EP0831771A2 - Administration par voie orale de produits de recombinaison geniques - Google Patents

Administration par voie orale de produits de recombinaison geniques

Info

Publication number
EP0831771A2
EP0831771A2 EP96918287A EP96918287A EP0831771A2 EP 0831771 A2 EP0831771 A2 EP 0831771A2 EP 96918287 A EP96918287 A EP 96918287A EP 96918287 A EP96918287 A EP 96918287A EP 0831771 A2 EP0831771 A2 EP 0831771A2
Authority
EP
European Patent Office
Prior art keywords
gene construct
delivery
gene
formulation
therapeutic protein
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.)
Withdrawn
Application number
EP96918287A
Other languages
German (de)
English (en)
Inventor
Peter E. Daddona
Gamil G. De Chadarevian
Joseph A. Fix
Phyllis I. Gardner
Howard B. Rosen
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.)
Alza Corp
Original Assignee
Alza Corp
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 Alza Corp filed Critical Alza Corp
Publication of EP0831771A2 publication Critical patent/EP0831771A2/fr
Withdrawn legal-status Critical Current

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
    • 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
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • 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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Definitions

  • FIG. 3 is a cross-sectional view of a further embodiment of the device of the present invention, the device being in closed or prepared form prior to placement in the environment of use.
  • FIG. 4 is the device of FIG. 3 in operation after activation by placement in the environment of use, showing the device opened to release the gene construct to the environment.
  • the present invention involves delivery of a gene construct to a targeted portion of the Gl tract.
  • Potential portions of the Gl tract that may be targeted include but are not limited to the distal small intestine, the M cells, the Peyer's Patches and the upper colon.
  • Such targeting will promote transduction of gastrointestinal epithelial cells or M cells at the delivery site.
  • devices such as those described below may be taken orally. These devices will retain the gene construct formulation such that delivery into the stomach and upper intestine will be prevented and a bolus dose will be delivered at the target site.
  • the housing 32 may be prepared as a hollow cylinder that is closed at one end.
  • the cylinder may be a water permeable material as described above and coated with an impermeable coating in the portion that contains the gene construct formulation 20.
  • the plug 36 may be a water-swellable material.
  • the device is assembled by preparing an osmotic plug as described above from the expansion agent 40 and the piston 42. This plug is placed into the closed end of the hollow cylinder, with the expansion agent 40 adjacent the closed end of the cylinder.
  • the gene construct formulation is then placed into the housing 32 adjacent the piston 42.
  • the plug 36 is then placed into the open end 34 of the housing 32.
  • the polymeric osmotic formulation has a composition of 60 wt% polyethylene oxide (Polyox® 303, Union Carbide), 29 wt% sodium chloride, 5 wt% polyacrylic acid (Carbomer® 934P, B.F. Goodrich), 5 wt% hydroxypropylmethylcellulose E-5, and 1 wt% ferric oxide.
  • Polyox® 303 Union Carbide
  • 29 wt% sodium chloride 5 wt% polyacrylic acid
  • Carbomer® 934P Polyacrylic acid
  • B.F. Goodrich 5 wt% hydroxypropylmethylcellulose E-5
  • 1 wt% ferric oxide 1 wt% ferric oxide.
  • each of the above components is screened through a 40 mesh screen, and the sized components are added to a mixing vessel in the appropriate proportions.
  • the dry components are mixed thoroughly for 10 minutes; then, SDA 3A ethanol is slowly added while mixing continues until a wet mass is formed.
  • Delivery devices according to the present invention containing non ⁇ viral vector formulations are prepared follows.
  • Liposomes are prepared by the dehydration-rehydration techniques described by Gregoriadis and Panagiotidi (Immunol. Lett. 1989, 20:237-240).
  • Distearolyphosphatidylcholine, hydrogenated phosphatidylse ne and cholesterol in a molar ratio of 1 :1 :2 are dissolved in chloroform/methanol (9:1 v/v).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Biotechnology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention porte sur un procédé d'administration d'un produit de recombinaison génique destiné à une région ciblée des voies digestives. Ledit produit de recombinaison se présente sous la forme d'une dose de charge en bolus qui produit l'expression d'une quantité à effet thérapeutique d'une protéine traitante dans le site cible. L'invention porte également sur le dispositif permettant d'acheminer ledit produit de recombinaison génique jusqu'à un site cible.
EP96918287A 1995-06-07 1996-06-07 Administration par voie orale de produits de recombinaison geniques Withdrawn EP0831771A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US47596195A 1995-06-07 1995-06-07
US475961 1995-06-07
PCT/US1996/009371 WO1996040081A2 (fr) 1995-06-07 1996-06-07 Administration par voie orale de produits de recombinaison geniques

Publications (1)

Publication Number Publication Date
EP0831771A2 true EP0831771A2 (fr) 1998-04-01

Family

ID=23889916

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96918287A Withdrawn EP0831771A2 (fr) 1995-06-07 1996-06-07 Administration par voie orale de produits de recombinaison geniques

Country Status (6)

Country Link
EP (1) EP0831771A2 (fr)
JP (1) JPH11507340A (fr)
KR (1) KR19990022184A (fr)
AU (1) AU6097896A (fr)
CA (1) CA2221323A1 (fr)
WO (1) WO1996040081A2 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5976571A (en) * 1991-01-31 1999-11-02 Port Systems, L.L.C. Method for making a multi-stage drug delivery system
IL122349A0 (en) * 1995-06-07 1998-04-05 Univ Yale Adeno-associated viral vectors
US6225290B1 (en) 1996-09-19 2001-05-01 The Regents Of The University Of California Systemic gene therapy by intestinal cell transformation
JP2002510319A (ja) 1997-07-01 2002-04-02 アイシス・ファーマシューティカルス・インコーポレーテッド オリゴヌクレオチドの消化管を介したデリバリーのための組成物及び方法
CA2314486A1 (fr) * 1997-12-12 1999-06-24 Synoptik A/S Reservoir servant a effectuer la liberation controlee de substances
CA2355237A1 (fr) * 1998-12-14 2000-06-22 Jorgen Bruun-Jensen Systeme de nettoyage de verres de contact
WO2002089855A1 (fr) * 2001-04-27 2002-11-14 Auckland Uniservices Limited Transduction perorale d'hepatocytes dans le traitement d'une maladie

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69233013T2 (de) * 1991-08-20 2004-03-04 The Government Of The United States Of America As Represented By The Secretary Of National Institute Of Health, Office Of Technology Transfer Adenovirus vermittelter gentransfer in den gastrointestinaltrakt
WO1993019660A1 (fr) * 1992-04-03 1993-10-14 Baylor College Of Medicine Therapie genique utilisant l'intestin

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9640081A2 *

Also Published As

Publication number Publication date
AU6097896A (en) 1996-12-30
JPH11507340A (ja) 1999-06-29
CA2221323A1 (fr) 1996-12-19
KR19990022184A (ko) 1999-03-25
WO1996040081A2 (fr) 1996-12-19
WO1996040081A3 (fr) 1997-02-20

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