WO1998027962A3 - Injectable depot gel composition and method of preparing the composition - Google Patents

Injectable depot gel composition and method of preparing the composition Download PDF

Info

Publication number
WO1998027962A3
WO1998027962A3 PCT/US1997/023341 US9723341W WO9827962A3 WO 1998027962 A3 WO1998027962 A3 WO 1998027962A3 US 9723341 W US9723341 W US 9723341W WO 9827962 A3 WO9827962 A3 WO 9827962A3
Authority
WO
WIPO (PCT)
Prior art keywords
composition
injectable depot
polymer
gel
gel composition
Prior art date
Application number
PCT/US1997/023341
Other languages
French (fr)
Other versions
WO1998027962A2 (en
Inventor
Kevin J Brodbeck
Theodore T Shen
Original Assignee
Alza Corp
Kevin J Brodbeck
Theodore T Shen
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=21870398&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO1998027962(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to JP52891698A priority Critical patent/JP2002512597A/en
Priority to DK97952507T priority patent/DK0949905T3/en
Priority to AT97952507T priority patent/ATE203157T1/en
Priority to EP97952507A priority patent/EP0949905B1/en
Priority to AU56097/98A priority patent/AU5609798A/en
Application filed by Alza Corp, Kevin J Brodbeck, Theodore T Shen filed Critical Alza Corp
Priority to CA002275587A priority patent/CA2275587C/en
Priority to DE69705746T priority patent/DE69705746T2/en
Publication of WO1998027962A2 publication Critical patent/WO1998027962A2/en
Publication of WO1998027962A3 publication Critical patent/WO1998027962A3/en
Priority to HK99105227A priority patent/HK1020009A1/en
Priority to GR20010401458T priority patent/GR3036599T3/en

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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • 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]
    • A61K38/212IFN-alpha
    • 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
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH] (Somatotropin)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

Abstract

An injectable depot gel composition containing a polymer, a solvent that can dissolve the polymer and thereby form a viscous gel, a beneficial agent; and an emulsifying agent in the form of a dispersed droplet phase in the viscous gel. The injectable depot gel composition can be prepared by mixing the polymer and the solvent so that the solvent dissolves the polymer and forms a viscous gel. The beneficial agent is dissolved or dispersed in the viscous gel and the emulsifying agent is mixed with the beneficial agent containing viscous gel. The emulsifying agent forms a dispersed droplet phase in the viscous gel to provide the injectable depot gel composition. The injectable depot gel composition can deliver a beneficial agent to a human or animal with a desired release profile.
PCT/US1997/023341 1996-12-20 1997-12-18 Injectable depot gel composition and method of preparing the composition WO1998027962A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
DE69705746T DE69705746T2 (en) 1996-12-20 1997-12-18 INJECTABLE DEPOT GEL PREPARATION AND PRODUCTION METHOD
DK97952507T DK0949905T3 (en) 1996-12-20 1997-12-18 Injectable depot preparation and method of preparation
AT97952507T ATE203157T1 (en) 1996-12-20 1997-12-18 INJECTABLE DEPOSIT GEL PREPARATION AND PRODUCTION METHOD
EP97952507A EP0949905B1 (en) 1996-12-20 1997-12-18 Injectable depot gel composition and method of preparing the composition
AU56097/98A AU5609798A (en) 1996-12-20 1997-12-18 Injectable depot gel composition and method of preparing the composition
JP52891698A JP2002512597A (en) 1996-12-20 1997-12-18 Injectable reservoir gel composition and method of making the composition
CA002275587A CA2275587C (en) 1996-12-20 1997-12-18 Injectable depot gel composition and method of preparing the composition
HK99105227A HK1020009A1 (en) 1996-12-20 1999-11-12 Injectable depot gel composition and method of preparing the composition
GR20010401458T GR3036599T3 (en) 1996-12-20 2001-09-12 Injectable depot gel composition and method of preparing the composition

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3343996P 1996-12-20 1996-12-20
US60/033,439 1996-12-20

Publications (2)

Publication Number Publication Date
WO1998027962A2 WO1998027962A2 (en) 1998-07-02
WO1998027962A3 true WO1998027962A3 (en) 1998-10-01

Family

ID=21870398

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US1997/023341 WO1998027962A2 (en) 1996-12-20 1997-12-18 Injectable depot gel composition and method of preparing the composition
PCT/US1997/023659 WO1998027963A2 (en) 1996-12-20 1997-12-18 Gel composition and methods

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/US1997/023659 WO1998027963A2 (en) 1996-12-20 1997-12-18 Gel composition and methods

Country Status (17)

Country Link
US (6) US6130200A (en)
EP (2) EP0959873B1 (en)
JP (4) JP4642946B2 (en)
KR (1) KR100616793B1 (en)
CN (1) CN1146402C (en)
AT (2) ATE318580T1 (en)
AU (2) AU5609798A (en)
CA (3) CA2275587C (en)
DE (2) DE69705746T2 (en)
DK (2) DK0959873T3 (en)
ES (2) ES2158611T3 (en)
GR (1) GR3036599T3 (en)
HK (2) HK1020009A1 (en)
IL (1) IL130532A0 (en)
NZ (1) NZ335851A (en)
PT (2) PT959873E (en)
WO (2) WO1998027962A2 (en)

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US8956644B2 (en) 2006-11-03 2015-02-17 Durect Corporation Transdermal delivery systems
US8992961B2 (en) 1999-02-08 2015-03-31 Intarcia Therapeutics, Inc. Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicles
US9095553B2 (en) 2005-02-03 2015-08-04 Intarcia Therapeutics Inc. Solvent/polymer solutions as suspension vehicles
US9539200B2 (en) 2005-02-03 2017-01-10 Intarcia Therapeutics Inc. Two-piece, internal-channel osmotic delivery system flow modulator
US9555113B2 (en) 2013-03-15 2017-01-31 Durect Corporation Compositions with a rheological modifier to reduce dissolution variability
US9572889B2 (en) 2008-02-13 2017-02-21 Intarcia Therapeutics, Inc. Devices, formulations, and methods for delivery of multiple beneficial agents
US9592204B2 (en) 2007-12-06 2017-03-14 Durect Corporation Oral pharmaceutical dosage forms

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