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DK1791542T3 - Diketopiperazinsalte til lægemiddel-levering - Google Patents

Diketopiperazinsalte til lægemiddel-levering Download PDF

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Publication number
DK1791542T3
DK1791542T3 DK05791798.1T DK05791798T DK1791542T3 DK 1791542 T3 DK1791542 T3 DK 1791542T3 DK 05791798 T DK05791798 T DK 05791798T DK 1791542 T3 DK1791542 T3 DK 1791542T3
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DK
Denmark
Prior art keywords
therapeutic composition
diketopiperazine
insulin
salt
biologically active
Prior art date
Application number
DK05791798.1T
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English (en)
Inventor
Andrea Leone-Bay
Destardi Moye-Sherman
Bryan R Wilson
Original Assignee
Mannkind Corp
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Publication date
Application filed by Mannkind Corp filed Critical Mannkind Corp
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Publication of DK1791542T3 publication Critical patent/DK1791542T3/da

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D241/00—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings
    • C07D241/02—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings
    • C07D241/06—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings having one or two double bonds between ring members or between ring members and non-ring members
    • C07D241/08—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings having one or two double bonds between ring members or between ring members and non-ring members with oxygen atoms directly attached to ring carbon atoms
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
    • 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
    • A61K31/4965—Non-condensed pyrazines
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D241/00—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings
    • C07D241/02—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P20/00—Technologies relating to chemical industry
    • Y02P20/50—Improvements relating to the production of bulk chemicals
    • Y02P20/582—Recycling of unreacted starting or intermediate materials

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (22)

1. Terapeutisk sammensætning omfattende et farmaceutisk acceptabelt salt af en heterocyklisk forbindelse ifølge formel 1 som et leveringsmiddel for et biologisk aktivt middel:
formel 1 og et biologisk aktivt middel; hvor Ri eller R2 omfatter mindst én carboxylat-funktionel gruppe; Ei og E2 er NH; saltet yderligere omfatter mindst én kation; hvor sammensætningen er et tørpulver opnåelig ved spraytørring; hvor saltet er et ikke-lithiumsalt af 2,5-diaspartyl-3,6-diketopiperazin eller 2,5-diglutamyl-3,6-diketopiperazin; hvor den heterocykliske forbindelse omfatter en diketopiperazin.
2. Terapeutisk sammensætning ifølge krav 1, hvor carboxylatgruppen er terminalt placeret.
3. Terapeutisk sammensætning ifølge krav 1 eller 2, hvor Ri og R2 omfatter 4-X-aminobutyl og hvor X er valgt fra gruppen bestående af succinyl, glutaryl, maleyl og fumaryl.
4. Terapeutisk sammensætning ifølge krav 3, hvor X er fumaryl.
5. Terapeutisk sammensætning ifølge krav 1, hvor diketopiperazin er 3,6-di(succinyl-4-aminobutyl)-2,5-diketopiperazin, 3,6-di(maleyl-4-aminobutyl)-2,5-diketopiperazin, 3,6-di(citraconyl-4-aminobutyl)-2,5-diketopiperazin, 3,6- di(glutaryl-4-aminobutyl)-2,5-diketopiperazin, 3,6-di(malony)-4-aminobutyl)-2,5-diketopiperazin eller 3,6-di(oxalyl-4-aminobutyl)-2,5-diketopiperazin.
6. Terapeutisk sammensætning ifølge krav 1, hvor kationen er valgt fra gruppen bestående af natrium, kalium, calcium, lithium, triethylamin, butylamin, diethanolamin og triethanolamin.
7. Terapeutisk sammensætning ifølge krav 6, hvor kationen er natrium.
8. Terapeutisk sammensætning ifølge krav 1, hvor det biologisk aktive middel er valgt fra gruppen bestående af hormoner, antikoagulanter, immunomoduleringsmidler, cytotoksiske midler, antibiotika, antivirale midler, antisense, antigener, antistoffer og aktive fragmenter og analoger deraf.
9. Terapeutisk sammensætning ifølge krav 8, hvor det biologisk aktive middel omfatter insulin.
10. Terapeutisk sammensætning ifølge krav 1 til oral, bukkal, rektal, eller vaginal administration.
11. Terapeutisk sammensætning ifølge krav 10 i form af en kapsel, en tablet, eller en suppositorie.
12. Terapeutisk sammensætning ifølge krav 1, hvor tørpulverpartiklerne har en diameter mellem ca. 0,5 pm (mikron) og ca. 10 pm (mikron).
13. Terapeutisk sammensætning ifølge krav 1, hvor tørpulverpartiklerne er egnede til pulmonær levering.
14. Terapeutisk sammensætning ifølge krav 1, hvor tørpulverpartiklerne har en rugositet på mindre end 2.
15. Terapeutisk sammensætning ifølge krav 1, til anvendelse til frigivelse af et biologisk aktivt middel i det systemiske blodkredsløb.
16. Terapeutisk sammensætning ifølge krav 1, til anvendelse i frigivelse af et biologisk aktivt middel til lungen.
17. Fremgangsmåde til fremstilling af en terapeutisk sammensætning ifølge et hvilket som helst af kravene 1 til 9 omfattende at: fremstille en opløsning indeholdende et biologisk aktivt middel og et farmaceutisk acceptabelt salt afen heterocyklisk forbindelse ifølge formel 1 ifølge krav 1 i et opløsningsmiddel; og spraytørre opløsningen for at danne et tørpulver.
18. Fremgangsmåden ifølge krav 17, hvor tørpulverpartiklerne er egnede til pulmonær levering.
19. Fremgangsmåden ifølge krav 17, hvor tørpulverpartiklerne haren rugositet på mindre end 2.
20. Terapeutisk sammensætning ifølge krav 1 til anvendelse i medicin.
21. Terapeutisk sammensætning ifølge krav 1 til anvendelse i medicin ifølge krav 20 ved frigivelse af et biologisk aktivt middel til lungen.
22. Terapeutisk sammensætning ifølge krav 1 til anvendelse i medicin ifølge krav 20 ved frigivelse afgivelse af et biologisk aktivt middel til det systemiske blodkredsløb.
DK05791798.1T 2004-08-23 2005-08-23 Diketopiperazinsalte til lægemiddel-levering DK1791542T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US60376104P 2004-08-23 2004-08-23
PCT/US2005/030026 WO2006023943A1 (en) 2004-08-23 2005-08-23 Diketopiperazine salts, diketomorpholine salts or diketodioxane salts for drug delivery

Publications (1)

Publication Number Publication Date
DK1791542T3 true DK1791542T3 (da) 2015-06-15

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ID=35355416

Family Applications (3)

Application Number Title Priority Date Filing Date
DK05791798.1T DK1791542T3 (da) 2004-08-23 2005-08-23 Diketopiperazinsalte til lægemiddel-levering
DK10075512.3T DK2314298T3 (da) 2004-08-23 2005-08-23 Mikropartikler omfattende diketopiperazinsalte til lægemiddel-afgivelse
DK10075511.5T DK2322180T3 (da) 2004-08-23 2005-08-23 Diketopiperazinsalte til lægemiddel-afgivelse

Family Applications After (2)

Application Number Title Priority Date Filing Date
DK10075512.3T DK2314298T3 (da) 2004-08-23 2005-08-23 Mikropartikler omfattende diketopiperazinsalte til lægemiddel-afgivelse
DK10075511.5T DK2322180T3 (da) 2004-08-23 2005-08-23 Diketopiperazinsalte til lægemiddel-afgivelse

Country Status (15)

Country Link
US (10) US7820676B2 (da)
EP (3) EP1791542B1 (da)
JP (1) JP4990142B2 (da)
KR (4) KR20150039211A (da)
CN (2) CN101027057B (da)
AU (1) AU2005277041B2 (da)
BR (2) BRPI0514293B1 (da)
CA (1) CA2578175C (da)
DK (3) DK1791542T3 (da)
ES (3) ES2540853T3 (da)
HU (3) HUE025151T2 (da)
IL (2) IL181516A (da)
MX (1) MX2007002189A (da)
PL (3) PL1791542T3 (da)
WO (1) WO2006023943A1 (da)

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