NZ618749B2 - Reconstitution method - Google Patents
Reconstitution method Download PDFInfo
- Publication number
- NZ618749B2 NZ618749B2 NZ618749A NZ61874912A NZ618749B2 NZ 618749 B2 NZ618749 B2 NZ 618749B2 NZ 618749 A NZ618749 A NZ 618749A NZ 61874912 A NZ61874912 A NZ 61874912A NZ 618749 B2 NZ618749 B2 NZ 618749B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- plunger
- internal passageway
- housings
- moveable member
- plungers
- Prior art date
Links
- 238000003168 reconstitution method Methods 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 22
- 239000000203 mixture Substances 0.000 claims abstract description 14
- 238000010008 shearing Methods 0.000 claims abstract description 13
- 201000001880 sexual dysfunction Diseases 0.000 claims abstract description 5
- 231100000872 sexual dysfunction Toxicity 0.000 claims abstract description 5
- 208000010195 Onychomycosis Diseases 0.000 claims abstract 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 4
- 230000002254 contraceptive Effects 0.000 claims 2
- 239000003433 contraceptive agent Substances 0.000 claims 2
- 239000002550 vasoactive agent Substances 0.000 claims 2
- 208000010228 Erectile Dysfunction Diseases 0.000 claims 1
- 206010057671 Female sexual dysfunction Diseases 0.000 claims 1
- 206010057672 Male sexual dysfunction Diseases 0.000 claims 1
- 206010036596 Premature ejaculation Diseases 0.000 claims 1
- 229960000711 alprostadil Drugs 0.000 claims 1
- 201000001881 impotence Diseases 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- GMVPRGQOIOIIMI-DWKJAMRDSA-N prostaglandin E1 Chemical group CCCCC[C@H](O)\C=C\[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(O)=O GMVPRGQOIOIIMI-DWKJAMRDSA-N 0.000 claims 1
- 230000000994 depressed Effects 0.000 abstract 2
- 239000007788 liquid Substances 0.000 description 4
- 239000000463 material Substances 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 2
- 230000004059 degradation Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 239000003085 diluting agent Substances 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 230000002335 preservative Effects 0.000 description 2
- 239000003755 preservative agent Substances 0.000 description 2
- 238000005057 refrigeration Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drugs Drugs 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 238000005020 pharmaceutical industry Methods 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
Abstract
reconstitution device, particularly a reconstitution device for combining two separated components of a pharmaceutical composition. The reconstitution device comprising a first (12, see figure 10) and second (14) housings, a conduit, a first (50), second (52) and third (54) plunger, a plunger rod, a moveable member and a shearing channel (32). The first and second housings are immovably engageable together. The conduit comprises an internal passageway, formed in the first housing, the internal passageway having a dispensing end and an inlet end. The first plunger is mounted within the passageway, proximate the dispensing end. The second plunger is mounted within the passageway, proximate the inlet end. The third plunger is mounted within the passageway intermediate the first and second plungers, the three plungers defining a first compartment (74) and a second compartment (76). The plunger rod extends at least partially within the internal passageway and may comprise a shaft (60) and an enlarged head (62). The moveable member is located within the second housing and engages the first plunger. The shearing channel is formed in the side wall of the conduit and permits the mixing of the contents located in the first and second compartments. Preferably, when the plunger rod is depressed the plungers translate along the channel until a first component (72) may travel via the shearing channel and mix with a second component (70), within the first compartment. The plunger is then allowed to return upwards, the moveable member acting on the first plunger to transfer the composition comprising both components into the second compartment. The first and second housings may be decoupled allowing the composition to be applied from the dispensing end of the internal passageway. Also disclosed is a method of filling the reconstitution device comprising placing, within the internal passageway, the first plunger, the first component, the third plunger, the second component, the second plunger and then the plunger rod. The device and/or pharmaceutical composition therein may be used to treat nail fungus, or sexual dysfunction. a moveable member and a shearing channel (32). The first and second housings are immovably engageable together. The conduit comprises an internal passageway, formed in the first housing, the internal passageway having a dispensing end and an inlet end. The first plunger is mounted within the passageway, proximate the dispensing end. The second plunger is mounted within the passageway, proximate the inlet end. The third plunger is mounted within the passageway intermediate the first and second plungers, the three plungers defining a first compartment (74) and a second compartment (76). The plunger rod extends at least partially within the internal passageway and may comprise a shaft (60) and an enlarged head (62). The moveable member is located within the second housing and engages the first plunger. The shearing channel is formed in the side wall of the conduit and permits the mixing of the contents located in the first and second compartments. Preferably, when the plunger rod is depressed the plungers translate along the channel until a first component (72) may travel via the shearing channel and mix with a second component (70), within the first compartment. The plunger is then allowed to return upwards, the moveable member acting on the first plunger to transfer the composition comprising both components into the second compartment. The first and second housings may be decoupled allowing the composition to be applied from the dispensing end of the internal passageway. Also disclosed is a method of filling the reconstitution device comprising placing, within the internal passageway, the first plunger, the first component, the third plunger, the second component, the second plunger and then the plunger rod. The device and/or pharmaceutical composition therein may be used to treat nail fungus, or sexual dysfunction.
Description
RECONSTITUTION METHODS
FIELD OF THE INVENTION
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
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.
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.
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.
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
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[0009a] According to a first aspect of the present invention, there is provided a mixed
pharmaceutical composition for treatment of a condition in a subject in need thereof, wherein
the mixed pharmaceutical composition is mixed in a device, wherein said device is used for an
administration of said mixed pharmaceutical composition to said subject, and wherein said
device comprises:
first and second housings (12, 14);
said first and second housings (12, 14) being non-movably, both rotationally and
translationally, engageable together;
a conduit (28) having an internal passageway (30) formed in said first housing (12),
said internal passageway having a dispensing end and an inlet end;
a first plunger (50) mounted in said internal passageway (30) proximate said dispensing
end;
a second plunger (52) mounted in said internal passageway (30) proximate said inlet end;
a third plunger (54) mounted in said internal passageway (30) intermediate said first and
second plungers (50, 52), said first and third plungers (50, 54) defining a first compartment (74)
therebetween, said second and third plungers (52, 54) defining a second compartment (76)
therebetween;
a plunger rod (58) at least partially within said internal passageway (30) at said inlet end;
a moveable member (42) located in said second housing (14); said moveable member (42)
engaging said first plunger (50); and
a shearing channel (32) formed in a side wall of said conduit (28) to permit mixing of
contents located in said first and second compartments (74, 76).
[0009b] According to a second aspect of the present invention, there is provided a kit
comprising:
a device for administration; and
a pharmaceutical product for the treatment of sexual dysfunction;
said device comprises:
first and second housings (12, 14);
first and second housings (12, 14) being non-movably, both rotationally and
translationally, engageable together; a conduit (28) having an internal passageway (3) formed in
said first housing (12);
said internal passageway having a dispensing end and an inlet end;
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a first plunger (50) mounted in said internal passageway (30) proximate said dispensing
end;
a second plunger (52) mounted in said internal passageway (30) proximate said inlet end;
a third plunger (54) mounted in said internal passageway (30) immediate said first and
second plungers (50, 52), said first and second plungers (50, 54) defining a first compartment
(74) therebetween, said second and third plungers (52, 54) defining a second compartment (76)
therebetween;
a plunger rod (58) at least partially within said internal passageway (30) at said inlet end;
a moveable member (42) located in said second housing (14);
said moveable member (42) engaging said first plunger (50; and
a shearing channel (32) formed in a side wall of said conduit (28) to permit mixing of
contents located in said first and second compartments (74, 76).
[0009c] According to a third aspect of the present invention, there is provided a method of
mixing comprising:
filling a device with at least two compositions;
optionally storing said at least two compositions; and
mixing said at least two compositions with said device;
wherein said device comprises:
first and second housings (12, 14);
said first and second housings (12, 14) being non-movably, both rotationally and
translationally, engageable together;
a conduit (28) having an internal passageway (30) formed in said first housing (12),
said internal passageway having a dispensing end and an inlet end;
a first plunger (50) mounted in said internal passageway (30) proximate said dispensing
end;
a second plunger (52) mounted in said internal passageway (30) proximate said inlet end;
a third plunger (54) mounted in said internal passageway (30) intermediate said first and
second plungers (50, 52), said first and third plungers (50, 54) defining a first compartment (74)
therebetween, said second and third plungers (52, 54) defining a second compartment (76)
therebetween;
a plunger rod (58) at least partially within said internal passageway (30) at said inlet end;
a moveable member (42) located in said second housing (14); said moveable member (42)
engaging said first plunger (50); and
11753017 (IRN: P096472NZ)
a shearing channel (32) formed in a side wall of said conduit (28) to permit mixing of contents
located in said first and second compartments (74, 76).
According to another 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.
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
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WE
Claims (16)
1. A mixed pharmaceutical composition for treatment of a condition in a subject in need thereof, wherein the mixed pharmaceutical composition is mixed in a device, wherein said device is used for an administration of said mixed pharmaceutical composition to said subject, and wherein said device comprises: first and second housings; said first and second housings being non-movably, both rotationally and translationally, engageable together,; a conduit having an internal passageway formed in said first housing, said internal passageway having a dispensing end and an inlet end; a first plunger mounted in said internal passageway proximate said dispensing end; a second plunger mounted in said internal passageway proximate said inlet end; a third plunger mounted in said internal passageway intermediate said first and second plungers, said first and third plungers defining a first compartment therebetween, said second and third plungers defining a second compartment therebetween; a plunger rod at least partially within said internal passageway at said inlet end; a moveable member located in said second housing; said moveable member engaging said first plunger; and a shearing channel formed in a side wall of said conduit to permit mixing of contents located in said first and second compartments.
2. The mixed pharmaceutical composition of claim 1, wherein said housings are adapted to prevent translation relative to each other.
3. The mixed pharmaceutical composition of claim 1 or 2, wherein said moveable member prevents rotation of said housings relative to each other.
4. A mixed pharmaceutical composition of claim 1, wherein said condition is nail fungus, sexual dysfunction, erectile dysfunction, or premature ejaculation.
5. The mixed pharmaceutical composition of claim 1 or claim 4, wherein said pharmaceutical composition is for administration is selected from a group consisting of transdermal, intranasal, buccal, and rectal.
6. The mixed pharmaceutical composition of claim 5, wherein said pharmaceutical composition is formulated for administration by injection. 11753665 (IRN: P096472NZ)
7. A kit comprising: A device for administration; and A pharmaceutical product for the treatment of sexual dysfunction, said device comprises: first and second housings; said first and second housings being non-movably, both rotationally and translationally, engageable together; a conduit having an internal passageway formed in said first housing, said internal passageway having a dispensing end and an inlet end; a first plunger mounted in said internal passageway proximate said dispensing end; a second plunger mounted in said internal passageway proximate said inlet end; a third plunger mounted in said internal passageway intermediate said first and second plungers, said first and third plungers defining a first compartment therebetween, said second and third plungers defining a second compartment therebetween; a plunger rod at least partially within said internal passageway at said inlet end; a moveable member located in said second housing; said moveable member engaging said first plunger; and a shearing channel formed in a side wall of said conduit to permit mixing of contents located in said first and second compartments.
8. The kit claim 7, wherein said housings are adapted to prevent translation relative to each other.
9. The kit of claim 7 or 8, wherein said moveable member prevents rotation of said housings relative to each other.
10. The kit of claim 7, further comprising a contraceptive and wherein said pharmaceutical product is for the treatment of male or female sexual dysfunction.
11. The kit of claim 10, wherein the contraceptive is a condom. 11753665 (IRN: P096472NZ)
12. A method of mixing comprising: filling a device with at least two compositions; optionally storing said at least two compositions; and mixing said at least two compositions with said device wherein said device comprises: first and second housings; said first and second housings being non-movably, both rotationally and translationally engageable together; a conduit having an internal passageway formed in said first housing, said internal passageway having a dispensing end and an inlet end; a first plunger mounted in said internal passageway proximate said dispensing end; a second plunger mounted in said internal passageway proximate said inlet end; a third plunger mounted in said internal passageway intermediate said first and second plungers, said first and third plungers defining a first compartment therebetween, said second and third plungers defining a second compartment therebetween; a plunger rod at least partially within said internal passageway at said inlet end; a moveable member located in said second housing; said moveable member engaging said first plunger; and a shearing channel formed in a side wall of said conduit to permit mixing of contents located in said first and second compartments.
13. The method of claim 12, wherein said housings are adapted to prevent translation relative to each other.
14. The method of claim 12 or 13, wherein said moveable member prevents rotation of said housings relative to each other.
15. The method of claim 12, wherein one of the at least two compositions comprises a vasoactive agent. 11753665 (IRN: P096472NZ)
16. The method of claim 15, wherein the vasoactive agent is alprostadil. Nexmed Holdings, Inc. By the Attorneys for the Applicant SPRUSON & FERGUSON Per: 11753665 (IRN: P096472NZ)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| NZ715742A NZ715742B2 (en) | 2012-07-06 | Reconstitution methods |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA2745320A CA2745320A1 (en) | 2011-07-06 | 2011-07-06 | Reconstitution device |
| PCT/US2012/045672 WO2013006757A2 (en) | 2011-07-06 | 2012-07-06 | Reconstitution device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ618749A NZ618749A (en) | 2016-09-30 |
| NZ618749B2 true NZ618749B2 (en) | 2017-01-05 |
Family
ID=
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