CA2009533A1 - Novel cyclosporin galenic forms - Google Patents

Novel cyclosporin galenic forms

Info

Publication number
CA2009533A1
CA2009533A1 CA002009533A CA2009533A CA2009533A1 CA 2009533 A1 CA2009533 A1 CA 2009533A1 CA 002009533 A CA002009533 A CA 002009533A CA 2009533 A CA2009533 A CA 2009533A CA 2009533 A1 CA2009533 A1 CA 2009533A1
Authority
CA
Canada
Prior art keywords
alkylene
galenic forms
glycol
ethanol
novel cyclosporin
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
CA002009533A
Other languages
French (fr)
Other versions
CA2009533C (en
Inventor
Birgit Hauer
Ulrich Posanski
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.)
Novartis AG
Original Assignee
Individual
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
Priority claimed from GB898902898A external-priority patent/GB8902898D0/en
Priority claimed from GB898902901A external-priority patent/GB8902901D0/en
Priority claimed from GB898903147A external-priority patent/GB8903147D0/en
Priority claimed from GB898903663A external-priority patent/GB8903663D0/en
Application filed by Individual filed Critical Individual
Publication of CA2009533A1 publication Critical patent/CA2009533A1/en
Application granted granted Critical
Publication of CA2009533C publication Critical patent/CA2009533C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13—Cyclosporins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • 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
    • 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
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

Pharmaceutical compositions comprising (a) a cyclosporin as active ingredient (b) a fatty acid saccharide monoester and (c) a diluent or carrier. Components (c) are typically ethanol, an alkylene glycol (e. g.
1,2-propylene glycol), an alkylene polyol (e.g. glycerol), a polyalkylene glycol (e. g. PEG), an alkylene polyol ether or ester (e. g. a Gelucir.TM.
product), paraffinum per- or sub-liquidum or an organosilicon oxide polymer, ethanol being less preferred.
CA002009533A 1989-02-09 1990-02-07 Novel cyclosporin galenic forms Expired - Lifetime CA2009533C (en)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
GB898902898A GB8902898D0 (en) 1989-02-09 1989-02-09 Improvements in or relating to organic compounds
GB898902901A GB8902901D0 (en) 1989-02-09 1989-02-09 Improvements in or relating to organic compounds
GB8902898 1989-02-09
GB8902901 1989-02-09
GB8903147 1989-02-13
GB898903147A GB8903147D0 (en) 1989-02-13 1989-02-13 Improvements in or relating to organic compounds
GB898903663A GB8903663D0 (en) 1989-02-17 1989-02-17 Improvements in or relating to organic compounds
GB8903663 1989-02-17

Publications (2)

Publication Number Publication Date
CA2009533A1 true CA2009533A1 (en) 1990-08-09
CA2009533C CA2009533C (en) 2002-11-12

Family

ID=27450262

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002009533A Expired - Lifetime CA2009533C (en) 1989-02-09 1990-02-07 Novel cyclosporin galenic forms

Country Status (25)

Country Link
JP (3) JP3484190B2 (en)
KR (1) KR0170769B1 (en)
AT (1) AT404552B (en)
AU (1) AU630413B2 (en)
BE (1) BE1003009A5 (en)
CA (1) CA2009533C (en)
CH (1) CH679277A5 (en)
CY (1) CY1903A (en)
DE (1) DE4003844B4 (en)
DK (1) DK176209B1 (en)
ES (1) ES2021942A6 (en)
FI (1) FI97524C (en)
FR (1) FR2642650B1 (en)
GB (1) GB2230440B (en)
HK (1) HK37296A (en)
HU (1) HU213394B (en)
IT (1) IT1240758B (en)
LU (1) LU87675A1 (en)
MY (1) MY107377A (en)
NL (1) NL195028C (en)
NO (1) NO301576B1 (en)
NZ (1) NZ232401A (en)
PH (1) PH30917A (en)
PT (1) PT93079B (en)
SE (1) SE511398C2 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5766629A (en) * 1995-08-25 1998-06-16 Sangstat Medical Corporation Oral cyclosporin formulations
US5827822A (en) * 1996-03-25 1998-10-27 Sangstat Medical Corporation Cyclosporin a formulations as nanoparticles
US5834017A (en) * 1995-08-25 1998-11-10 Sangstat Medical Corporation Oral cyclopsporin formulations
US5962019A (en) * 1995-08-25 1999-10-05 Sangstat Medical Corporation Oral cyclosporin formulations

Families Citing this family (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR0148748B1 (en) * 1988-09-16 1998-08-17 장 크라메르, 한스 루돌프 하우스 A multiphase cyclosporin composition
HU208491B (en) * 1990-11-27 1993-11-29 Gyogyszerkutato Intezet Process for producing oral pharmaceutical composition containing cyclosporin
MX9201782A (en) † 1991-04-19 1992-10-01 Sandoz Ag PARTICLES OF BIOLOGICALLY ACTIVE SUBSTANCES, SUBSTANTIALLY INSOLUBLE IN WATER, PROCESS FOR THEIR PRODUCTION AND PHARMACEUTICAL COMPOSITION THAT CONTAINS THEM.
US6262022B1 (en) 1992-06-25 2001-07-17 Novartis Ag Pharmaceutical compositions containing cyclosporin as the active agent
GB9113872D0 (en) * 1991-06-27 1991-08-14 Sandoz Ag Improvements in or relating to organic compounds
DK0642332T3 (en) 1992-05-13 1997-06-16 Sandoz Ltd Ophthalmic preparations containing cyclosporin
US5759566A (en) * 1992-07-28 1998-06-02 Poli Industria Chimica Spa Microemulsion pharmaceutical compositions for the delivery of pharmaceutically active agents
PT589843E (en) 1992-09-25 2002-04-29 Novartis Ag PHARMACEUTICAL COMPOSITIONS CONTAINING CYCLOSPORTS
CZ291237B6 (en) * 1993-04-20 2003-01-15 Novartis Ag Pharmaceutical preparation for oral administration and containing cyclosporin A
DE4412201A1 (en) * 1993-04-20 1994-11-10 Rentschler Arzneimittel New pharmaceutical preparations for oral administration containing cyclosporin
DE4340781C3 (en) * 1993-11-30 2000-01-27 Novartis Ag Liquid preparations containing cyclosporin and process for their preparation
KR0146671B1 (en) * 1994-02-25 1998-08-17 김충환 Cyclosporin-containing powder composition
RU2158601C2 (en) 1994-11-03 2000-11-10 Новартис Аг Novel medicinal forms of cyclosporine for oral administration having simple formulation and bioavailability, and method of preparation thereof
US5679566A (en) * 1995-01-20 1997-10-21 University Of Massachusetts Medical Center Yeast NMD2 gene
DE19544507B4 (en) 1995-11-29 2007-11-15 Novartis Ag Cyclosporin containing preparations
US5798333A (en) * 1996-09-17 1998-08-25 Sherman; Bernard C. Water-soluble concentrates containing cyclosporins
AU762247B2 (en) * 1997-01-30 2003-06-19 Novartis Ag Oil-free pharmaceutical compositions containing cyclosporin A
CA2278675A1 (en) * 1997-01-30 1998-08-06 Novartis Ag Hard gelatine capsules containing pharmaceutical compositions substantially free of any oil
JP4718653B2 (en) * 1997-03-12 2011-07-06 アボツト・ラボラトリーズ Hydrophilic two-component system for administration of cyclosporine
NZ328751A (en) * 1997-09-16 1999-01-28 Bernard Charles Sherman Solid medicament containing an anionic surfactant and cyclosporin
US6447806B1 (en) 1999-02-25 2002-09-10 Novartis Ag Pharmaceutical compositions comprised of stabilized peptide particles
US6979672B2 (en) 2002-12-20 2005-12-27 Polichem, S.A. Cyclosporin-based pharmaceutical compositions
JP4521554B2 (en) * 2004-03-31 2010-08-11 マイラン製薬株式会社 Cyclosporine preparation
WO2007050975A2 (en) * 2005-10-26 2007-05-03 Banner Pharmacaps, Inc. Hydrophilic vehicle-based dual controlled release matrix system as capsule fill
AU2007230716B2 (en) 2006-03-28 2012-05-03 Javelin Pharmaceuticals, Inc. Formulations of low dose diclofenac and beta-cyclodextrin
US7495024B2 (en) 2006-08-07 2009-02-24 Via Pharmaceuticals, Inc. Phenylalkyl N-hydroxyureas for combating atherosclerotic plaque
DE102008059201A1 (en) * 2008-11-27 2010-06-02 GÖPFERICH, Achim, Prof. Dr. In situ precipitating drug solutions
KR102146704B1 (en) 2018-04-13 2020-08-21 가천대학교 산학협력단 Cyclosporin a containing microstructures for transdermal and intradermal drug delivery
TW202330014A (en) * 2021-10-13 2023-08-01 日商中外製藥股份有限公司 Composition including peptide compound and surfactant

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE445174B (en) * 1978-03-07 1986-06-09 Sandoz Ag PHARMACEUTICAL COMPOSITION CONTAINING A CYCLOSPORIN AND A HEALING SUBSTANCE
JPS61280435A (en) * 1985-04-04 1986-12-11 Kanji Takada Lymph orienting preparation of cyclosporin
NL8600050A (en) * 1986-01-13 1987-08-03 Sanico Nv PHARMACEUTICAL PREPARATION WITH DELAYED DELIVERY OF THE ACTIVE SUBSTANCE AND METHOD FOR PREPARING IT.
GB8602372D0 (en) * 1986-01-31 1986-03-05 Sandoz Ltd Organic compounds
CA1290249C (en) * 1986-04-09 1991-10-08 Cetus Corporation COMBINATION THERAPY USING INTERLEUKIN-2 AND/OR INTERFERON-.beta. AND TUMOR NECROSIS FACTOR
EP0267615A3 (en) * 1986-11-13 1989-05-03 Sloan-Kettering Institute For Cancer Research Compositions and method for treatment of cancer using monoclonal antibody against gd3 ganglioside together with il-2
EP0296122B1 (en) * 1987-06-17 1993-09-29 Sandoz Ag Cyclosporins and their use as pharmaceuticals
JP2536876B2 (en) * 1987-07-31 1996-09-25 寛治 高田 Dissolvable powder formulation of cyclosporine
DE3830494B4 (en) * 1987-09-15 2006-05-18 Novartis Ag Water-soluble monoesters as solubilizers for pharmacologically active substances and pharmaceutical excipients
US5756450A (en) * 1987-09-15 1998-05-26 Novartis Corporation Water soluble monoesters as solubilisers for pharmacologically active compounds and pharmaceutical excipients and novel cyclosporin galenic forms
HU205010B (en) * 1987-09-15 1992-03-30 Sandoz Ag Process for producing pharmaceutical compositions comprising compounds soluble up to 1 per cent and having medical activity
JP2792862B2 (en) * 1988-07-30 1998-09-03 寛治 高田 Oral enteric formulation
KR0148748B1 (en) * 1988-09-16 1998-08-17 장 크라메르, 한스 루돌프 하우스 A multiphase cyclosporin composition
JPH1038029A (en) * 1996-07-26 1998-02-13 Ebara Corp Dick shape structure with vibration damping function
JPH10280435A (en) * 1997-04-03 1998-10-20 Sekisui Chem Co Ltd Construction method of basement

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5766629A (en) * 1995-08-25 1998-06-16 Sangstat Medical Corporation Oral cyclosporin formulations
US5834017A (en) * 1995-08-25 1998-11-10 Sangstat Medical Corporation Oral cyclopsporin formulations
US5962019A (en) * 1995-08-25 1999-10-05 Sangstat Medical Corporation Oral cyclosporin formulations
US6254885B1 (en) 1995-08-25 2001-07-03 Sangstat Medical Corporation Oral cyclosphorin formulations
US5827822A (en) * 1996-03-25 1998-10-27 Sangstat Medical Corporation Cyclosporin a formulations as nanoparticles

Also Published As

Publication number Publication date
NO900577D0 (en) 1990-02-07
ES2021942A6 (en) 1991-11-16
LU87675A1 (en) 1991-10-08
KR900012625A (en) 1990-09-01
AU4925290A (en) 1990-08-16
NL9000299A (en) 1990-09-03
HU900701D0 (en) 1990-04-28
HK37296A (en) 1996-03-15
PT93079B (en) 1996-04-30
NO301576B1 (en) 1997-11-17
NL195028C (en) 2003-12-02
MY107377A (en) 1995-11-30
FI900604A0 (en) 1990-02-07
IT9047609A0 (en) 1990-02-08
DE4003844A1 (en) 1990-08-16
JP4073641B2 (en) 2008-04-09
FR2642650A1 (en) 1990-08-10
NO900577L (en) 1990-08-10
GB9002504D0 (en) 1990-04-04
GB2230440A (en) 1990-10-24
AT404552B (en) 1998-12-28
PH30917A (en) 1997-12-23
CA2009533C (en) 2002-11-12
JPH02235817A (en) 1990-09-18
DK32790D0 (en) 1990-02-07
GB2230440B (en) 1993-05-19
NZ232401A (en) 1992-10-28
ATA27290A (en) 1998-05-15
JP3484190B2 (en) 2004-01-06
PT93079A (en) 1990-08-31
JP2006001947A (en) 2006-01-05
DK176209B1 (en) 2007-02-05
CH679277A5 (en) 1992-01-31
NL195028B (en) 2003-08-01
SE511398C2 (en) 1999-09-20
IT1240758B (en) 1993-12-17
DK32790A (en) 1990-08-10
FI97524C (en) 1997-01-10
KR0170769B1 (en) 1999-02-01
FI97524B (en) 1996-09-30
AU630413B2 (en) 1992-10-29
JP2001302538A (en) 2001-10-31
CY1903A (en) 1996-11-22
SE9000441L (en) 1991-08-08
IT9047609A1 (en) 1991-08-08
DE4003844B4 (en) 2007-09-20
BE1003009A5 (en) 1991-10-22
SE9000441D0 (en) 1990-02-07
HU213394B (en) 1997-06-30
FR2642650B1 (en) 1994-12-09

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