DK200100341A - Fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat - Google Patents
Fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat Download PDFInfo
- Publication number
- DK200100341A DK200100341A DK200100341A DKPA200100341A DK200100341A DK 200100341 A DK200100341 A DK 200100341A DK 200100341 A DK200100341 A DK 200100341A DK PA200100341 A DKPA200100341 A DK PA200100341A DK 200100341 A DK200100341 A DK 200100341A
- Authority
- DK
- Denmark
- Prior art keywords
- paroxetine hydrochloride
- hydrochloride anhydrate
- tablets containing
- preparation
- pharmaceutical tablets
- Prior art date
Links
- AHOUBRCZNHFOSL-UHFFFAOYSA-N 3-(1,3-benzodioxol-5-yloxymethyl)-4-(4-fluorophenyl)piperidine Chemical compound C1=CC(F)=CC=C1C1C(COC=2C=C3OCOC3=CC=2)CNCC1 AHOUBRCZNHFOSL-UHFFFAOYSA-N 0.000 title abstract description 15
- 238000000034 method Methods 0.000 title abstract description 14
- 229960005183 paroxetine hydrochloride Drugs 0.000 title abstract description 7
- 238000002360 preparation method Methods 0.000 title description 2
- 239000008187 granular material Substances 0.000 abstract description 8
- 239000000203 mixture Substances 0.000 abstract description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 6
- 239000000546 pharmaceutical excipient Substances 0.000 abstract description 3
- 238000005469 granulation Methods 0.000 abstract description 2
- 230000003179 granulation Effects 0.000 abstract description 2
- 239000007788 liquid Substances 0.000 abstract description 2
- 239000002671 adjuvant Substances 0.000 abstract 1
- 238000005550 wet granulation Methods 0.000 abstract 1
- 238000002156 mixing Methods 0.000 description 5
- 229920002472 Starch Polymers 0.000 description 4
- 239000011230 binding agent Substances 0.000 description 4
- 239000008107 starch Substances 0.000 description 4
- 229940032147 starch Drugs 0.000 description 4
- 235000019698 starch Nutrition 0.000 description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 3
- 239000007884 disintegrant Substances 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 239000008108 microcrystalline cellulose Substances 0.000 description 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 3
- 229940016286 microcrystalline cellulose Drugs 0.000 description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 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 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 229920001531 copovidone Polymers 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 239000008109 sodium starch glycolate Substances 0.000 description 2
- 229940079832 sodium starch glycolate Drugs 0.000 description 2
- 229920003109 sodium starch glycolate Polymers 0.000 description 2
- AHOUBRCZNHFOSL-YOEHRIQHSA-N (+)-Casbol Chemical compound C1=CC(F)=CC=C1[C@H]1[C@H](COC=2C=C3OCOC3=CC=2)CNCC1 AHOUBRCZNHFOSL-YOEHRIQHSA-N 0.000 description 1
- 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 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 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 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 229910000389 calcium phosphate Inorganic materials 0.000 description 1
- 235000011010 calcium phosphates Nutrition 0.000 description 1
- 229960000913 crospovidone Drugs 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000012458 free base Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 229960001855 mannitol Drugs 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 229960002296 paroxetine Drugs 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4525—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Plural Heterocyclic Compounds (AREA)
Description
PATENTKRAV 1. Fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat, kendetegnet ved, at man underkaster krystallinsk paroxetinhydrochlorid-anhydrat sammen med hjælpestoffer omfattende fyldstoffer, sprængningsmidler, bindemidler og vand en blandingsoperation med stor forskydning, - fortsætter blandeprocessen til granulering af den resulterende blanding, - fluidiserer det resulterende granulat i en strøm af opvarmet tørluft til tørring af granulatet, - fortsætter denne tørring, indtil fugtighedsindholdet af granulatet er reduceret i en sådan udstrækning, at vandaktiviteten af granulatet er mellem 0,10 og 0,25 aw, målt som beskrevet heri, om ønsket tilsætter et eller flere yderligere hjælpestoffer, - blander et glidemiddel i dette granulat, og - presser den resulterende blanding til tabletter, hver med et forudbestemt indhold af paroxetinhydrochlorid-anhydrat . 2. Fremgangsmåde ifølge krav 1, kendetegnet ved, at i det mindste en del af binde-midlet og i det mindste en del af vandet tilsættes som en vandig bindemiddelopløsning til en blanding af paroxetinhydrochlorid-anhydrat, fyldstof og sprængningsmiddel, medens blandingen underkastes en blandingsoperation med stor forskydning. 3. Fremgangsmåde ifølge krav 1 eller 2, kendetegnet ved, at granulatet tørres til en vandaktivitet mellem 0,15 og 0,22 aw. 4. Fremgangsmåde ifølge et vilkårligt af de foregående krav, kendetegnet ved, at fyldstoffet omfatter et eller flere af følgende stoffer: Mikrokrystallinsk cellulose, mannitol, calciumphos-phater, lactose, stivelse, sorbitol og succhrose. 5. Fremgangsmåde ifølge et vilkårligt af de foregående krav, kendetegnet ved, at sprængningsmidlet omfatter et eller flere af følgende stoffer: Natrium-stivelse-glycolat, stivelse, forklistret stivelse, crospovidon og mikrokrystallinsk cellulose. 6. Fremgangsmåde ifølge et vilkårligt af de foregående krav, kendetegnet ved, at binde-midlet omfatter et eller flere af følgende stoffer: Polyvinylpyrrolidon, gelatine, stivelse, methylcellu-lose, hydroxypropylcellulose og copovidon. 7. Fremgangsmåde ifølge et vilkårligt af de foregående krav, kendetegnet ved, at krystallinsk paroxetinhydrochlorid-anhydrat, mannitol, mikrokrystallinsk cellulose og natrium-stivelse-glycolat underkastes en blandingsoperation med stor forskydning og samtidig langsomt tilsættes en vandig opløsning af copovidon til opnåelse af den ønskede granulering. 8. Fremgangsmåde ifølge krav 7, kendetegnet ved, at nævnte vandige opløsning og, om nødvendigt, yderligere vand tilsættes i en sådan mængde, at der opnås et fugtighedsindhold i den granulerede blanding på 10-30 vægt%. 9. Fremgangsmåde ifølge et vilkårligt af de foregående krav, kendetegnet ved, at de fremstillede tabletter hver har en vægt mellem 100 og 600 mg, og hver indeholder fra 10 til 60 mg paroxe-tin, beregnet som den frie base. 10. Fremgangsmåde ifølge et vilkårligt af de foregående krav, kendetegnet ved, at tabletterne, som dannes ved presningen, underkastes en coating-operation under anvendelse af en vanding coating-væske .
Priority Applications (13)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK200100341A DK200100341A (da) | 2001-03-02 | 2001-03-02 | Fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat |
| SI200230154T SI1363633T1 (en) | 2001-03-02 | 2002-03-01 | A wet granulation process for the manufacture of pharmaceutical tablets containing paroxetine hydrochloride anhydrate |
| AU2002233182A AU2002233182B2 (en) | 2001-03-02 | 2002-03-01 | A process for the manufacture of pharmaceutical tablets containing paroxetine hydrochloride anhydrate |
| PCT/DK2002/000134 WO2002069969A1 (en) | 2001-03-02 | 2002-03-01 | A process for the manufacture of pharmaceutical tablets containing paroxetine hydrochloride anhydrate |
| CA002439460A CA2439460A1 (en) | 2001-03-02 | 2002-03-01 | A process for the manufacture of pharmaceutical tablets containing paroxetine hydrochloride anhydrate |
| ES02700190T ES2239707T3 (es) | 2001-03-02 | 2002-03-01 | Procedimiento de granulacion por via humeda para la preparacion de tabletas farmaceuticas que contienen anhidrato de hidrocloruro de paroxetina. |
| US10/469,031 US20040072912A1 (en) | 2001-03-02 | 2002-03-01 | Process for the manufacture of pharmaceutical tablets contaning paroxetine hydrochloride anhydrate |
| DK02700190T DK1363633T3 (da) | 2001-03-02 | 2002-03-01 | Vådgranulerings-fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat |
| EP02700190A EP1363633B1 (en) | 2001-03-02 | 2002-03-01 | A wet granulation process for the manufacture of pharmaceutical tablets containing paroxetine hydrochloride anhydrate |
| PT02700190T PT1363633E (pt) | 2001-03-02 | 2002-03-01 | Processo de granulacao humido para a preparacao de comprimidos farmaceuticos contendo anidrato do cloridrato de paroxetina |
| DE60203997T DE60203997T2 (de) | 2001-03-02 | 2002-03-01 | Nasses granulationsverfahren zur herstellung von pharmazeutischen tabletten mit paroxetinhydrochlorid anhydrat |
| AT02700190T ATE294580T1 (de) | 2001-03-02 | 2002-03-01 | Nasses granulationsverfahren zur herstellung von pharmazeutischen tabletten mit paroxetinhydrochlorid anhydrat |
| NO20033855A NO20033855D0 (no) | 2001-03-02 | 2003-09-01 | Fremgangsmåte ved fremstilling av farmasöytiske tabletter inneholdende paroxetinhydrokloridanhydrat |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK200100341A DK200100341A (da) | 2001-03-02 | 2001-03-02 | Fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK200100341A true DK200100341A (da) | 2002-09-03 |
Family
ID=8160333
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK200100341A DK200100341A (da) | 2001-03-02 | 2001-03-02 | Fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat |
| DK02700190T DK1363633T3 (da) | 2001-03-02 | 2002-03-01 | Vådgranulerings-fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK02700190T DK1363633T3 (da) | 2001-03-02 | 2002-03-01 | Vådgranulerings-fremgangsmåde til fremstilling af farmaceutiske tabletter indeholdende paroxetinhydrochlorid-anhydrat |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20040072912A1 (da) |
| EP (1) | EP1363633B1 (da) |
| AT (1) | ATE294580T1 (da) |
| AU (1) | AU2002233182B2 (da) |
| CA (1) | CA2439460A1 (da) |
| DE (1) | DE60203997T2 (da) |
| DK (2) | DK200100341A (da) |
| ES (1) | ES2239707T3 (da) |
| NO (1) | NO20033855D0 (da) |
| PT (1) | PT1363633E (da) |
| WO (1) | WO2002069969A1 (da) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1465601A4 (en) | 2001-12-28 | 2006-02-15 | Teva Pharma | STABLE PHARMACEUTICAL FORMULATION OF PAROXETINE ANHYDROUS HYDROCHLORIDE AND PREPARATION METHOD |
| US20040208932A1 (en) * | 2003-04-17 | 2004-10-21 | Ramachandran Thembalath | Stabilized paroxetine hydrochloride formulation |
| EP1675574A2 (en) * | 2003-10-08 | 2006-07-05 | Ranbaxy Laboratories, Ltd. | Pharmaceutical compositions of paroxetine containing microcrystalline cellulose, prepared by wet granulation |
| WO2006076797A1 (en) * | 2005-01-19 | 2006-07-27 | Merck Frosst Canada Ltd. | Cathepsin k inhibitors and atherosclerosis |
| AU2006274565B2 (en) * | 2005-08-02 | 2012-05-17 | Lupin Limited | Novel controlled release compositions of selective serotonin reuptake inhibitors |
| CN113350350A (zh) * | 2020-03-07 | 2021-09-07 | 齐鲁制药有限公司 | 一种含有盐酸培唑帕尼的药物组合物的制备方法 |
| CN113730369B (zh) * | 2020-05-27 | 2023-07-14 | 石药集团欧意药业有限公司 | 一种阿哌沙班片剂组合物及其制备方法 |
| WO2024088560A1 (en) * | 2022-10-28 | 2024-05-02 | Roquette Freres | Compound for formulating moisture sensitive active ingredients |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999048499A1 (en) * | 1998-03-24 | 1999-09-30 | Smithkline Beecham Plc | Paroxetine compositions |
| WO2000078288A2 (en) * | 1999-06-22 | 2000-12-28 | Smithkline Beecham P.L.C. | Novel process for paroxetine compositions |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0149266B1 (en) * | 1983-12-19 | 1988-05-18 | Duphar International Research B.V | Method of drying a solid and device therefor |
| US5856493A (en) * | 1995-02-06 | 1999-01-05 | Smithkline Beecham Corporation | Process for making novel form of paroxeting hydrochloride anhydrate |
| GB0003232D0 (en) * | 2000-02-11 | 2000-04-05 | Smithkline Beecham Plc | Novel composition |
| US6660298B1 (en) * | 2000-07-27 | 2003-12-09 | Pentech Pharmaceuticals, Inc. | Paroxetine tablets and capsules |
| HUP0303827A2 (hu) * | 2000-08-28 | 2004-04-28 | Synthon B.V. | Paroxetinkészítmények és eljárások ezek előállítására |
-
2001
- 2001-03-02 DK DK200100341A patent/DK200100341A/da not_active Application Discontinuation
-
2002
- 2002-03-01 ES ES02700190T patent/ES2239707T3/es not_active Expired - Lifetime
- 2002-03-01 AU AU2002233182A patent/AU2002233182B2/en not_active Ceased
- 2002-03-01 DK DK02700190T patent/DK1363633T3/da active
- 2002-03-01 US US10/469,031 patent/US20040072912A1/en not_active Abandoned
- 2002-03-01 CA CA002439460A patent/CA2439460A1/en not_active Abandoned
- 2002-03-01 DE DE60203997T patent/DE60203997T2/de not_active Expired - Fee Related
- 2002-03-01 AT AT02700190T patent/ATE294580T1/de not_active IP Right Cessation
- 2002-03-01 EP EP02700190A patent/EP1363633B1/en not_active Expired - Lifetime
- 2002-03-01 WO PCT/DK2002/000134 patent/WO2002069969A1/en not_active Application Discontinuation
- 2002-03-01 PT PT02700190T patent/PT1363633E/pt unknown
-
2003
- 2003-09-01 NO NO20033855A patent/NO20033855D0/no not_active Application Discontinuation
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999048499A1 (en) * | 1998-03-24 | 1999-09-30 | Smithkline Beecham Plc | Paroxetine compositions |
| WO2000078288A2 (en) * | 1999-06-22 | 2000-12-28 | Smithkline Beecham P.L.C. | Novel process for paroxetine compositions |
Also Published As
| Publication number | Publication date |
|---|---|
| DE60203997T2 (de) | 2006-02-23 |
| ES2239707T3 (es) | 2005-10-01 |
| CA2439460A1 (en) | 2002-09-12 |
| ATE294580T1 (de) | 2005-05-15 |
| EP1363633B1 (en) | 2005-05-04 |
| AU2002233182B2 (en) | 2004-10-14 |
| DK1363633T3 (da) | 2005-05-30 |
| WO2002069969A1 (en) | 2002-09-12 |
| NO20033855L (no) | 2003-09-01 |
| DE60203997D1 (de) | 2005-06-09 |
| PT1363633E (pt) | 2005-09-30 |
| US20040072912A1 (en) | 2004-04-15 |
| EP1363633A1 (en) | 2003-11-26 |
| NO20033855D0 (no) | 2003-09-01 |
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