ES2192781T3 - Composicion farmaceutica para combinacion de piperidinoalcanol y un descongestivo. - Google Patents
Composicion farmaceutica para combinacion de piperidinoalcanol y un descongestivo.Info
- Publication number
- ES2192781T3 ES2192781T3 ES98937010T ES98937010T ES2192781T3 ES 2192781 T3 ES2192781 T3 ES 2192781T3 ES 98937010 T ES98937010 T ES 98937010T ES 98937010 T ES98937010 T ES 98937010T ES 2192781 T3 ES2192781 T3 ES 2192781T3
- Authority
- ES
- Spain
- Prior art keywords
- amount
- formulation
- weight
- approximately
- base material
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 abstract 11
- 238000009472 formulation Methods 0.000 abstract 9
- 239000000463 material Substances 0.000 abstract 4
- 150000003839 salts Chemical class 0.000 abstract 3
- 239000000150 Sympathomimetic Substances 0.000 abstract 2
- 230000000694 effects Effects 0.000 abstract 2
- 230000001975 sympathomimetic effect Effects 0.000 abstract 2
- 229920000881 Modified starch Polymers 0.000 abstract 1
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 abstract 1
- 230000001387 anti-histamine Effects 0.000 abstract 1
- 239000000739 antihistaminic agent Substances 0.000 abstract 1
- 235000013869 carnauba wax Nutrition 0.000 abstract 1
- 239000004203 carnauba wax Substances 0.000 abstract 1
- 229920002678 cellulose Polymers 0.000 abstract 1
- 239000001913 cellulose Substances 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000000850 decongestant Substances 0.000 abstract 1
- 239000003085 diluting agent Substances 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 230000002035 prolonged effect Effects 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
-
- 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
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Virology (AREA)
- Molecular Biology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Otolaryngology (AREA)
- Immunology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
La invención se refiere a una composición farmacéutica que se presenta en forma de un comprimido constituido por dos capas, que comprende: a) una primera zona discontinua constituida por la fórmula (A), que contiene una cantidad, suficiente para tener una actividad descongestionante, de un medicamento simpaticomimético, o una sal farmacéuticamente aceptable de éste, en una cantidad comprendida entre 18 y 39% en peso aproximado de la formulación (A), y un primer material base de soporte que contiene una mezcla (i) de cera de carnauba, en una cantidad comprendida entre 59 y 81% en peso aproximadamente de la formulación (A); y (ii) de un antiadherente apropiado, en una cantidad comprendida entre 0,25 y 2,00 en peso aproximadamente de la formulación (A); garantizando dicho primer material base de soporte la liberación prolongada del simpaticomimético; y (b) una segunda zona discontinua constituida por la formulación (B), que contiene una cantidad, suficiente para tener una actividad antihistamínica, de un piperidino-alcanol, o una sal farmacéuticamente aceptable de éste, en una cantidad comprendida entre 15 y 30% en peso aproximadamente de la formulación (B), y un segundo material base de soporte, que contiene una mezcla (i) de un diluyente a base de celulosa, en una cantidad comprendida entre 27 y 73% en peso aproximadamente de la formulación (B); (ii) de un almidón pregelatinizado, en una cantidad comprendida entre 15 y 30% en peso aproximadamente de la formulación (B); (iii) de un agente de desintegración apropiado, en una cantidad comprendida entre 0,25 y 6.00% en peso de la formulación (B); y (iV) un lubricante apropiado en una cantidad de aproximadamente 0,25 a 2.00 en peso de Formulación (B); donde dicho segundo material base de soporte proporciona una liberación inmediata del piperidino-alcanol o una sal farmacéuticamente aceptable de éste.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US92015897A | 1997-08-26 | 1997-08-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2192781T3 true ES2192781T3 (es) | 2003-10-16 |
Family
ID=25443270
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES98937010T Expired - Lifetime ES2192781T3 (es) | 1997-08-26 | 1998-07-21 | Composicion farmaceutica para combinacion de piperidinoalcanol y un descongestivo. |
Country Status (30)
| Country | Link |
|---|---|
| US (1) | US6039974A (es) |
| EP (1) | EP0998272B1 (es) |
| JP (1) | JP4344405B2 (es) |
| KR (1) | KR100514264B1 (es) |
| CN (1) | CN1159012C (es) |
| AR (1) | AR013947A1 (es) |
| AT (1) | ATE238773T1 (es) |
| AU (1) | AU725811B2 (es) |
| BR (1) | BR9812001A (es) |
| CZ (1) | CZ295461B6 (es) |
| DE (1) | DE69814086T2 (es) |
| DK (1) | DK0998272T3 (es) |
| EE (1) | EE04294B1 (es) |
| ES (1) | ES2192781T3 (es) |
| HU (1) | HU224921B1 (es) |
| ID (1) | ID22891A (es) |
| IL (1) | IL133420A (es) |
| NO (1) | NO318246B1 (es) |
| NZ (1) | NZ501248A (es) |
| OA (1) | OA11285A (es) |
| PL (1) | PL192079B1 (es) |
| PT (1) | PT998272E (es) |
| RU (1) | RU2207879C2 (es) |
| SI (1) | SI0998272T1 (es) |
| SK (1) | SK283803B6 (es) |
| TR (1) | TR200000517T2 (es) |
| TW (1) | TW570812B (es) |
| UA (1) | UA60335C2 (es) |
| WO (1) | WO1999009957A1 (es) |
| ZA (1) | ZA987552B (es) |
Families Citing this family (45)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1148849A (zh) * | 1994-05-18 | 1997-04-30 | 赫彻斯特马里恩鲁斯公司 | 抗组胺哌啶衍生物，其多晶形物和假同晶物的无水和水合物形式的制备方法 |
| US20030045722A1 (en) * | 1994-05-18 | 2003-03-06 | Henton Daniel R. | Processes for preparing anhydrous and hydrate forms of antihistaminic piperidine derivatives, polymorphs and pseudomorphs thereof |
| WO1996026726A1 (en) * | 1995-02-28 | 1996-09-06 | Hoechst Marion Roussel, Inc. | Pharmaceutical composition for piperidinoalkanol compounds |
| US8022095B2 (en) | 1996-08-16 | 2011-09-20 | Pozen, Inc. | Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs |
| WO2001045676A2 (en) * | 1999-12-20 | 2001-06-28 | Schering Corporation | Extended release oral dosage composition |
| US20020094345A1 (en) | 2000-10-06 | 2002-07-18 | Sara Abelaira | Pharmaceutical compositions containing epinastine and pseudoephedrine |
| WO2002036077A2 (en) * | 2000-11-06 | 2002-05-10 | Andrx Pharmaceuticals, Inc. | Once a day antihistamine and decongestant formulation |
| FR2818552B1 (fr) * | 2000-12-26 | 2003-02-07 | Servier Lab | Compositions pharmaceutique solide thermoformable pour la liberation controlee d'ivabradine |
| CZ20033019A3 (cs) * | 2001-04-09 | 2004-07-14 | Teva Pharmaceutical Industries Ltd. | Polymorfní formy chloridu fexofenadinu |
| US20030021849A1 (en) * | 2001-04-09 | 2003-01-30 | Ben-Zion Dolitzky | Polymorphs of fexofenadine hydrochloride |
| US7052706B2 (en) * | 2001-06-08 | 2006-05-30 | Nostrum Pharmaceuticals, Inc. | Control release formulation containing a hydrophobic material as the sustained release agent |
| US6863901B2 (en) | 2001-11-30 | 2005-03-08 | Collegium Pharmaceutical, Inc. | Pharmaceutical composition for compressed annular tablet with molded triturate tablet for both intraoral and oral administration |
| US6827946B2 (en) * | 2001-12-05 | 2004-12-07 | Collegium Pharmaceutical, Inc. | Compositions containing both sedative and non-sedative antihistamines |
| US8263124B2 (en) | 2002-04-04 | 2012-09-11 | Dr. Reddy's Laboratories Limited | Anthistamine-decongestant pharmaceutical compositions |
| ES2239554T1 (es) * | 2002-06-10 | 2005-10-01 | Teva Pharmaceutical Industries Ltd. | Forma xvi polimorfica de hidrocloruro de fexofenadina. |
| US6663892B1 (en) | 2002-08-19 | 2003-12-16 | L. Perrigo Company | Multiple portion tablet |
| US20050152967A1 (en) * | 2003-03-28 | 2005-07-14 | Pfab, Lp | Dynamic variable release |
| AU2004312059A1 (en) * | 2003-12-31 | 2005-07-21 | Actavis Group Hf | Atomoxetine formulations |
| US20050220877A1 (en) * | 2004-03-31 | 2005-10-06 | Patel Ashish A | Bilayer tablet comprising an antihistamine and a decongestant |
| US20050256163A1 (en) * | 2004-04-26 | 2005-11-17 | Ilan Kor | Crystalline forms of fexofenadine hydrochloride and processes for their preparation |
| RS56037B1 (sr) | 2004-06-24 | 2017-09-29 | Vertex Pharma | Modulatori atp-vezujućih kasetnih transportera |
| JP2008514641A (ja) * | 2004-09-28 | 2008-05-08 | テバ ファーマシューティカル インダストリーズ リミティド | 結晶形フェキソフェナジン、およびその調製方法 |
| US20080095846A1 (en) * | 2004-11-04 | 2008-04-24 | Gour Mukherji | Pharmaceutical compositions of antihistamine and decongestant |
| US20080187581A1 (en) * | 2005-03-16 | 2008-08-07 | Subhash Pandurang Gore | Delivery System For Mulitple Drugs |
| EP3219705B1 (en) | 2005-12-28 | 2020-03-11 | Vertex Pharmaceuticals Incorporated | Pharmaceutical compositions of the amorphous form of n-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
| CN101478958A (zh) * | 2006-06-30 | 2009-07-08 | 特瓦制药工业有限公司 | 包含哌啶烷醇和减充血剂的组合的药物组合物 |
| EP2046299A1 (en) * | 2006-07-11 | 2009-04-15 | Mutual Pharmaceutical Company, Inc. | Controlled-release formulations |
| US20080085311A1 (en) * | 2006-10-05 | 2008-04-10 | Tripathi Sanjay S | Antihistamine-decongestant combinations |
| EP2124901B1 (en) * | 2007-02-01 | 2017-07-19 | Takeda Pharmaceutical Company Limited | Tablet preparation without causing a tableting trouble |
| WO2008105920A1 (en) * | 2007-02-28 | 2008-09-04 | Collegium Pharmaceutical, Inc. | Antihistamine combination |
| US20100143471A1 (en) * | 2007-03-21 | 2010-06-10 | Lupin Limited | Novel reduced dose pharmaceutical compositions of fexofenadine and pseudoephedrine |
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| KR101609279B1 (ko) | 2008-03-21 | 2016-04-05 | 밀란 파마슈티컬즈, 인코포레이티드 | 왁스를 포함하는 서방형 제형 |
| US12458635B2 (en) | 2008-08-13 | 2025-11-04 | Vertex Pharmaceuticals Incorporated | Pharmaceutical composition and administrations thereof |
| US20100074949A1 (en) * | 2008-08-13 | 2010-03-25 | William Rowe | Pharmaceutical composition and administration thereof |
| US20100256184A1 (en) * | 2008-08-13 | 2010-10-07 | Vertex Pharmaceuticals Incorporated | Pharmaceutical composition and administrations thereof |
| MY155497A (en) * | 2008-11-19 | 2015-10-30 | Merial Inc | Compositions comprising an aryl pyrazole and/or a formamidine, methods and use thereof |
| PL2408750T3 (pl) | 2009-03-20 | 2016-02-29 | Vertex Pharma | Sposób otrzymywania modulatorów błonowego regulatora przewodnictwa swoistego dla mukowiscydozy |
| US20120100221A1 (en) | 2009-06-02 | 2012-04-26 | Ranbaxy Laboratories Limited | Pharmaceutical compositions containing a combination of an antihistamine and a decongestant |
| JP2015511583A (ja) | 2012-02-27 | 2015-04-20 | バーテックス ファーマシューティカルズ インコーポレイテッドＶｅｒｔｅｘ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃｏｒｐｏｒａｔｅｄ | 薬学的組成物およびその投与 |
| ES2821528T3 (es) | 2012-11-14 | 2021-04-26 | Grace W R & Co | Composiciones que contienen un material biológicamente activo y un óxido inorgánico no ordenado |
| US10058542B1 (en) | 2014-09-12 | 2018-08-28 | Thioredoxin Systems Ab | Composition comprising selenazol or thiazolone derivatives and silver and method of treatment therewith |
| CN107250113B (zh) | 2014-10-07 | 2019-03-29 | 弗特克斯药品有限公司 | 囊性纤维化跨膜传导调节蛋白的调节剂的共晶 |
| JP2019218313A (ja) | 2018-06-21 | 2019-12-26 | 沢井製薬株式会社 | プソイドエフェドリン又はその薬学的に許容される塩を含有する徐放製剤 |
| KR20240019293A (ko) * | 2021-06-07 | 2024-02-14 | 알.피.쉐러 테크놀러지즈 엘엘씨 | 습기 감응성 약학 조성물용 보호 코팅 |
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-
1998
- 1998-07-21 CN CNB988085275A patent/CN1159012C/zh not_active Expired - Lifetime
- 1998-07-21 SI SI9830454T patent/SI0998272T1/xx unknown
- 1998-07-21 RU RU99125326/14A patent/RU2207879C2/ru active
- 1998-07-21 DK DK98937010T patent/DK0998272T3/da active
- 1998-07-21 HU HU0002183A patent/HU224921B1/hu unknown
- 1998-07-21 IL IL13342098A patent/IL133420A/en not_active IP Right Cessation
- 1998-07-21 KR KR10-1999-7011550A patent/KR100514264B1/ko not_active Expired - Lifetime
- 1998-07-21 DE DE69814086T patent/DE69814086T2/de not_active Expired - Lifetime
- 1998-07-21 UA UA99126576A patent/UA60335C2/uk unknown
- 1998-07-21 PT PT98937010T patent/PT998272E/pt unknown
- 1998-07-21 EP EP98937010A patent/EP0998272B1/en not_active Expired - Lifetime
- 1998-07-21 PL PL337348A patent/PL192079B1/pl unknown
- 1998-07-21 WO PCT/US1998/015237 patent/WO1999009957A1/en not_active Ceased
- 1998-07-21 JP JP51430099A patent/JP4344405B2/ja not_active Expired - Lifetime
- 1998-07-21 EE EEP200000098A patent/EE04294B1/xx unknown
- 1998-07-21 ES ES98937010T patent/ES2192781T3/es not_active Expired - Lifetime
- 1998-07-21 AT AT98937010T patent/ATE238773T1/de active
- 1998-07-21 ID IDW991512A patent/ID22891A/id unknown
- 1998-07-21 BR BR9812001-8A patent/BR9812001A/pt not_active IP Right Cessation
- 1998-07-21 NZ NZ501248A patent/NZ501248A/en not_active IP Right Cessation
- 1998-07-21 CZ CZ19994581A patent/CZ295461B6/cs not_active IP Right Cessation
- 1998-07-21 AU AU85820/98A patent/AU725811B2/en not_active Expired
- 1998-07-21 TR TR2000/00517T patent/TR200000517T2/xx unknown
- 1998-07-21 SK SK1777-99A patent/SK283803B6/sk not_active IP Right Cessation
- 1998-07-31 US US09/127,478 patent/US6039974A/en not_active Expired - Lifetime
- 1998-08-20 ZA ZA987552A patent/ZA987552B/xx unknown
- 1998-08-21 TW TW087113848A patent/TW570812B/zh not_active IP Right Cessation
- 1998-08-25 AR ARP980104196A patent/AR013947A1/es not_active Application Discontinuation
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2000
- 2000-02-04 OA OA1200000029A patent/OA11285A/en unknown
- 2000-02-25 NO NO20000932A patent/NO318246B1/no not_active IP Right Cessation
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