HK1111151A1 - Amorphous taclolimus solid dispersion having an enhanced solubility and pharmaceutical composition comprising same - Google Patents

Amorphous taclolimus solid dispersion having an enhanced solubility and pharmaceutical composition comprising same

Info

Publication number
HK1111151A1
HK1111151A1 HK08105836.9A HK08105836A HK1111151A1 HK 1111151 A1 HK1111151 A1 HK 1111151A1 HK 08105836 A HK08105836 A HK 08105836A HK 1111151 A1 HK1111151 A1 HK 1111151A1
Authority
HK
Hong Kong
Prior art keywords
pharmaceutical composition
same
solid dispersion
enhanced solubility
taclolimus
Prior art date
Application number
HK08105836.9A
Other languages
English (en)
Inventor
Jong Soo Woo
Hong Gi Yi
Jeong Hee Park
Original Assignee
Hanmi Pharm Co
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 Hanmi Pharm Co filed Critical Hanmi Pharm Co
Publication of HK1111151A1 publication Critical patent/HK1111151A1/xx

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D498/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D498/12—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms in which the condensed system contains three hetero rings
    • C07D498/18—Bridged systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • 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
    • A61K9/1617—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
    • A61K9/14—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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
    • A61P17/14—Drugs for dermatological disorders for baldness or alopecia
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D491/00—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00
    • C07D491/12—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00 in which the condensed system contains three hetero rings
    • C07D491/18—Bridged systems
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Ophthalmology & Optometry (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
HK08105836.9A 2005-02-04 2008-05-26 Amorphous taclolimus solid dispersion having an enhanced solubility and pharmaceutical composition comprising same HK1111151A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020050010302A KR100678824B1 (ko) 2005-02-04 2005-02-04 용해성이 증가된 무정형 타크로리무스 고체분산체 및 이를포함하는 약제학적 조성물
PCT/KR2006/000397 WO2006083130A1 (en) 2005-02-04 2006-02-03 Amorphous taclolimus solid dispersion having an enhanced solubility and pharmaceutical composition comprising same

Publications (1)

Publication Number Publication Date
HK1111151A1 true HK1111151A1 (en) 2008-08-01

Family

ID=36777474

Family Applications (1)

Application Number Title Priority Date Filing Date
HK08105836.9A HK1111151A1 (en) 2005-02-04 2008-05-26 Amorphous taclolimus solid dispersion having an enhanced solubility and pharmaceutical composition comprising same

Country Status (7)

Country Link
US (1) US20080153866A1 (xx)
EP (1) EP1848722A4 (xx)
JP (1) JP4825223B2 (xx)
KR (1) KR100678824B1 (xx)
CN (1) CN101115758B (xx)
HK (1) HK1111151A1 (xx)
WO (1) WO2006083130A1 (xx)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2913018A1 (fr) * 2007-02-23 2008-08-29 Sanofi Aventis Sa Solution solide amorphe contenant un derive de pyrazole-3-carboxamide sous forme amorphe et des excipients stabilisateurs
LT2167033T (lt) 2007-05-30 2017-08-10 Veloxis Pharmaceuticals A/S Kartą per dieną vartojama geriamoji vaisto forma, apimanti takrolimą
US12083103B2 (en) 2007-05-30 2024-09-10 Veloxis Pharmaceuticals, Inc. Tacrolimus for improved treatment of transplant patients
CN101909673B (zh) * 2007-12-31 2012-12-26 诺沃-诺迪斯克有限公司 电子监控的注射设备
CL2008000374A1 (es) * 2008-02-05 2008-04-04 Igloo Zone Chile S A Composicion farmaceutica que comprende un polvo para suspension oral de tacrolimus o una de sus sales, hidratos o solvatos y excipientes farmaceuticamente aceptables; procedimiento de preparacion de dicha composicion farmaceutica; y uso para la preve
CA2715802A1 (en) * 2008-02-28 2009-09-03 Bial - Portela & C.A., S.A. Pharmaceutical composition for poorly soluble drugs
WO2009118356A2 (en) * 2008-03-25 2009-10-01 Formac Pharmaceuticals N.V. Preparation method for solid disupersions
US20230101012A1 (en) * 2008-05-30 2023-03-30 Veloxis Pharmaceuticals, Inc. Stabilized tacrolimus composition
RS55118B1 (sr) 2010-02-17 2016-12-30 Veloxis Pharmaceuticals As Stabilizovana takrolimus kompozicija
CA2835232C (en) * 2011-07-01 2017-02-14 Fondazione Istituto Insubrico Di Ricerca Per La Vita A complex of amorphous tomoxiprole and cyclodextrin with fast dissolution rate and process for the preparation thereof
KR101986683B1 (ko) * 2012-12-13 2019-06-10 한미약품 주식회사 테트라졸 유도체를 활성 성분으로 포함하는 용해도가 개선된 고체 분산체
CN103479600B (zh) * 2013-09-17 2018-01-19 成都盛迪医药有限公司 一种他克莫司固体分散体
CN105616365B (zh) * 2014-11-08 2019-04-05 山东新时代药业有限公司 一种依维莫司片剂
CN106860408B (zh) * 2015-12-14 2021-06-22 山东新时代药业有限公司 一种格列美脲片
CN106880597B (zh) * 2015-12-14 2022-06-07 山东新时代药业有限公司 一种依维莫司片
CN106860407B (zh) * 2015-12-14 2021-07-30 山东新时代药业有限公司 一种利伐沙班片
CN106880617B (zh) * 2015-12-14 2021-08-31 山东新时代药业有限公司 一种他克莫司胶囊
CN106880598B (zh) * 2015-12-14 2021-08-31 山东新时代药业有限公司 一种依折麦布片剂
CN105803806A (zh) * 2016-04-21 2016-07-27 安徽皖翎羽绒制品有限公司 一种具有长效屏蔽电磁辐射功效羽绒的处理方法
CN106226430A (zh) * 2016-07-31 2016-12-14 合肥远志医药科技开发有限公司 一种他克莫司制剂的有关物质检测方法
CA3099901C (en) 2018-07-13 2024-03-19 Council Of Scientific & Industrial Research Solid dispersion comprising an anticancer compound for improved solubility and efficacy
CN109528738A (zh) * 2018-12-24 2019-03-29 陕西师范大学 甘草酸在制备促进髓鞘再生抑制神经炎症药物的应用
CN111830168B (zh) * 2020-07-23 2022-07-22 吉林医药学院 一种泊洛沙姆的lc-hr-ms/ms定量分析方法

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8608080D0 (en) * 1986-04-02 1986-05-08 Fujisawa Pharmaceutical Co Solid dispersion composition
BE1009856A5 (fr) * 1995-07-14 1997-10-07 Sandoz Sa Composition pharmaceutique sous la forme d'une dispersion solide comprenant un macrolide et un vehicule.
TW426516B (en) * 1996-12-06 2001-03-21 Fujisawa Pharmaceutical Co An oral pharmaceutical composition in solid dispersion containing water-insoluble tricyclic compounds
RU2214244C9 (ru) * 1998-03-26 2020-07-29 Астеллас Фарма Инк. Препараты с замедленным высвобождением
KR20030041577A (ko) * 2001-11-20 2003-05-27 디디에스텍주식회사 난용성 약물과 치환된 시클로덱스트린을 함유하는고체분산체 및 이를 함유하는 약제학적 조성물
CN100589809C (zh) * 2002-06-13 2010-02-17 诺瓦提斯公司 季铵环糊精化合物
WO2005004848A1 (en) * 2003-07-09 2005-01-20 Chong Kun Dang Pharmaceutical Corp. The solid dispersion of tacrolimus
ATE531368T1 (de) * 2003-08-29 2011-11-15 Veloxis Pharmaceuticals As Tacrolimus enthaltende zusammensetzungen mit modifizierter freisetzung
WO2005020994A1 (en) * 2003-08-29 2005-03-10 Lifecycle Pharma A/S Solid dispersions comprising tacrolimus

Also Published As

Publication number Publication date
US20080153866A1 (en) 2008-06-26
EP1848722A1 (en) 2007-10-31
JP4825223B2 (ja) 2011-11-30
JP2008529999A (ja) 2008-08-07
CN101115758B (zh) 2010-09-29
KR20060089328A (ko) 2006-08-09
WO2006083130A1 (en) 2006-08-10
KR100678824B1 (ko) 2007-02-05
EP1848722A4 (en) 2012-12-12
CN101115758A (zh) 2008-01-30

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Legal Events

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PC Patent ceased (i.e. patent has lapsed due to the failure to pay the renewal fee)

Effective date: 20180203