RS51115B - Oralne formulacije kladribina - Google Patents

Oralne formulacije kladribina

Info

Publication number
RS51115B
RS51115B YUP-2005/0734A YUP20050734A RS51115B RS 51115 B RS51115 B RS 51115B YU P20050734 A YUP20050734 A YU P20050734A RS 51115 B RS51115 B RS 51115B
Authority
RS
Serbia
Prior art keywords
cladribine
amorphous
cyclodextrin
oral formulations
complex
Prior art date
Application number
YUP-2005/0734A
Other languages
English (en)
Inventor
Nicholas S. Bodor
Yogesh Dandiker
Original Assignee
Ares Trading S.A.
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 Ares Trading S.A. filed Critical Ares Trading S.A.
Publication of RS20050734A publication Critical patent/RS20050734A/sr
Publication of RS51115B publication Critical patent/RS51115B/sr

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
    • A61K9/20—Pills, tablets, discs, rods
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • 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
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds 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
    • A61K31/7064—Compounds 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
    • A61K31/7076—Compounds 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
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/724—Cyclodextrins
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/727—Heparin; Heparan
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 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
    • A61K47/6949—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 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
    • A61K47/6951—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 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
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs 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
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nanotechnology (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Medical Informatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Cardiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Oncology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)

Abstract

Farmaceutska kompozicija, naznačena time, što sadrži složeni kompleks kladribin-ciklodekstrin koji je bliska amorfna smeša (a) amorfnog inkluzionog kompleksa kladribina sa amorfnim ciklodekstrinom i (b) amorfnog slobodnog kladribina koji je u vezi sa amorfnim ciklodekstrinom kao neinkluizoni kompleks, formulisanom u čvrsti oralni dozni oblik. Prijava sadrži još 5 nezavisnih i 69 zavisnih patentnih zahteva.
YUP-2005/0734A 2003-03-28 2004-03-26 Oralne formulacije kladribina RS51115B (sr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US45892203P 2003-03-28 2003-03-28
US48475603P 2003-07-02 2003-07-02
US54124704P 2004-02-04 2004-02-04
PCT/US2004/009387 WO2004087101A2 (en) 2003-03-28 2004-03-26 Oral formulations of cladribine

Publications (2)

Publication Number Publication Date
RS20050734A RS20050734A (en) 2008-06-05
RS51115B true RS51115B (sr) 2010-10-31

Family

ID=33135982

Family Applications (2)

Application Number Title Priority Date Filing Date
YUP-2005/0734A RS51115B (sr) 2003-03-28 2004-03-26 Oralne formulacije kladribina
YUP-2005/0735A RS20050735A (en) 2003-03-28 2004-03-26 Cladribine formulations for improved oral and transmucosal delivery

Family Applications After (1)

Application Number Title Priority Date Filing Date
YUP-2005/0735A RS20050735A (en) 2003-03-28 2004-03-26 Cladribine formulations for improved oral and transmucosal delivery

Country Status (27)

Country Link
US (2) US7888328B2 (sr)
EP (1) EP1608344B1 (sr)
JP (1) JP5256611B2 (sr)
KR (1) KR101129816B1 (sr)
AT (1) ATE476177T1 (sr)
AU (2) AU2004226437B2 (sr)
BR (2) BR122018068797B1 (sr)
CA (1) CA2520523C (sr)
CY (2) CY1112591T1 (sr)
DE (1) DE602004028448D1 (sr)
DK (2) DK1608344T3 (sr)
EA (1) EA009944B1 (sr)
ES (1) ES2409884T3 (sr)
HR (1) HRP20050925A2 (sr)
HU (1) HUS1800013I1 (sr)
IL (1) IL213853A0 (sr)
IS (1) IS2799B (sr)
LT (1) LTC1608344I2 (sr)
LU (1) LUC00065I2 (sr)
ME (1) ME00249B (sr)
MX (1) MXPA05010329A (sr)
NO (1) NO20054945L (sr)
PL (1) PL1608344T3 (sr)
PT (1) PT1608344E (sr)
RS (2) RS51115B (sr)
SG (1) SG175450A1 (sr)
WO (1) WO2004087101A2 (sr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070065492A1 (en) * 2003-03-28 2007-03-22 Ivax Corporation Cladribine formulations for improved oral and transmucosal delivery
HUE059133T2 (hu) 2004-12-22 2022-10-28 Merck Serono Sa Kladribin adagolási elõírás szklerózi multiplex kezelésére
MX2008014971A (es) 2006-05-24 2008-12-05 Serono Lab Regimen de cladribine para tratar esclerosis multiple.
EP2343074A1 (en) 2009-12-23 2011-07-13 Merck Serono S.A. Use of purine analogues for treating airway diseases
EP2428201A1 (en) 2010-09-08 2012-03-14 Merck Serono S.A. Oral administration of nucleoside monophosphates
WO2012097867A1 (en) 2011-01-18 2012-07-26 Synthon Bv Cladribine particles and pharmaceutical compositions comprising them
TWI869330B (zh) * 2017-11-24 2025-01-11 德商馬克專利公司 用於治療進展型多發性硬化症之克拉屈濱(cladribine)療程
EP3628310A1 (en) 2018-09-25 2020-04-01 Synbias Pharma AG Pharmaceutical composition comprising solid dispersions of amorphous cladribine and pharmaceutically acceptable water soluble carrier
RU2748311C1 (ru) * 2020-01-29 2021-05-21 Общество с ограниченной ответственностью "ФармЭко" Фармацевтическая композиция, содержащая твердые дисперсии аморфного кладрибина и фармацевтически приемлемый водорастворимый носитель
AU2021342333A1 (en) 2020-09-10 2023-04-06 Merck Patent Gmbh Novel treatment regimen for the treatment of autoimmune disorders
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
US20240207419A1 (en) * 2021-04-28 2024-06-27 Biophore India Pharmaceuticals Pvt. Ltd. SOLID FORM OF 2-CHLORO-2'-DEOXY-ADENOSINE COMPLEX WITH HPßCD
EP4539857A1 (en) 2022-06-15 2025-04-23 Vektor Pharma TF GmbH Sublingual formulation of anticancer compound for use in the treatment of autoimmune neurodegenerative diseases
WO2025125527A1 (en) 2023-12-14 2025-06-19 Ares Trading S.A. Cladribine regimen for treating myasthenia gravis

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Also Published As

Publication number Publication date
EA009944B1 (ru) 2008-04-28
LUC00065I2 (sr) 2018-03-28
CA2520523A1 (en) 2004-10-14
BR122018068797B1 (pt) 2021-04-27
SG175450A1 (en) 2011-11-28
LTC1608344I2 (lt) 2019-03-12
DK1608344T3 (da) 2010-09-06
WO2004087101A2 (en) 2004-10-14
LTPA2018502I1 (lt) 2018-03-12
PT1608344E (pt) 2010-09-02
KR20060015487A (ko) 2006-02-17
WO2004087101A3 (en) 2005-02-03
ME00249B (me) 2011-05-10
BRPI0408848A8 (pt) 2017-12-26
MEP34308A (en) 2011-02-10
MXPA05010329A (es) 2006-05-31
IL213853A0 (en) 2011-07-31
AU2010214777A1 (en) 2010-09-23
PL1608344T3 (pl) 2011-01-31
US20070197468A1 (en) 2007-08-23
RS20050735A (en) 2008-06-05
KR101129816B1 (ko) 2012-03-26
ATE476177T1 (de) 2010-08-15
ES2409884T3 (es) 2013-06-28
US20110097306A1 (en) 2011-04-28
HK1150266A1 (en) 2011-11-18
EA200600404A1 (ru) 2006-08-25
AU2010214777B2 (en) 2013-01-31
HUS1800013I1 (hu) 2018-03-28
HK1089654A1 (en) 2006-12-08
BRPI0408848B1 (pt) 2018-11-27
BRPI0408848A (pt) 2006-04-04
CY2018005I2 (el) 2018-06-27
DK2272503T3 (da) 2013-05-21
IS2799B (is) 2012-09-15
JP5256611B2 (ja) 2013-08-07
AU2004226437A1 (en) 2004-10-14
LUC00065I1 (sr) 2018-02-14
CA2520523C (en) 2011-10-11
DE602004028448D1 (de) 2010-09-16
RS20050734A (en) 2008-06-05
IS8051A (is) 2005-09-28
EP1608344A2 (en) 2005-12-28
HRP20050925A2 (en) 2006-08-31
BRPI0408848B8 (pt) 2021-07-27
US8785415B2 (en) 2014-07-22
NO20054945L (no) 2005-11-24
CY1112591T1 (el) 2016-02-10
EP1608344B1 (en) 2010-08-04
JP2006521403A (ja) 2006-09-21
US7888328B2 (en) 2011-02-15
NO20054945D0 (no) 2005-10-25
CY2018005I1 (el) 2018-06-27
AU2004226437B2 (en) 2010-06-03

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