DK2475354T3 - Implanterbar indretning til kontrolleret lægemiddelafgivelse - Google Patents

Implanterbar indretning til kontrolleret lægemiddelafgivelse Download PDF

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Publication number
DK2475354T3
DK2475354T3 DK10755277.0T DK10755277T DK2475354T3 DK 2475354 T3 DK2475354 T3 DK 2475354T3 DK 10755277 T DK10755277 T DK 10755277T DK 2475354 T3 DK2475354 T3 DK 2475354T3
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Denmark
Prior art keywords
drug
release
wall
housing
retention
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DK10755277.0T
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English (en)
Inventor
Michael J Cima
Karen Daniel
Cheryl Larrivee-Elkins
Heejin Lee
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Taris Biomedical Llc
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Priority claimed from US12/825,215 external-priority patent/US10543166B2/en
Application filed by Taris Biomedical Llc filed Critical Taris Biomedical Llc
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Publication of DK2475354T3 publication Critical patent/DK2475354T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0092Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1078Urinary tract
    • A61M2210/1085Bladder

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Nanotechnology (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (15)

1. Implanterbar medicinsk indretning (1200) til kontrolleret lægemiddelafgivelse omfattende: et første lægemiddelafsnit (1204), som omfatter et første lægemiddelhus fyldt med en første lægemiddelformulering omfattende et første lægemiddel i en fast eller halvfast form, hvor det første lægemiddelhus omfatter en første væg, som er gen-nemtrængelig for vand, men er i det væsentlige uigennemtrængelig for det første lægemiddel, og har i det mindste én passage (1210) igennem den første væg, idet det første lægemiddelafsnit frigiver det første lægemiddel in vivo i overensstemmelse med et første frigivelsesprofil; og et andet lægemiddelafsnit (1202), som omfatter et andet lægemiddelhus fyldt med en anden lægemiddelformulering omfattende et andet lægemiddel i en fast eller halvfast form, hvor det andet lægemiddelhus omfatter en anden væg, som er gen-nemtrængelig for vand og for det andet lægemiddel, idet det andet lægemiddelafsnit frigiver det andet lægemiddel in vivo i overensstemmelse med et andet frigivelsesprofil, hvor det andet frigivelsesprofil afviger fra det første frigivelsesprofil; og et retentionsafsnit, som er funktionsmæssigt knyttet til såvel det første som det andet lægemiddelafsnit (1202, 1204), hvor det første og andet lægemiddelhus er opdelte områder i et enkelt rørformet legeme, idet den første og anden væg omfatter en polymer valgt blandt silikone og medicinske kvaliteter af polyvinylchlorid, polyolefiner, og polyetherurethaner, hvor det første lægemiddel har en ladning og/eller molekylstørrelse, som gør den første væg uigennemtrængelig for det første lægemiddel, og hvor det andet lægemiddel har en ladning og/eller molekylstørrelse, som gør den anden væg gennemtrængelig for det andet lægemiddel.
2. Indretning ifølge krav 1, hvor den første lægemiddelformulering har en relativt højere opløselighed i vand end den anden lægemiddelformulering.
3. Indretning ifølge krav 1, hvor: det første lægemiddelhus (1204) er konfigureret til at frigive det første lægemiddel primært via osmotisk tryk; og det andet lægemiddelhus (1202) er konfigureret til at frigive den anden lægemiddelformulering primært via diffusion.
4. Indretning ifølge krav 3, hvor: det første lægemiddel foreligger i form af et salt med høj opløselighed i vand; og det andet lægemiddel er det samme lægemiddel som det første lægemiddel, men foreligger i en ikke-saltform med lav opløselighed i vand.
5. Indretning ifølge krav 1, hvor i det mindste én af lægemiddelformuleringerne omfatter adskillige faste lægemiddeltabletter anbragt i en række i det ene rørformede legeme.
6. Indretning ifølge krav 1, hvor retentionsafsnittet omfatter en retentionsramme og indretningen er deformerbar imellem en retentionsform og en indsætningsform.
7. Indretning ifølge krav 1, hvor det første lægemiddelhus (1204) omfatter adskillige frigivelsespassager og det første frigivelsesprofil i det mindste delvis afspejler diffusion af lægemidlet igemmen de adskillige frigivelsespassager.
8. Indretning ifølge krav 7, hvor hver frigivelsespassage (1210) omfatter enten en åbning, som strækker sig igennem en ikke porøs væg eller en passagepore, som strækker sig igennem en porøs væg.
9. Indretning ifølge krav 1, hvor den første lægemiddelformulering omfatter et farmaceutisk acceptablet salt af lidocain, og den anden lægemiddelformulering omfatter lido-cainbase.
10. Indretning ifølge krav 9, hvor det første lægemiddelhus (1204) tilvejebringer frigivelse af lidocainsaltet in vivo ved osmotisk tryk.
11. Indretning ifølge krav 9, hvor det andet lægemiddelhus (1202) tilvejebringer frigivelse af lidocainbasen in vivo ved diffusion.
12. Indretning ifølge krav 1, hvor i det mindste én af den første og anden lægemiddelformulering omfatter adskillige lægemiddeltabletter anbragt i en række i det ene rørformede legeme.
13. Indretning ifølge krav 12, hvor det ene rørformede legeme er dannet af silikone.
14. Indretning ifølge krav 10, hvor retentionsafsnittet omfatter en retentionsramme, således at indretningen er deformerbar imellem en retentionsform og en indsætningsform.
15. Indretning ifølge krav 14, hvor indretningen kan indsættes igennem en patients urinrør og ind i patientens blære, hvor indretningen (1200) er i indsætningsformen, og bliver fastholdt i blæren, når indretningen deformeres til retentionsformen.
DK10755277.0T 2009-09-10 2010-09-09 Implanterbar indretning til kontrolleret lægemiddelafgivelse DK2475354T3 (da)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US24127709P 2009-09-10 2009-09-10
US12/825,215 US10543166B2 (en) 2009-06-26 2010-06-28 Implantable drug delivery devices and methods of making the same
US12/851,494 US9017312B2 (en) 2009-09-10 2010-08-05 Implantable device for controlled drug delivery
PCT/US2010/048266 WO2011031855A2 (en) 2009-09-10 2010-09-09 Implantable device for controlled drug delivery

Publications (1)

Publication Number Publication Date
DK2475354T3 true DK2475354T3 (da) 2017-01-30

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US (4) US9017312B2 (da)
EP (1) EP2475354B1 (da)
JP (1) JP2013504584A (da)
KR (1) KR20120069715A (da)
CN (1) CN102596174A (da)
AU (1) AU2010292238A1 (da)
BR (1) BR112012005398A2 (da)
CA (1) CA2773491A1 (da)
DK (1) DK2475354T3 (da)
EA (1) EA201270379A1 (da)
ES (1) ES2606129T3 (da)
IL (1) IL218459A0 (da)
IN (1) IN2012DN02221A (da)
MX (1) MX2012002937A (da)
SG (1) SG179051A1 (da)
WO (1) WO2011031855A2 (da)
ZA (1) ZA201201751B (da)

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US9017312B2 (en) 2015-04-28

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