BR112013026473B1 - Comprimido do tipo liberação controlada contendo aceclofenaco - Google Patents
Comprimido do tipo liberação controlada contendo aceclofenaco Download PDFInfo
- Publication number
- BR112013026473B1 BR112013026473B1 BR112013026473-0A BR112013026473A BR112013026473B1 BR 112013026473 B1 BR112013026473 B1 BR 112013026473B1 BR 112013026473 A BR112013026473 A BR 112013026473A BR 112013026473 B1 BR112013026473 B1 BR 112013026473B1
- Authority
- BR
- Brazil
- Prior art keywords
- weight
- tablet
- aceclofenac
- release
- slow
- Prior art date
Links
- 238000013270 controlled release Methods 0.000 title claims abstract description 28
- MNIPYSSQXLZQLJ-UHFFFAOYSA-N Biofenac Chemical compound OC(=O)COC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl MNIPYSSQXLZQLJ-UHFFFAOYSA-N 0.000 claims abstract description 46
- 229960004420 aceclofenac Drugs 0.000 claims abstract description 46
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims abstract description 12
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 12
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 12
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 12
- 229960003943 hypromellose Drugs 0.000 claims abstract description 12
- 239000003085 diluting agent Substances 0.000 claims description 24
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 22
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 15
- 239000003607 modifier Substances 0.000 claims description 15
- 239000011230 binding agent Substances 0.000 claims description 12
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 11
- 235000019359 magnesium stearate Nutrition 0.000 claims description 11
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 10
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 10
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 10
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 10
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 10
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 10
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 10
- 239000003795 chemical substances by application Substances 0.000 claims description 9
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 claims description 9
- 235000012239 silicon dioxide Nutrition 0.000 claims description 9
- 235000010355 mannitol Nutrition 0.000 claims description 8
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 8
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 8
- 229940069328 povidone Drugs 0.000 claims description 8
- 108010010803 Gelatin Proteins 0.000 claims description 6
- 229920000159 gelatin Polymers 0.000 claims description 6
- 239000008273 gelatin Substances 0.000 claims description 6
- 235000019322 gelatine Nutrition 0.000 claims description 6
- 235000011852 gelatine desserts Nutrition 0.000 claims description 6
- 229920000609 methyl cellulose Polymers 0.000 claims description 6
- 239000001923 methylcellulose Substances 0.000 claims description 6
- 235000010981 methylcellulose Nutrition 0.000 claims description 6
- 239000000454 talc Substances 0.000 claims description 6
- 229910052623 talc Inorganic materials 0.000 claims description 6
- 235000012222 talc Nutrition 0.000 claims description 6
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound 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 GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 5
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 5
- 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 description 5
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 5
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 5
- 239000008101 lactose Substances 0.000 claims description 5
- 229920002261 Corn starch Polymers 0.000 claims description 3
- RGHNJXZEOKUKBD-SQOUGZDYSA-M D-gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O RGHNJXZEOKUKBD-SQOUGZDYSA-M 0.000 claims description 3
- 229920002472 Starch Polymers 0.000 claims description 3
- 239000008120 corn starch Substances 0.000 claims description 3
- 229940099112 cornstarch Drugs 0.000 claims description 3
- 229960000913 crospovidone Drugs 0.000 claims description 3
- 229940050410 gluconate Drugs 0.000 claims description 3
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 3
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 3
- 229920001592 potato starch Polymers 0.000 claims description 3
- 229940116317 potato starch Drugs 0.000 claims description 3
- 229940080313 sodium starch Drugs 0.000 claims description 3
- 229940100445 wheat starch Drugs 0.000 claims description 3
- 239000000463 material Substances 0.000 abstract description 11
- 229920001477 hydrophilic polymer Polymers 0.000 abstract description 2
- 239000003826 tablet Substances 0.000 description 48
- 238000010828 elution Methods 0.000 description 14
- 239000003814 drug Substances 0.000 description 13
- 229940079593 drug Drugs 0.000 description 11
- 230000000694 effects Effects 0.000 description 10
- 239000000203 mixture Substances 0.000 description 9
- 230000000052 comparative effect Effects 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 6
- 238000000034 method Methods 0.000 description 5
- 239000011248 coating agent Substances 0.000 description 4
- 238000000576 coating method Methods 0.000 description 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 239000006187 pill Substances 0.000 description 3
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 2
- 230000000202 analgesic effect Effects 0.000 description 2
- 230000003110 anti-inflammatory effect Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000001647 drug administration Methods 0.000 description 2
- 235000019325 ethyl cellulose Nutrition 0.000 description 2
- 229920001249 ethyl cellulose Polymers 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 150000003180 prostaglandins Chemical class 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 230000003637 steroidlike Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 description 1
- 208000008035 Back Pain Diseases 0.000 description 1
- GUBGYTABKSRVRQ-DCSYEGIMSA-N Beta-Lactose Chemical compound OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-DCSYEGIMSA-N 0.000 description 1
- 208000008930 Low Back Pain Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 208000004550 Postoperative Pain Diseases 0.000 description 1
- 102100038280 Prostaglandin G/H synthase 2 Human genes 0.000 description 1
- 108050003267 Prostaglandin G/H synthase 2 Proteins 0.000 description 1
- 208000008765 Sciatica Diseases 0.000 description 1
- 201000002661 Spondylitis Diseases 0.000 description 1
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 206010003246 arthritis Diseases 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 235000019700 dicalcium phosphate Nutrition 0.000 description 1
- 239000007948 fast release tablet Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 229940049654 glyceryl behenate Drugs 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 231100001261 hazardous Toxicity 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 1
- 239000007935 oral tablet Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 239000011593 sulfur Substances 0.000 description 1
- 229910052717 sulfur Inorganic materials 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
Images
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
- A61K9/2072—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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR10-2011-0034022 | 2011-04-13 | ||
KR1020110034022A KR101310099B1 (ko) | 2011-04-13 | 2011-04-13 | 아세클로페낙 함유 방출제어형 정제 |
PCT/KR2012/002769 WO2012141502A2 (fr) | 2011-04-13 | 2012-04-12 | Comprimé de type à libération prolongée contenant de l'aceclofénac |
Publications (3)
Publication Number | Publication Date |
---|---|
BR112013026473A2 BR112013026473A2 (pt) | 2016-12-20 |
BR112013026473A8 BR112013026473A8 (pt) | 2018-01-30 |
BR112013026473B1 true BR112013026473B1 (pt) | 2021-10-13 |
Family
ID=47009839
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112013026473-0A BR112013026473B1 (pt) | 2011-04-13 | 2012-04-12 | Comprimido do tipo liberação controlada contendo aceclofenaco |
Country Status (4)
Country | Link |
---|---|
KR (1) | KR101310099B1 (fr) |
BR (1) | BR112013026473B1 (fr) |
MX (1) | MX346466B (fr) |
WO (1) | WO2012141502A2 (fr) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102236650B1 (ko) * | 2019-04-16 | 2021-04-07 | 한국유나이티드제약 주식회사 | 아세클로페낙을 포함하는 약학조성물 및 이의 제조방법 |
KR102426727B1 (ko) | 2020-04-17 | 2022-07-28 | 성균관대학교산학협력단 | 방출 속도 조절 경구용 약물 전달 장치 및 방출 속도 조절 경구용 약물 전달 장치의 제조 방법 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU9062998A (en) | 1997-09-11 | 1999-03-29 | Nycomed Danmark A/S | Modified release multiple-units compositions of non-steroid anti-inflammatory drug substances (nsaids) |
KR100504013B1 (ko) * | 2003-02-28 | 2005-07-28 | 한국유나이티드제약 주식회사 | 제어방출형 경구 펠렛제제 및 그 제조방법 |
US7442387B2 (en) * | 2003-03-06 | 2008-10-28 | Astellas Pharma Inc. | Pharmaceutical composition for controlled release of active substances and manufacturing method thereof |
US20070092573A1 (en) * | 2005-10-24 | 2007-04-26 | Laxminarayan Joshi | Stabilized extended release pharmaceutical compositions comprising a beta-adrenoreceptor antagonist |
KR100911517B1 (ko) * | 2007-08-31 | 2009-08-10 | 주식회사 드림파마 | 신규한 서방출형 아세클로페낙 제제 조성물 및 그의제조방법 |
KR101076648B1 (ko) * | 2008-12-04 | 2011-10-26 | 한국유나이티드제약 주식회사 | 제어 방출성 아세클로페낙을 함유하는 경구 제제의 조성물 및 그의 제조방법 |
-
2011
- 2011-04-13 KR KR1020110034022A patent/KR101310099B1/ko active IP Right Grant
-
2012
- 2012-04-12 WO PCT/KR2012/002769 patent/WO2012141502A2/fr active Application Filing
- 2012-04-12 BR BR112013026473-0A patent/BR112013026473B1/pt not_active IP Right Cessation
- 2012-04-12 MX MX2013011891A patent/MX346466B/es active IP Right Grant
Also Published As
Publication number | Publication date |
---|---|
MX2013011891A (es) | 2014-03-31 |
BR112013026473A8 (pt) | 2018-01-30 |
MX346466B (es) | 2017-03-22 |
WO2012141502A3 (fr) | 2013-01-03 |
KR20120116545A (ko) | 2012-10-23 |
KR101310099B1 (ko) | 2013-09-23 |
WO2012141502A2 (fr) | 2012-10-18 |
BR112013026473A2 (pt) | 2016-12-20 |
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B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
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Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/04/2012, OBSERVADAS AS CONDICOES LEGAIS. |
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Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2718 DE 07-02-2023 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013. |