HRP20130114T4 - Farmaceutski oblik s brzim oslobađanjem sinakalcet hci - Google Patents
Farmaceutski oblik s brzim oslobađanjem sinakalcet hci Download PDFInfo
- 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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- Prior art keywords
- mixture
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- total mass
- amount
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Links
- 239000000203 mixture Substances 0.000 title claims 35
- VDHAWDNDOKGFTD-MRXNPFEDSA-N cinacalcet Chemical compound N([C@H](C)C=1C2=CC=CC=C2C=CC=1)CCCC1=CC=CC(C(F)(F)F)=C1 VDHAWDNDOKGFTD-MRXNPFEDSA-N 0.000 title 1
- 229960003315 cinacalcet Drugs 0.000 title 1
- 238000004090 dissolution Methods 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- QANQWUQOEJZMLL-PKLMIRHRSA-N cinacalcet hydrochloride Chemical compound Cl.N([C@H](C)C=1C2=CC=CC=C2C=CC=1)CCCC1=CC=CC(C(F)(F)F)=C1 QANQWUQOEJZMLL-PKLMIRHRSA-N 0.000 claims 7
- 239000002245 particle Substances 0.000 claims 6
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 5
- 201000002980 Hyperparathyroidism Diseases 0.000 claims 3
- 239000011230 binding agent Substances 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 239000000463 material Substances 0.000 claims 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 3
- 229940069328 povidone Drugs 0.000 claims 3
- 208000037147 Hypercalcaemia Diseases 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- 229920002472 Starch Polymers 0.000 claims 2
- MWKXCSMICWVRGW-UHFFFAOYSA-N calcium;phosphane Chemical compound P.[Ca] MWKXCSMICWVRGW-UHFFFAOYSA-N 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 229960000913 crospovidone Drugs 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 239000008187 granular material Substances 0.000 claims 2
- 230000000148 hypercalcaemia Effects 0.000 claims 2
- 208000030915 hypercalcemia disease Diseases 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 2
- 239000000843 powder Substances 0.000 claims 2
- 235000019698 starch Nutrition 0.000 claims 2
- 239000008107 starch Substances 0.000 claims 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 1
- 206010020707 Hyperparathyroidism primary Diseases 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 201000000981 Primary Hyperparathyroidism Diseases 0.000 claims 1
- 208000005770 Secondary Hyperparathyroidism Diseases 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 230000000996 additive effect Effects 0.000 claims 1
- 239000000853 adhesive Substances 0.000 claims 1
- 230000001070 adhesive effect Effects 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 238000005029 sieve analysis Methods 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
Classifications
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- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
-
- 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
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
- A61P5/20—Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH
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)
- 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.
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 |
Family
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) |
Families Citing this family (63)
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US20100074949A1 (en) * | 2008-08-13 | 2010-03-25 | William Rowe | Pharmaceutical composition and administration thereof |
DK3260117T3 (da) | 2003-09-12 | 2019-07-01 | Amgen Inc | Hurtigt opløsende formulering, der omfatter cinacalcet-hcl |
CN101006076B (zh) | 2004-06-24 | 2010-09-29 | 沃泰克斯药物股份有限公司 | Atp-结合弹夹转运蛋白的调控剂 |
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JP5409010B2 (ja) | 2005-12-28 | 2014-02-05 | バーテックス ファーマシューティカルズ インコーポレイテッド | N−[2,4−ビス(1,1−ジメチルエチル)−5−ヒドロキシフェニル]−1,4−ジヒドロ−4−オキソキノリン−3−カルボキサミドの固体形態 |
US8426391B2 (en) | 2006-02-03 | 2013-04-23 | Proventiv Therapeutics, Llc | Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 |
EP2001832A1 (en) * | 2006-03-23 | 2008-12-17 | Amgen Inc. | Methods and compositions for making and using polymorphs of cinacalcet |
KR20080011320A (ko) * | 2006-04-27 | 2008-02-01 | 테바 파마슈티컬 인더스트리즈 리미티드 | 시나칼셋 염기의 제조 방법 |
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US20080181959A1 (en) * | 2006-09-01 | 2008-07-31 | Ilan Zalit | Solid composites of a calcium receptor-active compound |
US20080146845A1 (en) * | 2006-11-20 | 2008-06-19 | Boaz Gome | Process for preparing Cinacalcet |
WO2008064202A2 (en) * | 2006-11-20 | 2008-05-29 | Dr. Reddy's Labortories, Ltd. | Modified-release formulations of calcium receptor-active compounds |
TWI573802B (zh) | 2007-03-06 | 2017-03-11 | 安美基公司 | 變異之活動素受體多肽及其用途 |
CA2701638A1 (en) * | 2007-04-02 | 2008-10-09 | Concert Pharmaceuticals Inc. | Pharmaceutical calcimimetics |
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EP2821400B1 (en) | 2009-03-20 | 2017-09-27 | Vertex Pharmaceuticals Incorporated | Process for making modulators of cystic fibrosis transmembrane conductance regulator |
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EP2435404A1 (en) | 2009-05-27 | 2012-04-04 | Leo Pharma A/S | Novel calcium sensing receptor modulating compounds and pharmaceutical use thereof |
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