HRP20161210T4 - Formulacija obložene tablete i postupak - Google Patents
Formulacija obložene tablete i postupak Download PDFInfo
- Publication number
- HRP20161210T4 HRP20161210T4 HRP20161210TT HRP20161210T HRP20161210T4 HR P20161210 T4 HRP20161210 T4 HR P20161210T4 HR P20161210T T HRP20161210T T HR P20161210TT HR P20161210 T HRP20161210 T HR P20161210T HR P20161210 T4 HRP20161210 T4 HR P20161210T4
- Authority
- HR
- Croatia
- Prior art keywords
- coating
- tablet
- coated tablet
- polymer
- pva
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 3
- 239000007916 tablet composition Substances 0.000 title 1
- 239000011247 coating layer Substances 0.000 claims 13
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 12
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 12
- 239000011248 coating agent Substances 0.000 claims 9
- 238000000576 coating method Methods 0.000 claims 9
- 229920001688 coating polymer Polymers 0.000 claims 9
- 229920000642 polymer Polymers 0.000 claims 8
- 239000010410 layer Substances 0.000 claims 7
- 239000004014 plasticizer Substances 0.000 claims 7
- 238000009472 formulation Methods 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- 150000003839 salts Chemical class 0.000 claims 5
- QGJUIPDUBHWZPV-SGTAVMJGSA-N saxagliptin Chemical compound C1C(C2)CC(C3)CC2(O)CC13[C@H](N)C(=O)N1[C@H](C#N)C[C@@H]2C[C@@H]21 QGJUIPDUBHWZPV-SGTAVMJGSA-N 0.000 claims 5
- 229960004937 saxagliptin Drugs 0.000 claims 5
- 108010033693 saxagliptin Proteins 0.000 claims 5
- 238000007789 sealing Methods 0.000 claims 5
- 239000003814 drug Substances 0.000 claims 4
- 229940079593 drug Drugs 0.000 claims 3
- 238000001035 drying Methods 0.000 claims 3
- 239000011253 protective coating Substances 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000008199 coating composition Substances 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 229960001021 lactose monohydrate Drugs 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 229940057948 magnesium stearate Drugs 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 239000011241 protective layer Substances 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
Classifications
-
- 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
-
- 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
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- 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
- A61K31/40—Heterocyclic 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
- A61K31/403—Heterocyclic 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
-
- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
-
- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
-
- 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
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
-
- 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
Claims (12)
1. Obložena tableta naznačena time da sadrži jezgru tablete i.
a) unutrašnji brtveni sloj premaza koji je obložen oko jezgre tablete, koji sadrži formulaciju polimera za oblaganje koji sadrži polimer temeljen na polivinilalkoholu (PVA) i plastifikator;
b) drugi sloj premaza koji sadrži lijek obložen na unutrašnji brtveni sloj premaza koji oblaže jezgru tablete, te drugi sloj premaza sadrži saksagliptin
ili njegovu farmaceutski prihvatljivu sol i formulaciju polimera za oblaganje koja sadrži polimer koji se temelji na PVA i plastifikator; i
c) vanjski zaštitni sloj premaza koji oblaže drugi sloj premaza jezgre tablete, pri čemu navedeni vanjski zaštitni sloj premaza sadrži formulaciju sloja premaza koja sadrži polimer koji se temelji na PVA i plastifikator,
te naznačena time da drugi sloj premaza sadrži od 0.1 do 70% težinski lijeka i od 30 do 99.5% težinski polimera za oblaganje, bazirano na težini drugog sloja premaza.
2. Obložena tableta kako je definirano u zahtjevu 1 naznačena time da je formulacija polimera za oblaganje u drugom sloju premaza najmanje oko 2 mg uz jezgru tablete od 200 mg, a saksagliptin ili njegova farmaceutski prihvatljiva sol je najmanje oko 0.2 mg uz jezgru tablete od 200 mg.
3. Obložena tableta kako je definirano u zahtjevu 1 naznačena time da je polimer baziran na PVA u drugom sloju premaza isti kao polimer baziran na PVA u drugim slojevima premaza.
4. Obložena tableta kako je definirano u zahtjevu 1 naznačena time da se polimer baziran na PVA sastoji od polivinil alkohola.
5. Obložena tableta kako je definirano u zahtjevu 1 naznačena time da je u drugom sloju premaza saksagliptin ili njegova farmaceutski prihvatljiva sol prisutan u količini koja je u rasponu od 0.2 do 140 mg i polimer za oblaganje je prisutan u količini koja je u rasponu od 2 do 140 mg, i u svakom unutrašnjem brtvenom sloju premaza i vanjskom zaštitnom sloju premaza, polimer za oblaganje je prisutan u količini u granicama od oko 1 do oko 100 mg.
6. Obložena tableta kako je definirano u zahtjevu 1 naznačena time da se jezgra tablete sastoji od jednog ili više punila, proizvoljno jednog ili više vezivnih sredstava, proizvoljno jednog ili više sredstava za razgradnju i proizvoljno jednog ili više sredstava za povećanje skliskosti za tabletiranje.
7. Obložena tableta kako je definirano u zahtjevu 6 naznačena time da se jezgra tablete sastoji od mikrokristalinične celuloze, laktoza monohidrata, kroskarmeloza natrija, te magnezijevog stearata.
8. Obložena tableta kako je definirano u zahtjevu 1, naznačena time da se početna tableta koristi umjesto jezgre tablete.
9. Obložena tableta kako je definirano u zahtjevu 8, naznačena time da početna tableta je tableta drugog lijeka.
10. Obložena tableta kako je definirana u zahtjevu 1, naznačena time, što se za snagu od 2,5 mg, sloj za oblaganje sastoji od 2,5 mg saksagliptina ili njegove farmaceutski prihvatljive soli i 20 mg premaza na bazi polimera.
11. Postupak za pripremanje obložene tablete kako je definirano u zahtjevu 1 naznačen time da sadrži:
a) osiguravanje jezgre tablete;
b) obložena tableta s formulacijom unutrašnjeg brtvenog sloja premaza koja sadrži najmanje jedan polimer koji je baziran na PVA i plastifikator;
c) sušenje obložene tablete da se na njoj stvori unutrašnji brtveni premaz;
d) oblaganje tako obložene tablete s formulacijom drugog sloja premaza koja sadrži lijek koji je saksagliptin ili njegova farmaceutski prihvatljiva sol i najmanje jedan polimer za oblaganje koji se temelji na PVA i plastifikator;
e) sušenje tako obložene tablete da se na njoj stvori drugi sloj premaza; i
f) oblaganje tako obložene tablete s formulacijom trećeg vanjskog zaštitnog sloja premaza koja sadrži najmanje jedan polimer za oblaganje koji se temelji na PVA i plastifikator; i
g) sušenje tako obložene tablete da se oblikuje obložena tablete prema izumu.
12. Postupak kao što je definirano u patentnom zahtjevu 11, naznačen time da se slojevi za oblaganje primjenjuju kao suspenzija polimera za oblaganje koji se temelji na PVA i plastifikatora.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US57531904P | 2004-05-28 | 2004-05-28 | |
EP10179007.9A EP2298288B2 (en) | 2004-05-28 | 2005-05-26 | Coated tablet formulation and method |
Publications (2)
Publication Number | Publication Date |
---|---|
HRP20161210T1 HRP20161210T1 (hr) | 2016-11-18 |
HRP20161210T4 true HRP20161210T4 (hr) | 2019-08-09 |
Family
ID=34971747
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20160880TT HRP20160880T4 (hr) | 2004-05-28 | 2016-07-15 | Formulacija obložene tablete i postupak |
HRP20161210TT HRP20161210T4 (hr) | 2004-05-28 | 2016-09-21 | Formulacija obložene tablete i postupak |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20160880TT HRP20160880T4 (hr) | 2004-05-28 | 2016-07-15 | Formulacija obložene tablete i postupak |
Country Status (33)
Country | Link |
---|---|
US (4) | US7951400B2 (hr) |
EP (3) | EP3078369B1 (hr) |
JP (1) | JP4901727B2 (hr) |
KR (2) | KR20120064141A (hr) |
CN (2) | CN1988891B (hr) |
AR (2) | AR049062A1 (hr) |
AU (1) | AU2005249467B2 (hr) |
BR (1) | BRPI0510419B8 (hr) |
CA (1) | CA2568391C (hr) |
CY (2) | CY1117813T1 (hr) |
DK (2) | DK1753406T4 (hr) |
ES (3) | ES2582646T5 (hr) |
GE (1) | GEP20094639B (hr) |
HK (2) | HK1155399A1 (hr) |
HR (2) | HRP20160880T4 (hr) |
HU (2) | HUE029446T2 (hr) |
IL (2) | IL179454A (hr) |
LT (1) | LT2298288T (hr) |
ME (2) | ME02516B (hr) |
MX (1) | MXPA06013711A (hr) |
MY (1) | MY147639A (hr) |
NO (1) | NO343907B1 (hr) |
NZ (1) | NZ551591A (hr) |
PE (1) | PE20060425A1 (hr) |
PL (2) | PL1753406T5 (hr) |
PT (2) | PT1753406E (hr) |
RS (2) | RS54929B2 (hr) |
RU (1) | RU2372894C2 (hr) |
SI (3) | SI1753406T2 (hr) |
TW (2) | TWI415635B (hr) |
UA (1) | UA88168C2 (hr) |
WO (1) | WO2005117841A1 (hr) |
ZA (1) | ZA200609541B (hr) |
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US7407955B2 (en) | 2002-08-21 | 2008-08-05 | Boehringer Ingelheim Pharma Gmbh & Co., Kg | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
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GB0526291D0 (en) * | 2005-12-23 | 2006-02-01 | Prosidion Ltd | Therapeutic method |
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EA015687B1 (ru) | 2006-05-04 | 2011-10-31 | Бёрингер Ингельхайм Интернациональ Гмбх | Полиморфы |
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PE20080251A1 (es) | 2006-05-04 | 2008-04-25 | Boehringer Ingelheim Int | Usos de inhibidores de dpp iv |
US20070172525A1 (en) * | 2007-03-15 | 2007-07-26 | Ramesh Sesha | Anti-diabetic combinations |
US20080064701A1 (en) * | 2007-04-24 | 2008-03-13 | Ramesh Sesha | Anti-diabetic combinations |
ATE550319T1 (de) * | 2007-03-22 | 2012-04-15 | Kyorin Seiyaku Kk | Verfahren zur herstellung eines aminoacetylpyrrolidincarbonitrilderivats |
PE20090185A1 (es) | 2007-03-22 | 2009-02-28 | Bristol Myers Squibb Co | Formulaciones farmaceuticas que contienen un inhibidor sglt2 |
PE20090696A1 (es) * | 2007-04-20 | 2009-06-20 | Bristol Myers Squibb Co | Formas cristalinas de saxagliptina y procesos para preparar las mismas |
AU2008268537B2 (en) * | 2007-06-22 | 2012-11-01 | Bristol-Myers Squibb Holdings Ireland | Tableted compositions containing atazanavir |
KR20100033379A (ko) * | 2007-06-22 | 2010-03-29 | 브리스톨-마이어스 스큅 컴퍼니 | 아타자나비르를 함유하는 정제 조성물 |
AU2008268625B2 (en) * | 2007-06-22 | 2013-11-28 | Bristol-Myers Squibb Holdings Ireland Unlimited Company | Tableted compositions containing atazanavir |
EP2178511B1 (en) * | 2007-06-22 | 2011-03-02 | Bristol-Myers Squibb Company | Tableted compositions containing atazanavir |
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- 2016-07-19 CY CY20161100703T patent/CY1117813T1/el unknown
- 2016-09-21 HR HRP20161210TT patent/HRP20161210T4/hr unknown
- 2016-09-22 CY CY20161100945T patent/CY1118162T1/el unknown
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