CA2651855A1 - Two-piece, internal-channel osmotic delivery system flow modulator - Google Patents

Two-piece, internal-channel osmotic delivery system flow modulator Download PDF

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Publication number
CA2651855A1
CA2651855A1 CA002651855A CA2651855A CA2651855A1 CA 2651855 A1 CA2651855 A1 CA 2651855A1 CA 002651855 A CA002651855 A CA 002651855A CA 2651855 A CA2651855 A CA 2651855A CA 2651855 A1 CA2651855 A1 CA 2651855A1
Authority
CA
Canada
Prior art keywords
flow modulator
reservoir
outer shell
delivery system
inner core
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002651855A
Other languages
French (fr)
Other versions
CA2651855C (en
Inventor
Scott D. Lautenbach
Pedro E. De La Serna
Pauline C. Zamora
Michael A. Desjardin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Intarcia Therapeutics Inc
Original Assignee
Intarcia Therapeutics, Inc.
Scott D. Lautenbach
Pedro E. De La Serna
Pauline C. Zamora
Michael A. Desjardin
Alza Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Intarcia Therapeutics, Inc., Scott D. Lautenbach, Pedro E. De La Serna, Pauline C. Zamora, Michael A. Desjardin, Alza Corporation filed Critical Intarcia Therapeutics, Inc.
Publication of CA2651855A1 publication Critical patent/CA2651855A1/en
Application granted granted Critical
Publication of CA2651855C publication Critical patent/CA2651855C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00Fluid handling
    • Y10T137/0318Processes
    • Y10T137/0402Cleaning, repairing, or assembling
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49229Prime mover or fluid pump making
    • Y10T29/49236Fluid pump or compressor making
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/494Fluidic or fluid actuated device making

Abstract

An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening of a reservoir of an osmotic delivery system, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Claims (20)

1. An osmotic delivery system flow modulator, comprising:
an outer shell constructed and arranged for positioning in an opening of a reservoir of an osmotic delivery system;
an inner core inserted in the outer shell; and a fluid channel having a spiral shape defined between the outer shell and the inner core, the fluid channel being adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.
2. The flow modulator of claim 1, wherein the fluid channel is formed on an outer surface of the inner core which mates with an inner surface of the outer shell.
3. The flow modulator of claim 1, wherein the fluid channel is formed on an inner surface of the outer shell which mates with an outer surface of the inner core.
4. The flow modulator of claim 1, further comprising a flow insert disposed between the outer shell and inner core, wherein the fluid channel is formed in the flow insert.
5. The flow modulator of claim 4, wherein the outer shell, inner core, and flow insert are made of an inert material.
6. The flow modulator of claim 5, wherein the inert material is a non-metallic material.
7. The flow modulator of claim 1, wherein the outer shell and inner core are made of an inert material.
8. The flow modulator of claim 7, wherein the inert material is a non-metallic material.
9. The flow modulator of claim 1, wherein the outer shell sealingly engages the inner core.
10. The flow modulator of claim 1, wherein the inner core includes an outer shoulder and the outer shell includes an inner shoulder, wherein the outer shoulder and inner shoulder engage to prevent expulsion of the inner core from the outer shell in use.
11. The flow modulator of claim 1, wherein a length of the fluid channel ranges from 10 to 50 mm.
12. The flow modulator of claim 1, wherein an effective cross-sectional diameter of the fluid channel ranges from 0.1 to 0.5 mm.
13. An osmotic delivery system, comprising:
a reservoir;
a semipermeable plug disposed at a first end of the reservoir to selectively permit fluid flow into the reservoir; and a flow modulator disposed at a second end of the reservoir, the flow modulator comprising an internal spiral channel adapted for delivery of an active agent formulation contained in the reservoir to a fluid environment in which the osmotic delivery system operates.
14. The osmotic delivery system of claim 13, wherein the flow modulator comprises an outer shell and an inner core inserted in the outer shell, wherein the spiral channel is defined between the outer shell and the inner core.
15. The osmotic delivery system of claim 14, wherein the flow modulator is press-fitted into the second end of the reservoir.
16. The osmotic delivery system of claim 14, further comprising a partition disposed and movable within the reservoir, the partition defining a first chamber containing an osmotic engine and a second chamber containing the active agent formulation, wherein the first chamber is adjacent the semipermeable plug and the second chamber is adjacent the flow modulator.
17. The osmotic delivery system of claim 13, wherein the active agent formulation comprises interferon-omega.
18. An implantable delivery system for an active agent formulation, comprising:
a reservoir made of an impermeable material;
a first chamber in the reservoir containing an osmotic engine;
a second chamber in the reservoir containing an active agent formulation;

a semipermeable plug disposed at a first end of the reservoir adjacent the first chamber; and a flow modulator according to any of claims 1-12 disposed at a second end of the reservoir adjacent the second chamber.
19. The implantable delivery system of claim 18, wherein the active agent formulation comprises interferon-omega.
20. The implantable delivery system of claim 18, further comprising a partition between the osmotic engine and the active agent formulation.
CA2651855A 2006-05-30 2007-05-30 Two-piece, internal-channel osmotic delivery system flow modulator Active CA2651855C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US80945106P 2006-05-30 2006-05-30
US60/809,451 2006-05-30
PCT/US2007/069990 WO2007140416A2 (en) 2006-05-30 2007-05-30 Two-piece, internal-channel osmotic delivery system flow modulator

Publications (2)

Publication Number Publication Date
CA2651855A1 true CA2651855A1 (en) 2007-12-06
CA2651855C CA2651855C (en) 2011-08-02

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2651855A Active CA2651855C (en) 2006-05-30 2007-05-30 Two-piece, internal-channel osmotic delivery system flow modulator

Country Status (16)

Country Link
US (8) US8052996B2 (en)
EP (1) EP2020990B1 (en)
JP (1) JP5143131B2 (en)
KR (1) KR101106510B1 (en)
CN (1) CN101453982B (en)
AT (1) ATE481963T1 (en)
AU (1) AU2007266475B2 (en)
CA (1) CA2651855C (en)
DE (1) DE602007009377D1 (en)
DK (1) DK2020990T3 (en)
ES (1) ES2351527T3 (en)
HK (1) HK1129203A1 (en)
IL (1) IL194746A (en)
MX (1) MX2008014870A (en)
NZ (1) NZ572003A (en)
WO (1) WO2007140416A2 (en)

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ATE481963T1 (en) 2010-10-15
US20130247376A1 (en) 2013-09-26
WO2007140416A3 (en) 2008-10-30
US8158150B2 (en) 2012-04-17
CA2651855C (en) 2011-08-02
MX2008014870A (en) 2009-02-12
DK2020990T3 (en) 2010-12-13
NZ572003A (en) 2010-07-30
JP2009538717A (en) 2009-11-12
US20120184945A1 (en) 2012-07-19
US20150231062A1 (en) 2015-08-20
CN101453982B (en) 2011-05-04
AU2007266475A1 (en) 2007-12-06
US20130138089A1 (en) 2013-05-30
US8273365B2 (en) 2012-09-25
ES2351527T3 (en) 2011-02-07
AU2007266475B2 (en) 2009-12-03
US8992962B2 (en) 2015-03-31
US20120330282A1 (en) 2012-12-27
IL194746A (en) 2014-05-28
US20110301576A1 (en) 2011-12-08
IL194746A0 (en) 2009-09-22
US8367095B2 (en) 2013-02-05
JP5143131B2 (en) 2013-02-13
HK1129203A1 (en) 2009-11-20
US8052996B2 (en) 2011-11-08
CN101453982A (en) 2009-06-10
EP2020990A2 (en) 2009-02-11
US20170181964A1 (en) 2017-06-29
US9539200B2 (en) 2017-01-10
KR101106510B1 (en) 2012-01-20
KR20090003342A (en) 2009-01-09
US20070281024A1 (en) 2007-12-06
EP2020990B1 (en) 2010-09-22
US8470353B2 (en) 2013-06-25
DE602007009377D1 (en) 2010-11-04
WO2007140416A2 (en) 2007-12-06

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