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EP1135152A1 - Composition pharmaceutique contenant cyclosporine dans un vehicule lipidique - Google Patents

Composition pharmaceutique contenant cyclosporine dans un vehicule lipidique

Info

Publication number
EP1135152A1
EP1135152A1 EP99963798A EP99963798A EP1135152A1 EP 1135152 A1 EP1135152 A1 EP 1135152A1 EP 99963798 A EP99963798 A EP 99963798A EP 99963798 A EP99963798 A EP 99963798A EP 1135152 A1 EP1135152 A1 EP 1135152A1
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical composition
cyclosporin
lipids
monoglycerides
cyclosporine
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.)
Withdrawn
Application number
EP99963798A
Other languages
German (de)
English (en)
Inventor
Bengt Herslöf
Peter Kaufmann
Carl-Gunnar Kroon
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.)
Lipocore Holding AB
Original Assignee
Lipocore Holding AB
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 Lipocore Holding AB filed Critical Lipocore Holding AB
Publication of EP1135152A1 publication Critical patent/EP1135152A1/fr
Withdrawn legal-status Critical Current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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A61K9/1274—Non-vesicle bilayer structures, e.g. liquid crystals, tubules, cubic phases or cochleates; Sponge phases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13—Cyclosporins
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

Definitions

  • Neoral ® , Neoral ® or Sandimmune ® from the gastro-intestinal tract is, however, incomplete and variable and it is recommended that transplant patients taking the soft gelatin capsules or the oral solution over a period of time are monitored .at repeated intervals for cyclosporine blood levels to avoid toxicity due to high levels, and possible organ rejection due to low absorption, respectively.
  • the pharmaceutical composition of the invention can also contain conventional additives and excipients, such as antiseptic agents, preservatives, thickening agents, pigments, flavouring and the like, in combinations as needed.
  • a formulation in accordance with WO 95/20945 was prepared by mixing the following ingredients I- g-rfidi-e-n-t -k-b-y weig-ht-
  • PC phosphatidylcholine, from Lucas Meyer SL, h-GL and h-PE were obtained from Ontario LipidTeknik AB .
  • Soy bean oil is a long-chain C16-C20 triglyceride, CPL ® - Soybean oil from Ontario LipidTeknik AB .

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Transplantation (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Composition pharmaceutique contenant une cyclosporine en tant que substance active dans un véhicule lipidique comprenant des lipides membranaires combinés à des monoglycérides et éventuellement à des lipides non polaires, cette composition étant caractérisée par le fait qu'elle est liquide à température ambiante et contient 0,5-25 % de cyclosporine, 10-45 % de lipides membranaires, 10-55 % de monoglycérides et 0.45 % de lipides non polaires. Cette composition présente une bioéquivalence par rapport à un médicament commercialisé contenant en plus de la cyclosporine et d'additifs, également des émulsifiants toxiques et de l'éthanol.
EP99963798A 1998-12-03 1999-12-03 Composition pharmaceutique contenant cyclosporine dans un vehicule lipidique Withdrawn EP1135152A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9804192 1998-12-03
SE9804192A SE9804192D0 (sv) 1998-12-03 1998-12-03 New formulation
PCT/SE1999/002259 WO2000032219A1 (fr) 1998-12-03 1999-12-03 Composition pharmaceutique contenant cyclosporine dans un vehicule lipidique

Publications (1)

Publication Number Publication Date
EP1135152A1 true EP1135152A1 (fr) 2001-09-26

Family

ID=20413540

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99963798A Withdrawn EP1135152A1 (fr) 1998-12-03 1999-12-03 Composition pharmaceutique contenant cyclosporine dans un vehicule lipidique

Country Status (10)

Country Link
EP (1) EP1135152A1 (fr)
JP (1) JP2002531412A (fr)
AU (1) AU764413B2 (fr)
CA (1) CA2352388A1 (fr)
HU (1) HUP0105399A3 (fr)
NO (1) NO20012736D0 (fr)
NZ (1) NZ512194A (fr)
PL (1) PL348062A1 (fr)
SE (1) SE9804192D0 (fr)
WO (1) WO2000032219A1 (fr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE0200475D0 (sv) * 2002-02-15 2002-02-15 Ltp Lipid Technologies Provide Oral farmaceutisk beredning
US20050058671A1 (en) * 2003-05-09 2005-03-17 Bedding Peter M.J. Dietary supplement and method for treating digestive system-related disorders
SE0303135D0 (sv) * 2003-11-25 2003-11-25 Lipocore Holding Ab Controlled food effect composition
SE0401942D0 (sv) * 2004-07-28 2004-07-28 Lipopeptide Ab New antimicrobial peptide complexes
MX2007013421A (es) * 2005-04-28 2008-01-16 Galenica Technology Ab Formas de dosificacion farmaceutica que comprenden una fase lipida.
WO2012144943A1 (fr) * 2011-04-18 2012-10-26 Lipidor Ab Véhicule liquide pour administration orale d'un agent pharmacologiquement actif
WO2014103742A1 (fr) * 2012-12-25 2014-07-03 ポーラ化成工業株式会社 Composition vésiculaire réversible et son procédé de fabrication
JP6334151B2 (ja) * 2012-12-25 2018-05-30 ポーラ化成工業株式会社 逆ベシクル組成物
JP6242582B2 (ja) * 2013-04-01 2017-12-06 ポーラ化成工業株式会社 逆ベシクル組成物の製造方法
JP6242581B2 (ja) * 2013-04-01 2017-12-06 ポーラ化成工業株式会社 逆ベシクル組成物の製造方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR0148748B1 (ko) * 1988-09-16 1998-08-17 장 크라메르, 한스 루돌프 하우스 사이클로스포린을 함유하는 약학조성물
US5529785A (en) * 1993-05-12 1996-06-25 Dietl; Hans Pharmaceutical preparation containing cyclosporin(s) for oral administration and process for producing same
WO1995020945A1 (fr) * 1994-02-04 1995-08-10 Scotia Lipidteknik Ab Preparation de porteurs lipophiles
MY129435A (en) * 1994-10-26 2007-04-30 Novartis Ag Pharmaceutical microemulsion preconcentrates
IT1289939B1 (it) * 1997-02-20 1998-10-19 Angelini Ricerche Spa Composizione farmaceutica acquosa comprendente un principio attivo altamente insolubile in acqua
US6063762A (en) * 1997-12-05 2000-05-16 Chong Kun Dang Corp. Cyclosporin-containing microemulsion preconcentrate composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0032219A1 *

Also Published As

Publication number Publication date
NO20012736L (no) 2001-06-01
HUP0105399A2 (en) 2002-06-29
AU2016700A (en) 2000-06-19
WO2000032219A1 (fr) 2000-06-08
NZ512194A (en) 2002-09-27
NO20012736D0 (no) 2001-06-01
CA2352388A1 (fr) 2000-06-08
AU764413B2 (en) 2003-08-21
PL348062A1 (en) 2002-05-06
HUP0105399A3 (en) 2005-06-28
SE9804192D0 (sv) 1998-12-03
JP2002531412A (ja) 2002-09-24

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