AR062509A1 - PROCESS TO PREPARE PRAMIPEXOL DIHYDROCLORIDE TABLETS - Google Patents
PROCESS TO PREPARE PRAMIPEXOL DIHYDROCLORIDE TABLETSInfo
- Publication number
- AR062509A1 AR062509A1 ARP070103757A ARP070103757A AR062509A1 AR 062509 A1 AR062509 A1 AR 062509A1 AR P070103757 A ARP070103757 A AR P070103757A AR P070103757 A ARP070103757 A AR P070103757A AR 062509 A1 AR062509 A1 AR 062509A1
- Authority
- AR
- Argentina
- Prior art keywords
- tablets
- pramipexole dihydrochloride
- solution
- fluid bed
- tablet forming
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 2
- FASDKYOPVNHBLU-ZETCQYMHSA-N pramipexole Chemical compound C1[C@@H](NCCC)CCC2=C1SC(N)=N2 FASDKYOPVNHBLU-ZETCQYMHSA-N 0.000 title 1
- 229960002652 pramipexole dihydrochloride Drugs 0.000 abstract 6
- VQMNWIMYFHHFMC-UHFFFAOYSA-N tert-butyl 4-hydroxyindole-1-carboxylate Chemical compound C1=CC=C2N(C(=O)OC(C)(C)C)C=CC2=C1O VQMNWIMYFHHFMC-UHFFFAOYSA-N 0.000 abstract 6
- 239000000203 mixture Substances 0.000 abstract 5
- 239000011230 binding agent Substances 0.000 abstract 3
- 239000012530 fluid Substances 0.000 abstract 3
- 239000004615 ingredient Substances 0.000 abstract 3
- 239000000243 solution Substances 0.000 abstract 3
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 238000004519 manufacturing process Methods 0.000 abstract 2
- 239000002245 particle Substances 0.000 abstract 2
- 239000012453 solvate Substances 0.000 abstract 2
- 239000000725 suspension Substances 0.000 abstract 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 239000008187 granular material Substances 0.000 abstract 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract 1
- 229940069328 povidone Drugs 0.000 abstract 1
- 238000004321 preservation Methods 0.000 abstract 1
- 239000007921 spray Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 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
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/428—Thiazoles condensed with carbocyclic rings
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Psychology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
En particular, se refiere a un proceso para preparar comprimidos de dihidrocloruro de pramipexol, en el que los comprimidos muestran elevadas propiedades de estabilidad de conservacion. Reivindicacion 1: Un proceso para preparar comprimidos de dihidrocloruro de pramipexol que comprenden ingredientes de formacion de comprimidos intragranulares, dihidrocloruro de pramipexol o su solvato farmacéuticamente aceptable, un ligante y agentes de formacion de comprimidos extragranulares, en el que el proceso se realiza en un sistema cerrado, y comprende las etapas de: (a) cargar partículas de los ingredientes de formacion de comprimidos intragranulares en un granulador de lecho fluido, (b) disolver el dihidrocloruro de pramipexol, o su solvato farmacéuticamente aceptable, y povidona en agua para formar una disolucion acuosa de dihidrocloruro de pramipexol, y pulverizar la disolucion de dihidrocloruro de pramipexol sobre las partículas de los ingredientes de formacion de comprimidos intragranulares en el granulador de lecho fluido, (c) preparar una disolucion, suspension o pasta de ligante, y anadir la disolucion, suspension o pasta de ligante al granulador de lecho fluido para formar un granulado, (d) secar dicha premezcla granulada hasta un contenido en humedad final de aproximadamente 1,0% a aproximadamente 2,5%, (g) mezclar dicha mezcla granulada con los agentes de formacion de comprimidos extragranulares y mezclar para formar una mezcla final, (f) comprimir la mezcla final en comprimidos utilizando una prensa de comprimidos.In particular, it refers to a process for preparing pramipexole dihydrochloride tablets, in which the tablets show high preservation stability properties. Claim 1: A process for preparing pramipexole dihydrochloride tablets comprising intragranular tablet forming ingredients, pramipexole dihydrochloride or its pharmaceutically acceptable solvate, a binder and extragranular tablet forming agents, wherein the process is performed in a system closed, and comprises the steps of: (a) loading particles of the intragranular tablet formation ingredients in a fluid bed granulator, (b) dissolving pramipexole dihydrochloride, or its pharmaceutically acceptable solvate, and povidone in water to form a aqueous solution of pramipexole dihydrochloride, and spray the solution of pramipexole dihydrochloride on the particles of the intragranular tablet forming ingredients in the fluid bed granulator, (c) prepare a solution, suspension or binder paste, and add the solution , suspension or binder paste to the fluid bed granulator p To form a granulate, (d) dry said granulated premix to a final moisture content of about 1.0% to about 2.5%, (g) mix said granulated mixture with the extragranular tablet forming agents and mix to form a final mixture, (f) compressing the final mixture into tablets using a tablet press.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US46705006A | 2006-08-24 | 2006-08-24 | |
| US11/734,041 US20080254118A1 (en) | 2007-04-11 | 2007-04-11 | Process for preparing pramipexole dihydrochloride tablets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR062509A1 true AR062509A1 (en) | 2008-11-12 |
Family
ID=38963081
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP070103757A AR062509A1 (en) | 2006-08-24 | 2007-08-24 | PROCESS TO PREPARE PRAMIPEXOL DIHYDROCLORIDE TABLETS |
Country Status (13)
| Country | Link |
|---|---|
| EP (1) | EP2056795A2 (en) |
| JP (1) | JP2010501525A (en) |
| KR (1) | KR20090045943A (en) |
| AR (1) | AR062509A1 (en) |
| AU (1) | AU2007287560A1 (en) |
| BR (1) | BRPI0715835A2 (en) |
| CA (1) | CA2661616A1 (en) |
| CL (1) | CL2007002477A1 (en) |
| IL (1) | IL197130A0 (en) |
| MX (1) | MX2009001884A (en) |
| RU (1) | RU2009110253A (en) |
| TW (1) | TW200816998A (en) |
| WO (1) | WO2008023027A2 (en) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8518926B2 (en) | 2006-04-10 | 2013-08-27 | Knopp Neurosciences, Inc. | Compositions and methods of using (R)-pramipexole |
| KR20090021169A (en) | 2006-05-16 | 2009-02-27 | 크놉 뉴로사이언시스 인코포레이티드 | Compositions comprising R (+) and S (-) pramipexole and methods of use thereof |
| US8524695B2 (en) | 2006-12-14 | 2013-09-03 | Knopp Neurosciences, Inc. | Modified release formulations of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and methods of using the same |
| JP2010521496A (en) | 2007-03-14 | 2010-06-24 | ノップ ニューロサイエンシーズ、インク． | Synthesis of chiral purified substituted benzothiazolediamine |
| US20080254117A1 (en) * | 2007-04-10 | 2008-10-16 | Noel Cotton | Process for preparing pramipexole dihydrochloride tablets |
| US20110190356A1 (en) | 2008-08-19 | 2011-08-04 | Knopp Neurosciences Inc. | Compositions and Methods of Using (R)- Pramipexole |
| TR200906997A1 (en) | 2009-09-11 | 2011-03-21 | Sanovel �La� San. Ve T�C. A. �. | Pramipexole pharmaceutical compositions. |
| EP2462925A1 (en) | 2010-11-12 | 2012-06-13 | Neuraxpharm Arzneimittel GmbH | Pramipexole Dihydrochloride Granulate |
| KR101712049B1 (en) * | 2010-11-17 | 2017-03-03 | 엘지이노텍 주식회사 | Light emitting device |
| US9512096B2 (en) | 2011-12-22 | 2016-12-06 | Knopp Biosciences, LLP | Synthesis of amine substituted 4,5,6,7-tetrahydrobenzothiazole compounds |
| US9662313B2 (en) | 2013-02-28 | 2017-05-30 | Knopp Biosciences Llc | Compositions and methods for treating amyotrophic lateral sclerosis in responders |
| US9468630B2 (en) | 2013-07-12 | 2016-10-18 | Knopp Biosciences Llc | Compositions and methods for treating conditions related to increased eosinophils |
| ES3043076T3 (en) | 2013-07-12 | 2025-11-24 | Areteia Therapeutics Inc | Treating elevated levels of eosinophils and/or basophils |
| EP3038467B1 (en) | 2013-08-13 | 2020-07-29 | Knopp Biosciences LLC | Compositions and methods for treating plasma cell disorders and b-cell prolymphocytic disorders |
| US9763918B2 (en) | 2013-08-13 | 2017-09-19 | Knopp Biosciences Llc | Compositions and methods for treating chronic urticaria |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0998933A1 (en) * | 1998-10-09 | 2000-05-10 | Boehringer Mannheim Gmbh | Process for producing pharmaceutical compositions containing diphosphonates for oral administration |
| MXPA01007463A (en) * | 1999-01-29 | 2002-06-04 | Losan Pharma Gmbh | Pharmaceutical compositions. |
| BR0215262A (en) * | 2001-12-20 | 2004-12-28 | Pharmacia Corp | Zero-order sustained release dosage forms and manufacturing process |
| US7749533B2 (en) * | 2003-05-07 | 2010-07-06 | Akina, Inc. | Highly plastic granules for making fast melting tablets |
| KR20070050081A (en) * | 2004-08-13 | 2007-05-14 | 베링거 인겔하임 인터내셔날 게엠베하 | Extended release pellet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof, preparation method thereof and use thereof |
| RS52057B2 (en) * | 2004-08-13 | 2018-03-30 | Boehringer Ingelheim Int | Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof |
| JP4446177B2 (en) * | 2005-01-21 | 2010-04-07 | 東和薬品株式会社 | Method for producing moisture-resistant orally disintegrating tablets |
| JP2009519970A (en) * | 2005-12-15 | 2009-05-21 | アキュスフィア， インコーポレイテッド | Process for producing particle-based pharmaceutical dosage forms for oral administration |
-
2007
- 2007-08-22 RU RU2009110253/15A patent/RU2009110253A/en not_active Application Discontinuation
- 2007-08-22 WO PCT/EP2007/058696 patent/WO2008023027A2/en not_active Ceased
- 2007-08-22 EP EP07788511A patent/EP2056795A2/en not_active Withdrawn
- 2007-08-22 AU AU2007287560A patent/AU2007287560A1/en not_active Abandoned
- 2007-08-22 MX MX2009001884A patent/MX2009001884A/en not_active Application Discontinuation
- 2007-08-22 CA CA002661616A patent/CA2661616A1/en not_active Abandoned
- 2007-08-22 JP JP2009525064A patent/JP2010501525A/en active Pending
- 2007-08-22 KR KR1020097006052A patent/KR20090045943A/en not_active Withdrawn
- 2007-08-22 BR BRPI0715835-1A patent/BRPI0715835A2/en not_active IP Right Cessation
- 2007-08-23 CL CL200702477A patent/CL2007002477A1/en unknown
- 2007-08-23 TW TW096131278A patent/TW200816998A/en unknown
- 2007-08-24 AR ARP070103757A patent/AR062509A1/en unknown
-
2009
- 2009-02-19 IL IL197130A patent/IL197130A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| KR20090045943A (en) | 2009-05-08 |
| BRPI0715835A2 (en) | 2013-07-23 |
| CA2661616A1 (en) | 2008-02-28 |
| AU2007287560A1 (en) | 2008-02-28 |
| EP2056795A2 (en) | 2009-05-13 |
| WO2008023027A2 (en) | 2008-02-28 |
| RU2009110253A (en) | 2010-09-27 |
| TW200816998A (en) | 2008-04-16 |
| JP2010501525A (en) | 2010-01-21 |
| MX2009001884A (en) | 2009-03-06 |
| IL197130A0 (en) | 2009-11-18 |
| WO2008023027A3 (en) | 2008-04-17 |
| CL2007002477A1 (en) | 2008-04-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |