CA2670821A1 - Osmotic delivery systems and piston assemblies - Google Patents

Osmotic delivery systems and piston assemblies Download PDF

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Publication number
CA2670821A1
CA2670821A1 CA002670821A CA2670821A CA2670821A1 CA 2670821 A1 CA2670821 A1 CA 2670821A1 CA 002670821 A CA002670821 A CA 002670821A CA 2670821 A CA2670821 A CA 2670821A CA 2670821 A1 CA2670821 A1 CA 2670821A1
Authority
CA
Canada
Prior art keywords
agent formulation
piston assembly
reservoir
osmotic
active agent
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
CA002670821A
Other languages
French (fr)
Other versions
CA2670821C (en
Inventor
Thomas R. Alessi
Michael A. Desjardin
Stan Lam
Scott D. Lautenbach
Pauline C. Zamora
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.
Thomas R. Alessi
Michael A. Desjardin
Stan Lam
Scott D. Lautenbach
Pauline C. Zamora
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., Thomas R. Alessi, Michael A. Desjardin, Stan Lam, Scott D. Lautenbach, Pauline C. Zamora filed Critical Intarcia Therapeutics, Inc.
Publication of CA2670821A1 publication Critical patent/CA2670821A1/en
Application granted granted Critical
Publication of CA2670821C publication Critical patent/CA2670821C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J9/00—Piston-rings, e.g. non-metallic piston-rings, seats therefor; Ring sealings of similar construction
    • F16J9/26—Piston-rings, e.g. non-metallic piston-rings, seats therefor; Ring sealings of similar construction characterised by the use of particular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14526—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons the piston being actuated by fluid pressure
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J9/00—Piston-rings, e.g. non-metallic piston-rings, seats therefor; Ring sealings of similar construction
    • F16J9/28—Piston-rings, e.g. non-metallic piston-rings, seats therefor; Ring sealings of similar construction of non-metals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M2005/14513—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons with secondary fluid driving or regulating the infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

Abstract

An osmotic delivery system is disclosed for delivering an active agent formulation to a fluid environment. The osmotic delivery system typically comprises a reservoir having a lumen that contains the active agent formulation and an osmotic agent formulation and a piston assembly positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation. The piston assembly typically comprises a body constructed and arranged for positioning in the lumen. The body is typically made of a polymeric material that is, for example, resistant to leaching in an organic solvent. In one embodiment, the body is a columnar body having a rim at a distal end thereof for engaging and sealing against a wall of the reservoir and the piston assembly further comprises a spring retained at the distal end of the columnar body for biasing the rim of the columnar body against the wall of the reservoir.

Claims (15)

1. A piston assembly for positioning in a lumen of a reservoir for an osmotic delivery system, characterized by a body constructed and arranged for positioning in the lumen, the body being made of a polymeric material selected from the group consisting of polyaryletherketone, ultra-high-molecular-weight polyethylene, perfluoroelastomer, and perfluorinated polymers, wherein the polymeric material is resistant to leaching in the presence of an organic solvent comprising a solvent selected from the group consisting of lauryl alcohol, benzyl benzoate, benzyl alcohol, lauryl lactate, decanol, ethyl hexyl lactate, long chain (C8 to C24) aliphatic alcohols, and long chain (C8 to C24) esters, wherein the piston assembly is capable of engaging and sealing against an interior wall of the reservoir.
2. The piston assembly of claim 1, wherein the body is a columnar body comprising a rim at a distal end thereof for engaging and sealing against the wall of the reservoir, and a spring retained at the distal end for biasing the rim against the wall of the reservoir.
3. The piston assembly of claim 2, wherein the spring is a radial spring.
4. The piston assembly of claim 3, wherein the spring is a canted coil spring.
5. The piston assembly of any of claims 2-4, wherein the spring is made of a non-reactive metal.
6. The piston assembly of claim 1, wherein the piston assembly comprises a body constructed and arranged for positioning in the lumen, the body being made of a polymeric material that is resistant to leaching in an organic solvent and comprising one or more concentric grooves, each groove formed to retain an elastomeric O-ring that is capable of engaging and sealing against an interior wall of the reservoir.
7. The piston assembly of any of claims 1-6, wherein the polymeric material produces volatile leachates of less than about 1.4 µg/ml when exposed to the organic solvent at 40°C for at least about 45 days.
8. An osmotic delivery system for delivering an active agent formulation to a fluid environment, comprising:
a reservoir, comprising an interior wall, that defines a lumen containing the active agent formulation and an osmotic agent formulation; and the piston assembly of any of claims 1-7 positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation, wherein the piston assembly engages and seals against the interior wall of the reservoir.
9. The osmotic delivery system of claim 8, further comprising a semipermeable membrane positioned at a first distal end of the reservoir adjacent the osmotic agent formulation.
10. The osmotic delivery system of claim 8 or claim 9, further comprising a flow modulator positioned at a second distal end of the reservoir adjacent the active agent formulation, said flow modulator having an orifice for delivering the active agent formulation to the fluid environment.
11. The osmotic delivery system of any of claims 8-10, wherein the active agent formulation is a suspension formulation comprising a suspension vehicle comprising one or more organic solvent.
12. The osmotic delivery system of claim 11, wherein the suspension formulation further comprises a particle formulation comprising one or more polypeptide selected from the group consisting of interferon and insulinotropic peptide.
13. The osmotic delivery system of claim 12, wherein the polypeptide is selected from the group consisting of alpha interferon, beta interferon, delta interferon, gamma interferon, omega interferon, lambda interferon, tau interferon, interferon analogs, interferon derivatives, and mixtures thereof.
14. The osmotic delivery system of claim 12, wherein the polypeptide is selected from the group consisting of glucagon like protein 1 (GLP-1), GLP-1 derivatives and analogs, exendin-4, and exendin-4 derivatives and analogs.
15. A method of manufacturing the osmotic delivery system of any of claims 8-14, comprising providing the reservoir, the active agent formulation, the osmotic agent formulation, the piston assembly, a semipermeable membrane and a flow modulator;
assembling the reservoir, the active agent formulation, the osmotic agent formulation, the piston assembly, the semipermeable membrane and the flow modulator, such that the piston assembly is positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation, the semipermeable membrane is positioned at a first distal end of the reservoir adjacent the osmotic agent formulation, and the flow modulator is positioned at a second distal end of the reservoir adjacent the active agent formulation.
CA2670821A 2006-08-09 2007-08-08 Osmotic delivery systems and piston assemblies Active CA2670821C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US82183006P 2006-08-09 2006-08-09
US60/821,830 2006-08-09
US93020507P 2007-05-15 2007-05-15
US60/930,205 2007-05-15
PCT/US2007/017634 WO2008021133A2 (en) 2006-08-09 2007-08-08 Osmotic delivery systems and piston assemblies

Publications (2)

Publication Number Publication Date
CA2670821A1 true CA2670821A1 (en) 2008-02-21
CA2670821C CA2670821C (en) 2012-05-15

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2670821A Active CA2670821C (en) 2006-08-09 2007-08-08 Osmotic delivery systems and piston assemblies

Country Status (17)

Country Link
US (4) US7682356B2 (en)
EP (4) EP3421031A1 (en)
JP (1) JP5048773B2 (en)
KR (1) KR101200728B1 (en)
CN (2) CN101495094B (en)
AU (1) AU2007284759B2 (en)
CA (1) CA2670821C (en)
CY (1) CY1114358T1 (en)
DK (2) DK2359808T3 (en)
ES (2) ES2422864T3 (en)
HK (2) HK1130680A1 (en)
IL (1) IL196141A (en)
MX (1) MX2009001114A (en)
NZ (2) NZ593017A (en)
PL (1) PL2359808T3 (en)
PT (1) PT2359808E (en)
WO (1) WO2008021133A2 (en)

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US20080091176A1 (en) 2008-04-17
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CA2670821C (en) 2012-05-15
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