ES2584183T3 - Formulaciones de cladribina para suministro mejorado oral y transmucosa - Google Patents

Formulaciones de cladribina para suministro mejorado oral y transmucosa Download PDF

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Publication number
ES2584183T3
ES2584183T3 ES04758440.4T ES04758440T ES2584183T3 ES 2584183 T3 ES2584183 T3 ES 2584183T3 ES 04758440 T ES04758440 T ES 04758440T ES 2584183 T3 ES2584183 T3 ES 2584183T3
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ES
Spain
Prior art keywords
cyclodextrin
cladribine
transmucosal delivery
improved oral
complex
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.)
Expired - Lifetime
Application number
ES04758440.4T
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English (en)
Spanish (es)
Inventor
Nicholas S. Bodor
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Ares Trading SA
Original Assignee
Ares Trading SA
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Filing date
Publication date
Application filed by Ares Trading SA filed Critical Ares Trading SA
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Publication of ES2584183T3 publication Critical patent/ES2584183T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • C08L5/16Cyclodextrin; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7076Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/04Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C08B37/0012Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
    • C08B37/0015Inclusion compounds, i.e. host-guest compounds, e.g. polyrotaxanes
    • 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
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • 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
    • A61K9/0043Nose
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Nanotechnology (AREA)
  • Biomedical Technology (AREA)
  • Polymers & Plastics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biophysics (AREA)
  • Materials Engineering (AREA)
  • Rheumatology (AREA)
  • Biochemistry (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Medical Informatics (AREA)
  • Oncology (AREA)
  • General Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biotechnology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Communicable Diseases (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Obesity (AREA)
  • Transplantation (AREA)
ES04758440.4T 2003-03-28 2004-03-26 Formulaciones de cladribina para suministro mejorado oral y transmucosa Expired - Lifetime ES2584183T3 (es)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US45892203P 2003-03-28 2003-03-28
US458922P 2003-03-28
US48475603P 2003-07-02 2003-07-02
US484756P 2003-07-02
US54124604P 2004-02-04 2004-02-04
US541246P 2004-02-04
PCT/US2004/009384 WO2004087100A2 (en) 2003-03-28 2004-03-26 Cladribine formulations for improved oral and transmucosal delivery

Publications (1)

Publication Number Publication Date
ES2584183T3 true ES2584183T3 (es) 2016-09-26

Family

ID=33135981

Family Applications (1)

Application Number Title Priority Date Filing Date
ES04758440.4T Expired - Lifetime ES2584183T3 (es) 2003-03-28 2004-03-26 Formulaciones de cladribina para suministro mejorado oral y transmucosa

Country Status (16)

Country Link
US (2) US20070065492A1 (https=)
EP (1) EP1608343B1 (https=)
JP (1) JP5412709B2 (https=)
KR (1) KR20060011943A (https=)
CN (1) CN101912615B (https=)
AU (2) AU2004226435B2 (https=)
BR (1) BRPI0408895A (https=)
CA (1) CA2520522C (https=)
EA (1) EA009714B1 (https=)
ES (1) ES2584183T3 (https=)
HR (1) HRP20050924A2 (https=)
IS (1) IS8047A (https=)
ME (1) MEP34508A (https=)
MX (1) MXPA05010330A (https=)
NO (1) NO20054944L (https=)
WO (1) WO2004087100A2 (https=)

Families Citing this family (23)

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EP3332789B1 (en) 2004-12-22 2022-04-06 Merck Serono SA Cladribine regimen for treating multiple sclerosis
JP2008524310A (ja) * 2004-12-22 2008-07-10 ラボラトワール セローノ ソシエテ アノニム 多発性硬化症の組み合せ治療
US7893040B2 (en) 2005-07-22 2011-02-22 Oculis Ehf Cyclodextrin nanotechnology for ophthalmic drug delivery
AU2007253254B2 (en) 2006-05-24 2013-01-17 Merck Serono Sa Cladribine regimen for treating multiple sclerosis
CN100486645C (zh) * 2006-09-12 2009-05-13 南京师范大学 含有环糊精紫杉醇包合物的药物组合物及其制备方法
CN100411688C (zh) * 2006-09-12 2008-08-20 南京师范大学 含有环糊精/多烯紫杉醇包合物的药物组合物及其制备方法
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WO2012097867A1 (en) 2011-01-18 2012-07-26 Synthon Bv Cladribine particles and pharmaceutical compositions comprising them
WO2014075935A1 (de) 2012-11-15 2014-05-22 Sapiotec Gmbh Delphinidinkomplex als antiphlogistischer oder immunsuppressiver wirkstoff
US9949947B2 (en) 2012-12-11 2018-04-24 Sapiotec Gmbh Delphinidin for combating melanoma cells
GB201401465D0 (en) 2014-01-29 2014-03-12 Roach Arthur H Use of cladribine for treating autoimmune inflammatory disease
WO2015140790A1 (en) * 2014-03-17 2015-09-24 Mapi Pharma Ltd. Sublingual delivery of glatiramer acetate
JP7138103B2 (ja) 2016-11-29 2022-09-15 オキュリス エスエー 眼科用活性医薬成分送達のためのシクロデキストリン固体複合体の製造
GB2564717A (en) 2017-07-21 2019-01-23 Chord Therapeutics S A R L Use of cladribine for treating autoimmune neuromuscular disease
EP3713582A1 (en) 2017-11-24 2020-09-30 Merck Patent GmbH Cladribine regimen for use intreating progressive forms of multiple sclerosis
EP4670738A3 (en) 2019-07-01 2026-03-04 Oculis Operations Sàrl Method for stabilizing the ph of an aqueous composition comprising a drug
CA3194812A1 (en) 2020-09-10 2022-03-17 Merck Patent Gmbh Novel treatment regimen for the treatment of autoimmune disorders
GB2601786A (en) 2020-12-10 2022-06-15 Chord Therapeutics S A R L Use of cladribine for treating immune brain disease
US20240077481A1 (en) 2021-03-03 2024-03-07 Ares Trading S.A. Improved treatment methods using dmds for the treatment of autoimmune diseases, and biomarker for predicting and/or optimising said treatment methods
RU2758436C1 (ru) * 2021-04-05 2021-10-28 Общество с ограниченной ответственностью «ФармЭко» Способ получения аморфных ко-эвапоратов кладрибина с циклодекстринами
US20260000606A1 (en) 2022-06-15 2026-01-01 Vektor Pharma Tf Gmbh Sublingual Formulation of Anticancer Compound for Use in the Treatment of Autoimmune Neurodegenerative Diseases
TW202541818A (zh) 2023-12-14 2025-11-01 瑞士商亞利斯貿易公司 用於治療重症肌無力之克拉屈濱(cladribine)療程

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Also Published As

Publication number Publication date
CN101912615A (zh) 2010-12-15
EP1608343A2 (en) 2005-12-28
JP2006526009A (ja) 2006-11-16
JP5412709B2 (ja) 2014-02-12
BRPI0408895A (pt) 2006-04-11
AU2009227811B2 (en) 2012-02-02
KR20060011943A (ko) 2006-02-06
AU2009227811A1 (en) 2009-11-05
IS8047A (is) 2005-09-26
HRP20050924A2 (en) 2006-08-31
MEP34508A (en) 2011-02-10
WO2004087100A2 (en) 2004-10-14
AU2004226435B2 (en) 2009-11-12
NO20054944L (no) 2005-11-24
NO20054944D0 (no) 2005-10-25
US8623408B2 (en) 2014-01-07
EP1608343B1 (en) 2016-04-27
CA2520522A1 (en) 2004-10-14
WO2004087100A3 (en) 2005-03-03
AU2004226435A1 (en) 2004-10-14
CA2520522C (en) 2012-05-29
US20110015145A1 (en) 2011-01-20
CN101912615B (zh) 2013-03-27
US20070065492A1 (en) 2007-03-22
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MXPA05010330A (es) 2006-05-31
EA009714B1 (ru) 2008-02-28

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