WO2001032142A1 - Formulation de cyclosporine - Google Patents

Formulation de cyclosporine Download PDF

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Publication number
WO2001032142A1
WO2001032142A1 PCT/GB2000/004143 GB0004143W WO0132142A1 WO 2001032142 A1 WO2001032142 A1 WO 2001032142A1 GB 0004143 W GB0004143 W GB 0004143W WO 0132142 A1 WO0132142 A1 WO 0132142A1
Authority
WO
WIPO (PCT)
Prior art keywords
component
preconcentrate
composition
composition according
solid
Prior art date
Application number
PCT/GB2000/004143
Other languages
English (en)
Inventor
Yusuf Khwaja Hamied
Vinay G. Nayak
Geena Malhotra
Original Assignee
Cipla Limited
Wain, Christopher, Paul
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 PCT/IN1999/000062 external-priority patent/WO2001032143A1/fr
Priority claimed from GB0012816A external-priority patent/GB2362573A/en
Application filed by Cipla Limited, Wain, Christopher, Paul filed Critical Cipla Limited
Priority to AU10432/01A priority Critical patent/AU1043201A/en
Priority to EP00971598A priority patent/EP1227793A1/fr
Publication of WO2001032142A1 publication Critical patent/WO2001032142A1/fr

Links

Classifications

    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds

Abstract

La présente invention concerne une composition pharmaceutique sous la forme d'un préconcentré mélangé soit avec une phase hydrophile liquide afin de former une micro-émulsion stable huile dans eau, soit avec un support solide afin de former un mélange solide, stable, de support et de préconcentré. Cette composition comprend a) un principe, actif sur le plan pharmaceutique, insoluble dans l'eau, b) un ou plusieurs esters de propylène glycol d'acide gras, c) un agent tensio-actif, et d) une phase hydrophile, ou e) un support solide. Dans cette composition, le composant (a) a été en totalité directement dissout dans le composant (b) et le composant (b) est dispersé sous forme de fines particules dans le composant (d) ou dans le composant (e). La composition ne contient sensiblement pas d'éthanol.
PCT/GB2000/004143 1999-11-02 2000-10-27 Formulation de cyclosporine WO2001032142A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU10432/01A AU1043201A (en) 1999-11-02 2000-10-27 Cyclosporin formulation
EP00971598A EP1227793A1 (fr) 1999-11-02 2000-10-27 Formulation de cyclosporine

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
PCT/IN1999/000062 WO2001032143A1 (fr) 1999-11-02 1999-11-02 Composition pharmaceutique pour administer des substances actives sur le plan pharmaceutique insolubles dans l'eau et procede de preparation afferent
INPCT/IN99/00062 1999-11-02
GB0012816.5 2000-05-25
GB0012816A GB2362573A (en) 2000-05-25 2000-05-25 Cyclosporin formulation

Publications (1)

Publication Number Publication Date
WO2001032142A1 true WO2001032142A1 (fr) 2001-05-10

Family

ID=26244360

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2000/004143 WO2001032142A1 (fr) 1999-11-02 2000-10-27 Formulation de cyclosporine

Country Status (3)

Country Link
EP (1) EP1227793A1 (fr)
AU (1) AU1043201A (fr)
WO (1) WO2001032142A1 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006501208A (ja) * 2002-08-02 2006-01-12 パテル、サティシュチャンドラ・プナンバイ 経口投与用シクロスポリン、プロピレングリコールエステルおよび非イオン性界面活性剤含有医薬組成物。
WO2006021709A2 (fr) * 2004-08-05 2006-03-02 Gattefosse Holding Particule solide anhydre contenant une composition lipidique et composition pharmaceutique contenant lesdites particules
WO2006085217A2 (fr) * 2005-02-08 2006-08-17 Pfizer Products Inc. Adsorbes solides de medicaments hydrophobes
WO2007016073A1 (fr) * 2005-07-27 2007-02-08 Allergan, Inc. Compositions pharmaceutiques sous forme d'emulsions, a base de cyclosporine
EP1767193A3 (fr) * 2000-04-10 2009-01-28 Novartis AG Compositions pharmaceutiques
JP2010120930A (ja) * 2008-10-22 2010-06-03 Santen Pharmaceut Co Ltd 腸管吸収性を改善する医薬組成物
US8501174B2 (en) 2005-10-14 2013-08-06 Allergan, Inc. Prevention and treatment of ocular side effects with a cyclosporin
US9248191B2 (en) 2003-09-15 2016-02-02 Allergan, Inc. Methods of providing therapeutic effects using cyclosporin components
US9278070B2 (en) 2009-05-18 2016-03-08 Sigmoid Pharma Limited Composition comprising oil drops
US9320746B2 (en) 2013-02-21 2016-04-26 Sigmoid Pharma Limited Method for treating intestinal fibrosis
US9387179B2 (en) 2007-04-04 2016-07-12 Sigmoid Pharma Limited Pharmaceutical cyclosporin compositions
US9821024B2 (en) 2010-11-25 2017-11-21 Sigmoid Pharma Limited Immunomodulatory compositions
US9839667B2 (en) 2005-10-14 2017-12-12 Allergan, Inc. Prevention and treatment of ocular side effects with a cyclosporin
US9878036B2 (en) 2009-08-12 2018-01-30 Sigmoid Pharma Limited Immunomodulatory compositions comprising a polymer matrix and an oil phase
US10993987B2 (en) 2014-11-07 2021-05-04 Sublimity Therapeutics Limited Compositions comprising Cyclosporin

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2222770A (en) * 1988-09-16 1990-03-21 Sandoz Ltd Cyclosporin emulsion compositions
US5543393A (en) * 1994-02-25 1996-08-06 Chong Kun Dang Corp. Cyclosporin containing powder composition
EP0760237A1 (fr) * 1995-08-30 1997-03-05 Cipla Limited Microémulsions huile-dans-l'eau
WO1998040051A1 (fr) * 1997-03-12 1998-09-17 Abbott Laboratories Systemes lipophiles binaires permettant l'administration de composes lipophiles
WO1999044584A1 (fr) * 1998-03-06 1999-09-10 Novartis Ag Preconcentres d'emulsion a base de cyclosporine ou d'un macrolide

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2222770A (en) * 1988-09-16 1990-03-21 Sandoz Ltd Cyclosporin emulsion compositions
US5543393A (en) * 1994-02-25 1996-08-06 Chong Kun Dang Corp. Cyclosporin containing powder composition
EP0760237A1 (fr) * 1995-08-30 1997-03-05 Cipla Limited Microémulsions huile-dans-l'eau
WO1998040051A1 (fr) * 1997-03-12 1998-09-17 Abbott Laboratories Systemes lipophiles binaires permettant l'administration de composes lipophiles
WO1999044584A1 (fr) * 1998-03-06 1999-09-10 Novartis Ag Preconcentres d'emulsion a base de cyclosporine ou d'un macrolide

Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1767193A3 (fr) * 2000-04-10 2009-01-28 Novartis AG Compositions pharmaceutiques
JP2006501208A (ja) * 2002-08-02 2006-01-12 パテル、サティシュチャンドラ・プナンバイ 経口投与用シクロスポリン、プロピレングリコールエステルおよび非イオン性界面活性剤含有医薬組成物。
US9248191B2 (en) 2003-09-15 2016-02-02 Allergan, Inc. Methods of providing therapeutic effects using cyclosporin components
WO2006021709A2 (fr) * 2004-08-05 2006-03-02 Gattefosse Holding Particule solide anhydre contenant une composition lipidique et composition pharmaceutique contenant lesdites particules
WO2006021709A3 (fr) * 2004-08-05 2006-10-12 Gattefosse Holding Particule solide anhydre contenant une composition lipidique et composition pharmaceutique contenant lesdites particules
WO2006085217A2 (fr) * 2005-02-08 2006-08-17 Pfizer Products Inc. Adsorbes solides de medicaments hydrophobes
WO2006085217A3 (fr) * 2005-02-08 2006-09-28 Pfizer Prod Inc Adsorbes solides de medicaments hydrophobes
US8906861B2 (en) 2005-07-27 2014-12-09 Allergan, Inc. Pharmaceutical compositions comprising cyclosporins
WO2007016073A1 (fr) * 2005-07-27 2007-02-08 Allergan, Inc. Compositions pharmaceutiques sous forme d'emulsions, a base de cyclosporine
US7501393B2 (en) 2005-07-27 2009-03-10 Allergan, Inc. Pharmaceutical compositions comprising cyclosporins
US9839667B2 (en) 2005-10-14 2017-12-12 Allergan, Inc. Prevention and treatment of ocular side effects with a cyclosporin
US8501174B2 (en) 2005-10-14 2013-08-06 Allergan, Inc. Prevention and treatment of ocular side effects with a cyclosporin
US10434140B2 (en) 2007-04-04 2019-10-08 Sublimity Therapeutics Limited Pharmaceutical cyclosporin compositions
US9387179B2 (en) 2007-04-04 2016-07-12 Sigmoid Pharma Limited Pharmaceutical cyclosporin compositions
US9585844B2 (en) 2007-04-04 2017-03-07 Sigmoid Pharma Limited Oral pharmaceutical composition
US9675558B2 (en) 2007-04-04 2017-06-13 Sigmoid Pharma Limited Pharmaceutical cyclosporin compositions
US10434139B2 (en) 2007-04-04 2019-10-08 Sublimity Therapeutics Limited Oral pharmaceutical composition
JP2010120930A (ja) * 2008-10-22 2010-06-03 Santen Pharmaceut Co Ltd 腸管吸収性を改善する医薬組成物
US9999651B2 (en) 2009-05-18 2018-06-19 Sigmoid Pharma Limited Composition comprising oil drops
US9278070B2 (en) 2009-05-18 2016-03-08 Sigmoid Pharma Limited Composition comprising oil drops
US9878036B2 (en) 2009-08-12 2018-01-30 Sigmoid Pharma Limited Immunomodulatory compositions comprising a polymer matrix and an oil phase
US9821024B2 (en) 2010-11-25 2017-11-21 Sigmoid Pharma Limited Immunomodulatory compositions
US9980902B2 (en) 2013-02-21 2018-05-29 Sigmoid Pharma Limited Method for treating intestinal fibrosis
US9320746B2 (en) 2013-02-21 2016-04-26 Sigmoid Pharma Limited Method for treating intestinal fibrosis
US10993987B2 (en) 2014-11-07 2021-05-04 Sublimity Therapeutics Limited Compositions comprising Cyclosporin

Also Published As

Publication number Publication date
EP1227793A1 (fr) 2002-08-07
AU1043201A (en) 2001-05-14

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