OA13303A - Sustained-release tablet composition of pramipexole. - Google Patents
Sustained-release tablet composition of pramipexole. Download PDFInfo
- Publication number
- OA13303A OA13303A OA1200500016A OA1200500016A OA13303A OA 13303 A OA13303 A OA 13303A OA 1200500016 A OA1200500016 A OA 1200500016A OA 1200500016 A OA1200500016 A OA 1200500016A OA 13303 A OA13303 A OA 13303A
- Authority
- OA
- OAPI
- Prior art keywords
- composition
- tablet
- pramipexole
- coating
- release
- Prior art date
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- FASDKYOPVNHBLU-ZETCQYMHSA-N pramipexole Chemical group C1[C@@H](NCCC)CCC2=C1SC(N)=N2 FASDKYOPVNHBLU-ZETCQYMHSA-N 0.000 title claims abstract description 42
- 229960003089 pramipexole Drugs 0.000 title claims abstract description 35
- 239000000203 mixture Substances 0.000 title claims description 61
- 239000007939 sustained release tablet Substances 0.000 title description 17
- 229920002472 Starch Polymers 0.000 claims abstract description 41
- 235000019698 starch Nutrition 0.000 claims abstract description 41
- 239000008107 starch Substances 0.000 claims abstract description 37
- 239000007787 solid Substances 0.000 claims abstract description 27
- 229920001477 hydrophilic polymer Polymers 0.000 claims abstract description 15
- 238000013268 sustained release Methods 0.000 claims abstract description 15
- 239000012730 sustained-release form Substances 0.000 claims abstract description 15
- 239000011159 matrix material Substances 0.000 claims abstract description 13
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 8
- 239000011248 coating agent Substances 0.000 claims description 52
- 238000000576 coating method Methods 0.000 claims description 52
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 39
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 39
- 229920000881 Modified starch Polymers 0.000 claims description 33
- 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 claims description 21
- 229960002652 pramipexole dihydrochloride Drugs 0.000 claims description 17
- VQMNWIMYFHHFMC-UHFFFAOYSA-N tert-butyl 4-hydroxyindole-1-carboxylate Chemical group C1=CC=C2N(C(=O)OC(C)(C)C)C=CC2=C1O VQMNWIMYFHHFMC-UHFFFAOYSA-N 0.000 claims description 17
- 229950010601 pramipexole dihydrochloride monohydrate Drugs 0.000 claims description 13
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 10
- 229940096895 Dopamine D2 receptor agonist Drugs 0.000 claims description 3
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- 239000002288 dopamine 2 receptor stimulating agent Substances 0.000 claims description 3
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- 235000010981 methylcellulose Nutrition 0.000 claims description 3
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
- 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 2
- 229960001631 carbomer Drugs 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 abstract description 4
- 239000003826 tablet Substances 0.000 description 116
- 239000000463 material Substances 0.000 description 21
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 16
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- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 description 2
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- APVQOOKHDZVJEX-QTPLPEIMSA-N pramipexole hydrochloride Chemical compound O.Cl.Cl.C1[C@@H](NCCC)CCC2=C1SC(N)=N2 APVQOOKHDZVJEX-QTPLPEIMSA-N 0.000 description 2
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- ZAMLGGRVTAXBHI-UHFFFAOYSA-N 3-(4-bromophenyl)-3-[(2-methylpropan-2-yl)oxycarbonylamino]propanoic acid Chemical compound CC(C)(C)OC(=O)NC(CC(O)=O)C1=CC=C(Br)C=C1 ZAMLGGRVTAXBHI-UHFFFAOYSA-N 0.000 description 1
- HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 description 1
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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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
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- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
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- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
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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
- 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
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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
- 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
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- 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
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- 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
-
- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- 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
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- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hospice & Palliative Care (AREA)
- Psychiatry (AREA)
- Psychology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Thiazole And Isothizaole Compounds (AREA)
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US39844702P | 2002-07-25 | 2002-07-25 | |
US39842702P | 2002-07-25 | 2002-07-25 | |
US47951303P | 2003-06-18 | 2003-06-18 |
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OA13303A true OA13303A (en) | 2007-04-13 |
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OA1200500016A OA13303A (en) | 2002-07-25 | 2003-07-25 | Sustained-release tablet composition of pramipexole. |
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EP (2) | EP1987832A1 (pt) |
JP (1) | JP4700963B2 (pt) |
KR (1) | KR100712832B1 (pt) |
CN (1) | CN1313092C (pt) |
AP (1) | AP2201A (pt) |
AR (1) | AR040681A1 (pt) |
AT (1) | ATE406162T1 (pt) |
AU (1) | AU2003261241B2 (pt) |
BR (1) | BR0312960A (pt) |
CA (1) | CA2492854C (pt) |
CR (1) | CR7661A (pt) |
CU (1) | CU23440B7 (pt) |
CY (1) | CY1110408T1 (pt) |
DE (1) | DE60323235D1 (pt) |
DK (1) | DK1531814T3 (pt) |
EA (2) | EA200702187A1 (pt) |
EC (1) | ECSP055568A (pt) |
ES (1) | ES2310673T3 (pt) |
GE (1) | GEP20074048B (pt) |
HK (1) | HK10777456A1 (pt) |
HR (1) | HRP20041235B1 (pt) |
IL (1) | IL166078A0 (pt) |
IS (1) | IS7623A (pt) |
MA (1) | MA27328A1 (pt) |
ME (1) | MEP52308A (pt) |
MX (1) | MXPA05001054A (pt) |
MY (1) | MY138846A (pt) |
NO (1) | NO334298B1 (pt) |
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PA (1) | PA8578301A1 (pt) |
PE (1) | PE20040130A1 (pt) |
PL (1) | PL215587B1 (pt) |
PT (1) | PT1531814E (pt) |
RS (1) | RS51719B (pt) |
SI (1) | SI1531814T1 (pt) |
TW (1) | TWI347849B (pt) |
UY (1) | UY27912A1 (pt) |
WO (1) | WO2004010997A1 (pt) |
ZA (1) | ZA200500439B (pt) |
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- 2003-07-24 PA PA20038578301A patent/PA8578301A1/es unknown
- 2003-07-24 PE PE2003000734A patent/PE20040130A1/es not_active Application Discontinuation
- 2003-07-24 MY MYPI20032784A patent/MY138846A/en unknown
- 2003-07-25 JP JP2004524787A patent/JP4700963B2/ja not_active Expired - Fee Related
- 2003-07-25 GE GEAP8599A patent/GEP20074048B/en unknown
- 2003-07-25 CA CA002492854A patent/CA2492854C/en not_active Expired - Fee Related
- 2003-07-25 AT AT03771807T patent/ATE406162T1/de active
- 2003-07-25 PL PL375696A patent/PL215587B1/pl unknown
- 2003-07-25 CN CNB038178737A patent/CN1313092C/zh not_active Expired - Fee Related
- 2003-07-25 EA EA200702187A patent/EA200702187A1/ru unknown
- 2003-07-25 EA EA200500079A patent/EA009663B1/ru not_active IP Right Cessation
- 2003-07-25 NZ NZ537790A patent/NZ537790A/en unknown
- 2003-07-25 OA OA1200500016A patent/OA13303A/en unknown
- 2003-07-25 BR BR0312960-8A patent/BR0312960A/pt not_active IP Right Cessation
- 2003-07-25 AU AU2003261241A patent/AU2003261241B2/en not_active Ceased
- 2003-07-25 SI SI200331350T patent/SI1531814T1/sl unknown
- 2003-07-25 DE DE60323235T patent/DE60323235D1/de not_active Expired - Lifetime
- 2003-07-25 EP EP08159203A patent/EP1987832A1/en not_active Withdrawn
- 2003-07-25 WO PCT/US2003/023205 patent/WO2004010997A1/en active IP Right Grant
- 2003-07-25 ES ES03771807T patent/ES2310673T3/es not_active Expired - Lifetime
- 2003-07-25 MX MXPA05001054A patent/MXPA05001054A/es active IP Right Grant
- 2003-07-25 RS YU20050059A patent/RS51719B/sr unknown
- 2003-07-25 AP AP2005003205A patent/AP2201A/xx active
- 2003-07-25 KR KR1020057001392A patent/KR100712832B1/ko not_active Expired - Fee Related
- 2003-07-25 TW TW092120406A patent/TWI347849B/zh not_active IP Right Cessation
- 2003-07-25 PT PT03771807T patent/PT1531814E/pt unknown
- 2003-07-25 ME MEP-523/08A patent/MEP52308A/xx unknown
- 2003-07-25 DK DK03771807T patent/DK1531814T3/da active
- 2003-07-25 EP EP03771807A patent/EP1531814B1/en not_active Expired - Lifetime
- 2003-07-31 UY UY27912A patent/UY27912A1/es not_active Application Discontinuation
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2004
- 2004-12-29 IS IS7623A patent/IS7623A/is unknown
- 2004-12-30 HR HRP20041235AA patent/HRP20041235B1/hr not_active IP Right Cessation
- 2004-12-30 IL IL16607804A patent/IL166078A0/xx unknown
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2005
- 2005-01-06 NO NO20050093A patent/NO334298B1/no not_active IP Right Cessation
- 2005-01-17 ZA ZA200500439A patent/ZA200500439B/xx unknown
- 2005-01-24 CR CR7661A patent/CR7661A/es unknown
- 2005-01-24 EC EC2005005568A patent/ECSP055568A/es unknown
- 2005-01-25 CU CU20050018A patent/CU23440B7/es not_active IP Right Cessation
- 2005-01-25 MA MA28066A patent/MA27328A1/fr unknown
- 2005-11-08 HK HK05109947A patent/HK10777456A1/xx unknown
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2008
- 2008-10-13 CY CY20081101125T patent/CY1110408T1/el unknown
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2010
- 2010-03-03 US US12/716,755 patent/US8399016B2/en not_active Expired - Lifetime
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