WO1984001287A1 - Organismes vivants encapsules programmes genetiquement produisant des substances therapeutiques - Google Patents

Organismes vivants encapsules programmes genetiquement produisant des substances therapeutiques Download PDF

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Publication number
WO1984001287A1
WO1984001287A1 PCT/US1983/001362 US8301362W WO8401287A1 WO 1984001287 A1 WO1984001287 A1 WO 1984001287A1 US 8301362 W US8301362 W US 8301362W WO 8401287 A1 WO8401287 A1 WO 8401287A1
Authority
WO
WIPO (PCT)
Prior art keywords
organisms
wall
therapeutic
human
enclosed
Prior art date
Application number
PCT/US1983/001362
Other languages
English (en)
Inventor
Theodore E Spielberg
Original Assignee
Theodore E Spielberg
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 Theodore E Spielberg filed Critical Theodore E Spielberg
Publication of WO1984001287A1 publication Critical patent/WO1984001287A1/fr

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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings

Definitions

  • the invention relates to therapeutic agents for internal administration to an animal body such as a human and to methods of their manufacture and administration.
  • Prior Art Internally administered therapeutic agents usually ' encompass drugs and other non-living materials which are ingested by a user, or implanted or inserted in the user for therapeutic purposes. They are delivered to the body of the user in a variety of ways, such as in the form of capsules for oral administration or or by insertion as suppositories, or in the form of liquids for oral administration or injection, among other techniques. Also, living organisms have been administered by injection e.g., small pox, vaccination, or- by the oral route in the form of liquid droplets e.g., Sabin polio immunization. These agents are prepared by a variety of manufacturing processes, and are stored until their administration to the end user.
  • Objects of the Invention Accordingly, it is an object of the invention to provide an improved mechanism for administering selected therapeutic agents derived from genetically altered organism to an animal body. Further, it is an object of my invention to provide an improved method of generating therapeutic agents derived from genetically altered organisms for administration to an animal body.
  • genetically programmed organisms which produce the desired therapeutic agents to be administered to an animal m body such as a human are prepared in situ and enclosed within a protective membrane providing mechanical confinement to the organisms while they are being administered to the animal body.
  • the membrane may include an inner layer containing material providing sustenance to the enclosed bacteria for at least the time they are outside the human body, or a nutrient material may be included in the organism section of the chamber itself.
  • a microporous membrane that contains the organisms but allows passage of nutrients from a nutrient source or culture medium may be employed.
  • the membrane and its contents may be orally ingested by the human, or may be inserted as a suppository or otherwise implanted within the body.
  • the capsule may either remain intact, exchanging its therapeutic product for nutrients until removed or excreted, or may dissolve, allowing the therapeutic organisms to colonize the target areas releasing their therapeutic products there.
  • a genetically altered strain is preselected that itself produces the therapeutic agent which is to be utilized by the body.
  • altered bacteria of the type E. Coli produce insulin which is used to treat diseases such as diabetes.
  • the membrane dissolves within the body to a sufficient extent to release the enclosed bacteria.
  • the bacteria then operate, within the body environment, to produce the selected therapeutic agent [e_.g, insulin].
  • the number of bacteria are, of course, proportioned to the desired dosage of agent to be administered to the body, taking into consideration the type of bacteria, the specific portion of the body in which they were lodged, and their expected lifetime and productivity time within that body portion.
  • the therapeutic agent is generated by the bacteria within the membrane and is transferred across the membrane walls by A-
  • the membrane walls 5 may be such as to be dissolvable when ingested or 6 inserted into the body, or may be such that the walls 7 are relatively resistant to degradation within the 8 body but allow passage of therapeutic products 9 generated by the bacteria into the body.
  • dissolvable capsules may be modified 1 to dissolve under optimal conditions for specific 2 locality colonization and as such may be acid 3 resistant and more soluable in an alkaline environment 4 for intestinal colonization, or by other physical or 5 chemical modifications designed to enhance successful
  • 27 capsules may be stored at cold or freezing
  • Fig. 1 is a cross-sectional view of a
  • Fig. 2 is a cross-sectional view of a
  • a therapeutic device in the form of 1 a capsule comprises a membraneous wall 10 enclosing, 2 on the interior thereof, selected organisms 12 for 3 manufacture of therapeutic agents to be internally 4 administered to a human body.
  • Wall 10 may comprise a 5 material such as gelatin which is essentially 6 impermeable both to the organism and to the 7 therapeutic agents formed thereby, but which is broken 8 down by the body on ingestion or insertion of the 9 device into it or, alternatively, may comprise a 0 material such as a icroporous membrane which has a 1 pore size sufficient to allow passage of the 2 therapeutic agents formed by the organisms through the 3 membrane wall and into the body on ingestion or 4 insertion therein, while blocking escape of the 5 organism therethrough, and which is relatively inert 6 to degradation by the body when ingested or inserted.
  • the therapeutic agent is formed 8 within the body largely outside the membraneous wall, - while in the second case the therapeutic agent is formed within the membraneous enclosure.
  • Fig. 2 a further alternative version of my invention is shown.
  • a first or inner membraneous wall 20 encloses organisms 22 therein.
  • a second or outer membraneous wall 24 encloses a layer
  • the inner and outer chamber may be reversed.
  • This embodiment of the invention is expected to be useful in cases where extended pe.riods of time are expected to elapse between the preparation of the device and its ultimate utilization.
  • the membraneous walls 20 and 24 may be selected to allow escape of the enclosed organism 22 into the body following ingestion or insertion, or may be resistant to degradation by the body but sufficiently permeable to the organism that the therapeutic agent generated by the organism escape through these walls, and through the nutrient layer 26.
  • the layer 26 may also, in addition to, or instead of, providing nutrient to the organism 22, provide an absorptive layer which selectively absorbs constituents generated by the organism which it is desired to preclude from passage into the body.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)

Abstract

Un dispositif consiste en des organismes programmés génétiquement enfermés dans une variété de structures à membranes pour former une capsule thérapeutique. Cette capsule, lorsqu'elle est administrée en une personne, produit des agents thérapeutiques et peut, soit rester intacte jusqu'à être expulsée ou retirée, soit dissoudre sa paroi pour permettre aux organismes enfermés de coloniser les régions désirées pour ensuite produire les agents thérapeutiques.
PCT/US1983/001362 1982-09-29 1983-09-09 Organismes vivants encapsules programmes genetiquement produisant des substances therapeutiques WO1984001287A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US42842482A 1982-09-29 1982-09-29

Publications (1)

Publication Number Publication Date
WO1984001287A1 true WO1984001287A1 (fr) 1984-04-12

Family

ID=23698842

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1983/001362 WO1984001287A1 (fr) 1982-09-29 1983-09-09 Organismes vivants encapsules programmes genetiquement produisant des substances therapeutiques

Country Status (3)

Country Link
EP (1) EP0120061A4 (fr)
JP (1) JPS59501747A (fr)
WO (1) WO1984001287A1 (fr)

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4615883A (en) * 1985-10-23 1986-10-07 Plant Genetics, Inc. Hydrogel encapsulated nematodes
US4701326A (en) * 1985-10-23 1987-10-20 Plant Genetics, Inc. Membrane-coated hydrogel encapsulated nematodes
US4753799A (en) * 1985-10-23 1988-06-28 Plant Genetics, Inc. Production of hydrogel encapsulated nematodes
WO1991000119A1 (fr) * 1989-06-30 1991-01-10 Baxter International Inc. Dispositif implantable
US5314471A (en) * 1991-07-24 1994-05-24 Baxter International Inc. Tissue inplant systems and methods for sustaining viable high cell densities within a host
US5344454A (en) * 1991-07-24 1994-09-06 Baxter International Inc. Closed porous chambers for implanting tissue in a host
US5545223A (en) * 1990-10-31 1996-08-13 Baxter International, Inc. Ported tissue implant systems and methods of using same
US5639275A (en) * 1993-08-12 1997-06-17 Cytotherapeutics, Inc. Delivery of biologically active molecules using cells contained in biocompatible immunoisolatory capsules
US5713888A (en) * 1990-10-31 1998-02-03 Baxter International, Inc. Tissue implant systems
US5741330A (en) * 1990-10-31 1998-04-21 Baxter International, Inc. Close vascularization implant material
US5798113A (en) * 1991-04-25 1998-08-25 Brown University Research Foundation Implantable biocompatible immunoisolatory vehicle for delivery of selected therapeutic products
US5800829A (en) * 1991-04-25 1998-09-01 Brown University Research Foundation Methods for coextruding immunoisolatory implantable vehicles with a biocompatible jacket and a biocompatible matrix core
US5902745A (en) * 1995-09-22 1999-05-11 Gore Hybrid Technologies, Inc. Cell encapsulation device
US5908623A (en) * 1993-08-12 1999-06-01 Cytotherapeutics, Inc. Compositions and methods for the delivery of biologically active molecules using genetically altered cells contained in biocompatible immunoisolatory capsules
US5980889A (en) * 1993-08-10 1999-11-09 Gore Hybrid Technologies, Inc. Cell encapsulating device containing a cell displacing core for maintaining cell viability
US6773458B1 (en) * 1991-07-24 2004-08-10 Baxter International Inc. Angiogenic tissue implant systems and methods
EP1499288A1 (fr) * 2002-04-30 2005-01-26 Kimberly-Clark Worldwide, Inc. Appareil et procede d'introduction de bacteries dans le conduit vaginal

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6097918A (ja) * 1983-11-01 1985-05-31 Sumitomo Chem Co Ltd インタ−フエロン持続性製剤

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3317393A (en) * 1964-06-08 1967-05-02 Robert M Chanock Immunization by selective infection of the intestinal tract with an encapsulated live virus
US3767790A (en) * 1972-02-11 1973-10-23 Nat Patent Dev Corp Microorganisms
US3823228A (en) * 1971-09-29 1974-07-09 Univ Illinois Tge virus vaccine
JPS504232A (fr) * 1973-05-10 1975-01-17
US4235871A (en) * 1978-02-24 1980-11-25 Papahadjopoulos Demetrios P Method of encapsulating biologically active materials in lipid vesicles
US4322790A (en) * 1979-11-26 1982-03-30 General Electric Company Calibration source for instruments to measure power and negative sequence current of dynamoelectric machines

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE605803C (de) * 1931-06-26 1934-11-19 Iwan Arbatsky Kapsel fuer Mittel zur Bekaempfung von Faeulnisprozessen im Dickdarm
GB1540461A (en) * 1975-08-20 1979-02-14 Damon Corp Chemical processes

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3317393A (en) * 1964-06-08 1967-05-02 Robert M Chanock Immunization by selective infection of the intestinal tract with an encapsulated live virus
US3823228A (en) * 1971-09-29 1974-07-09 Univ Illinois Tge virus vaccine
US3767790A (en) * 1972-02-11 1973-10-23 Nat Patent Dev Corp Microorganisms
JPS504232A (fr) * 1973-05-10 1975-01-17
US4235871A (en) * 1978-02-24 1980-11-25 Papahadjopoulos Demetrios P Method of encapsulating biologically active materials in lipid vesicles
US4322790A (en) * 1979-11-26 1982-03-30 General Electric Company Calibration source for instruments to measure power and negative sequence current of dynamoelectric machines

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0120061A4 *

Cited By (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4615883A (en) * 1985-10-23 1986-10-07 Plant Genetics, Inc. Hydrogel encapsulated nematodes
US4701326A (en) * 1985-10-23 1987-10-20 Plant Genetics, Inc. Membrane-coated hydrogel encapsulated nematodes
US4753799A (en) * 1985-10-23 1988-06-28 Plant Genetics, Inc. Production of hydrogel encapsulated nematodes
AU605749B2 (en) * 1985-10-23 1991-01-24 Plant Genetics, Inc. Hydrogel encapsulated nematodes
WO1991000119A1 (fr) * 1989-06-30 1991-01-10 Baxter International Inc. Dispositif implantable
US5782912A (en) * 1990-10-31 1998-07-21 Baxter International, Inc. Close vascularization implant material
US5800529A (en) * 1990-10-31 1998-09-01 Baxter International, Inc. Close vascularization implant material
US5545223A (en) * 1990-10-31 1996-08-13 Baxter International, Inc. Ported tissue implant systems and methods of using same
US5593440A (en) * 1990-10-31 1997-01-14 Baxter International Inc. Tissue implant systems and methods for sustaining viable high cell densities within a host
US5882354A (en) * 1990-10-31 1999-03-16 Baxter International Inc. Close vascularization implant material
US5741330A (en) * 1990-10-31 1998-04-21 Baxter International, Inc. Close vascularization implant material
US5733336A (en) * 1990-10-31 1998-03-31 Baxter International, Inc. Ported tissue implant systems and methods of using same
US5713888A (en) * 1990-10-31 1998-02-03 Baxter International, Inc. Tissue implant systems
US5871767A (en) * 1991-04-25 1999-02-16 Brown University Research Foundation Methods for treatment or prevention of neurodegenerative conditions using immunoisolatory implantable vehicles with a biocompatible jacket and a biocompatible matrix core
US5798113A (en) * 1991-04-25 1998-08-25 Brown University Research Foundation Implantable biocompatible immunoisolatory vehicle for delivery of selected therapeutic products
US6960351B2 (en) 1991-04-25 2005-11-01 Brown University Research Foundation Implantable biocompatible immunoisolatory vehicle for delivery of selected therapeutic products
US5869077A (en) * 1991-04-25 1999-02-09 Brown University Research Foundation Methods for treating diabetes by delivering insulin from biocompatible cell-containing devices
US5874099A (en) * 1991-04-25 1999-02-23 Brown University Research Foundation Methods for making immunoisolatary implantable vehicles with a biocompatible jacket and a biocompatible matrix core
US5800829A (en) * 1991-04-25 1998-09-01 Brown University Research Foundation Methods for coextruding immunoisolatory implantable vehicles with a biocompatible jacket and a biocompatible matrix core
US5800828A (en) * 1991-04-25 1998-09-01 Brown University Research Foundation Implantable biocompatible immunoisolatory vehicle for delivery of selected therapeutic products
US5834001A (en) * 1991-04-25 1998-11-10 Brown University Research Foundation Methods for making immunoisolatory implantable vehicles with a biocompatiable jacket and a biocompatible matrix core
US5344454A (en) * 1991-07-24 1994-09-06 Baxter International Inc. Closed porous chambers for implanting tissue in a host
US6773458B1 (en) * 1991-07-24 2004-08-10 Baxter International Inc. Angiogenic tissue implant systems and methods
US5314471A (en) * 1991-07-24 1994-05-24 Baxter International Inc. Tissue inplant systems and methods for sustaining viable high cell densities within a host
US5980889A (en) * 1993-08-10 1999-11-09 Gore Hybrid Technologies, Inc. Cell encapsulating device containing a cell displacing core for maintaining cell viability
US6426214B1 (en) 1993-08-10 2002-07-30 Gore Enterprise Holdings, Inc. Cell encapsulating device containing a cell displacing core for maintaining cell viability
US5656481A (en) * 1993-08-12 1997-08-12 Cyto Therapeutics, Inc. Compositions and methods for the delivery of biologically active molecules using cells contained in biocompatible capsules
US5908623A (en) * 1993-08-12 1999-06-01 Cytotherapeutics, Inc. Compositions and methods for the delivery of biologically active molecules using genetically altered cells contained in biocompatible immunoisolatory capsules
US6264941B1 (en) 1993-08-12 2001-07-24 Neurotech S.A. Compositions for the delivery of biologically active molecules using genetically altered cells contained in biocompatible immunoisolatory capsules
US5653975A (en) * 1993-08-12 1997-08-05 Cytotherapeutics, Inc. Compositions and methods for the delivery of biologically active molecules using cells contained in biocompatible capsules
US5639275A (en) * 1993-08-12 1997-06-17 Cytotherapeutics, Inc. Delivery of biologically active molecules using cells contained in biocompatible immunoisolatory capsules
US5676943A (en) * 1993-08-12 1997-10-14 Cytotherapeutics, Inc. Compositions and methods for the delivery of biologically active molecules using genetically altered cells contained in biocompatible immunoisolatory capsules
US5902745A (en) * 1995-09-22 1999-05-11 Gore Hybrid Technologies, Inc. Cell encapsulation device
EP1499288A1 (fr) * 2002-04-30 2005-01-26 Kimberly-Clark Worldwide, Inc. Appareil et procede d'introduction de bacteries dans le conduit vaginal

Also Published As

Publication number Publication date
EP0120061A1 (fr) 1984-10-03
EP0120061A4 (fr) 1986-08-21
JPS59501747A (ja) 1984-10-18

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