HRP20130114T4 - Farmaceutski oblik s brzim oslobađanjem sinakalcet hci - Google Patents

Farmaceutski oblik s brzim oslobađanjem sinakalcet hci Download PDF

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Publication number
HRP20130114T4
HRP20130114T4 HRP20130114TT HRP20130114T HRP20130114T4 HR P20130114 T4 HRP20130114 T4 HR P20130114T4 HR P20130114T T HRP20130114T T HR P20130114TT HR P20130114 T HRP20130114 T HR P20130114T HR P20130114 T4 HRP20130114 T4 HR P20130114T4
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Croatia
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HRP20130114TT
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English (en)
Inventor
Francisco J. Alvarez
Glen Gary Lawrence
Hung-Ren Lin
Tzuchi R. Ju
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Amgen Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34434844&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20130114(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc. filed Critical Amgen Inc.
Publication of HRP20130114T1 publication Critical patent/HRP20130114T1/hr
Publication of HRP20130114T4 publication Critical patent/HRP20130114T4/hr

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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
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • 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
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • A61P5/20Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH

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  • 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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (24)

1. Farmaceutska smjesa koja sadrži (a) od 10% do 40% težinski sinakalcet HCl; (b) od 45% do 85% težinski barem jednog punila; i (c) od 1% do 5% težinski barem jednog veziva; gdje se težinski postotak odnosi na ukupnu masu smjese, pri čemu je najmanje jedno vezivo izabrano između povidona, hidroksipropil metilceluloze, dihidroksi propilceluloze,i natrijeve karboksil metilceluloze, i pri čemu je najmanje jedan razrjeđivač mješavina mikrokristalne celuloze i škroba, a pri čemu je mikrokristalna celuloza je prisutna u količini od 40 do 75 masenih%, a škrob je prisutan u količini od 5% do 10% po težini, u odnosu na ukupnu masu smjese.
2. Smjesa prema zahtjevu 1 koja dalje sadrži od 1% do 10% težinski barem jednog sredstva za raspadanje, gdje se težinski postotak odnosi na ukupnu masu smjese.
3. Smjesa prema zahtjevu 1 koja dalje sadrži od 0.05% do 5% barem jednog aditiva izabranog između sredstava za klizenje, lubrikanta i sredstva za prianjanje, gdje se težinski postotak odnosi na ukupnu masu smjese.
4. Smjesa prema zahtjevu 1 koja sadrži od 0.05% do 1.5% težinski barem jednog sredstva za klizenje.
5. Smjesa prema zahtjevu 1 koja sadrži od 0.05% do 1.5% težinski sredstva za prianjanje.
6. Smjesa prema zahtjevu 1 koja dalje sadrži barem jedan sastojak izabran između lubrikanta i bezbojnih i obojenih materijala za oblaganje.
7. Smjesa prema zahtjevu 1, gdje je sinakalcet HCl u obliku izbranom između amorfnih prašaka, kristalnih čestica, matriks čestica i bilo kakvih njihovih mješavina.
8. Smjesa prema zahtjevu 1, gdje je sinakalcet HCl u obliku izbranom između čestica u obliku igala, čestica u obliku štapića, čestica u obliku pločica i bilo kakvih njihovih mješavina.
9. Smjesa prema zahtjevu 8, gdje je D50 čestica sinakalcet HCl manji ili jednak 50 µm.
10. Smjesa prema zahtjevu 1, gdje je smjesa u obliku granula.
11. Smjesa prema zahtjevu 1, gdje je smjesa u obliku izbranom između tableta, kapsula i praška.
12. Smjesa prema zahtjevu 10, gdje granule imaju D50 izmjeren pomoću analize sitom u rasponu od 50 µm do 150 µm, poželjno od 80 µm do 130 µm.
13. Smjesa prema zahtjevu 1, gdje je sinakalcet HCl prisutan u količini u rasponu od 15% do 20%, težinski u odnosu na ukupnu masu smjese.
14. Smjesa prema zahtjevu 1, gdje je barem jedno vezivno sredstvo povidon.
15. Smjesa prema zahtjevu 14, gdje je povidon prisutan u količini u rasponu od 1% do 5% težinski u odnosu na ukupnu masu smjese.
16. Smjesa prema zahtjevu 1, gdje je barem jedno sredstvo za raspadanje krospovidon.
17. Smjesa prema zahtjevu 16, gdje je krospovidon prisutan intergranularno, intragranularno, ili u kombinaciji istih.
18. Smjesa prema zahtjevu 1, nadalje sadrži od 1% do 6% po težini barem jednog pokrivnog materijala odabranih između prozirnih i obojanih pokrivnih materijala u odnosu na ukupnu težinu smjese.
19. Smjesa prema zahtjevu 1, pri čemu je cinakalcet HCl prisutan u terapeutski učinkovitoj količini ili učinkovitoj dozi za liječenje barem jednog od hiperparatireoidizma, hiperfosfonije, hiperkalcemije, i povišen produkt kalcijevog fosfora.
20. Smjesa prema zahtjevu 19, pri čemu je hiperparatiroidizam odabran između primarnog hiperparatireoidizma i sekundarnog hiperparatiroidizma.
21. Smjesa prema zahtjevu 1 pri čemu efektivna količina doze ili terapeutski učinkovita količina cinakalceta HCl kreće se od 1 mg do 360 mg, poželjno od 5 mg do 240 mg, poželjnije od 20 mg do 100 mg, ili se bira između 5 mg, 15 mg, 30 mg , 50 mg, 60 mg, 75 mg, 90 mg, 120 mg, 150 mg, 180 mg, 210 mg, 240 mg, 300 mg i 360 mg.
22. Uporaba učinkovite dozirajuće količine pripravka u skladu s patentnim zahtjevom 1, za dobivanje lijeka za liječenje pacijenta koji pati od najmanje jedne bolesti izabrane od hiperparatiroidizma, hiperfosfonije, hiperkalcemije i povišenog proizvoda kalcijevog fosfora.
23. Uporaba u skladu s patentnim zahtjevom 22, naznačena time što je pacijent čovjek.
24. Upotreba u skladu s patentnim zahtjevom 22, naznačena time što je učinkovita dozirajuća količina farmaceutskog pripravka odabrana između 5 mg, 15 mg, 30 mg, 50 mg, 60 mg, 75 mg, 90 mg, 120 mg, 150 mg, 180 mg, 210 mg, 240 mg, 300 mg, 360 mg.
HRP20130114TT 2003-09-12 2013-02-08 Farmaceutski oblik s brzim oslobađanjem sinakalcet hci HRP20130114T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US50221903P 2003-09-12 2003-09-12
EP04781429.8A EP1663182B2 (en) 2003-09-12 2004-09-10 RAPID DISSOLUTION FORMULATION OF CINACALCET HCl
PCT/US2004/026732 WO2005034928A1 (en) 2003-09-12 2004-09-10 Rapid dissolution formulation of a calcium receptor-active compound

Publications (2)

Publication Number Publication Date
HRP20130114T1 HRP20130114T1 (en) 2013-03-31
HRP20130114T4 true HRP20130114T4 (hr) 2019-12-27

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ID=34434844

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20130114TT HRP20130114T4 (hr) 2003-09-12 2013-02-08 Farmaceutski oblik s brzim oslobađanjem sinakalcet hci

Country Status (30)

Country Link
US (7) US7829595B2 (hr)
EP (8) EP3395338B1 (hr)
JP (3) JP5026077B2 (hr)
KR (1) KR101332058B1 (hr)
CN (1) CN1946382B (hr)
AR (1) AR045637A1 (hr)
AU (1) AU2004279318C1 (hr)
BR (2) BR122018013029B1 (hr)
CA (1) CA2536487C (hr)
CY (5) CY1119609T1 (hr)
DE (1) DE19164145T1 (hr)
DK (6) DK3260117T3 (hr)
EA (1) EA013425B1 (hr)
ES (7) ES2735226T3 (hr)
HR (1) HRP20130114T4 (hr)
HU (5) HUE045411T2 (hr)
IL (1) IL173737A (hr)
IS (1) IS3027B (hr)
MX (1) MXPA06002616A (hr)
MY (1) MY142046A (hr)
NO (1) NO335739B1 (hr)
NZ (1) NZ545498A (hr)
PL (6) PL1663182T5 (hr)
PT (6) PT2821067T (hr)
SG (1) SG146608A1 (hr)
SI (6) SI3395340T1 (hr)
TR (4) TR201910447T4 (hr)
TW (1) TWI344363B (hr)
WO (1) WO2005034928A1 (hr)
ZA (1) ZA200602710B (hr)

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