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WO2011160146A1 - Préparation pharmaceutique contenant du dextrane et de l'hyaluronate de sodium pour le traitement de troubles articulaires - Google Patents

Préparation pharmaceutique contenant du dextrane et de l'hyaluronate de sodium pour le traitement de troubles articulaires Download PDF

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Publication number
WO2011160146A1
WO2011160146A1 PCT/AT2011/000269 AT2011000269W WO2011160146A1 WO 2011160146 A1 WO2011160146 A1 WO 2011160146A1 AT 2011000269 W AT2011000269 W AT 2011000269W WO 2011160146 A1 WO2011160146 A1 WO 2011160146A1
Authority
WO
WIPO (PCT)
Prior art keywords
molecular weight
dextran
sodium hyaluronate
average molecular
pharmaceutical preparation
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/AT2011/000269
Other languages
English (en)
Inventor
Margit Hornof
Martin Prinz
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.)
Croma Pharma GmbH
Original Assignee
Croma Pharma GmbH
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 Croma Pharma GmbH filed Critical Croma Pharma GmbH
Publication of WO2011160146A1 publication Critical patent/WO2011160146A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K31/721—Dextrans
    • 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
    • A61K31/728—Hyaluronic acid
    • 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

Definitions

  • the present invention is directed to a pharmaceutical preparation for intraarticular injection for treating inflammatory and degenerative joint disorders.
  • Osteoarthritis also known as degenerative arthritis, degenerative joint disease
  • OA is a group of diseases and mechanical abnormalities involving degradation of joints, including articular cartilage and the subchondral bone next to it.
  • OA OA-related diseases
  • a variety of potential forces— hereditary, developmental, metabolic, and mechanical— may initiate processes leading to loss of cartilage ⁇ a strong protein matrix that lubricates and cushions the joints.
  • OA is the most common form of arthritis.
  • joint disorders such as rheumatoid arthritis can lead to degradation of articular cartilage structures caused by chronic inflammation of synovial tissues.
  • Anti-inflammatory agents which are orally ingested, are used to temporarily treat pain and inflammation of the joint. Corticosteroids are also used for local treatment
  • the replacement of sodium hyaluronate (a natural component of the synovial fluid) via local injection alleviates symptoms of OA by increasing lubrication and cushioning within the synovial cavity. This treatment is not always effective and does not have any positive influence on inflammatory processes.
  • EP 1 066 044 Bl describes the use of a composition for intraarticular injection containing clinical grade dextran (a biocompatible colloid) with a bimodal molecular weight distribution: 0.2% to 32% (m/v) dextran with an average molecular weight between 30,000 and 110,000 Da (e.g. dextran 70 for injection with an average molecular weight of 70,000 Da; as described in the European Pharmacopoeia) and 0.2% to 6% (m/v) dextran with an average molecular weight between 500 and 3,000 Da.
  • dextran 70 for injection with an average molecular weight of 70,000 Da as described in the European Pharmacopoeia
  • 0.2% to 6% (m/v) dextran with an average molecular weight between 500 and 3,000 Da.
  • the combination of both dextrans was shown to provide almost immediate and sustained pain relief after injection. This effect was attributed to the addition of the smaller dextran to the formulation, which diffuses into surrounding tissues much faster than the larger molecular weight dextran.
  • Dextrans with an average molecular weight between 30,000 and 110,000 Da e.g. dextran 70
  • DIAR Dextran Induced Anaphylactic Reactions
  • the inventive pharmaceutical preparation for intraarticular injection for treating inflammatory and degenerative joint disorders contains 0.2-32% (m/v) dextran with an average molecular weight of 500 to 3,000 Da and 0.1-10% sodium hyaluronate with an average molecular weight of 500,000 to 3500,000 Da, with the proviso that no further dextran having an average molecular weight in the range of 30,000 and 110,000 Da is contained.
  • the invention is based on the finding that a colloidal viscoelastic formulation containing only low molecular weight dextran (e.g. dextran 1 for injection with an average molecular weight of 1000 Da; as listed in the European Pharmacopoeia), i.e. no further dextran having an average molecular weight in the range of 30,000 and 110,000 Da, and sodium hyaluronate has the same unexpected positive effects which are described in EP1 066 044 Bl using dextran with a bimodal distribution of the molecular weight, i.e. rapid onset of pain relief and improved joint mobility and extension of pain relief to adjacent tissues.
  • the invention provides a physiologically acceptable composition for intraarticular injection without the risk of serious side effects.
  • the formulation additionally contains physiologically acceptable salts, buffer substances, additional lubricants, substances to enhance viscosity, substances to adjust osmolality; is administered via intraarticular injection; contains a volume suitable for the intraarticular space; is sterile.
  • Preferred embodiment 0.2-32% (m/v) injection grade low mol. weight fraction of dextran with an average molecular weight of 500 to 3,000 Da and 0,1-10% sodium hyaluronate with an average molecular weight of 500,000 to 3500,000 Da.
  • sodium hyaluronate is partially crosslinked, preferably via disulfide bonds.
  • European Pharmacopoeia with an average molecular weight of 1,000 Da; dextran 70 for injection (as listed in the European Pharmacopoeia) with an average molecular weight of 70,000 Da; sodium hyaluronate with an average molecular weight in the range of 2200,000 to 2700,000 Da.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention porte sur une préparation pharmaceutique pour injection intra-articulaire pour le traitement de troubles articulaires inflammatoires et dégénératifs contenant 0,2-32 % (m/v) de dextrane présentant une masse moléculaire moyenne de 500 à 3 000 Da et 0,1-10 % d'hyaluronate de sodium présentant une masse moléculaire moyenne de 500 000 à 3 500 000 Da, à condition qu'elle ne contienne pas d'autre dextrane présentant une masse moléculaire moyenne dans la plage de 30 000 à 110 000 Da.
PCT/AT2011/000269 2010-06-23 2011-06-16 Préparation pharmaceutique contenant du dextrane et de l'hyaluronate de sodium pour le traitement de troubles articulaires Ceased WO2011160146A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT10552010 2010-06-23
ATA1055/2010 2010-06-23

Publications (1)

Publication Number Publication Date
WO2011160146A1 true WO2011160146A1 (fr) 2011-12-29

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AT2011/000269 Ceased WO2011160146A1 (fr) 2010-06-23 2011-06-16 Préparation pharmaceutique contenant du dextrane et de l'hyaluronate de sodium pour le traitement de troubles articulaires

Country Status (1)

Country Link
WO (1) WO2011160146A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190065771A (ko) * 2017-12-04 2019-06-12 이일훈 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR20200015671A (ko) * 2020-02-04 2020-02-12 이일훈 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR20200126948A (ko) * 2020-02-04 2020-11-09 메디슨파크 주식회사 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR20210127909A (ko) * 2020-10-26 2021-10-25 메디슨파크 주식회사 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003000191A2 (fr) * 2001-06-25 2003-01-03 Depuy Composition comprenant des glycosaminoglycanes et des inhibiteurs d'hyaluronidase destinee au traitement d'articulations arthritiques
EP1066044B1 (fr) 1998-03-27 2004-03-10 Glenpharma Formulations de dextrane servant a traiter des troubles articulaires inflammatoires
WO2005110278A2 (fr) * 2003-04-29 2005-11-24 Musculoskeletal Transplant Foundation Melange pour reparation du cartilage contenant des chondrocytes d'allogreffe

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1066044B1 (fr) 1998-03-27 2004-03-10 Glenpharma Formulations de dextrane servant a traiter des troubles articulaires inflammatoires
WO2003000191A2 (fr) * 2001-06-25 2003-01-03 Depuy Composition comprenant des glycosaminoglycanes et des inhibiteurs d'hyaluronidase destinee au traitement d'articulations arthritiques
WO2005110278A2 (fr) * 2003-04-29 2005-11-24 Musculoskeletal Transplant Foundation Melange pour reparation du cartilage contenant des chondrocytes d'allogreffe

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ALY M N S: "Intra-articular drug delivery: A fast growing approach", RECENT PATENTS ON DRUG DELIVERY & FORMULATION, BENTHAM SCIENCE PUBLISHERS LTD, NL, vol. 2, no. 3, 1 November 2008 (2008-11-01), pages 231 - 237, XP009151166, ISSN: 1872-2113 *

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023089978A (ja) * 2017-12-04 2023-06-28 メディシン、パーク、カンパニー、リミテッド デキストランまたはポロキサマーを含む、関節疾患または結合組織疾患の治療用組成物
US11801260B2 (en) 2017-12-04 2023-10-31 Medicine Park Co., Ltd Compositions for treating joint or connective tissue disease comprising dextran or poloxamer
KR102075596B1 (ko) * 2017-12-04 2020-02-10 이일훈 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
JP7796077B2 (ja) 2017-12-04 2026-01-08 メディシン、パーク、カンパニー、リミテッド デキストランまたはポロキサマーを含む、関節疾患または結合組織疾患の治療用組成物
CN111491640A (zh) * 2017-12-04 2020-08-04 医药产业园有限公司 包含葡聚糖或泊咯沙姆的用于治疗关节疾病或结缔组织病的组合物
EP4588514A3 (fr) * 2017-12-04 2025-10-15 Medicine Park Co., Ltd. Composition pour le traitement d'une maladie articulaire ou d'une maladie du tissu conjonctif contenant du dextrane ou du poloxamère
CN111491640B (zh) * 2017-12-04 2025-05-30 医药产业园有限公司 包含葡聚糖或泊咯沙姆的用于治疗关节疾病或结缔组织病的组合物
JP2021505680A (ja) * 2017-12-04 2021-02-18 メディシン、パーク、カンパニー、リミテッドＭｅｄｉｃｉｎｅ Ｐａｒｋ Ｃｏ．， Ｌｔｄ． デキストランまたはポロキサマーを含む、関節疾患または結合組織疾患の治療用組成物
WO2019112291A1 (fr) * 2017-12-04 2019-06-13 이일훈 Composition destinée au traitement de maladies des articulations ou de maladies du tissu conjonctif, contenant du dextrane ou du poloxamère
US11278565B2 (en) 2017-12-04 2022-03-22 Medicine Park Co., Ltd. Compositions for treating joint or connective tissue disease comprising dextran or poloxamer
JP7674103B2 (ja) 2017-12-04 2025-05-09 メディシン、パーク、カンパニー、リミテッド デキストランまたはポロキサマーを含む、関節疾患または結合組織疾患の治療用組成物
KR20190065771A (ko) * 2017-12-04 2019-06-12 이일훈 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR102316719B1 (ko) * 2020-02-04 2021-10-25 메디슨파크 주식회사 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR20200126948A (ko) * 2020-02-04 2020-11-09 메디슨파크 주식회사 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR102172290B1 (ko) 2020-02-04 2020-10-30 메디슨파크 주식회사 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR20200015671A (ko) * 2020-02-04 2020-02-12 이일훈 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR102468374B1 (ko) * 2020-10-26 2022-11-17 메디슨파크 주식회사 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물
KR20210127909A (ko) * 2020-10-26 2021-10-25 메디슨파크 주식회사 덱스트란 또는 폴록사머를 포함하는 관절 질환 또는 결체조직 질환 치료용 조성물

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