SI9500220B - Vodne formulacije risperidona - Google Patents
Vodne formulacije risperidona Download PDFInfo
- Publication number
- SI9500220B SI9500220B SI9500220A SI9500220A SI9500220B SI 9500220 B SI9500220 B SI 9500220B SI 9500220 A SI9500220 A SI 9500220A SI 9500220 A SI9500220 A SI 9500220A SI 9500220 B SI9500220 B SI 9500220B
- Authority
- SI
- Slovenia
- Prior art keywords
- solution
- solution according
- range
- water
- risperidone
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- 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)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (13)
10 PATENTNI ZAHTEVKI 1. Vodna raztopina, prikladna za oralno ali parenteralno dajanje, ki vsebuje vodo, risperidon ali njegovo farmacevtsko sprejemljivo kislinsko adicijsko sol, označena s tem, da vsebuje pufer za vzdrževanje pH v območju od 2 do 6 in je v bistvu brez sorbitola.
2. Raztopina po zahtevku 1, označena s tem, da območje pH naravnamo s pufrom: vinska kislina/natrijev hidroksid.
3. Raztopina po zahtevku 1, označena s tem, da je količina risperidona v območju od 0,01 mas.% do 1 mas.% glede na celotni volumen raztopine.
4. Raztopina po zahtevku 1, označena s tem, da ima pH v območju od 3 do 4 in je prikladna za oralno dajanje.
5. Raztopina po zahtevku 4, označena s tem, da nadalje vsebuje benzojsko kislino kot varovalno sredstvo.
6. Raztopina po zahtevku 5, označena s tem, da vsebuje: (a) 1 mg/ml risperidona (b) 2 mg/ml benzojske kisline (c) 7,5 mg/ml vinske kisline in zadostno količino natrijevega hidroksida, da naravnamo pH v območju od 3 do 4 ter (d) vodo q.s. ad 1 ml.
7. Raztopina po zahtevku 6, označena s tem, da nadalje vsebuje eno ali več sladil in/ali arom.
8. Raztopina po zahtevku 1, označena s tem, da ima pH v območju od 5 do 6 in je prikladna za parenteralno dajanje.
9. Raztopina po zahtevku 8, označena s tem, da nadalje vsebuje natrijev klorid kot izotonično sredstvo.
10. Raztopina po zahtevku 9, označena s tem, da vsebuje: 11 (a) 1 mg/ml risperidona (b) 5 mg/ml natrijevega klorida (c) 7,5 mg/ml vinske kisline in zadostno količino natrijevega hidroksida, da naravnamo pH v območju od 5 do 6 ter (d) vodo q.s. ad 1 ml.
11. Postopek za pripravo raztopine po zahtevku 1, označen s tem, da obsega stopnje: (a) dodajanje kislinske komponente pufra in aktivne sestavine risperidona v vodo, ki je prednostno nad sobno temperaturo (b) mešanje zmesi do popolne raztopitve in ohlajevanje raztopine na sobno temperaturo (c) naravnavanje pH z bazno komponento pufra in (d) nadaljnje razredčevanje raztopine z vodo do potrebnega končnega volumna.
12. Postopek po zahtevku 11 za pripravo oralne raztopine, kot je definirana v zahtevku 5, označen s tem, da stopnji (a) sledita stopnji: - raztapljanje varovalnega sredstva v segreti vodi in - razredčevanje raztopine s približno enako količino vode.
13. Postopek po zahtevku 11 za pripravo parenteralne raztopine, kot je definirana v zahtevku 9, označen s tem, da stopnji (d) takoj sledita stopnji: - naravnavanje približne izotoničnosti raztopine z dodatkom ustrezne količine izotoničnega sredstva in - avtoklaviranje.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/272,462 US5453425A (en) | 1994-07-11 | 1994-07-11 | Risperidone oral formulation |
| US08/429,435 US5616587A (en) | 1994-07-11 | 1995-04-26 | Aqueous risperidone formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SI9500220A SI9500220A (en) | 1996-02-29 |
| SI9500220B true SI9500220B (sl) | 2004-12-31 |
Family
ID=26955530
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI9500220A SI9500220B (sl) | 1994-07-11 | 1995-07-10 | Vodne formulacije risperidona |
Country Status (37)
| Country | Link |
|---|---|
| US (3) | US5453425A (sl) |
| EP (1) | EP0769965B1 (sl) |
| JP (1) | JP2872412B2 (sl) |
| KR (1) | KR100212942B1 (sl) |
| CN (1) | CN1148226C (sl) |
| AP (1) | AP774A (sl) |
| AT (1) | ATE206931T1 (sl) |
| AU (1) | AU684193B2 (sl) |
| BG (1) | BG63070B1 (sl) |
| BR (1) | BR9508253A (sl) |
| CA (1) | CA2194564C (sl) |
| CY (1) | CY2268B1 (sl) |
| CZ (1) | CZ285204B6 (sl) |
| DE (1) | DE69523313T2 (sl) |
| DK (1) | DK0769965T3 (sl) |
| EE (1) | EE03426B1 (sl) |
| ES (1) | ES2165918T3 (sl) |
| FI (1) | FI116510B (sl) |
| HK (1) | HK1010691A1 (sl) |
| HR (1) | HRP950397B1 (sl) |
| HU (1) | HU222352B1 (sl) |
| IL (1) | IL114525A (sl) |
| MX (1) | MX9700374A (sl) |
| MY (1) | MY114389A (sl) |
| NO (1) | NO320366B1 (sl) |
| NZ (1) | NZ289432A (sl) |
| PH (1) | PH31626A (sl) |
| PL (1) | PL179972B1 (sl) |
| PT (1) | PT769965E (sl) |
| RO (1) | RO116778B1 (sl) |
| RU (1) | RU2161965C2 (sl) |
| SI (1) | SI9500220B (sl) |
| SK (1) | SK282159B6 (sl) |
| TR (1) | TR199500778A1 (sl) |
| TW (1) | TW420615B (sl) |
| WO (1) | WO1996001652A1 (sl) |
| ZA (1) | ZA955720B (sl) |
Families Citing this family (37)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK0729357T3 (da) | 1993-11-19 | 2005-06-06 | Janssen Pharmaceutica Nv | Mikroindkapslede 1,2-benzazoler |
| US5453425A (en) * | 1994-07-11 | 1995-09-26 | Janssen Pharmaceutica N.V. | Risperidone oral formulation |
| UA72189C2 (uk) * | 1997-11-17 | 2005-02-15 | Янссен Фармацевтика Н.В. | Фармацевтична композиція, що містить водну суспензію субмікронних ефірів 9-гідроксирисперидон жирних кислот |
| US6682758B1 (en) | 1998-12-22 | 2004-01-27 | The United States Of America As Represented By The Department Of Health And Human Services | Water-insoluble drug delivery system |
| US6495164B1 (en) * | 2000-05-25 | 2002-12-17 | Alkermes Controlled Therapeutics, Inc. I | Preparation of injectable suspensions having improved injectability |
| US20050232995A1 (en) | 2002-07-29 | 2005-10-20 | Yam Nyomi V | Methods and dosage forms for controlled delivery of paliperidone and risperidone |
| WO2004017975A1 (en) * | 2002-08-23 | 2004-03-04 | Ranbaxy Laboratories Limited | Stable aqueous solutions of risperidone and methods for their preparation |
| EP1615924A1 (en) * | 2003-04-22 | 2006-01-18 | Synthon B.V. | Water soluble salts of risperidone |
| PE20050285A1 (es) | 2003-06-24 | 2005-06-09 | Novartis Ag | Composicion farmaceutica que comprende analogos ciclicos de somatostatina |
| US20050036977A1 (en) * | 2003-08-11 | 2005-02-17 | Dilip Gole | Taste-masked resinate and preparation thereof |
| ES2245252B1 (es) * | 2004-06-15 | 2007-03-01 | Farmalider, S.A. | Solucion acuosa de risperidona para administracion oral. |
| ES2245891B1 (es) * | 2004-07-09 | 2006-11-16 | Clinmet S.L. | "metodo para la obtencion de un excipiente universal para la administracion oral de principios activos farmaceuticos y composiciones de excipientes resultantes del metodo". |
| WO2006129160A2 (en) * | 2005-06-01 | 2006-12-07 | Aurobindo Pharma Limited | Stable aqueous oral solution of risperidone |
| DE602006005423D1 (de) * | 2005-06-29 | 2009-04-16 | Verisfield Uk Ltd | Pharmazeutische Zusammensetzungen von Risperidon in wässriger Lösung |
| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| JP4922657B2 (ja) * | 2006-05-09 | 2012-04-25 | 高田製薬株式会社 | リスペリドン経口用液剤 |
| WO2007138462A2 (en) * | 2006-06-01 | 2007-12-06 | Wockhardt Ltd | Aqueous oral formulations of risperidone |
| CN101801415B (zh) | 2007-05-25 | 2015-09-23 | Rb医药品有限公司 | 利培酮化合物的持续递送制剂 |
| US7776866B2 (en) * | 2007-09-15 | 2010-08-17 | Protia, Llc | Deuterium-enriched risperidone |
| JP5825786B2 (ja) * | 2007-12-19 | 2015-12-02 | ジヤンセン・フアーマシユーチカ・ナームローゼ・フエンノートシヤツプＪａｎｓｓｅｎ Ｐｈａｒｍａｃｅｕｔｉｃａ Ｎａａｍｌｏｚｅ Ｖｅｎｎｏｏｔｓｃｈａｐ | 長時間作用型注入可能パリペリドンエステルに関連する投薬計画 |
| EP3006023B1 (en) | 2009-01-20 | 2019-06-26 | Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Sorbic acid and derivatives thereof to enhance the activity of a neuropharmaceutical |
| GB2513060B (en) | 2010-06-08 | 2015-01-07 | Rb Pharmaceuticals Ltd | Microparticle buprenorphine suspension |
| US9272044B2 (en) | 2010-06-08 | 2016-03-01 | Indivior Uk Limited | Injectable flowable composition buprenorphine |
| EP2763676B1 (en) * | 2011-10-03 | 2019-12-25 | The University of Utah Research Foundation | Application of 5-ht6 receptor antagonists for the alleviation of cognitive deficits of down syndrome |
| GB201404139D0 (en) | 2014-03-10 | 2014-04-23 | Rb Pharmaceuticals Ltd | Sustained release buprenorphine solution formulations |
| CA2965895C (en) | 2014-11-07 | 2019-08-06 | Indivior Uk Limited | The use of sustained-release buprenorphine formulations for the treatment of pain or opioid use disorders |
| ES2936094T3 (es) | 2016-06-13 | 2023-03-14 | Syneurx Int Taiwan Corp | Cocristales de benzoato de sodio y usos de los mismos |
| KR102338171B1 (ko) | 2016-06-13 | 2021-12-09 | 신유알엑스 인터내셔널 (타이완) 코포레이션 | 벤조산리튬의 공-결정 및 그의 용도 |
| KR20230093349A (ko) * | 2016-09-23 | 2023-06-27 | 델포어, 인코포레이티드 | 소분자 치료제 화합물 조성물 |
| US11369579B2 (en) | 2016-10-24 | 2022-06-28 | Syneurx International (Taiwan) Corp. | Polymorphic forms of sodium benzoate and uses thereof |
| RU2646812C1 (ru) * | 2016-10-24 | 2018-03-07 | Общество с ограниченной ответственностью "Трейдсервис" | Жидкая лекарственная форма рисперидона и способ ее получения |
| US10336679B2 (en) | 2016-10-24 | 2019-07-02 | Syneurx International (Taiwan) Corp. | Polymorphic forms of sodium benzoate and uses thereof |
| US10646484B2 (en) | 2017-06-16 | 2020-05-12 | Indivior Uk Limited | Methods to treat opioid use disorder |
| CN107260662A (zh) * | 2017-06-21 | 2017-10-20 | 南京正科医药股份有限公司 | 一种利培酮口服溶液及其制备方法 |
| CN107441037A (zh) * | 2017-08-16 | 2017-12-08 | 南京正科医药股份有限公司 | 一种利培酮口服溶液 |
| CN109589304A (zh) * | 2017-10-01 | 2019-04-09 | 万特制药(海南)有限公司 | 利培酮口服溶液及其制备方法 |
| US10098861B1 (en) | 2017-10-24 | 2018-10-16 | Syneurx International (Taiwan) Corp. | Pharmaceutical composition comprising sodium benzoate compound and clozapine, and uses thereof |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4337261A (en) * | 1980-07-28 | 1982-06-29 | Hoechst-Roussel Pharmaceuticals Inc. | (1,2-Benzisoxazol)phenoxyacetic acids as diuretics |
| IL88233A (en) * | 1987-11-03 | 1993-08-18 | Genentech Inc | Gamma interferon formulation |
| FR2641278B1 (fr) * | 1989-01-05 | 1991-03-22 | Lipha | Piperidines, procedes de preparation et medicaments les contenant |
| DK203990D0 (da) * | 1990-08-24 | 1990-08-24 | Novo Nordisk As | Piperazinylderivater |
| TW376319B (en) * | 1993-04-28 | 1999-12-11 | Janssen Pharmaceutica Nv | Pharmaceutical composition containing risperidone pamoate and having a long acting activity for treating psychoses induced by the release of dopamine |
| US5453425A (en) * | 1994-07-11 | 1995-09-26 | Janssen Pharmaceutica N.V. | Risperidone oral formulation |
| FR2796273B1 (fr) * | 1999-07-15 | 2003-09-12 | Oreal | Composition a phase grasse liquide gelifiee par un polyamide a groupements ester terminaux |
-
1994
- 1994-07-11 US US08/272,462 patent/US5453425A/en not_active Expired - Lifetime
-
1995
- 1995-04-26 US US08/429,435 patent/US5616587A/en not_active Ceased
- 1995-05-19 TW TW084104959A patent/TW420615B/zh not_active IP Right Cessation
- 1995-05-31 PH PH50624A patent/PH31626A/en unknown
- 1995-06-29 TR TR95/00778A patent/TR199500778A1/xx unknown
- 1995-07-04 BR BR9508253A patent/BR9508253A/pt not_active IP Right Cessation
- 1995-07-04 EE EE9700009A patent/EE03426B1/xx unknown
- 1995-07-04 CN CNB951940821A patent/CN1148226C/zh not_active Expired - Lifetime
- 1995-07-04 NZ NZ289432A patent/NZ289432A/en not_active IP Right Cessation
- 1995-07-04 AT AT95924978T patent/ATE206931T1/de active
- 1995-07-04 WO PCT/EP1995/002615 patent/WO1996001652A1/en active IP Right Grant
- 1995-07-04 KR KR1019970700039A patent/KR100212942B1/ko not_active IP Right Cessation
- 1995-07-04 AU AU29275/95A patent/AU684193B2/en not_active Expired
- 1995-07-04 CA CA002194564A patent/CA2194564C/en not_active Expired - Lifetime
- 1995-07-04 RO RO97-00032A patent/RO116778B1/ro unknown
- 1995-07-04 RU RU97102139/14A patent/RU2161965C2/ru active
- 1995-07-04 JP JP8504108A patent/JP2872412B2/ja not_active Expired - Lifetime
- 1995-07-04 DK DK95924978T patent/DK0769965T3/da active
- 1995-07-04 PL PL95318132A patent/PL179972B1/pl unknown
- 1995-07-04 DE DE69523313T patent/DE69523313T2/de not_active Expired - Lifetime
- 1995-07-04 ES ES95924978T patent/ES2165918T3/es not_active Expired - Lifetime
- 1995-07-04 SK SK22-97A patent/SK282159B6/sk not_active IP Right Cessation
- 1995-07-04 HU HU9700082A patent/HU222352B1/hu active IP Right Grant
- 1995-07-04 CZ CZ9727A patent/CZ285204B6/cs not_active IP Right Cessation
- 1995-07-04 EP EP95924978A patent/EP0769965B1/en not_active Expired - Lifetime
- 1995-07-04 AP APAP/P/1997/000910A patent/AP774A/en active
- 1995-07-04 PT PT95924978T patent/PT769965E/pt unknown
- 1995-07-04 MX MX9700374A patent/MX9700374A/es unknown
- 1995-07-10 HR HR950397A patent/HRP950397B1/xx not_active IP Right Cessation
- 1995-07-10 ZA ZA955720A patent/ZA955720B/xx unknown
- 1995-07-10 SI SI9500220A patent/SI9500220B/sl active Search and Examination
- 1995-07-10 IL IL11452595A patent/IL114525A/xx not_active IP Right Cessation
- 1995-07-11 MY MYPI95001944A patent/MY114389A/en unknown
-
1997
- 1997-01-04 BG BG101106A patent/BG63070B1/bg active Active
- 1997-01-07 NO NO19970051A patent/NO320366B1/no not_active IP Right Cessation
- 1997-01-10 FI FI970109A patent/FI116510B/fi not_active IP Right Cessation
-
1998
- 1998-10-29 HK HK98111584A patent/HK1010691A1/xx not_active IP Right Cessation
-
2001
- 2001-12-04 US US09/955,274 patent/USRE39181E1/en not_active Expired - Lifetime
-
2002
- 2002-04-25 CY CY0200019A patent/CY2268B1/xx unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| OU02 | Decision according to article 73(2) ipa 1992, publication of decision on partial fulfilment of the invention and change of patent claims |
Effective date: 20041103 |
|
| IF | Valid on the event date |