle in alignment
within the
well, said second region accommodating a first end of the receptacle aligned
in the well
-17-

and having a mouth portion enlarged from said 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 said well.
3. The packaging of claim 2 wherein said second region includes a concave
surface characterized by a radius of curvature that is greater than a radius
of curvature of
a proximal end of the receptacle.
4. The packaging of claim 3 wherein said second region includes a concave
surface characterized by a radius of curvature that is twice the radius of
curvature of a
proximal end of the receptacle.
5. The packaging of claim 3 wherein said first region includes a concave
surface characterized by a radius of curvature that is less than the radius of
curvature of
said second region.
6. The packaging of claim 2 wherein said mouth portion includes a sloping
surface facing the first end of the receptacle, said sloping surface including
a concave
portion wherein said sloping surface has an angle of between 30° and
60° from vertical.
7. The packaging of claim 2 wherein said mouth portion includes a sloping
surface facing the first end of the receptacle, said sloping surface including
a concave
portion and a convex portion, said concave portion being deeper within said
well than
said convex portion.
8. The packaging of claim 7 wherein, along a longitudinal cross-section of
said well through a central length of the receptacle aligned within said well,
an inflexion
-18-

point between said concave portion and said convex portion is disposed within
a middle
portion of the depth of the well.
9. The packaging of claim 2 wherein said mouth portion includes a concave
surface facing the first end of the receptacle and extending below the central
height of the
receptacle, said concave surface having a curvature with a larger radius than
a radius of
curvature of the first end of the receptacle, whereby the receptacle can ramp
up said
concave surface when being scooped from the well.
10. The packaging of claim 2 wherein said well-defining surface includes a
third region that forms a receptacle stop surface for abutment by a second end
of the
receptacle aligned within said well during scooping of the receptacle from
said well.
11. The packaging of claim 10 wherein a bottom end of said third region
transitions to a bottom of the well along a surface having a radius of
curvature, wherein
the ratio of the radius of curvature of said transition surface to the radius
of curvature of a
second end of the receptacle is less than 1.3.
12. The packaging of claim 9 wherein a bottom end of said third region
transitions to a bottom of the well along a surface having a radius of
curvature, wherein
the radius of curvature of said transition surface is smaller than a radius of
curvature of a
second end of the receptacle.
13. The package of Claim 12 wherein the slope of said third region is
5° from
vertical.
14. The packaging of claim 2 wherein said well-defining surface comprises an
inhaler stop surface.
-19-

15. The packaging of claim 1 wherein said well-defining surface comprises a
thermoplastic blister.
16. The packaging of claim 1 wherein said cover comprises a layer that is
connected to said base to be peelable from over the entire well to fully
expose the
receptacle within said well.
17. A kit comprising a packaging of any one of Claims 2-16 having disposed
therein a receptacle comprising an inhalable powdered pharmaceutical and an
inhaler.
18. A method of loading an inhalation chamber of an inhaler with a receptacle
filled with a powdered pharmaceutical without manually touching the
receptacle, said
method comprising:
providing a receptacle packaged within a blister pack, the blister pack
including
an asymmetrical well defined by a base of the blister pack, the lower section
of the well
having a first end and a second end, the portion of the well proximate the
first end having
a first width and serving as a mouth portion, the portion of the well adjacent
the second
end portion having a width lesser than the first width for aligning the
receptacle, wherein
the mouth portion is sized and shaped to accommodate a tip of the inhaler;
opening a cover of the blister pack to expose at least the mouth region of the
well
and at least an end of the receptacle;
inserting into the mouth region of the well the tip of the inhaler having an
opening
leading to the inhalation chamber; and
moving the inhaler and blister pack relative to each other such that the
inhaler
scoops the receptacle out of the well and through the inhaler opening so as to
enter the
inhalation chamber.
-20-

Description

Note: Descriptions are shown in the official language in which they were submitted.


CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
RECEPTACLE PACKAGING WITH INHALER-ACCOMMODATING
GEOMETRY
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 pharinaceutical 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

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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
-2-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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
having a blister shaped to permit an inhaler end to be inserted therein,
whereby a
receptacle within the blister may be scooped directly into an inhalation
chainber of the
inhaler.
Yet another advantage of the present invention is that a packaging may be
provided that allows a 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 conjunction with the accompanying drawings, wherein:
Fig. 1 is a top perspective view of a first embodiment of a receptacle
packaging of
the present invention;
-3-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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;
-4-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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 Figure 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
-5-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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). Figure 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 Figure 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,
-6-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
continuously around wel126. 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,
NC, 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
-7-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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
wel126 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.
We1126 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 wel126 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 40, 30, or
-8-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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 we1126.
In the embodiment shown in Figure 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 between 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 Figure 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 we1126 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
we1126.
-9-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
In the embodiments depicted in Figures 12-15, the surface 33 has been omitted,
as
well as the 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
Figure 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 Figures 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 wel126 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
-10-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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 Figures 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 Figures 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
Figures 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.
-11-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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 Figures 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 we1126
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, wel126 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 Figure 13.
The
transition surface 39 (from well bottom surface 37 to upper surface 29) is
preferably
sloped away from the mouth portion 40. In Figure 13, the slope shown is
between about
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
-12-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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 einbodiment 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
Figure 12. Packaging 120 shown in Figure 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 Figure 14. In the embodiment of Figure 12, cover
28
includes a fused or sealed region that forms a halo around well 26. The sealed
region is
illustrated in Figure 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
Figure 12, cover 28 includes an unsealed border 129 that surrounds seal 128
between seal
-13-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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 Figure 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 Figure 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 we1126. 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. Patent 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.
-14-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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 we1126 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 Figure 11 depicts the
packaging
-15-

CA 02626708 2008-04-21
WO 2007/061621 PCT/US2006/043310
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.
-16-

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

2024-08-01:As part of the Next Generation Patents (NGP) transition, the Canadian Patents Database (CPD) now contains a more detailed Event History, which replicates the Event Log of our new back-office solution.

Please note that "Inactive:" events refers to events no longer in use in our new back-office solution.

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Event History , Maintenance Fee  and Payment History  should be consulted.

Event History

Description Date
Inactive: IPC expired 2023-01-01
Application Not Reinstated by Deadline 2011-05-09
Inactive: Dead - No reply to s.30(2) Rules requisition 2011-05-09
Deemed Abandoned - Failure to Respond to Maintenance Fee Notice 2010-11-08
Inactive: Abandoned - No reply to s.30(2) Rules requisition 2010-05-10
Inactive: S.30(2) Rules - Examiner requisition 2009-11-09
Letter Sent 2009-06-04
Request for Examination Received 2009-04-17
Request for Examination Requirements Determined Compliant 2009-04-17
All Requirements for Examination Determined Compliant 2009-04-17
Letter Sent 2009-03-03
Inactive: Single transfer 2009-01-19
Inactive: Cover page published 2008-07-29
Letter Sent 2008-07-24
Inactive: Notice - National entry - No RFE 2008-07-24
Letter Sent 2008-07-24
Letter Sent 2008-07-24
Letter Sent 2008-07-24
Letter Sent 2008-07-24
Inactive: First IPC assigned 2008-05-09
Application Received - PCT 2008-05-08
National Entry Requirements Determined Compliant 2008-04-21
Application Published (Open to Public Inspection) 2007-05-31

Abandonment History

Abandonment Date Reason Reinstatement Date
2010-11-08

Maintenance Fee

The last payment was received on 2009-10-21

Note : If the full payment has not been received on or before the date indicated, a further fee may be required which may be one of the following

  • the reinstatement fee;
  • the late payment fee; or
  • additional fee to reverse deemed expiry.

Patent fees are adjusted on the 1st of January every year. The amounts above are the current amounts if received by December 31 of the current year.
Please refer to the CIPO Patent Fees web page to see all current fee amounts.

Fee History

Fee Type Anniversary Year Due Date Paid Date
Registration of a document 2008-04-21
Basic national fee - standard 2008-04-21
MF (application, 2nd anniv.) - standard 02 2008-11-06 2008-10-20
Registration of a document 2009-01-19
Request for examination - standard 2009-04-17
MF (application, 3rd anniv.) - standard 03 2009-11-06 2009-10-21
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
ALKERMES, INC.
Past Owners on Record
ETHAN JACOBY
PETER EHLING
RODNEY HAL MONSON
WILLIAM M., II HUNDLEY
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

To view selected files, please enter reCAPTCHA code :



To view images, click a link in the Document Description column. To download the documents, select one or more checkboxes in the first column and then click the "Download Selected in PDF format (Zip Archive)" or the "Download Selected as Single PDF" button.

List of published and non-published patent-specific documents on the CPD .

If you have any difficulty accessing content, you can call the Client Service Centre at 1-866-997-1936 or send them an e-mail at CIPO Client Service Centre.


Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Description 2008-04-20 16 728
Drawings 2008-04-20 8 156
Abstract 2008-04-20 2 81
Representative drawing 2008-04-20 1 11
Claims 2008-04-20 4 151
Reminder of maintenance fee due 2008-07-23 1 114
Notice of National Entry 2008-07-23 1 195
Courtesy - Certificate of registration (related document(s)) 2008-07-23 1 104
Courtesy - Certificate of registration (related document(s)) 2008-07-23 1 104
Courtesy - Certificate of registration (related document(s)) 2008-07-23 1 104
Courtesy - Certificate of registration (related document(s)) 2008-07-23 1 104
Courtesy - Certificate of registration (related document(s)) 2008-07-23 1 104
Courtesy - Certificate of registration (related document(s)) 2009-03-02 1 103
Acknowledgement of Request for Examination 2009-06-03 1 174
Courtesy - Abandonment Letter (R30(2)) 2010-08-01 1 164
Courtesy - Abandonment Letter (Maintenance Fee) 2011-01-03 1 173
PCT 2008-04-20 3 120
PCT 2008-04-21 1 46