SK95099A3 - Process for the preparation of free-flowing form of paroxetine hydrochloride, pharmaceutical composition containing same and use thereof - Google Patents

Process for the preparation of free-flowing form of paroxetine hydrochloride, pharmaceutical composition containing same and use thereof Download PDF

Info

Publication number: SK95099A3
Authority: SK; Slovakia
Prior art keywords: paroxetine hydrochloride; spray; paroxetine; hydrochloride; free
Prior art date: 1997-01-15

Application number

SK950-99A

Other languages

English (en)

Slovak (sk)

Inventor

Viktor W Jacewicz

Neal Ward

Original Assignee

Smithkline Beecham Plc

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

1997-01-15

Filing date

1998-01-12

Publication date

2000-01-18

1997-01-15 Priority claimed from GBGB9700692.8A external-priority patent/GB9700692D0/en

1997-07-15 Priority claimed from GBGB9714873.8A external-priority patent/GB9714873D0/en

1998-01-12 Application filed by Smithkline Beecham Plc filed Critical Smithkline Beecham Plc

2000-01-18 Publication of SK95099A3 publication Critical patent/SK95099A3/sk

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 claims abstract description 73
229960005183 paroxetine hydrochloride Drugs 0.000 title claims abstract description 34
238000000034 method Methods 0.000 title claims description 19
239000008194 pharmaceutical composition Substances 0.000 title claims description 4
238000001694 spray drying Methods 0.000 claims abstract description 12
239000000203 mixture Substances 0.000 claims abstract description 10
239000000243 solution Substances 0.000 claims abstract description 7
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 claims abstract description 6
229960002296 paroxetine Drugs 0.000 claims abstract description 6
239000007787 solid Substances 0.000 claims abstract description 6
239000007864 aqueous solution Substances 0.000 claims abstract description 5
239000012453 solvate Substances 0.000 claims abstract description 3
239000007921 spray Substances 0.000 claims description 12
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 9
208000035475 disorder Diseases 0.000 claims description 9
238000004519 manufacturing process Methods 0.000 claims description 9
239000003960 organic solvent Substances 0.000 claims description 8
QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 6
WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 6
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 6
LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims description 6
BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 claims description 6
239000011550 stock solution Substances 0.000 claims description 6
238000011282 treatment Methods 0.000 claims description 6
VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 5
JUJWROOIHBZHMG-UHFFFAOYSA-N Pyridine Chemical group C1=CC=NC=C1 JUJWROOIHBZHMG-UHFFFAOYSA-N 0.000 claims description 4
WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims description 4
238000011321 prophylaxis Methods 0.000 claims description 4
239000002904 solvent Substances 0.000 claims description 4
239000003814 drug Substances 0.000 claims description 3
239000003937 drug carrier Substances 0.000 claims description 2
239000012458 free base Substances 0.000 claims description 2
239000007788 liquid Substances 0.000 claims description 2
UMJSCPRVCHMLSP-UHFFFAOYSA-N pyridine Natural products COC1=CC=CN=C1 UMJSCPRVCHMLSP-UHFFFAOYSA-N 0.000 claims description 2
YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims description 2
238000009472 formulation Methods 0.000 abstract description 6
239000002245 particle Substances 0.000 description 8
230000000694 effects Effects 0.000 description 7
239000000047 product Substances 0.000 description 6
150000001875 compounds Chemical class 0.000 description 3
238000001035 drying Methods 0.000 description 3
238000005516 engineering process Methods 0.000 description 3
238000002560 therapeutic procedure Methods 0.000 description 3
206010036618 Premenstrual syndrome Diseases 0.000 description 2
238000013270 controlled release Methods 0.000 description 2
239000000428 dust Substances 0.000 description 2
230000007613 environmental effect Effects 0.000 description 2
238000010438 heat treatment Methods 0.000 description 2
QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical compound N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 description 1
208000007848 Alcoholism Diseases 0.000 description 1
208000024827 Alzheimer disease Diseases 0.000 description 1
208000019901 Anxiety disease Diseases 0.000 description 1
208000032841 Bulimia Diseases 0.000 description 1
206010006550 Bulimia nervosa Diseases 0.000 description 1
208000000094 Chronic Pain Diseases 0.000 description 1
208000019695 Migraine disease Diseases 0.000 description 1
208000008589 Obesity Diseases 0.000 description 1
208000021384 Obsessive-Compulsive disease Diseases 0.000 description 1
208000002193 Pain Diseases 0.000 description 1
206010039966 Senile dementia Diseases 0.000 description 1
206010041250 Social phobia Diseases 0.000 description 1
201000007930 alcohol dependence Diseases 0.000 description 1
208000022531 anorexia Diseases 0.000 description 1
230000001430 anti-depressive effect Effects 0.000 description 1
230000000648 anti-parkinson Effects 0.000 description 1
239000000935 antidepressant agent Substances 0.000 description 1
229940005513 antidepressants Drugs 0.000 description 1
239000000939 antiparkinson agent Substances 0.000 description 1
230000036506 anxiety Effects 0.000 description 1
244000052616 bacterial pathogen Species 0.000 description 1
230000015572 biosynthetic process Effects 0.000 description 1
239000011248 coating agent Substances 0.000 description 1
238000000576 coating method Methods 0.000 description 1
238000002425 crystallisation Methods 0.000 description 1
230000008025 crystallization Effects 0.000 description 1
206010061428 decreased appetite Diseases 0.000 description 1
238000004090 dissolution Methods 0.000 description 1
239000002552 dosage form Substances 0.000 description 1
229940079593 drug Drugs 0.000 description 1
208000024732 dysthymic disease Diseases 0.000 description 1
238000005538 encapsulation Methods 0.000 description 1
238000001914 filtration Methods 0.000 description 1
238000005755 formation reaction Methods 0.000 description 1
238000000265 homogenisation Methods 0.000 description 1
238000002955 isolation Methods 0.000 description 1
206010027599 migraine Diseases 0.000 description 1
238000002156 mixing Methods 0.000 description 1
235000020824 obesity Nutrition 0.000 description 1
239000000825 pharmaceutical preparation Substances 0.000 description 1
229940127557 pharmaceutical product Drugs 0.000 description 1
238000001556 precipitation Methods 0.000 description 1
230000000069 prophylactic effect Effects 0.000 description 1
239000008247 solid mixture Substances 0.000 description 1
239000012265 solid product Substances 0.000 description 1
230000001225 therapeutic effect Effects 0.000 description 1

Classifications

- 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
- 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
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
- 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
- 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
- A61P25/24—Antidepressants

Landscapes

Health & Medical Sciences (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
General Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Animal Behavior & Ethology (AREA)
Chemical & Material Sciences (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
Medicinal Chemistry (AREA)
Epidemiology (AREA)
Neurosurgery (AREA)
Neurology (AREA)
Biomedical Technology (AREA)
Organic Chemistry (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Pain & Pain Management (AREA)
Psychiatry (AREA)
Psychology (AREA)
Plural Heterocyclic Compounds (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Medicinal Preparation (AREA)

SK950-99A 1997-01-15 1998-01-12 Process for the preparation of free-flowing form of paroxetine hydrochloride, pharmaceutical composition containing same and use thereof SK95099A3 (en)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
GBGB9700692.8A GB9700692D0 (en)	1997-01-15	1997-01-15	Novel process and compound
GBGB9714873.8A GB9714873D0 (en)	1997-07-15	1997-07-15	Novel process and compound
PCT/GB1998/000081 WO1998031365A1 (en)	1997-01-15	1998-01-12	Paroxetine compositions

Publications (1)

Publication Number	Publication Date
SK95099A3 true SK95099A3 (en)	2000-01-18

Family

ID=26310796

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
SK950-99A SK95099A3 (en)	1997-01-15	1998-01-12	Process for the preparation of free-flowing form of paroxetine hydrochloride, pharmaceutical composition containing same and use thereof

Country Status (21)

Country	Link
US (1)	US20010049442A1 (xx)
EP (1)	EP0952831A1 (xx)
JP (1)	JP2001508460A (xx)
KR (1)	KR20000070151A (xx)
CN (1)	CN1249686A (xx)
AP (1)	AP9901604A0 (xx)
AU (1)	AU730532B2 (xx)
BG (1)	BG103648A (xx)
BR (1)	BR9806754A (xx)
CA (1)	CA2277480A1 (xx)
EA (1)	EA002034B1 (xx)
HU (1)	HUP0000960A3 (xx)
ID (1)	ID23250A (xx)
IL (1)	IL130856A (xx)
NO (1)	NO993460L (xx)
NZ (1)	NZ336587A (xx)
OA (1)	OA11077A (xx)
PL (1)	PL334568A1 (xx)
SK (1)	SK95099A3 (xx)
TR (1)	TR199901622T2 (xx)
WO (1)	WO1998031365A1 (xx)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
GB9724544D0 (en) *	1997-11-21	1998-01-21	Smithkline Beecham Plc	Novel Formulation
US6168805B1 (en) *	1998-05-07	2001-01-02	Endo Pharmaceuticals, Inc.	Aqueous process for manufacturing paroxetine solid dispersions
GB9810181D0 (en) *	1998-05-13	1998-07-08	Smithkline Beecham Plc	Novel formulations
TR200100444T2 (tr) *	1998-08-07	2001-07-23	Smithkline Beecham P.L.C.	Paroksetin Hidroklorid'in bir kristalin olmayan anhidrat formunun hazırlanma yöntemi
GB9824298D0 (en) *	1998-11-05	1998-12-30	Smithkline Beecham Plc	Novel process
CA2367402C (en)	1999-03-12	2010-11-23	Basf Aktiengesellschaft	Stable pharmaceutical dosage form for paroxetine anhydrate
GB9914600D0 (en) *	1999-06-22	1999-08-25	Smithkline Beecham Plc	Novel,process
ES2162560B1 (es) *	1999-06-25	2002-07-16	Rodriguez Concepcion Pena	Uso de fluoxetina, paroxetina y otros isrs para la fabricacion de medicamentos con el fin de aumentar la capacidad de abstenerse de substancias o actividades que crean dependencia.
JP2003503493A (ja)	1999-07-01	2003-01-28	イタルファルマコソシエタペルアチオニ	パロキセチンとシクロデキストリンまたはシクロデキストリン誘導体との錯体
GB9919052D0 (en) *	1999-08-12	1999-10-13	Smithkline Beecham Plc	Novel compound composition and process
GB9923446D0 (en) *	1999-10-04	1999-12-08	Smithkline Beecham Plc	Novel process
GB9923439D0 (en) *	1999-10-04	1999-12-08	Smithkline Beecham Plc	Novel process
US6660298B1 (en) *	2000-07-27	2003-12-09	Pentech Pharmaceuticals, Inc.	Paroxetine tablets and capsules
WO2002017921A2 (en) *	2000-08-28	2002-03-07	Synthon B.V.	Paroxetine compositions and processes for making the same
US20060039975A1 (en) *	2004-08-20	2006-02-23	Zalman Vilkov	Paroxetine formulations
CN104027306A (zh) *	2014-06-25	2014-09-10	万特制药(海南)有限公司	帕罗西汀口服混悬液及其制备方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
GB2297550B (en) *	1995-02-06	1997-04-09	Smithkline Beecham Plc	Paroxetine hydrochloride anhydrate substantially free of bound organic solvent
CA2206592A1 (en) *	1996-05-30	1997-11-30	Shu-Zhong Wang	Method of producing amorphous paroxetine hydrochloride

1998
- 1998-01-12 SK SK950-99A patent/SK95099A3/sk unknown
- 1998-01-12 ID IDW990687A patent/ID23250A/id unknown
- 1998-01-12 CA CA002277480A patent/CA2277480A1/en not_active Abandoned
- 1998-01-12 IL IL13085698A patent/IL130856A/en not_active IP Right Cessation
- 1998-01-12 PL PL98334568A patent/PL334568A1/xx unknown
- 1998-01-12 BR BR9806754-0A patent/BR9806754A/pt not_active IP Right Cessation
- 1998-01-12 KR KR1019997006377A patent/KR20000070151A/ko not_active Withdrawn
- 1998-01-12 AP APAP/P/1999/001604A patent/AP9901604A0/en unknown
- 1998-01-12 NZ NZ336587A patent/NZ336587A/xx unknown
- 1998-01-12 HU HU0000960A patent/HUP0000960A3/hu unknown
- 1998-01-12 TR TR1999/01622T patent/TR199901622T2/xx unknown
- 1998-01-12 WO PCT/GB1998/000081 patent/WO1998031365A1/en not_active Ceased
- 1998-01-12 CN CN98803170A patent/CN1249686A/zh active Pending
- 1998-01-12 EP EP98900575A patent/EP0952831A1/en not_active Withdrawn
- 1998-01-12 JP JP53392198A patent/JP2001508460A/ja active Pending
- 1998-01-12 AU AU55673/98A patent/AU730532B2/en not_active Ceased
- 1998-01-12 EA EA199900655A patent/EA002034B1/ru not_active IP Right Cessation
1999
- 1999-07-14 NO NO993460A patent/NO993460L/no not_active Application Discontinuation
- 1999-07-15 OA OA9900158A patent/OA11077A/en unknown
- 1999-08-10 BG BG103648A patent/BG103648A/xx unknown
2001
- 2001-08-03 US US09/922,072 patent/US20010049442A1/en not_active Abandoned

Also Published As

Publication number	Publication date
ID23250A (id)	2000-03-30
PL334568A1 (en)	2000-03-13
BR9806754A (pt)	2000-03-14
CN1249686A (zh)	2000-04-05
IL130856A (en)	2001-09-13
WO1998031365A1 (en)	1998-07-23
NO993460D0 (no)	1999-07-14
TR199901622T2 (xx)	1999-09-21
NO993460L (no)	1999-09-14
AU5567398A (en)	1998-08-07
NZ336587A (en)	2001-01-26
CA2277480A1 (en)	1998-07-23
OA11077A (en)	2003-03-13
EP0952831A1 (en)	1999-11-03
AU730532B2 (en)	2001-03-08
EA002034B1 (ru)	2001-12-24
IL130856A0 (en)	2001-01-28
HUP0000960A3 (en)	2001-04-28
AP9901604A0 (en)	1999-09-30
KR20000070151A (ko)	2000-11-25
BG103648A (en)	2000-04-28
JP2001508460A (ja)	2001-06-26
HUP0000960A2 (hu)	2001-02-28
EA199900655A1 (ru)	2000-02-28
US20010049442A1 (en)	2001-12-06

Publication	Publication Date	Title
SK95099A3 (en)	2000-01-18	Process for the preparation of free-flowing form of paroxetine hydrochloride, pharmaceutical composition containing same and use thereof
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