U.S. patent application number 14/130668 was filed with the patent office on 2014-11-27 for reconstitution device.
The applicant listed for this patent is Bassam B. Damaj, Daniel W. Frank, Richard Martin, Michael Mueller. Invention is credited to Bassam B. Damaj, Daniel W. Frank, Richard Martin, Michael Mueller.
Application Number | 20140350482 14/130668 |
Document ID | / |
Family ID | 46548846 |
Filed Date | 2014-11-27 |
United States Patent
Application |
20140350482 |
Kind Code |
A1 |
Damaj; Bassam B. ; et
al. |
November 27, 2014 |
RECONSTITUTION DEVICE
Abstract
The present invention relates to methods for reconstituting and
relates to reconstitution devices suitable for reconstituting many
different materials. Furthermore, the present invention includes
methods of treatment and methods of use related to a reconstitution
device or apparatus. Some embodiments are suitable for
reconstituting small amounts of a pharmaceutical compositions and
using the pharmaceutical composition for the treatment of sexual
dysfunction.
Inventors: |
Damaj; Bassam B.; (San
Diego, CA) ; Martin; Richard; (San Diego, CA)
; Mueller; Michael; (San Diego, CA) ; Frank;
Daniel W.; (Broomall, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Damaj; Bassam B.
Martin; Richard
Mueller; Michael
Frank; Daniel W. |
San Diego
San Diego
San Diego
Broomall |
CA
CA
CA
PA |
US
US
US
US |
|
|
Family ID: |
46548846 |
Appl. No.: |
14/130668 |
Filed: |
July 6, 2012 |
PCT Filed: |
July 6, 2012 |
PCT NO: |
PCT/US2012/045672 |
371 Date: |
August 6, 2014 |
Current U.S.
Class: |
604/218 ;
206/219; 206/570; 514/573; 514/655 |
Current CPC
Class: |
B65D 81/3211 20130101;
A61P 17/00 20180101; A61J 1/2031 20150501; A61P 15/10 20180101;
A61J 2200/40 20130101; A61K 31/137 20130101; A61J 2200/72 20130101;
A61P 27/02 20180101; A61J 1/2051 20150501; A61J 1/2093 20130101;
A61K 31/5575 20130101; A61P 9/00 20180101 |
Class at
Publication: |
604/218 ;
514/573; 514/655; 206/570; 206/219 |
International
Class: |
A61J 1/20 20060101
A61J001/20; A61K 31/5575 20060101 A61K031/5575; A61K 31/137
20060101 A61K031/137; A61M 5/315 20060101 A61M005/315 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 6, 2011 |
CA |
2745320 |
Claims
1. A method of mixing comprising: filling a device with at least
two compositions; storing said at least two compositions; and
mixing said at least two compositions with said device.
2. The method of claim 1, wherein said device comprises: at least
one housing element capable of containing at least two
compositions; and at least one dispensing element for applying said
at least two compositions.
3. The method of claim 1, wherein said at least two compositions
are mixed immediately prior to dispensing said at least two
compositions.
4. The method of claim 1, wherein said at least two compositions
form a pharmaceutical composition.
5. The method of claim 1, wherein the first composition of said at
least two compositions is a pharmaceutically acceptable
composition.
6. The method of claim 1, wherein the first composition of said at
least two compositions is a vasoactive agent.
7. The method of claim 1, wherein a first composition of said at
least two compositions is stored in a first compartment and a
second composition of said at least two compositions is stored in a
second compartment prior to mixing.
8. The method of claim 1, further comprising the step of
administering said at least two compositions to a subject.
9. The method of claim 4, wherein said pharmaceutical composition
is administered through a route of administration selected from a
group consisting of transdermal, intranasal, buccal, and
rectal.
10. The method of claim 4, wherein the temperature of said at least
two compositions is changed immediately prior to
administration.
11. The method of claim 4, wherein said at least two compositions
are mixed a predetermined amount.
12. The method of claim 4, further comprising the step of
administering a pre-treatment composition contained within said
device to said subject immediately prior to administration of said
at least two compositions.
13. The method of claim 4, further comprising the step of
administering a post-treatment composition contained within said
device to said subject immediately after administration of said at
least two compositions.
14. The method of claim 13, wherein said post-treatment composition
is an anti-irritant.
15. The method of claim 1, wherein said at least two compositions
comprise at least three compositions, whereby a first composition
and second composition are mixed within said device, and
subsequently, a third composition is mixed with said first
composition and said second composition.
16. The method of claim 8, wherein the amount of at least two
compositions administered to said subject is selected from a
predetermined range.
17. The method of claim 11, wherein mixing is limited to said
predetermined amount.
18. The method of claim 1, wherein the said at least two
compositions are stored in at least three compartments and an
effective dosage of a pharmaceutical composition is selected by a
device user who selects which said at least two compositions are
mixed.
19. The method of claim 5, wherein the effective dose is between
approximately 100 mcg and 400 mcg of alprostadil.
18. The method of claim 1, wherein an actuator is used to select
the amount of a least one composition of said at least two
compositions.
19. The method of claim 1, wherein said at least two compositions
are mixed with a shearing channel.
20. A method of treatment comprising: mixing a pharmaceutical
composition for the treatment of a condition in a subject
immediately prior to administration; and administering said
pharmaceutical composition to a subject, wherein said mixing occurs
in a device and said device is used for said administration of said
pharmaceutical composition to said subject.
21. A method of claim 20, wherein said condition is nail
fungus.
22. A method of claim 20, wherein said condition is male sexual
dysfunction.
23. A method of claim 22, wherein said condition is erectile
dysfunction.
24. A method of claim 22, wherein said condition is premature
ejaculation.
25. A method of claim 20, further comprising a step of
administering a pre-treatment composition immediately prior to
administering said pharmaceutical composition.
26. A method of claim 20, further comprising a step of
administering a post-treatment composition immediately after
administering said pharmaceutical composition.
27. A method of claim 20, wherein said condition is female sexual
dysfunction.
28. A method of treating sexual dysfunction comprising: mixing a
pharmaceutical composition for the treatment of sexual dysfunction
in a subject immediately prior to administration; and administering
an effect amount of said pharmaceutical composition to a
subject.
29. A method of claim 20, wherein said pharmaceutical compositions
is administered by a route of administration selected from a group
consisting of transdermal, intranasal, buccal, and rectal.
30. A method of claim 20, wherein said pharmaceutical compositions
is administered to the urethra and urethral meatus for male sexual
dysfunction; direct vaginal and/or clitoral application for female
sexual dysfunction; intraoral application of a vaccine or oral care
product; intranasal application of a vaccine or medicament;
intra-aural application; or ophthalmic application of a
medicament.
31. A method of claim 20, where said pharmaceutical compositions is
administered by injection.
32. A kit comprising: a device for administration; and a
pharmaceutical product for the treatment of sexual dysfunction.
33. The kit of claim 32, further comprising a contraceptive.
34. The kit of claim 33, wherein said contraceptive is a
condom.
35. The kit of claim 32, wherein said pharmaceutical product is for
the treatment of male sexual dysfunction.
36. The kit of claim 32, wherein said pharmaceutical product is for
the treatment of female sexual dysfunction.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to methods for reconstituting
and relates to reconstitution devices suitable for reconstituting
many different materials. Furthermore, the present invention
includes methods of treatment and methods of use related to a
reconstitution device or apparatus.
BACKGROUND OF THE DISCLOSURE
[0002] In the pharmaceutical industry, the step of reconstituting a
drug or other material is well known. Many pharmaceutical
compositions are not capable of being stored for extended periods
of time since their potency may change. In order to overcome this
problem of a short shelf life, such pharmaceutical products are
stored as a solid component and a liquid component. Prior to use,
the two components must be mixed together.
[0003] Furthermore, while preservatives are effective in preserving
some ingredients included in a pharmaceutical composition, such
preservatives may cause adverse reactions with other ingredients of
the pharmaceutical composition, namely the active ingredient, and
result in degradation and/or spoilage. In some situations,
refrigeration may be used to combat degradation or spoilage of a
pharmaceutical composition. However, refrigeration is not always
accessible and administration of a cooled pharmaceutical
composition may reduce the effectiveness, namely solubility and
penetration, of the pharmaceutical composition.
[0004] Although many reconstitution systems are directed for use
with a powdered solid component and a diluent component, there are
also occasions when other forms of material may be utilized. Thus,
the reconstitution system may employ two liquids, or a semi liquid
component such a paste along with a second component which is
typically a liquid.
[0005] Several problems must be addressed in any reconstitution
device such as the problem of obtaining a proper mixture. For
highly soluble products such as a powder and a diluent therefore, a
simple mixing of the two components is sufficient. Typically in
such an arrangement, the diluent and dry components are stored in
separate compartments of a device. The device will include a
by-pass such that pressure on a plunger will cause the liquid to go
through the by-pass to mix with the dry ingredient. Usually a
simple shaking of the mixture is sufficient to assure that the
mixture is properly constituted.
[0006] However, certain pharmaceutical products require a more
thorough mixing and the conventional devices cannot be used. One
other problem which is frequently encountered is that the
components to be mixed are utilized in a small quantity and
conventional mixing devices are not suitable. This is particularly
the case when one of the components is in the form of a paste into
which a liquid like constituent must be mixed.
[0007] Furthermore, poor application of a pharmaceutical
composition can hinder the effectiveness of the pharmaceutical
composition. Some advances in the ergonomics and delivery of
pharmaceutical compositions have been made, see for example U.S.
Pat. No. 6,224,573 (Yeager et al.). However, previous applicators
that combined more than one composition together prior to
administration do not have sufficient mixing mechanisms to achieve
optimal composition storage, mixing, and application. Thus, there
remain needs for methods of treating and devices to overcome all
the issues that remain with the storage, mixing, and administration
of pharmaceutical compositions.
SUMMARY OF THE INVENTION
[0008] It is an object of the present invention to provide a
reconstitution system or device which is suitable for
reconstituting small amounts of pharmaceutical compounds.
[0009] It is a further object of the present invention to provide
methods for the reconstitution of pharmaceutical compounds and
methods of treatment. Some embodiments are suitable for
reconstituting small amounts of a pharmaceutical compositions and
using the pharmaceutical composition for the treatment of sexual
dysfunction.
[0010] According to one aspect of the present invention, there is
provided a reconstitution device comprising a device suitable for
mixing a first component with a second component, the device
comprising first and second housings, the first and second housings
being engageable together, a conduit having an internal passageway
formed in the first housing, the internal passageway having a
dispensing end and an inlet end, a first plunger mounted in the
internal passageway proximate the dispensing end, a second plunger
mounted in the internal passageway proximate the inlet end, a third
plunger mounted in the internal passageway intermediate the first
and second plungers, the first and third plungers defining a first
compartment therebetween, the second and third plungers defining a
second compartment therebetween, a plunger rod at least partially
within the internal passageway at the inlet end, a moveable member
located in the second housing, the moveable member engaging the
first plunger, and a shearing channel formed in a side wall of the
conduit to permit mixing of contents located in the first and
second compartments.
[0011] According to a further aspect of the present invention,
there is also provided a device for mixing a first component with a
second component, the device comprising first and second housings,
the first and second housing each having a partial screw thread
formed on an exterior surface thereof, the first and second
housings being engageable together by means of the screw threads, a
conduit having an internal passageway formed in the first housing,
the internal passageway having a dispensing end and an inlet end, a
first plunger mounted in the internal passageway proximate the
dispensing end, a second plunger mounted in the internal passageway
proximate the inlet end, a third plunger mounted in the internal
passageway intermediate the first and second plungers, the first
and third plungers defining a first compartment therebetween, the
second and third plungers defining a second compartment
therebetween, a plunger rod at least partially within the internal
passageway at the inlet end, a moveable member located in the
second housing, the moveable member engaging the first plunger, the
moveable member having at least one leg extending upwardly
therefrom, the upwardly extending leg engaging the first housing
such that the first and second housing cannot be disengaged from an
initial first position, the arrangement being such that when the
plunger rod is moved to commence transfer from the second
compartment to the first compartment, the leg on the moveable
member disengages from the first housing to permit rotatable
movement of the first and second housings.
[0012] According to a still further aspect of the present
invention, there is also provided a method of filling a
reconstitution device comprising the steps of supplying first and
second housings, the first and second housings being engageable
together, a conduit having an internal passageway formed in the
first housing, the internal passageway having a dispensing end and
an inlet end, a moveable member mounted in the second housing,
placing a first plunger on the moveable member, the plunger sealing
the dispensing end of the internal passageway, inserting a first
material in the internal passageway on the first plunger, inserting
a second plunger in the internal passageway from the inlet end to
seal the first material in a first compartment formed between the
first and second plungers, placing a second material on top of the
second plunger, inserting a third plunger to seal the second
material between the second and third plungers, and placing a
plunger rod adjacent the third plunger.
[0013] In one embodiment, the device, as above mentioned, includes
first and second housings. The first and second housings are
engageable together such that they may be retained in the assembled
position for a period of time as will be discussed hereinbelow. The
first and second housings are releasable.
[0014] Within one of the housings, there is provided a conduit
having a hollow passageway therein. The passageway has three
plungers mounted therein for containing the ingredients to be
reconstituted. In one embodiment, there is provided a first plunger
which is located proximate the outlet or dispensing end of the
conduit as will be discussed in greater detail hereinbelow. A
second plunger is mounted in the internal passageway closer to the
inlet end of the conduit. However, this second plunger is not
located at the very end, but rather is usually proximate the middle
of the conduit.
[0015] A third plunger mounted in the passageway is intermediate of
the first and second plungers. The first and third plungers define
a first compartment for receiving a first ingredient while the
second and third plungers define a second compartment therebetween
for containing a second ingredient. Typically, the second
compartment will contain the less viscous of the ingredients. A
shearing channel is formed in the side wall of the conduit, again
for reasons which will be discussed hereinbelow. The shearing
channel is initially at least partially covered by the third
plunger so as to maintain the ingredients apart.
[0016] A plunger rod is utilized to exert pressure or push on the
second plunger. This results in movement of the third plunger such
that access to the shearing channel is obtained. Subsequently, the
ingredient in the second compartment will pass through the shearing
channel to mix with the component in the first compartment.
[0017] In one embodiment, a spring member is provided which is
arranged to exert pressure or bias the first plunger. Thus, after
transferring the ingredient from the second compartment to the
first compartment, a mixture or admixture is achieved.
Subsequently, with release of the pressure on the plunger rod, the
spring will cause the first plunger to move rearwardly such that
the mixture or admixture is again forced to pass through the
shearing channel. This can be repeated several times to ensure that
the composition formed by the at least two ingredients is properly
mixed. Naturally, one could use the finger of the user instead of
the spring.
[0018] To assist in proper mixing, the shearing channel is sized to
provide a relatively small cross-sectional area such that
significant shearing is obtained. Typically, the shearing channel
will have a diameter of less than 1 mm. In alternative embodiments,
the diameter of the shearing channel is greater than 1 mm, less
than 1 mm, 0.5 mm, or 0.3 mm. In other embodiments, the shearing
channel does not have a fixed diameter; rather, the shearing
channel is tapered.
[0019] As previously mentioned, the device is particularly suited
for mixing of small amounts. In some instances, the total volume of
the constituents would range between 0.1 and 0.2 of a cc. In
alternative embodiments, the total volume is greater than 10 cc,
less than 10 cc, 5 cc, 1 cc, or 0.5 cc.
[0020] The moveable member mounted in the second housing in one
embodiment is connected to the first plunger. In order to do so,
the moveable member has a small rod like element with an enlarged
end in some embodiments. The enlarged end would enter the plunger
such that the plunger will move back and forth with the moveable
member.
[0021] The plunger rod is positioned to initially contact the
second plunger. Thus, a portion of the plunger fits within the
passageway while a further portion extends to the end of the
housing which is open and thus forms a head for applying pressure
to the plunger rod by the thumb or a finger of the user.
[0022] To prevent accidental movement of the plunger rod, the head
is retained in position by a projection on the interior wall of the
housing. The projection is sufficient to maintain the plunger rod
in position until sufficient pressure is applied to the head.
[0023] Once the initial pressure is applied to the plunger rod, it
will start moving the second plunger downwardly and apply pressure
to the ingredient in the second compartment. This in turn will
cause sufficient movement of the third plunger such that access is
had to the shearing channel. The liquid will then mix with the
ingredient in the first compartment. Upon releasing the plunger
rod, the spring will apply sufficient pressure to the moveable
member which in turn will move the first plunger rearwardly and
force the mixture to again pass through the shearing channel. In
some embodiments, these steps are repeated. Instead of using the
spring to move the moveable member, a manual arrangement wherein a
digit of the user may be employed.
[0024] In one embodiment, the initial movement of the third plunger
will cause the disengagement of the first and second housings to
thereby permit the housings to be disengaged when so desired. This
arrangement provides the advantage that the user cannot access the
ingredients without at least having gone through one mixing
operation.
[0025] The present invention also includes methods of
reconstitution and methods of treatment with reconstituted
compositions, namely pharmaceutical compositions. Although the some
embodiments have compositions for reconstitution and use for
treatment are pharmaceutical compositions suitable for the
treatment of sexual dysfunction, the methods disclosed herein are
suitable for other compositions, such as cosmetics, foods, and
vaccines.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Having thus generally described the invention, reference
will be made to the accompanying drawings illustrating embodiments
thereof in which.
[0027] FIG. 1 is a perspective view of a reconstitution device
according to an embodiment of the present invention;
[0028] FIG. 2 is a side elevational view thereof;
[0029] FIG. 3 is a top plan view thereof;
[0030] FIG. 4 is an exploded view of the reconstitution device;
[0031] FIG. 5 is a cross sectional view of a lower portion of the
reconstitution device;
[0032] FIG. 6 is a cross sectional view similar to FIG. 4 but
rotated through 90 degrees;
[0033] FIG. 7 is a cross sectional view of the upper portion of the
reconstitution device;
[0034] FIG. 8 is a cross sectional and exploded view of both
housings forming the reconstitution device;
[0035] FIG. 9 is cross sectional view illustrating the assembled
reconstitution device;
[0036] FIG. 10 is a cross sectional view similar to FIG. 8
illustrating commencement of the reconstitution constituting
step;
[0037] FIGS. 11 to 14 are cross sectional views illustrating the
functioning of the reconstitution device;
[0038] FIGS. 15 and 16 are cross sectional views illustrating the
separating of the two housings for application of the contents;
and
[0039] FIG. 17 is a cross sectional view of one of the housings
showing an alternative embodiment.
DETAILED DESCRIPTION OF THE EMBODIMENTS
Definitions.
[0040] Unless otherwise stated, the following terms used in this
application, including the specification and claims, have the
definitions given below. As used in the specification and the
appended claims, the singular forms "a", "an", and "the" include
plural referents unless the context clearly dictates otherwise.
[0041] The term "administer" or "administration" means the act of
giving a pharmaceutical composition to a subject.
[0042] The term "compound", "composition", "ingredient", and
"component" may sometimes be used interchangeably to refer one or
more chemical components.
[0043] "Disease" means any disease, condition, symptom, or
indication.
[0044] The term "drug" or "pharmaceutically active agent" as used
herein is intended to mean a compound or composition of matter
which, when administered to an organism/subject, which is human or
animal, induces a desired pharmacologic and/or physiologic effect
by local and/or systemic action.
[0045] An "effective amount" means an amount of a compound that,
when administered to a subject for treating a disease, is
sufficient to effect such treatment for the disease or condition.
The "effective amount" will vary depending on the compound, the
disease state being treated, the severity or the disease being
treated, the age and relative health of the subject, the route and
form of administration, the judgment of the attending medical or
veterinary practitioner and other factors.
[0046] As used herein "excipient" means a component or an
ingredient that is acceptable in the sense of being compatible with
the other components of the formulation and not deleterious to a
subject to which the formulation is to be administered.
[0047] The term "immediately before" or "immediately prior"
generally means less than two hours before application of a
composition or before the desired next step; however, this term is
not limited to this timeframe because the chemical properties or
desired state of a pharmaceutical composition may require a
timeframe more than two hours before proceeding with the next
step.
[0048] The term "immediately after" or "immediately following"
generally means less than two hours after application of a
composition before the desired next step; however, this term is not
limited to this timeframe because the chemical properties or
desired state of a pharmaceutical composition may require a
timeframe more than two hours before proceeding with the next
step.
[0049] "Optional" or "optionally" means that the subsequent
described event or circumstance may but need not occur, and that
the description includes instances where the event or circumstances
occurs and instances in which it does not occur.
[0050] The term "penetration enhancer" means a chemical compound
that increases the permeability of the skin to a drug.
[0051] "Pharmaceutical compositions" means a composition that is
generally safe, non-toxic, and neither biologically nor otherwise
undesirable and includes that which is actable for veterinary as
well as human pharmaceutical use.
[0052] "Pharmaceutically acceptable" means that which is useful in
preparing a pharmaceutical composition that is generally safe,
non-toxic, and neither biologically nor otherwise undesirable and
includes that which is actable for veterinary as well as human
pharmaceutical use. This language may also include pharmaceutically
acceptable salts of a pharmaceutically acceptable composition.
[0053] "Subject" means mammals and non-mammals and the term does
not denote a particular age or sex.
[0054] The term "pharmacological effect" as used herein encompasses
effects produced in the subject that achieve the intended purpose
of a therapy.
[0055] "Transdermal" application or drug delivery means delivery of
a drug by passage into and though the skin and/or the underlying
tissues and into the blood stream.
[0056] "Treating" or "treatment" of a disease includes preventing
the disease, inhibiting the disease, and/or relieving the effects
of a disease.
[0057] The methods and apparatuses disclosed herein can be used in
the mixing and/or application of numerous different compositions,
including vaccines, medicaments, pharmaceutical compositions,
cosmetics, and food products. Although the some embodiments include
applications and methods for pharmaceutical compositions, one
skilled in the art will appreciate applicability of this disclosure
in other areas.
[0058] Referring to the drawings in greater detail and by reference
characters thereto, there is illustrated a reconstitution device
which is generally designated by reference numeral 10.
[0059] Referring to FIG. 1, an embodiment of a reconstitution
device 10 includes a first housing generally designated by
reference numeral 12 and a second housing generally designated by
reference numeral 14. First housing 12 includes a wall 16, wall 16
having first projections 18 located at a first distance from the
top thereof and second projections 20 at a second distance from the
top thereof. In the illustrated embodiment, there are provided two
such projections 18 and 20; it will be understood that in
alternative embodiments, one or more is utilized.
[0060] At a narrower end 22 of first housing 12, there is provided
a pair of screw threads 24, 26 for reasons which will become
apparent hereinbelow. Narrower end 22 also defines first and second
recesses 53, 55 intermediate screw threads 24, 26.
[0061] A conduit 28 is located interiorly of first housing 12 and
includes an internal passageway 30 extending therethrough. A
shearing recess 32 is provided within the interior wall of conduit
28.
[0062] A ring member generally designated by reference numeral 34
mounts over narrower end 22 of first housing 12.
[0063] On a wall 35 of second housing 14, there are provided a set
of lugs 36 which act as threads for engaging with screw threads 24,
26. An end cover 38 covers the larger end of second housing 14 and
is secured thereto by adhesives or welding or the like. End cover
38 includes a centering structure 40.
[0064] Mounted interiorly of second housing 14 is a moveable member
42. As may be seen in the drawings, moveable member 42 is provided
with a center post 44 having an enlarged portion 45. Moveable
member 42 has a spring recess 46 formed therein to receive a spring
48. At the other end, spring 48 is mounted around centering
structure 40. Moveable member 42 also has a guide rib 47. Guide rib
47 is designed to fit within a channel 51 formed in an inner wall
57 of second housing 14. Moveable member 42 also has first and
second legs 43, 49 extending upwardly therefrom. In an initial
position, legs 43, 49 fit within recesses 53 and 55 which will then
block relative rotation of housings 12, 14 with respect to each
other. Thus, the housings cannot be easily unscrewed until moveable
member 42 is moved out of position.
[0065] Reconstitution device 10 includes a first plunger 50 which
is situated near the dispensing end of conduit 28. A second plunger
52 is located rearwardly towards the inlet end of conduit 28 while
a third plunger 54 is situated therebetween. It will be noted that
first plunger 50 has a recess 56 to receive center post 44 of
moveable member 42.
[0066] Third plunger 54 has a side wall 80 with a concave
structure. A first end wall 82 is relatively flat or planar while
end wall 84 has a somewhat conical configuration. First plunger 50
has a side wall 86 with a plurality of concave recesses therein and
end wall 88 (which faces third plunger 54) has a conical
configuration. Similarly, second plunger 52 also has a pair of
concave recesses formed therein and an end wall 92 which is
somewhat conical in configuration.
[0067] A plunger rod generally designated by reference numeral 58
is situated within conduit 28. Plunger rod 58 includes a stem
portion 60 which abuts second plunger 52 and a head 62 which fills
the open end of first housing 12. Head 62 has at least one aperture
64 which are designed to receive or engage first projections 18. In
some embodiments, the device contains two recesses or more than two
recesses. Stem 60 also has a rib 66 which functions as a guide for
the movement of plunger rod 58 and which engages in a slot formed
in conduit 28.
[0068] The first and third plungers define therebetween a first
compartment 74 while second and third plungers define therebetween
a second compartment 76.
[0069] Within first compartment 74, there is provided a first
component 70. In one embodiment, the first component 70 is in the
form of a powder, paste or other fluid. Second compartment 76
contains a second component 72 which typically will be a less
viscous material such a liquid. Both compartments 74 and 76 are
thus sealed from any contamination.
[0070] As shown in FIG. 9, pressure on plunger rod 58 will cause
movement of second plunger 52 and third plunger 54. Third plunger
54 will advance to a point such that shearing recess 32 is aligned
with both first compartment 74 and second compartment 76 permitting
a mixture 78 to be formed. The initial movement of plunger rod 58
will cause moveable member 42 to move out of its position blocking
rotation of housings 12, 14. After removal of the pressure, as
shown in FIG. 11, spring 48 will exert pressure on moveable member
42 which in turn will drive second plunger 52 rearwardly or
upwardly as shown in the drawing. The mixture 78 will then flow
back into second compartment 76. A continuing back and forth
movement is exerted such that continued passage through shearing
recess 32 will ensure adequate mixing of the composition 78. The
spring 48 will not cause moveable member 42 to return to its
original position due to projection 20.
[0071] After repeating the steps for the desired number of times,
first housing 12 and second housing 14 are separated and mixture 78
is exposed for use.
[0072] In the embodiment of FIG. 16, there is provided a different
type of shearing channel 122. As will be noted, shearing channel
122 is formed within the wall defining conduit 28. Thus, third
plunger 54 will abut the wall and is sized such that there is
provided an inlet 125 and an outlet 127 from shearing channel 122.
When the mixing flow is reversed, the mixture enters outlet 127 and
exits inlet 125.
[0073] In addition to the embodiment described above, alternate
embodiments are contemplated. For example, a plunger need not be
used as a means for forcing flow or mixing of compositions held
within. Therefore, as one skilled in the art would appreciate,
other embodiment use other types of mechanisms to cause a
composition to flow out of or into a compartment. For example, in
an alternative embodiment, the walls of the conduit are compressed,
causing the available volume in a compartment to decrease, and thus
causing a composition contained within to flow out of the
compartment. Accordingly, if the walls of the conduit are expanded
outward, causing the internal volume to increase and creating a
relative lower pressure, composition contained elsewhere in the
device is forced to flow into the compartment. In such case, the
conduct is made of a flexible and durable plastic.
[0074] Alternatively, the compartment has walls that are separate
from the conduit, and in such case, the compartment is a distinct
chamber. For the purposes of this disclosure, compartment and
chamber may be used interchangeably to describe various
embodiments.
[0075] In one embodiment, the conduit and or the chambers that form
the areas for mixing is at least one removable and disposable
component of the device. These components, which include chambers,
plungers, shearing channels, or other components described herein,
are be pre-filled with the desired compositions for mixing and
administration. Therefore, in one embodiment, the device is
reusable and chambers with compositions are in the form of
disposable cartridges. Active ingredients and other compositions to
the final pharmaceutical composition are stored in one or more
pre-packaged cartridges. As noted above, such cartridges serve as
chambers themselves or be inserted into chambers in certain
embodiments. In such an embodiment, plungers, conduits, and other
components for mixing are part of the one or more disposable
cartridges.
[0076] When a composition is a chamber in subject to settling or
separation, pre-mixing in a single chamber prior to combining the
composition with the other chambers is desired. In such a case, as
one skilled in the art would appreciate, alternative embodiments
use different means of mixing, such as one of the means described
herein.
[0077] Although the embodiment illustrated in the figures includes
compartments shown as being separated by a plunger, alternative
embodiments use different means of separation, such as a door,
wall, or permeable membrane. In the case of a wall, one embodiment
includes a separation device in the shearing channel, which opens
for mixing. In some embodiments, more than one conduit is used. One
such embodiment uses two conduits to mix two compositions
separately, which are then combined prior to or at the time of
dispensing. In an alternative embodiment, the two conduits are
dispensed through separate openings in the device or through the
same opening but in separate steps, in which case the
administration is sequential.
[0078] The coil spring, illustrated and described herein, is not
the only contemplated embodiment. Other mechanical (including
electronically powered) components are used to facilitate mixing in
alternative embodiments. For example, one embodiment has a
mechanical crank or motor. In an embodiment containing a motor, a
battery is used; it should be noted, however, that a motor need not
be present in the device for a battery to be included. A battery is
desired for some embodiments because it allows for additional
components to be included in the device.
[0079] Contemplated components include: sensors to measure the
temperature, pH, viscosity, and/or other physical and chemical
properties; external electronic displays; heating and/or cooling
component(s); microprocessors, transmitters, and other electrical
components; and/or values.
[0080] A heating or cooling component provides for two additional
utilities. First, in one embodiment, the heating and/or cooling
component aids in the storage of a composition in at least one
chamber by providing temperature modification, notification, and/or
control. Second, in another embodiment or combined with the
previous embodiment, the heating and/or cooling component is used
as a thermodynamic catalyst for reactions in one or more chambers.
In one embodiment, the heating and/or cooling component is
electrically powered or chemically facilitated. In one embodiment,
one or more valves is desired or necessary to achieve a desired
result because of changes in pressure before, during, or after the
mixing of one or more compositions. In one embodiment, such a valve
is a one way valve, capable of releasing gases resulting from
mixing.
[0081] In some embodiments, compositions are stored at a pressure
above or below atmospheric pressure. In one embodiment, one or more
chambers fill with air. In other embodiments, one or more chambers
contain a gas at above atmospheric pressure or below atmospheric
pressure.
[0082] The second plunger need not be the only means of blocking
passage through the shearing channel prior to activation by a user.
In an alternative embodiment, the wall of the conduit has a door
that is connected to the compression systems, the plungers and
springs for example, that simultaneously opens the shearing channel
upon initiation by a device user. In addition, in some embodiments,
a third composition is stored in the shearing channel. As one
skilled in the art would appreciate, one embodiment contains a
shearing channel where the mixing means is one or a combination
means of mixing, depending on the desired result. For example, the
shearing channel may create vortex flow or utilize baffles and
other protruding mixing members. In another example, the shearing
channel is replaced by other mixing means. In one embodiment for
example, the third plunger, which separated the two compartments in
the illustrated embodiment, operates as to open a passage way for
exchange of compositions stored in the two compartments; for
instance, the third plunger pivots open upon activation of mixing
by a user. In one embodiment, the disclosed device allows for high
shear flow for efficient emulsification of components with a
minimum or exact number of mixing cycles. Although high shear flow
is desired in some instances, low shear flow may be desired. In
such situations, another embodiment includes at least one shearing
channel that is enlarged or a less shearing mixing means is
used.
[0083] Depending on the compositions being mixed, the number of
cycles varies in alternate embodiments. In order to ensure a proper
number of cycles, in some embodiments, the device includes a cycle
counter and/or a component to limit the number of cycles possible
for a given administration of a dosage. In an embodiment, a cycle
counter includes a mechanical wheel or crank and the counter is
internal with a stopping mechanism and/or contains an external
readable display for the user. A component to count and/or limit
the number of cycles is mechanical in one embodiment and electrical
in another.
[0084] In an alternative embodiment, the upper housing is a
disposable component and the lower housing is component made for
repeated use. Therefore, in one embodiment, the lower housing
component is the location for features such as the cycle counter,
temperature monitor, battery, and other features discussed in and
foreseeable from this disclosure.
[0085] In some embodiments, after a pre-determined number of
cycles, a composition in a third chamber is released into the
chamber(s) where mixing is occurring. More than three chambers is
used in this manner in other embodiments. Therefore, where
sequential reactions of multiple components are require or desired
for a final composition, the device and method can achieve the
desired result. In one embodiment for example, a first composition
is stored in a first chamber, a second composition is stored in a
second chamber, and a third composition is then stored in a third
chamber. Upon initiation of mixing the first and second
compositions are combined for a desired number of mixing cycles.
Next, the third composition in the third chamber is combined with
the already mixed first composition and second composition. This
example is useful for a reaction where initial compound in the
first and second compositions cause adverse reactions with the
compounds in the third composition. However, upon mixing the first
and second compositions, the undesired components are chemically
altered via chemical reaction and therefore, no adverse reaction
occurs when the third composition is mixed with the first two. In
alternative embodiments, it is desired to have the product of the
reaction of the first and second compositions at equilibrium prior
to mixing and reacting the product with the third composition.
[0086] Because of the area of application in some instances, one
embodiment includes a throttle or regulator for limiting the rate
at which the composition can be dispensed from the device. For
example, one embodiment is for the treatment of male sexual
dysfunction calls for application of the pharmaceutical composition
in the urethra. Therefore, dispensing the pharmaceutical
composition at a high rate may result in a less then desired amount
of pharmaceutical composition entering and penetrating the urethra
due to splatter and/or off-target application.
[0087] In an alternative embodiment, the amount in one or more
chambers that is mixed and/or dispensed can be set and/or
calibrated. For example, one embodiment includes 300 mcg of
alprostadil in 100 mg of cream. However, in some cases, it is
desirable to titrate the dosage down to 200 mcg of alprostadil. In
addition, a patient sometimes finds that the most effective and/or
most tolerated dosage is somewhere between 300 mcg and 200 mcg of
alprostadil. In this embodiment, the composition containing the
active ingredient, alprostadil, is stored in the first chamber, a
third chamber, and a fourth chamber. A different composition
containing inactive ingredients is stored in the second chamber. In
such an embodiment, the combined volume of all chambers is between
1 mL and 2 mL. Therefore, the first chamber contains 200 mcg of
alprostadil and the third and fourth chambers each contain 50 mcg
of alprostadil. In an alternative embodiment, there are only three
chambers, whereby the third chamber contains 100 mcg of
alprostadil. The sum of all chambers results in total of 300 mcg of
alprostadil. In the device, the contents are mixed in the first
chamber and second chamber. The contents of the third chamber and
fourth chamber are added to the first chamber or second chamber if
selected to be included in the final pharmaceutical product to be
dispensed, which depends on the desired dosage.
[0088] For example, prior to mixing, the subject determines whether
a dose of 200 mcg, 250 mcg, or 300 mcg is desired. If the subject
desires to administer a dose of 250 mcg, the contents of either the
third chamber or the fourth chamber are mixed with the first
chamber and the second chamber. This mixing selection is controlled
by the either mechanical or electrical components on the device;
for example, the user presses an external button on the device that
sets the third chamber to be mixed with the first and second
chambers. Then upon mixing initiation by the user, contents of the
three chambers are mixed and dispensed as a dosage of 250 mcg in
one of the manners described in this disclosure.
[0089] In some embodiments, the device contains one or more
components for more exact mixing. For example, hand actuated
plungers, such as those disclosed in U.S. Pat. No. 4,250,755
(Kenney), are used to allow for more exact dosages. Other actuating
components, electronic for example, are also contemplated and
desired for other embodiments. Furthermore, more precise actuating
plungers are used in the dispensing of the composition other
embodiments.
[0090] In one embodiment, the device is built as one assembly;
therefore, the upper and lower housing element is not separated for
dispensing because there is no second housing to be separated.
Instead, there is an opening that can be opened at the time for
dispensing. The body and components of the device are made
utilizing molding or other fabrication techniques. In one
embodiment, materials for such components is rigid plastic, such as
polyolefin, including polyethylene, polypropylene, and the like,
suitable for injection molding, and in some embodiments the
plastics are clear, translucent or opaque. In the case of clear or
translucent material, compositions that are subject to color change
or physical property change due to spoilage is viewable by a
user.
[0091] In addition to flexibility in the dimensions of the device,
some embodiments of the device are designed for better application,
and included additional components such as nozzles or adapters.
Such nozzles or adapter are be suitable for delivery of the
pharmaceutical composition onto or into the body, including the
urethra, the vagina, the ear and the eye, the mouth, but delivery
is not limited to those parts expressly listed here. In one such
embodiment, the device includes a suitable conical nozzle for
administration of a pharmaceutical composition for the treatment of
male sexual dysfunction into the urethra of a subject. In another
embodiment, the device includes a suitable conical nozzle for
administration of a pharmaceutical composition for the treatment of
female sexual dysfunction into the vagina of a subject.
[0092] In one embodiment, the device and composition are provided
in a kit. In another embodiment, the kit includes additional
components. For example, for the use of treating male sexual
dysfunction, the kit comprises a pharmaceutical composition for
treatment of erectile dysfunction, an applicator, and a
contraceptive device (such as a condom). A condom is a desired kit
accessory because in the case where alprostadil is used for the
treatment of male sexual dysfunction, it is advisable for the male
subject to use a condom when sexual intercourse is planned or takes
place with a pregnant or lactating woman because the effects of
alprostadil on women is not well studied.
[0093] As one skilled in the art would appreciate, the present
device and components thereof can be made with nearly any
dimensions, constructions, and materials suitable to practice the
details of this disclosure and achieve the desired results.
Methods of Treatment.
[0094] In one embodiment, methods are used to administer a
pharmaceutical composition. Where embodiments are used for the
administration of a pharmaceutical application, such application
includes, but is not limited to, delivery of medicament to the
urethra and urethral meatus for male sexual dysfunction; direct
vaginal and/or clitoral application for female sexual dysfunction;
intraoral application of a vaccine or oral care product; intranasal
application of a vaccine or medicament; intra-aural application; or
ophthalmic application of a medicament.
[0095] In another embodiment, the methods are used to prepare and
administer a pharmaceutical composition. In some embodiments,
pharmaceutical compositions include an effective amount of an
active ingredient and at least one other compound. However, as
previously noted, the applications and methods of this disclosure
not limit to pharmaceutical products. Hence, the methods herein can
be used for vitamins, beauty products, foods, and the like.
[0096] Suitable formulations for mixing and administration include
for example, creams, ointments, lotions, gels, semi-solids,
spray-aerosols, oils, aqueous solutions, oil-in-water or
water-in-oil emulsions, ointments, pastes, and solutions or
suspensions. The specific compounds of a composition to be used, as
will be appreciated by those skilled in the art, is one that
provides for optimum drug delivery and effectiveness of the active
ingredient or ingredients. For some methods, formulations for
topical administration further comprise one or more of the
additional ingredients as described herein. The compounds may be
acid or base. Thickeners, preservatives, lubricants, penetration
enhancers, excipients, suspending agents, and other non-active
ingredients are included in alternative embodiments, as one skilled
in the art would appreciate. In some embodiments, it is required
that the compositions, components, and/or the device be
sterilize.
[0097] In one embodiment, the pharmaceutical composition is stored
in the device in more than one chamber. However, in some
embodiments, only one chamber is used for storage. In one
embodiment, one compartment contains a vasoactive agent, and an at
least second compartment contains a diluent composition. When
combined in the device, these at least two composition are mixed to
form a pharmaceutical composition. The storing of the compositions
in separate compartments prior to mixing increases the shelf-life
of the compositions and prevents time-caused degradation of the
pharmaceutical composition. Pharmaceutical compositions for
alternative embodiments are disclosed in U.S. Pat. No. 7,560,489
(Frank et al.). One such composition comprises a pharmaceutically
acceptable excipient and a prostaglandin, such as prostaglandin E1
(alprostadil), in the amount of 200 mcg or 300 mcg in 100 mg of
cream. Other pharmaceutical compositions include, but are not
limited to those compositions disclosed in U.S. Pat. No. 6,486,207
(Yeager et al.), U.S. 2002/0045665 A1 (Yeager et al.), and U.S.
2004/0241245 A1 (Lu et al.).
[0098] Routes of administration include, but are not limited to
transdermal, intranasal, buccal, or rectal. In one embodiments, the
route of administration is topical and transdermal. However, in
some embodiment, the device is used to deliver compositions orally,
as an aerosol, or liquid for example. Another example includes
administration to a subject's eye, where the pharmaceutical
composition is mixed immediately prior and then administered on the
eye of the subject. In one embodiment, the disease for treatment is
sexual dysfunction, which includes male sexual dysfunction and
female sexual dysfunction.
[0099] In the treatment of female sexual dysfunction, namely female
sexual arousal disorder, alprostadil acts directly on local tissues
to produce increases in vaginal secretion, increases in vaginal
engorgement, and acts indirectly on the central nervous system to
increase sexual responsiveness and arousal.
[0100] In one embodiment for the treatment of female sexual
dysfunction, at least 0.5 mg to 10 mg of the active ingredient,
such as alprostadil, is topically administered. In some
embodiments, compositions contain between 0.05% a 0.4% alprostadil.
In such case, the pharmaceutical product is applied to the labia,
clitoris and/or the vulvar region of the vagina. Optionally, the
reconstitution device includes a modified applicator tip for
administration in such region.
[0101] For the treatment of male sexual dysfunction, a method of
treatment includes application of the pharmaceutical composition in
the proximal fossa navicularis and the distal portion of the penile
urethra proper. The high glycogen content and bacterial flora
within the fossa navicularis provides a naturally lower pH within
the space, so that lower pH compositions that provide for high
solubility of alprostadil can be more easily tolerated without
excess irritation of the tissues.
[0102] In the treatment of a disease, such as those mentioned
above, it is sometimes necessary to pre-treat and/or post-treat an
area of application, namely in transdermal administration. As
mentioned above, alprostadil has a higher solubility at a lower pH.
Therefore, lowering the pH of an application area with a
pre-treatment and bringing the pH to a more natural level with a
post-treatment is advantageous and desirable.
[0103] In one embodiment, a pre-treatment step is included, in
which the area of application for the pharmaceutical composition is
first contacted with a composition for pre-treating or preparation
the area of application. By adding a pre-treatment step immediately
before administering the pharmaceutical composition, absorption can
be increased or decreased, which can allow for more control of the
drug interaction and produce a more desired result. Possible
pre-treatment methods include increasing or decreasing the
temperature at the application area, sterilizing the application
site, lowering or raising the pH, soaking the application site,
which in some embodiments is a subject's tissue (Grasso &
Lansdown, Methods of measuring, and factors affecting, percutaneous
absorbtion, J. SOC. COSMET. CHEM. 23, 484-509).
[0104] In another embodiment, a post-treatment step is included.
Furthermore, embodiments include one or more pre-treatment steps
and one or more post-treatment steps. The post-treatment is an
important step in reducing side effects, namely skin irritation in
the case of topical application. Therefore, application of a
post-treatment immediately after administration of a pharmaceutical
composition typically decreases undesired effects.
[0105] For example, to combat side-effects of burning sensations or
skin irritation, any of the following steps are taken: applying a
topical vitamin E formulation (Nachbar & Korting, The role of
vitamin E in normal and damaged skin, J. MOL. MED. 73:7-17 (1995));
rinsing the affected area with a basic soap and room temperature or
cooler water to neutralize the pH, restore the area to ambient
temperatures and dilute remaining drug compound (Grasso &
Lansdown, Methods of measuring, and factors affecting, percutaneous
absorbtion, J. SOC. COSMET. CHEM. 23, 484-509); application of
topical immunosuppressant, such as hydrocortisone, to affected
area; application of a topical analgesic, such as menthol, to the
affected area (Galeotti et al, Menthol: a natural analgesic
compound, Neuroscience Letters 322, 3:145-148 (April 2002)).
[0106] In some embodiments, the post-treatment is for sites or
locations other than the pharmaceutical drug composition
application site. For example, a common effect of alprostadil is
irritation to skin, including hands. A subject who applies
alprostadil for the treatment of sexual dysfunction must wash his
or her hands after application to prevent irritation to his or her
hands. Therefore, combining the pharmaceutical composition for
treatment of sexual dysfunction and a post-application cleansing
composition or object is desirable. In some embodiments, the
post-application may be in the form of a moist tissue, which
includes one or more compositions for treating irritation.
[0107] In one embodiment, the device includes a separate chamber
and a separate dispenser for dispensing an anti-irritant cream.
Examples of anti-irritants include but are not limited to: glycerin
esters of fatty acids such as mono- or tri-glycerides of fatty
acids, including their polyethylene glycol complex, polyethylene
glycol or propylene glycol esters of fatty acids or vegetable oils;
vegetable oils, including their hydrogenated form, such as sesame
oil, soybean oil, castor oil, corn oil, palm oil, peanut oil, cacao
oil, cotton seed oil, sunflower seed oil, safflower oil, almond oil
or olive oil; fatty acids and fatty alcohols, and their esters,
such as oleic acid, linolenic acid, linoleic acid, palmitic acid,
palmitoleic acid, arachidonic acid, myristic acid, capric acid,
caprylic acid, lauric acid, stearic acid, lauryl alcohol, oleyl
alcohol, cetyl alcohol, stearyl alcohol, ethyl oleate, oleyl
laurate, isopropyl myristate, isopropyl palmitate, 2-octyldodecyl
myristate or cetyl palmitate; and a mixture thereof.
[0108] In another embodiment, for the treatment of nail fungus, the
compositions to be applied include two part formulation that is
sequentially applied, as described in U.S. Pat. No. 7,462,362
(Kepda et al.). In such an embodiment, the first part is a
composition for quick penetration comprising an active ingredient,
such as terbinafine and pharmaceutically acceptable carrier. The
second part is a composition to act as a protective barrier,
comprising additional active ingredient for gradual penetration, an
effective amount of film-forming polymer, and a pharmaceutically
acceptable carrier.
[0109] In some embodiments, it is necessary for time passage
between administration of a first product and administration of a
second product.
[0110] As one skilled in the art would appreciate, the present
device and components thereof can be made with nearly any
dimensions, constructions, and materials suitable to practice the
details of this disclosure and achieve the desired results.
EXAMPLE 1
Device and Method of Treatment of Male Sexual Dysfunction
[0111] In one embodiment for the treatment of male sexual
dysfunction, two separate components of a pharmaceutically
acceptable compound for the treatment of male sexual dysfunction
are stored separately and mixed immediately prior to
administration. In this embodiment, a reconstitution device stores,
mixes, and applies the final composition. The device is constructed
out of plastic and comprises an upper housing and lower housing.
The conduit inside the upper housing forms two compartments. The
first chamber and second chamber are designed according to the
embodiment illustrated in FIG. 3-FIG. 9.
[0112] The first compartment includes an effective amount of the
active ingredient, alprostadil in this example, and a diluent. The
second compartment includes a pharmaceutically acceptable
penetration enhancer, DDAIP.HCl
(dodecyl-2-N,N-dimethylaminopropionate hydrochloride) in this
example. The total volume of the combined compositions is
approximately 1 cc.
[0113] The device is made for one time use; therefore, the
compositions contained in the device are put into the respective
compartments prior to a subject being giving the device.
[0114] This example contains a method of storing and mixing,
whereby the two separate compositions are stored separately until
mixing immediately prior to administration. Since the compositions
are stable at room temperature when stored in separate
compartments, there is generally no need to refrigerate the device
and compositions. The compositions are then mixed immediately prior
to application, which results in minimal degradation of the final
pharmaceutical composition. In this example, the compositions of
the two chambers are mixed thirty seconds prior to administration
of the mixed composition, comprises is an effective amount of
alprostadil for the treatment of sexual dysfunction. This example
contains a method of treatment, where the male subject mixes the
compositions immediately prior to administration and administered
the composition to the urethra of the subject.
[0115] When a subject, who is typically the device user, desires to
apply the pharmaceutical treatment, the subject presses down on the
top of the device, where the surface of the plunger head is exposed
to the external environment. Upon the user pushing down on the
plunger head, the plunger is released from a locked position
between two projections.
[0116] After being released from the locked position, the subject
again applies downward pressure on the plunger head, which in turn
engages the mixing components of the device. This pressure on the
plunger rod causes movement of the second plunger and third
plunger, thereby creating flow though the shearing channel and
between the two chambers.
[0117] After the desired number of mixing cycles, four in this
example, the upper housing and lower housing are separated and the
mixture is exposed for use. The subject then dispenses the
composition onto the subject's urethra.
EXAMPLE 2
Device and Method for Treatment of Nail Fungus
[0118] In one embodiment for the treatment of nail fungus, two
separate pharmaceutical products are used and are administered
sequentially. Furthermore, the pharmaceutical products are to be
administered multiple times throughout the course of treatment.
[0119] In this embodiment, a reconstitution device stores, mixes,
and applies the pharmaceutical products. The device is constructed
out of plastic, has a upper housing and lower housing, two
conduits, and one dispensing end.
[0120] The conduit inside the upper housing forms two compartments.
The first chamber and second chamber are designed according to the
embodiment illustrated in FIG. 3-FIG. 9.
[0121] The two compartments part of a cartridge. A first
compartment includes a first composition comprising terbinafine and
a pharmaceutically acceptable carrier. A second compartment
includes a second composition comprising terbinafine, a
film-forming polymer, and a pharmaceutically acceptable
carrier.
[0122] The two compartments each contain two sub-compartments. In
the first compartment, the first sub-compartment contains
terbinafine in a diluent, and the second sub-compartment contains
the pharmaceutically acceptable carrier. In the second compartment,
the first sub-compartment contains terbinafine in a diluent, and
the second sub-compartment contains the pharmaceutically acceptable
carrier and a film-forming polymer.
[0123] The device and methods described herein may be combined with
any suitable compositions and/or instructions for operation. It
will be understood that the above described embodiment is for
purposes of illustration only and that changes and modifications
may be made thereto without departing from the spirit and scope of
the invention.
* * * * *