U.S. patent application number 12/399415 was filed with the patent office on 2009-09-10 for pacifier with thin-film reservoir and method for use thereof.
This patent application is currently assigned to MONOSOL RX, LLC. Invention is credited to Joseph M. Fuisz, Richard C. Fuisz, Tushar Misra, Pradeep Sanghvi.
Application Number | 20090227977 12/399415 |
Document ID | / |
Family ID | 35500910 |
Filed Date | 2009-09-10 |
United States Patent
Application |
20090227977 |
Kind Code |
A1 |
Fuisz; Richard C. ; et
al. |
September 10, 2009 |
PACIFIER WITH THIN-FILM RESERVOIR AND METHOD FOR USE THEREOF
Abstract
The invention relates to a pacifier and nipple member for
delivery of active ingredients into the oral cavity of an infant or
patient. The pacifier includes a porous nipple member and a base
member adapted to remain outside the oral cavity of the infant. The
porous nipple member includes at least one reservoir or chamber
therein for receiving a thin-film containing an active ingredient.
The base member may be removably attached to the neck of the nipple
member, or the nipple and base members may form a single unit.
Reusable and disposable forms are disclosed.
Inventors: |
Fuisz; Richard C.; (McLean,
VA) ; Fuisz; Joseph M.; (Washington, DC) ;
Misra; Tushar; (Leesburg, VA) ; Sanghvi; Pradeep;
(Schererville, IN) |
Correspondence
Address: |
HOFFMANN & BARON, LLP
6900 JERICHO TURNPIKE
SYOSSET
NY
11791
US
|
Assignee: |
MONOSOL RX, LLC
Portage
IN
|
Family ID: |
35500910 |
Appl. No.: |
12/399415 |
Filed: |
March 6, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10939752 |
Sep 13, 2004 |
7500984 |
|
|
12399415 |
|
|
|
|
Current U.S.
Class: |
604/500 ; 604/77;
606/236 |
Current CPC
Class: |
A61J 7/0053 20130101;
A61J 17/001 20150501; A61P 29/00 20180101; A61J 11/0015 20130101;
A61J 7/0046 20130101; A61J 11/0005 20130101 |
Class at
Publication: |
604/500 ;
606/236; 604/77 |
International
Class: |
A61J 7/00 20060101
A61J007/00; A61J 17/00 20060101 A61J017/00 |
Claims
1-23. (canceled)
24. A pacifier for delivering an active comprising: a porous nipple
member comprising an inner surface, wherein said inner surface is
in contiguous contact with a first reservoir and a second
reservoir, said first reservoir comprising a retaining mechanism
extending from said inner surface and having at least one
unattached end; and a dissolvable thin-film housed in said first
reservoir comprising a first active, wherein said unattached end of
said retaining mechanism is in contact with said thin-film.
25. The pacifier of claim 24, further comprising a second film
housed in said second reservoir comprising a second active.
26. The pacifier of claim 25, wherein said first active and said
second active are different.
27. The pacifier according to claim 24, wherein said first active
is selected from the group consisting of: pharmaceutical agents;
cosmetic agents; drugs; medicaments; antidotes; vaccines; antigens
or allergens; mouthwash components; flavors; fragrances; enzymes;
preservatives; sweetening agents; colorants; spices; vitamins; and
combinations thereof.
28. The pacifier according to claim 25, wherein said second active
is selected from the group consisting of: pharmaceutical agents;
cosmetic agents; drugs; medicaments; antidotes; vaccines; antigens
or allergens; mouthwash components; flavors; fragrances; enzymes;
preservatives; sweetening agents; colorants; spices; vitamins; and
combinations thereof.
29. The pacifier according to claim 24, wherein said first active
is selected from the group consisting of: aspirin; benzocaine;
lidocaine; diphenhydramine; simethicone; vitamins; cold and cough
medications; and combinations thereof.
30. The pacifier of claim 24, further comprising a liquid housed in
said second reservoir.
31. The pacifier of claim 30, wherein said liquid is water.
32. The pacifier of claim 24, wherein said porous nipple member is
translucent.
33. A bottle nipple for delivering an active comprising: a porous
nipple member comprising a nipple, a neck adapted to removably
attach said porous nipple member to a baby bottle and a reservoir
in contiguous contact with an inner wall of said porous nipple
member; and a dissolvable thin-film housed in said reservoir
comprising an active and being held-in-place by a retaining
mechanism, wherein said retaining mechanism extends from said inner
surface and has at least one unattached end.
34. The bottle nipple according to claim 33, wherein said active is
selected from the group consisting of: pharmaceutical agents;
cosmetic agents; drugs; medicaments; antidotes; vaccines; antigens
or allergens; mouthwash components; flavors; fragrances; enzymes;
preservatives; sweetening agents; colorants; spices; vitamins; and
combinations thereof.
35. The bottle nipple according to claim 33, wherein said active is
selected from the group consisting of: aspirin; benzocaine;
lidocaine; diphenhydramine; simethicone; vitamins; cold and cough
medications; and combinations thereof.
36. The bottle nipple of claim 33, further comprising a second
reservoir, wherein said second reservoir comprises water.
37. The bottle nipple of claim 33, further comprising a second
reservoir comprising a second dissolvable thin-film.
38. A method for delivering an active to an infant, patient or
animal in need thereof comprising the steps of: (a) providing a
dissolvable thin-film comprising an active; (b) providing a porous
nipple member comprising an inner surface, wherein said inner
surface is in contiguous contact with a first reservoir and a
second reservoir, said reservoirs comprising at least one retaining
mechanism; (c) inserting said dissolvable thin-film into said first
reservoir; (d) inserting a liquid into said second reservoir; (e)
orally administering said porous nipple member to an infant,
patient or animal in need thereof; and (f) permitting said an
infant, patient or animal to suckle on said porous nipple member,
wherein said liquid is released to facilitate in the dissolution of
said dissolvable thin-film and allowing said active to be released
into the oral cavity.
39. The method of claim 38, wherein said active is selected from
the group consisting of: aspirin; benzocaine; lidocaine;
diphenhydramine; simethicone; vitamins; cold and cough medications;
and combinations thereof.
40. The method of claim 38, wherein said liquid is water.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of and claims the benefit
of U.S. application Ser. No. 10/939,752, filed Sep. 13, 2004, now
U.S. Pat. No. 7,500,984, the contents of which are incorporated
herein by reference.
FIELD OF THE INVENTION
[0002] The invention relates to a pacifier or nipple member for
delivery of active ingredients into the oral cavity of an infant or
patient. The pacifier has a porous nipple member and a reservoir or
chamber therein for receiving a thin-film that contains an active
ingredient. Active ingredients may include drugs and/or vitamins
suitable for administration to infants or patients.
BACKGROUND OF THE RELATED TECHNOLOGY
[0003] It often is desirable to administer medications and/or
vitamins to infants or patients in need thereof. Commonly used
administration forms, however, experience certain known
shortcomings. Due to an infant's natural propensity to suckle,
pacifiers can be a useful tool for delivering such actives.
[0004] The prior art teaches pacifiers that have been modified to
administer liquids and liquid medications to infants. Liquid
medications may be difficult to insert into a pacifier, which can
cause inaccuracy in the administration dosage. The present
invention provides a pacifier that incorporates a thin-film dosage
unit, thereby alleviating problems associated with the prior
art.
SUMMARY OF THE INVENTION
[0005] In accordance with the present invention, there is provided
a reusable pacifier for delivering an active ingredient to an
infant or patient including: a porous nipple member having a nipple
and a neck and having at least one reservoir therein for receiving
a thin-film containing an active ingredient; and a base member
removably attached to the neck of the nipple member and adapted to
remain outside the oral cavity of the infant.
[0006] There also is provided a reusable pacifier for delivering an
active ingredient to an infant or patient including: a porous
nipple member having a nipple and a neck and having at least one
reservoir therein; a thin-film housed in the reservoir, the film
containing an active ingredient; and a base member removably
attached to the neck of the nipple member and adapted to remain
outside the oral cavity of the infant.
[0007] Another embodiment of the present invention provides a
single-use pacifier for delivering an active ingredient to an
infant or patient including: a base member adapted to remain
outside the oral cavity of the infant, the base member including a
shield having a concave side and a convex side; a porous nipple
member disposed on the concave side of the base member, the nipple
member having at least one reservoir therein; and a thin-film
housed in the reservoir, the film containing an active
ingredient.
[0008] In accordance with another embodiment of the present
invention, there is provided a reusable pacifier for delivering an
active ingredient to an infant or patient including: a base member
adapted to remain outside the oral cavity of the infant, the base
member including a shield having a concave side and a convex side;
and a porous nipple member disposed on the concave side of the base
member, the nipple member having at least one flap defining at
least one chamber for receiving a thin-film containing an active
ingredient.
[0009] Yet another embodiment of the present invention provides a
baby bottle nipple for delivering an active ingredient to an infant
including: a porous nipple member having a nipple and a neck and
having at least one reservoir therein, wherein the neck is adapted
to removably attach to a baby bottle; and a thin-film housed in the
reservoir, the film containing an active ingredient.
[0010] The present invention also provides a method for delivering
an active ingredient to an infant or patient including the steps
of: providing a thin-film containing an active ingredient;
providing a porous nipple member of a pacifier having a reservoir
or chamber for receiving the thin-film containing an active;
inserting the thin-film into the reservoir or chamber of the porous
nipple member; and orally administering the pacifier to an infant
or patient thereby allowing the thin-film to dissolve and release
the active ingredient into the oral cavity.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a side plan view of a reusable pacifier in
accordance with an embodiment of the present invention;
[0012] FIG. 2 is a side plan view of a single-use pacifier in
accordance with an embodiment of the present invention;
[0013] FIG. 3 is a cross-sectional view of the reservoir in the
nipple member taken along line 3-3 of FIG. 1;
[0014] FIG. 4 is a side plan view of a pacifier with insertion
flaps for accessing a reservoir or chamber in accordance with an
embodiment of the present invention;
[0015] FIG. 5a is a side plan view of a reusable nipple member with
a hollow reservoir in accordance with an embodiment of the present
invention;
[0016] FIG. 5b is a cross-sectional view of the reservoir in the
nipple member taken along line 5-5 of FIG. 5a;
[0017] FIG. 6 is a side plan view of a nipple for a baby bottle in
accordance with an embodiment of the present invention;
[0018] FIG. 7 is a side plan view of a reusable pacifier including
retaining fingers on the base portion in accordance with an
embodiment of the present invention;
[0019] FIG. 8 is a side plan view of a solid plug shaped to fit
within the neck of the nipple member in accordance with an
embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0020] The present invention relates to delivery devices for drugs
and other actives which are designed particularly for infants and
patients such as the elderly, and those who have had surgery or
other illnesses which prevent the ordinary dispensing of
medication. The devices may be used for veterinary applications as
well. The device of the present invention may be termed pacifiers
or nipple members, since they are designed to administer the active
through pores in the nipple member.
[0021] In particular, the present invention provides a pacifier or
nipple unit for bottles, both of which are designed to deliver an
active ingredient to a patient. The pacifier includes a porous
nipple member and a base member, The pores in the nipple may be of
any suitable shape and size. The nipple member includes a reservoir
or other like chamber therein for receiving a thin-film that
contains the active ingredient. The base member, which is adapted
to remain outside the oral cavity of the infant or patient, may be
removably attached to the nipple member. The pacifier may be a
reusable or single-use device.
[0022] In one embodiment, the film containing active may be placed
inside the hollow portion of the nipple and which by means of the
nipple's porosity is in communication with saliva in the patient's
oral cavity such that the saliva dissolves the film and releases
the active into the oral cavity.
[0023] In another embodiment, as discussed herein, the nipple has a
reservoir or chamber adapted to receive a film containing an
active, the reservoir or chamber having pores which allow passage
of the film and its active contents for release into the oral
cavity.
[0024] In accordance with some embodiments of the present
invention, as shown in FIGS. 1 and 5a, the pacifier 10 includes a
nipple member 100 and a base member 200. The nipple member 100
includes a nipple 110 wherein a rounded tip is contiguous with a
neck 120. The nipple member 100 also has a reservoir therein 130 to
receive a thin-film containing the active. Pores 105 permit the
saliva to contact the film and the active to be released in the
oral cavity. The pacifier 10 also may include a solid plug 300
shaped to fit within the neck 120 of the nipple member 100, as
shown in FIG. 8.
[0025] The base member 200 includes a shield 210, which may have a
concave side and a convex side. The base member 200 may include a
handle member 230 or 330 that is pivotally attached to the convex
side of the shield 210.
[0026] In a reusable embodiment, the base member 200 includes an
attachment member 220 disposed on the concave side of the shield
210. The neck 120 of the nipple member 100 engages the attachment
member 220 to removably attach the base member 200 to the nipple
member 100. The attachment member 220 and neck 120 are attached via
any mechanical connection known to those skilled in the art. For
instance, the connection may be a threaded connection, as shown in
FIG. 1. In this embodiment, the attachment member 220 and the neck
120 of the nipple member 100 each include threaded-mating portions.
When the neck 120 engages the attachment member 220, a threaded
connection is formed therebetween thereby removably attaching the
nipple member 100 to the base member 200. The nipple member 100 may
be removed from the base member 200 by unthreading the connection.
This permits the user to reinsert a thin-film into the reservoir of
the nipple member as desired. Other connections include, for
example, but are not limited to, snap-fit or bayonet-lock fit.
[0027] In accordance with a single-use embodiment of the present
invention, the nipple member 100 and base member 200 form a single
molded device, as shown in FIG. 2. The nipple member and base
member are a one-piece construction. Alternatively, the nipple
member and base member may be molded separately and then attached
to one another using a suitable nontoxic adhesive, press fit or
other similar attachment means. The thin-film is inserted into
reservoir 130 formed in the nipple portion of the pacifier during
manufacture. Single-use embodiments are constructed to be
disposable devices. As such, it may be desirable to produce the
pacifier in a hermetically sealed package for sanitary reasons.
[0028] The nipple member of the pacifiers of the present invention
may be constructed from any suitable resilient material that is
acceptable for oral administration. Such materials are known to
those skilled in the art. Suitable materials include, for example,
rubber or plastic materials such as polyurethane, silicone,
acrylics, polyethylene or polyvinyl chloride. The material is
desirably porous or permeable to allow delivery of an active
ingredient into the oral cavity of an infant or patient. For
instance, the nipple member may contain a series of perforations or
pores, such as pores 105 and slits 106, as shown in FIGS. 1, 2, 4,
5a, 6 and 7. The pores may be very small, as long as they are large
enough to allow saliva to pass through the nipple to dissolve the
film and release the active into the oral cavity. The pores,
however, may be as large as desired to provide different release
properties of the active. For example, it may be desirable to
release some actives quickly, whereas other actives may work more
effectively with a slower, controlled release. Moreover, the
material may be porous throughout or selectively porous in certain
regions to provide different release properties.
[0029] The active ingredient desirably is released from a thin-film
contained in the reservoir or chamber of the nipple member. More
specifically, the infant's or patient's sucking on the nipple
allows saliva to reach the thin-film via the porous material of the
nipple. The saliva dissolves the film and the active ingredient
contained therein is released into the oral cavity. The material
may further be translucent so that a user can visually determine
when the film has dissolved. The size and shape of the nipple
member can vary to accommodate different age groups or various
animals for use in veterinary medicine.
[0030] The reservoir 130 in the nipple member 100 is adapted to
receive the thin-film. The reservoir may be such that the nipple
member is hollow or a chamber sized to fit the piece of thin-film.
In general, the films, when dried, have a thickness from about 3
.mu.m to about 250 .mu.m, or about 0.1 mils to about 10 mils.
Desirably, the dried films will have a thickness of about 2 mils to
about 8 mils, and more desirably, from about 3 mils to about 6
mils. Accordingly, the reservoir may have a thickness of slightly
larger than about 0.1 mils to slightly larger than about 10 mils.
The reservoir may have any shape suitable to receive thin-films as
such. For example, as shown in FIG. 3, the reservoir 130 has a
generally flat shape. As shown in FIG. 5b, the nipple member is
generally hollow. The reservoir could have square or rounded
edges.
[0031] In some embodiments, it may be desirable to include multiple
reservoirs in the nipple member to house more than one film at a
time. For example, it may be desirable to deliver more than one
active ingredient to the infant or patient at the same time. In
such case, different films each containing a different active may
be inserted into separate reservoirs in the nipple member.
Alternatively, it may be desirable to include a liquid, such as
water, in one reservoir and a film in another reservoir. The liquid
facilitates quick dissolution of the film as the infant or patient
sucks on the nipple member. In other embodiments, the infant's or
patient's saliva acts as the liquid source.
[0032] The film may be free-standing in the reservoir or it may be
held in-place by a retaining mechanism such as, but not limited to,
clips or retaining fingers, as depicted in FIG. 6. As shown in FIG.
6, the retaining fingers 125 are disposed on the internal surface
of the nipple member 100. Reservoir 130 may includes film 400,
which is held against the internal surface of nipple member 100 by
retaining fingers 125. Alternatively, the retaining fingers 125 may
be disposed on the concave side of the base member 200, as shown in
FIG. 7. The film 400 is thereby held in-place insider the reservoir
once the nipple member is attached to the base member. Alternative
retaining mechanisms are contemplated herein and would be known to
those skilled in the art.
[0033] In some embodiments, the film may have a preformed curled
shape to fit inside the nipple member and mate therewith.
Alternatively, the film may be manufactured in a flat shape and
curled for insertion into the nipple member. The curled film may be
adapted to abut against part or the entire inner surface of the
nipple member.
[0034] In accordance with another embodiment of the present
invention, the nipple member of the pacifier contains at least one
chamber created by a flap 140 in the external surface of the
nipple, as shown in FIG. 4. For instance, one or more flaps 140 may
be created by small cuts in the surface of the nipple member. A
thin-film may be inserted into each of the flaps. As in the
embodiments described above, the material of the nipple member is
porous, thereby allowing release of the active from the film into
the oral cavity.
[0035] Yet another embodiment of the present invention provides a
nipple member for attachment to a baby bottle as shown in FIG. 6.
As described in the embodiments above, the nipple member 100 may
include a reservoir 130 adapted to receive a thin-film that
contains an active ingredient. More specifically, the nipple member
100 is hollow as seen in FIG. 6. The film is inserted into the
hollow nipple member via the base 115 of the nipple member and held
in-place against the internal surface of the nipple by retaining
fingers 125. Holding the film against the internal surface of the
nipple as such allows saliva or liquid to reach the film quickly
and thus may assist in quickly releasing the active. The nipple
member similarly is formed of a porous or permeable material, as
shown by pores 105 in FIG. 6. As the infant sucks on the nipple to
obtain the liquid contained in the bottle, the infant's saliva and
the liquid together act to dissolve the film thereby releasing the
active ingredient into the oral cavity. The nipple member for the
baby bottle may be disposable or reusable by reinserting another
film as desired.
[0036] The active ingredients used in embodiments of the present
invention may be any active suitable for administration to an
infant or patient in need thereof. The active ingredient is
desirably in a solid form, such as particulate, powder, dissolvable
tablet, or most desirably a thin-film. The active ingredients
include, without limitation, pharmaceutical and cosmetic actives,
drugs, medicaments, antigens or allergens such as ragweed pollen,
spores, microorganisms, seeds, mouthwash components, flavors,
fragrances, enzymes, preservatives, sweetening agents, colorants,
spices, vitamins and supplements and combinations thereof. Suitable
active ingredients are more fully described in Applicants'
co-pending U.S. application Ser. Nos. 10,074,272, filed Feb. 14,
2002, 10/768,809, filed Jan. 30, 2004, and 10/856,176, filed May
28, 2004, which are incorporated herein by reference in their
entirety. Particularly suitable actives for delivery to infants
include aspirin, benzocaine, lidocaine, diphenhydramine,
simethicone, vitamins and cold and cough medications. Other
suitable actives include medicaments for the treatment of pain,
such as, for example, narcotic analgesics including fentanyl. Some
embodiments are adapted for emergency or antidotal use and
therefore include, for example, poison antidotes as actives. In
other embodiments, it may be desirable to include mucosally active
vaccines, such as, but not limited to, flu and west nile virus
vaccines.
[0037] The thin-films which contain the active ingredients may be
any film disclosed in U.S. application Ser. Nos. 10,074,272,
10/768,809 and 10/856,176, referred to above. These applications
provide an extensive description of thin-films and methods for
producing such films.
[0038] A variety of optional components also may be incorporated
into the thin-films, as described in U.S. application Ser. Nos.
10/074,272, 10/768,809 and 10/856,176, referred to above. These may
include, without limitation, anti-foaming agents, pigments,
coloring agents, sweetening agents and flavoring agents, among
others.
[0039] The present invention also is directed to methods for
delivering the active ingredient to the oral cavity of an infant or
patient. In accordance therewith, at least one thin-film containing
an active ingredient is provided. The thin-film may be inserted
into the reservoir or chamber of the porous nipple member. The film
may be inserted through the neck of the nipple member. The film may
be free-standing or clipped or retained in-place by a retaining
member. In the single-use, or disposable, embodiments, the final
pacifier device is manufactured with a base member. In the reusable
embodiments, the porous nipple member may be attached to the base
member to form the pacifier apparatus. Once the nipple member and
base member are attached, or manufactured as a disposable pacifier,
the pacifier may be orally administered to an infant or patient.
The infant's or patient's saliva penetrates the porous nipple
member and dissolves the thin-film. In accordance with some
embodiments, the film's dissolution is facilitated by wetting the
reservoir or chamber. The active ingredient contained in the film
is thereby released into the oral cavity of the infant or
patient.
[0040] Once the thin-film dissolves and the active is fully
released, the pacifier may be removed from the oral cavity of the
infant or patient. As discussed above, the material forming the
nipple member may be translucent, thereby enabling the user to
determine when the film is substantially consumed. In the reusable
embodiments, the nipple member may be removed from the base member
for administration of another thin-film as desired.
* * * * *