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ME00076B - Lijek u čvrstom obliku za oralnu primjenu - Google Patents

Lijek u čvrstom obliku za oralnu primjenu

Info

Publication number
ME00076B
ME00076B MEP-2008-108A MEP2008108A ME00076B ME 00076 B ME00076 B ME 00076B ME P2008108 A MEP2008108 A ME P2008108A ME 00076 B ME00076 B ME 00076B
Authority
ME
Montenegro
Prior art keywords
pharmaceutical
agent
dysuria
pharmaceuticals
capsule
Prior art date
Application number
MEP-2008-108A
Other languages
English (en)
Inventor
Tsuyoshi Naganuma
Mitsuo Muramatsu
Original Assignee
Kissei Pharmaceutical
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32588229&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME00076(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Kissei Pharmaceutical filed Critical Kissei Pharmaceutical
Publication of ME00076B publication Critical patent/ME00076B/me

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • A61K31/4045Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • 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
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/04Drugs for disorders of the urinary system for urolithiasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/12Antidiuretics, e.g. drugs for diabetes insipidus

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Communicable Diseases (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Indole Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Ovaj pronalazak obezbedjuje oralni dozni oblik farmaceutika u čvrstom stanju za tretman disurije, koja sadrži, aktivni sastojak, indolin l jedinjenje koje ima α1-adrenoceptor blokirajuću aktivnost i koje je prikazano sa formulom: Ovaj pronalazak obezbedjuje oralni dozni oblik farmaceutika u čvrstom stanju za tretman disurije, koja sadrži, aktivni sastojak, indolin l jedinjenje koje ima α 1-adrenoceptor blokirajuću aktivnost i koje je prikazano sa formulom:        njegov proderivat, njegova farmaceutski prihvatljiva so ili njegov farmaceutski prihvatljiv solvat, gde je za navedeni farmaceutik vreme za koje se postigne 85% rastvaranja ne više od 60 minuta u testu rastvorljivosti prema metodi 2(propelerski metod) iz japanske farmakopeje u uslovima u kojima se koristi voda. njegov proderivat, njegova farmaceutski prihvatljiva so ili njegov farmaceutski prihvatljiv solvat, gde je za navedeni farmaceutik vreme za koje se postigne 85% rastvaranja ne više od 60 minuta u testu rastvorljivosti prema metodi 2(propelerski metod) iz japanske farmakopeje u uslovima u kojima se koristi voda.

Claims (18)

1. Oralni dozni oblici farmaceutika u čvrstom stanju za tretman disurije, koji sadrže, kao aktivni sastojak, anindolin jedinjenje koje ima aradrenoceptor blokirajuću aktivnost i prikazano je sa formulom: njegov proderivat, njegova farmaceutski prihvatljiva so ili njegov farmaceutski prihvatljiv solvat, gde vreme za koje se postigne 85 % rastvaranja je ne više od 60 minuta u testu rastvorljivosti prema metodi 2 (propelerski metod) iz japanske farmakopeje u uslovima u kojima se koristi voda kao medijum za testiranje i pri brzini propelera od 50 rpm.
2. Farmaceutik prema zahtevu l, gde vreme rastvaranja 85% nije više od 60 minuta u testu rastvorljivosti prema metodi 2 (propelerski metod) iz japanske farmakopeje u uslovima u kojima se koristi prvi fluid koji je odredjen u testu razgradivosti iz japanske farmakopeje kao medijum za testiranje i pri brzini propelera od 50 rpm.
3. Farmaceutik prema zahtevu 1 ili 2, gde je vreme rastvaranja 85 % ne više od 30 minuta.
4. Farmaceutik prema zahtevu 3, gde je vreme rastvaranja 85 % ne više od 15 minuta
5. Farmaceutik prema bilo kom od zahteva l do 4, koji sadrži D- manitol kao punioc.
6. Farmaceutik prema zahtevu 5, koji dalje sadrži lubrikant.
7. Farmaceutik prema zahtevu 6, gde je kao lubrikant magnezijum stearat, kalcijum stearat ili talk.
8. Farmaceutik prema zahtevu 6, gde je kao lubrikant magnezijum stearat.
9. Farmaceutik prema zahtevu 8, koji dalje sadrži 0.1 do 2 dela natrijum lauril sulfata na 1 deo magnezijum stearata.
10. Farmaceutik prema bilo kom od zahteva 1 do 9, gde je dozna forma u obliku kapsule ili tablete.
11. Farmaceutik prema zahtevu 10, gde kapsula je kapsula sa omotačem sa zaštitom od svetlosti ili je tableta omotana sa agensom za zaštitu od svetlosti.
12. Farmaceutik prema zahtevu 11 , gde je kapsula sa omotačem sa zaštitom od svetlosti, kapsula koja sadrži titanijum oksid .
13. Farmaceutik prema zahtevu ll, gde je agens za zaštitu od svetlosti, agens za zaštitu od svetlosti koji sadrži titanijum oksid.
14. Farmaceutik prema bilo kom od zahteva l do 13, koji dalje sadrži, kao aktivni sastojak, najmanje jedan agens koji je odabran iz grupe koja se sastoji od uradrenoceptor blokirajućeg agensa, antiholinergičnog agensa, antiinflamatornog agensa i antibakterijskog agensa koji se razlikuju od indolin jedinjenje iz zahteva l.
15. Farmaceutik za tretman disurije, koji obuhvata farmaceu tik prema bilo kom od zahteva 1 do 14, u kombinaciji sa farmaceutikom koji uključuje, kao aktivni sastojak, najmanje jedan agens koji je odabran iz grupe koja se sastoji od aradrenoceptor blokirajućeg agensa, antiholinergičnog agensa, antiinflamatornog agensa i antibakterijskog agensa koji se razlikuju od indolin jedinjenje iz zahteva 1.
16. Farmaceutik prema bilo kom od zahteva 1 do 15, koji se koristi za treatman disurije.
17. Farmaceutik prema zahtevu 16, gde je disurija udružena sa blokiranjem organizacije mokraćnog kanala, poremećajima nerva za kontrolu uriniranja ili blokiranjem funkcije mokraćnog kanala.
18. Farmaceutik prema zahtevu 16, gde je disurija udružena sa hipertrofijom prostate, neurogenom bešikom ili poremećajem donjeg dela urinarnog trakta.
MEP-2008-108A 2002-12-16 2003-12-11 Lijek u čvrstom obliku za oralnu primjenu ME00076B (me)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2002364238 2002-12-16
PCT/JP2003/015837 WO2004054574A1 (ja) 2002-12-16 2003-12-11 経口固形医薬

Publications (1)

Publication Number Publication Date
ME00076B true ME00076B (me) 2011-02-10

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MEP-2008-108A ME00076B (me) 2002-12-16 2003-12-11 Lijek u čvrstom obliku za oralnu primjenu
MEP-108/08A MEP10808A (en) 2002-12-16 2003-12-11 Solid drug for oral use

Family Applications After (1)

Application Number Title Priority Date Filing Date
MEP-108/08A MEP10808A (en) 2002-12-16 2003-12-11 Solid drug for oral use

Country Status (24)

Country Link
US (2) US20060018959A1 (me)
EP (2) EP1574215B1 (me)
JP (1) JP4633469B2 (me)
KR (2) KR101077061B1 (me)
CN (2) CN101069685B (me)
AU (1) AU2003289320C1 (me)
BR (1) BR0317349A (me)
CA (1) CA2507002C (me)
EA (1) EA008196B1 (me)
ES (1) ES2544560T3 (me)
HK (2) HK1085131A1 (me)
HR (1) HRP20050544B1 (me)
IL (1) IL169040A (me)
IS (1) IS7929A (me)
ME (2) ME00076B (me)
MX (1) MXPA05006513A (me)
NO (1) NO20053467L (me)
NZ (1) NZ540664A (me)
PL (1) PL220457B1 (me)
RS (1) RS58025B1 (me)
TW (2) TWI382838B (me)
UA (2) UA85359C2 (me)
WO (1) WO2004054574A1 (me)
ZA (1) ZA200504613B (me)

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CN108685867A (zh) * 2017-04-06 2018-10-23 昆明积大制药股份有限公司 一种赛洛多辛薄膜衣片及其制备方法
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EP1574215A4 (en) 2009-07-01
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MEP10808A (en) 2010-06-10
IL169040A (en) 2013-04-30
KR20100133024A (ko) 2010-12-20
RS20050470A (en) 2007-09-21
NZ540664A (en) 2007-09-28
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TWI382838B (zh) 2013-01-21
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EP1574215A1 (en) 2005-09-14
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CA2507002C (en) 2012-09-18
UA85359C2 (ru) 2009-01-12
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