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WO2000040220A1 - Procede de preparation d'un principe actif pharmaceutique contenant un medicament non hydrosoluble et composition pharmaceutique pour l'administration orale contenant ledit principe - Google Patents

Procede de preparation d'un principe actif pharmaceutique contenant un medicament non hydrosoluble et composition pharmaceutique pour l'administration orale contenant ledit principe Download PDF

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Publication number
WO2000040220A1
WO2000040220A1 PCT/KR1999/000025 KR9900025W WO0040220A1 WO 2000040220 A1 WO2000040220 A1 WO 2000040220A1 KR 9900025 W KR9900025 W KR 9900025W WO 0040220 A1 WO0040220 A1 WO 0040220A1
Authority
WO
WIPO (PCT)
Prior art keywords
water
oil
drug
insoluble drug
active ingredient
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.)
Ceased
Application number
PCT/KR1999/000025
Other languages
English (en)
Inventor
Soon-Hong Yuk
Sun-Hang Cho
Hai-Bang Lee
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.)
Korea Research Institute of Chemical Technology KRICT
Original Assignee
Korea Research Institute of Chemical Technology KRICT
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 Korea Research Institute of Chemical Technology KRICT filed Critical Korea Research Institute of Chemical Technology KRICT
Priority to PCT/KR1999/000025 priority Critical patent/WO2000040220A1/fr
Priority to JP2000591977A priority patent/JP2002534371A/ja
Priority to EP99901236A priority patent/EP1058539A1/fr
Publication of WO2000040220A1 publication Critical patent/WO2000040220A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61K9/4858—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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers

Definitions

  • the mixed solution and air are injected into a spray-dryer body, while raising the ambient temperature by the heated air and mixed solution is changed from solution form to microparticle form by heated air.
  • the drug microparticles combined with polymer may be mixed with oil in the weight of 1 : 1 to 10. It is preferred that the drug microparticles mixed with oil because bioavailability increases.
  • oil amount is lower than 1 , it is difficult to mix the drug micropartices with oil. On the contrary, oil amount exceeds 10, it is difficult to charge the mixture to a capsule.
  • oil corn oil, peanut oil, coconut oil, caster oil, sesame oil, perilla oil, sunflower oil, walnut oil and cacao butter may be used.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Procédé de préparation d'un principe actif pharmaceutique contenant un médicament non hydrosoluble. Selon ledit procédé, un médicament non hydrosoluble se trouvant dans un solvant organique est mélangé avec un polymère hydrosoluble se trouvant dans un solvant aqueux et séché par atomisation. Ensuite, les microparticules de médicament sont mélangées à de l'huile. Ledit procédé permet de préparer facilement un principe actif pharmaceutique contenant un médicament non hydrosoluble, qui possède une excellente biodisponibilité. Par conséquent, la préparation dudit principe ne nécessite pas une technologie spécifique.
PCT/KR1999/000025 1999-01-06 1999-01-06 Procede de preparation d'un principe actif pharmaceutique contenant un medicament non hydrosoluble et composition pharmaceutique pour l'administration orale contenant ledit principe Ceased WO2000040220A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PCT/KR1999/000025 WO2000040220A1 (fr) 1999-01-06 1999-01-06 Procede de preparation d'un principe actif pharmaceutique contenant un medicament non hydrosoluble et composition pharmaceutique pour l'administration orale contenant ledit principe
JP2000591977A JP2002534371A (ja) 1999-01-06 1999-01-06 水不溶性薬物を含む医薬的活性成分の製造方法及びそれを含む経口投与用医薬組成物
EP99901236A EP1058539A1 (fr) 1999-01-06 1999-01-06 Procede de preparation d'un principe actif pharmaceutique contenant un medicament non hydrosoluble et composition pharmaceutique pour l'administration orale contenant ledit principe

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/KR1999/000025 WO2000040220A1 (fr) 1999-01-06 1999-01-06 Procede de preparation d'un principe actif pharmaceutique contenant un medicament non hydrosoluble et composition pharmaceutique pour l'administration orale contenant ledit principe

Publications (1)

Publication Number Publication Date
WO2000040220A1 true WO2000040220A1 (fr) 2000-07-13

Family

ID=19570693

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR1999/000025 Ceased WO2000040220A1 (fr) 1999-01-06 1999-01-06 Procede de preparation d'un principe actif pharmaceutique contenant un medicament non hydrosoluble et composition pharmaceutique pour l'administration orale contenant ledit principe

Country Status (3)

Country Link
EP (1) EP1058539A1 (fr)
JP (1) JP2002534371A (fr)
WO (1) WO2000040220A1 (fr)

Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001047492A1 (fr) * 1999-12-23 2001-07-05 F H Faulding & Co Limited Compositions pharmaceutiques ameliorees pour medicaments peu solubles
WO2004050061A1 (fr) * 2002-11-29 2004-06-17 Hanmi Pharm. Co., Ltd. Composition sous forme de microemulsion pour l'administration orale de biphenyldimethyldicarboxylate
US6835396B2 (en) 2001-09-26 2004-12-28 Baxter International Inc. Preparation of submicron sized nanoparticles via dispersion lyophilization
US6869617B2 (en) 2000-12-22 2005-03-22 Baxter International Inc. Microprecipitation method for preparing submicron suspensions
US6884436B2 (en) 2000-12-22 2005-04-26 Baxter International Inc. Method for preparing submicron particle suspensions
US6951656B2 (en) 2000-12-22 2005-10-04 Baxter International Inc. Microprecipitation method for preparing submicron suspensions
US6977085B2 (en) 2000-12-22 2005-12-20 Baxter International Inc. Method for preparing submicron suspensions with polymorph control
US7112340B2 (en) 2001-10-19 2006-09-26 Baxter International Inc. Compositions of and method for preparing stable particles in a frozen aqueous matrix
US7193084B2 (en) 2000-12-22 2007-03-20 Baxter International Inc. Polymorphic form of itraconazole
WO2008006712A3 (fr) * 2006-07-13 2009-02-26 Unilever Plc Améliorations concernant des nanodispersions
EP2123255A4 (fr) * 2007-02-16 2010-06-02 Aska Pharm Co Ltd Composition pharmaceutique contenant une suspension à base d'huile en fines particules
WO2010020518A3 (fr) * 2008-08-18 2010-10-14 Unilever Plc Améliorations concernant des compositions de nanodispersion
US8067032B2 (en) 2000-12-22 2011-11-29 Baxter International Inc. Method for preparing submicron particles of antineoplastic agents
US20120076838A1 (en) * 2009-05-27 2012-03-29 Samyang Biopharmaceuticals Corporation Poorly soluble drug containing microsphere with improved bioavailabilty and method of preparing the same
WO2012045994A1 (fr) * 2010-10-05 2012-04-12 Iota Nanosolutions Limited Procédés de préparation de compositions améliorées
US8268349B2 (en) 2003-08-28 2012-09-18 Abbott Laboratories Solid pharmaceutical dosage form
US8377952B2 (en) 2003-08-28 2013-02-19 Abbott Laboratories Solid pharmaceutical dosage formulation
US8470347B2 (en) 2000-05-30 2013-06-25 AbbVie Deutschland GmbH and Co KG Self-emulsifying active substance formulation and use of this formulation
US8613946B2 (en) 2006-12-21 2013-12-24 Isp Investment Inc. Carotenoids of enhanced bioavailability
US8722091B2 (en) 2001-09-26 2014-05-13 Baxter International Inc. Preparation of submicron sized nanoparticles via dispersion lyophilization
US8921374B2 (en) 2012-06-21 2014-12-30 Mayne Pharma International Pty Ltd Itraconazole compositions and dosage forms, and methods of using the same
WO2015071841A1 (fr) 2013-11-12 2015-05-21 Druggability Technologies Holdings Limited Complexes de dabigatran et ses dérivés, procédé de préparation de ceux-ci et compositions pharmaceutiques contenant ceux-ci
US9700866B2 (en) 2000-12-22 2017-07-11 Baxter International Inc. Surfactant systems for delivery of organic compounds
US10189957B2 (en) 2007-01-26 2019-01-29 Isp Investments Llc Formulation process method to produce spray dried products
US10532028B2 (en) 2005-07-28 2020-01-14 Isp Investments Llc Method to improve characteristics of spray dried powders and granulated materials, and the products thereby produced

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5672880B2 (ja) * 2010-09-14 2015-02-18 大正製薬株式会社 イプリフラボン可溶化組成物

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0012496A1 (fr) * 1978-12-08 1980-06-25 Beecham Group Plc Procédé de préparation du sel de sodium de l'amoxycilline et solutions aqueuses correspondantes
EP0670166A2 (fr) * 1994-03-01 1995-09-06 Eli Lilly And Company Compositions pharmaceutiques administrables par voie buccale
WO1995032726A1 (fr) * 1994-06-01 1995-12-07 Yuhan Corporation Composition a base de cyclosporine et son procede de preparation
US5817343A (en) * 1996-05-14 1998-10-06 Alkermes, Inc. Method for fabricating polymer-based controlled-release devices

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0012496A1 (fr) * 1978-12-08 1980-06-25 Beecham Group Plc Procédé de préparation du sel de sodium de l'amoxycilline et solutions aqueuses correspondantes
EP0670166A2 (fr) * 1994-03-01 1995-09-06 Eli Lilly And Company Compositions pharmaceutiques administrables par voie buccale
WO1995032726A1 (fr) * 1994-06-01 1995-12-07 Yuhan Corporation Composition a base de cyclosporine et son procede de preparation
US5817343A (en) * 1996-05-14 1998-10-06 Alkermes, Inc. Method for fabricating polymer-based controlled-release devices

Cited By (41)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8771739B2 (en) 1999-12-23 2014-07-08 Mayne Pharma International Pty Ltd Pharmaceutical compositions for poorly soluble drugs
US6881745B2 (en) 1999-12-23 2005-04-19 F H Faulding & Co Limited Pharmaceutical compositions for poorly soluble drugs
WO2001047492A1 (fr) * 1999-12-23 2001-07-05 F H Faulding & Co Limited Compositions pharmaceutiques ameliorees pour medicaments peu solubles
US8470347B2 (en) 2000-05-30 2013-06-25 AbbVie Deutschland GmbH and Co KG Self-emulsifying active substance formulation and use of this formulation
US7193084B2 (en) 2000-12-22 2007-03-20 Baxter International Inc. Polymorphic form of itraconazole
US6884436B2 (en) 2000-12-22 2005-04-26 Baxter International Inc. Method for preparing submicron particle suspensions
US7037528B2 (en) 2000-12-22 2006-05-02 Baxter International Inc. Microprecipitation method for preparing submicron suspensions
US6977085B2 (en) 2000-12-22 2005-12-20 Baxter International Inc. Method for preparing submicron suspensions with polymorph control
US6951656B2 (en) 2000-12-22 2005-10-04 Baxter International Inc. Microprecipitation method for preparing submicron suspensions
US9700866B2 (en) 2000-12-22 2017-07-11 Baxter International Inc. Surfactant systems for delivery of organic compounds
US6869617B2 (en) 2000-12-22 2005-03-22 Baxter International Inc. Microprecipitation method for preparing submicron suspensions
US8067032B2 (en) 2000-12-22 2011-11-29 Baxter International Inc. Method for preparing submicron particles of antineoplastic agents
US8722091B2 (en) 2001-09-26 2014-05-13 Baxter International Inc. Preparation of submicron sized nanoparticles via dispersion lyophilization
US6835396B2 (en) 2001-09-26 2004-12-28 Baxter International Inc. Preparation of submicron sized nanoparticles via dispersion lyophilization
US7112340B2 (en) 2001-10-19 2006-09-26 Baxter International Inc. Compositions of and method for preparing stable particles in a frozen aqueous matrix
WO2004050061A1 (fr) * 2002-11-29 2004-06-17 Hanmi Pharm. Co., Ltd. Composition sous forme de microemulsion pour l'administration orale de biphenyldimethyldicarboxylate
US8309613B2 (en) 2003-08-28 2012-11-13 Abbvie Inc. Solid pharmaceutical dosage form
US8691878B2 (en) 2003-08-28 2014-04-08 Abbvie Inc. Solid pharmaceutical dosage form
US8268349B2 (en) 2003-08-28 2012-09-18 Abbott Laboratories Solid pharmaceutical dosage form
US8333990B2 (en) 2003-08-28 2012-12-18 Abbott Laboratories Solid pharmaceutical dosage form
US8377952B2 (en) 2003-08-28 2013-02-19 Abbott Laboratories Solid pharmaceutical dosage formulation
US8399015B2 (en) 2003-08-28 2013-03-19 Abbvie Inc. Solid pharmaceutical dosage form
US10532028B2 (en) 2005-07-28 2020-01-14 Isp Investments Llc Method to improve characteristics of spray dried powders and granulated materials, and the products thereby produced
AU2007271827B2 (en) * 2006-07-13 2010-10-14 Unilever Plc Improvements relating to nanodispersions
WO2008006712A3 (fr) * 2006-07-13 2009-02-26 Unilever Plc Améliorations concernant des nanodispersions
US8613946B2 (en) 2006-12-21 2013-12-24 Isp Investment Inc. Carotenoids of enhanced bioavailability
US10189957B2 (en) 2007-01-26 2019-01-29 Isp Investments Llc Formulation process method to produce spray dried products
EP2123255A4 (fr) * 2007-02-16 2010-06-02 Aska Pharm Co Ltd Composition pharmaceutique contenant une suspension à base d'huile en fines particules
US8309138B2 (en) 2007-02-16 2012-11-13 Aska Pharmaceutical Co., Ltd. Pharmaceutical composition comprising microparticle oily suspension
WO2010020518A3 (fr) * 2008-08-18 2010-10-14 Unilever Plc Améliorations concernant des compositions de nanodispersion
AU2010253578B2 (en) * 2009-05-27 2014-01-30 Samyang Biopharmaceuticals Corporation A poorly soluble drug containing microsphere with improved bioavailability and method of preparing the same
US20120076838A1 (en) * 2009-05-27 2012-03-29 Samyang Biopharmaceuticals Corporation Poorly soluble drug containing microsphere with improved bioavailabilty and method of preparing the same
US9511026B2 (en) 2009-05-27 2016-12-06 Samyang Biopharmaceuticals Corporation Poorly soluble drug containing microspheres with improved bioavailability and method of preparing the same
WO2012045994A1 (fr) * 2010-10-05 2012-04-12 Iota Nanosolutions Limited Procédés de préparation de compositions améliorées
US10463740B2 (en) 2012-06-21 2019-11-05 Mayne Pharma International Pty. Ltd. Itraconazole compositions and dosage forms, and methods of using the same
US9713642B2 (en) 2012-06-21 2017-07-25 Mayne Pharma International Pty. Ltd. Itraconazole compositions and dosage forms, and methods of using the same
US9272046B2 (en) 2012-06-21 2016-03-01 Mayne Pharma International Pty. Ltd. Itraconazole compositions and dosage forms, and methods of using the same
US8921374B2 (en) 2012-06-21 2014-12-30 Mayne Pharma International Pty Ltd Itraconazole compositions and dosage forms, and methods of using the same
US10806792B2 (en) 2012-06-21 2020-10-20 Mayne Pharma International Pty Ltd. Itraconazole compositions and dosage forms, and methods of using the same
US11638758B2 (en) 2012-06-21 2023-05-02 Mayne Pharma International Pty. Ltd Itraconazole compositions and dosage forms, and methods of using the same
WO2015071841A1 (fr) 2013-11-12 2015-05-21 Druggability Technologies Holdings Limited Complexes de dabigatran et ses dérivés, procédé de préparation de ceux-ci et compositions pharmaceutiques contenant ceux-ci

Also Published As

Publication number Publication date
EP1058539A1 (fr) 2000-12-13
JP2002534371A (ja) 2002-10-15

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