DK1776137T3 - Farmaceutisk sammensætning indeholdende botulinumneurotoksin A2 - Google Patents

Farmaceutisk sammensætning indeholdende botulinumneurotoksin A2 Download PDF

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Publication number
DK1776137T3
DK1776137T3 DK05767871.6T DK05767871T DK1776137T3 DK 1776137 T3 DK1776137 T3 DK 1776137T3 DK 05767871 T DK05767871 T DK 05767871T DK 1776137 T3 DK1776137 T3 DK 1776137T3
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Prior art keywords
disorders
botulinum toxin
type
botulinum
toxin type
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DK05767871.6T
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English (en)
Inventor
Naveed Panjwani
Paul Webb
Andy Pickett
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Ipsen Biopharm Ltd
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Priority claimed from GB0417367A external-priority patent/GB2416692A/en
Priority claimed from GB0421290A external-priority patent/GB2418359A/en
Priority claimed from GB0421288A external-priority patent/GB2418358A/en
Priority claimed from GB0423952A external-priority patent/GB2419526A/en
Priority claimed from GB0423953A external-priority patent/GB2419527A/en
Application filed by Ipsen Biopharm Ltd filed Critical Ipsen Biopharm Ltd
Application granted granted Critical
Publication of DK1776137T3 publication Critical patent/DK1776137T3/da

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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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893Botulinum neurotoxin (3.4.24.69)
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/99Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from microorganisms other than algae or fungi, e.g. protozoa or bacteria
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular 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
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • 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
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • A61Q19/08Anti-ageing preparations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q7/00Preparations for affecting hair growth

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Neurology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Birds (AREA)
  • Endocrinology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Biotechnology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Pulmonology (AREA)
  • Diabetes (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)

Claims (14)

1
1. Botulinumtoksin type A2 til anvendelse ved behandling, forudsat at botuli-numtoksinet A2 ikke anvendes til behandling af hirsutisme eller hypertricho- 5 se.
2. Botulinumtoksin type A2 til anvendelse ved behandling ifølge krav 1, hvor botulinumtoksinet type A2 er botulinumneurotoksinkompleks type A2 eller botulinumneurotoksin type A2 med høj renhed, og hvor botulinumtoksinet 10 type A2 er en del af en fast eller flydende farmaceutisk sammensætning, der endvidere omfatter et overfladeaktivt stof, fortrinsvis et ikke-ionisk overfladeaktivt stof.
3. Botulinumtoksin type A2 til anvendelse ved behandling ifølge krav 2, hvor 15 den faste eller flydende farmaceutiske sammensætning endvidere omfatter et krystallinsk stof, fortrinsvis natriumchlorid.
4. Botulinumtoksin type A2 til anvendelse ved behandling ifølge krav 2 eller 3, hvor den faste eller flydende farmaceutiske sammensætning endvidere 20 omfatter en buffer til at holde en pH-værdi på mellem 5,5 og 7,5, fortrinsvis på mellem 5,8 og 7,0.
5. Botulinumtoksin type A2 til anvendelse ved behandling ifølge et af kravene 2 til 4, hvor den faste eller flydende farmaceutiske sammensætning endvide- 25 re omfatter et disaccharid, fortrinsvis valgt fra gruppen bestående af saccha rose, trehalose, laktose og mannitol.
6. Botulinumtoksin type A2 til anvendelse ved behandling ifølge et af kravene 2 til 5, hvor det overfladeaktive stof er ikke-ionisk overfladeaktivt stof, der er 30 valgt fra gruppen bestående af polysorbater og blokcopolymerer.
7. Botulinumtoksin type A2 til anvendelse ved behandling ifølge krav 6, hvor det ikke-ioniske overfladeaktive stof er valgt fra gruppen bestående af polysorbater med en gennemsnitlig polymeriseringsgrad i området fra 20 til 100 35 monomerenheder og poloxamere. 2
8. Botulinumtoksin type A2 til anvendelse ved behandling ifølge et af kravene 2 til 7, hvor det ikke-ioniske overfladeaktive stof er polysorbat 80.
9. Botulinumtoksin type A2 ifølge et af kravene 1 til 8 til anvendelse ved be- 5 handling af en sygdom, en lidelse eller et syndrom, der er udvalgt fra oftalmo- logiske forstyrrelser, bevægelsesforstyrrelser, otorhinolaryngologiske forstyrrelser, gastrointestinale forstyrrelser, urogenitale forstyrrelser, dermatologiske forstyrrelser, smerteforstyrrelser, inflammatoriske forstyrrelser, sekretori-ske forstyrrelser, respiratoriske forstyrrelser, hypertrofiske forstyrrelser, arti-10 kulære forstyrrelser, endokrine forstyrrelser, autoimmune sygdomme, prolife- rativ sygdom, traumatiske læsioner og veterinære forstyrrelser.
10. Ikke-terapeutisk anvendelse af botulinumtoksin type A2 til behandling af kosmetiske forstyrrelser, der er valgt fra gruppen bestående af: 15 · huddefekter; • ansigtsasymmetri; • rynker, der er valgt blandt glabellapanderynker og ansigtsrynker; • nedadvendt mund; og • hårtab; 20 hvor anvendelsen omfatter administration af en virksom dosis botulinumtok sin type A2 til det område, hvor der er en kosmetisk forstyrrelse.
11. Anvendelse ifølge krav 10, hvor botulinumtoksinet type A2 er botulinum-neurotoksinkompleks type A2 eller botulinumneurotoksin type A2 med høj 25 renhed, og hvor botulinumtoksinet type A2 er en del af en fast eller flydende farmaceutisk sammensætning, der endvidere omfatter et overfladeaktivt stof.
12. Anvendelse ifølge krav 11, hvor den faste eller flydende farmaceutiske sammensætning endvidere omfatter en eller flere af de følgende bestandde- 30 le: • et krystallinsk stof, • en buffer til at holde en pH-værdi på mellem 5,5 og 7,5; • et disaccharid.
13. Anvendelse ifølge krav 12, hvor 3 • det overfladeaktive stof er valgt fra gruppen bestående af polysorbater med en gennemsnitlig polymeriseringsgrad i området fra 20 til 100 monomerenheder og poloxamere; • det krystallinske stof er natriumchlorid; 5 · bufferen bibeholder pH-værdien på mellem 5,8 og 7,0; • disaccharidet er valgt fra gruppen bestående af saccharose, trehalose, lak-tose og mannitol.
14. Anvendelse ifølge et af kravene 11 til 13, hvor det overfladeaktive stof er 10 polysorbat 80.
DK05767871.6T 2004-08-04 2005-08-03 Farmaceutisk sammensætning indeholdende botulinumneurotoksin A2 DK1776137T3 (da)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
GB0417367A GB2416692A (en) 2004-08-04 2004-08-04 Pharmaceutical composition containing botulinum neurotoxin
GB0421290A GB2418359A (en) 2004-09-24 2004-09-24 Pharmaceutical composition comprising botulinum neurotoxin
GB0421288A GB2418358A (en) 2004-09-24 2004-09-24 Pharmaceutical composition comprising botulinum neurotoxin
GB0423952A GB2419526A (en) 2004-10-28 2004-10-28 Pharmaceutical composition containing botulinum neurotoxin
GB0423953A GB2419527A (en) 2004-10-28 2004-10-28 Pharmaceutical composition containing botulinum neurotoxin
PCT/GB2005/003036 WO2006013357A1 (en) 2004-08-04 2005-08-03 Pharmaceutical composition containing botulinum neurotoxin a2

Publications (1)

Publication Number Publication Date
DK1776137T3 true DK1776137T3 (da) 2015-01-05

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ID=35063257

Family Applications (2)

Application Number Title Priority Date Filing Date
DK05767871.6T DK1776137T3 (da) 2004-08-04 2005-08-03 Farmaceutisk sammensætning indeholdende botulinumneurotoksin A2
DK14180875.8T DK2813239T3 (da) 2004-08-04 2005-08-03 Farmaceutisk sammensætning indeholdende botulinumneurotoksin A2

Family Applications After (1)

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DK14180875.8T DK2813239T3 (da) 2004-08-04 2005-08-03 Farmaceutisk sammensætning indeholdende botulinumneurotoksin A2

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US (2) US20080069841A1 (da)
EP (3) EP1776137B1 (da)
DK (2) DK1776137T3 (da)
ES (2) ES2627627T3 (da)
HU (1) HUE032950T2 (da)
PL (2) PL1776137T3 (da)
PT (2) PT1776137E (da)
TR (1) TR201708749T4 (da)
WO (1) WO2006013357A1 (da)

Families Citing this family (16)

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GB2416122A (en) 2004-07-12 2006-01-18 Ipsen Ltd Botulinum neurotoxin composition
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US8512715B2 (en) 2008-08-14 2013-08-20 The Cleveland Clinic Foundation Apparatus and method for treating a neuromuscular defect
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IL268980B (en) * 2009-06-25 2022-09-01 Revance Therapeutics Inc Botulinum toxin formulations without albumin
ES2643507T3 (es) * 2012-03-12 2017-11-23 William J. Binder Tratamiento de las cefaleas por migraña con la neurotoxina presináptica
CA2889833A1 (en) 2012-10-28 2014-05-01 Revance Therapeutics, Inc. Compositions and methods for safe treatment of rhinitis
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US20240024220A1 (en) * 2019-05-11 2024-01-25 Youngsuk Yi Neurotoxin compositions and methods
KR20220169510A (ko) * 2021-06-18 2022-12-28 충북대학교 산학협력단 불멸화 줄기세포의 엑소좀 풍부 배양액 및 보툴리눔 독소를 포함하는 기능성 조성물

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Also Published As

Publication number Publication date
EP3210620A1 (en) 2017-08-30
DK2813239T3 (da) 2017-06-06
EP2813239A1 (en) 2014-12-17
EP2813239B1 (en) 2017-03-22
US20100184689A1 (en) 2010-07-22
PL2813239T3 (pl) 2017-11-30
ES2526912T3 (es) 2015-01-16
EP1776137A1 (en) 2007-04-25
EP1776137B1 (en) 2014-11-26
PL1776137T3 (pl) 2015-03-31
US20080069841A1 (en) 2008-03-20
TR201708749T4 (tr) 2018-03-21
PT2813239T (pt) 2017-06-09
HUE032950T2 (en) 2017-11-28
ES2627627T3 (es) 2017-07-28
WO2006013357A1 (en) 2006-02-09
PT1776137E (pt) 2014-12-31

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