PE20040416A1 - Formulacion de alta dosis de ibandronato - Google Patents
Formulacion de alta dosis de ibandronatoInfo
- Publication number
- PE20040416A1 PE20040416A1 PE2003000829A PE2003000829A PE20040416A1 PE 20040416 A1 PE20040416 A1 PE 20040416A1 PE 2003000829 A PE2003000829 A PE 2003000829A PE 2003000829 A PE2003000829 A PE 2003000829A PE 20040416 A1 PE20040416 A1 PE 20040416A1
- Authority
- PE
- Peru
- Prior art keywords
- weight
- ibandronate
- coating film
- active substance
- high dose
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 4
- MPBVHIBUJCELCL-UHFFFAOYSA-N Ibandronate Chemical compound CCCCCN(C)CCC(O)(P(O)(O)=O)P(O)(O)=O MPBVHIBUJCELCL-UHFFFAOYSA-N 0.000 title abstract 3
- 229940015872 ibandronate Drugs 0.000 title abstract 2
- 238000009472 formulation Methods 0.000 title 1
- 239000013543 active substance Substances 0.000 abstract 2
- 239000011248 coating agent Substances 0.000 abstract 2
- 238000000576 coating method Methods 0.000 abstract 2
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 abstract 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 abstract 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- 229920003080 Povidone K 25 Polymers 0.000 abstract 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 abstract 1
- 235000021355 Stearic acid Nutrition 0.000 abstract 1
- 239000008119 colloidal silica Substances 0.000 abstract 1
- 229960000913 crospovidone Drugs 0.000 abstract 1
- 239000007884 disintegrant Substances 0.000 abstract 1
- 229960005236 ibandronic acid Drugs 0.000 abstract 1
- 229960001021 lactose monohydrate Drugs 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 229960003511 macrogol Drugs 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 abstract 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 abstract 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 abstract 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000008117 stearic acid Substances 0.000 abstract 1
Classifications
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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
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
-
- 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
- A61K31/66—Phosphorus compounds
- A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
- A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
-
- 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
- A61K9/2004—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
- A61K9/2072—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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Physical Education & Sports Medicine (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Endocrinology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Cosmetics (AREA)
- Materials For Medical Uses (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Abstract
QUE COMPRENDE: 1)250 mg DE BIFOSFONATOS ESPECIALMENTE IBANDRONATO O UNA SAL FISIOLOGICAMENTE SEGURA DEL MISMO COMO SUSTANCIA ACTIVA, PARA APLICACION ORAL. DONDE LA FORMA DE PRESENTACION DE LA COMPOSICION SON COMPRIMIDOS, PREFERIBLEMENTE RECUBIERTOS, QUE COMPRENDE: 1)DE 30% A 36% DE SUSTANCIA ACTIVA; 2)DE 4% A 6%, POR PESO, DE ENLAZANTE; 3)DE 39,6% A 59,4%, POR PESO, DE RELLENO; 4)DE 4,5% A 5,5%, POR PESO, DE DESINTEGRANTE; 5)DE 1,8% A 2,2%, POR PESO DE LUBRICANTE; 6)DE 0,9% A 1,1%, POR PESO, DE REGULADOR DE FLUJO. PUDIENDO ESTAR UNA COMPOSICION PARTICULAR CONFORMADA POR: a)100 mg DE ACIDO IBANDRONICO; b)15 mg DE POVIDONE K25; c)108,50 mg DE MONOHIDRATO DE LACTOSA; d)40 mg DE CELULOSA MICROCRISTALINA; e)15 mg DE CROSPOVIDONA; f)6 mg DE ACIDO ESTEARICO 95; g)3 mg DE SILICE COLOIDAL ANHIDRO; Y, h)UNA PELICULA RECUBRIDORA FORMADA POR UNA MEZCLA DE PELICULA RECUBRIDORA EN UNA CANTIDAD DE 10,2 mg Y 1,80 mg DE MACROGOL 6000
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP02028745 | 2002-12-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20040416A1 true PE20040416A1 (es) | 2004-07-12 |
Family
ID=32524013
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2003000829A PE20040416A1 (es) | 2002-12-20 | 2003-08-15 | Formulacion de alta dosis de ibandronato |
Country Status (35)
| Country | Link |
|---|---|
| US (1) | US7923028B2 (es) |
| EP (2) | EP1790347B1 (es) |
| JP (1) | JP4427453B2 (es) |
| KR (1) | KR100694550B1 (es) |
| CN (1) | CN1649598B (es) |
| AR (2) | AR037560A1 (es) |
| AT (1) | ATE369139T1 (es) |
| AU (1) | AU2003250218B2 (es) |
| BR (1) | BR0309691A (es) |
| CA (1) | CA2484494C (es) |
| CR (1) | CR7549A (es) |
| CY (2) | CY1107757T1 (es) |
| DE (1) | DE60315514T3 (es) |
| DK (2) | DK1596870T4 (es) |
| EC (1) | ECSP045418A (es) |
| EG (1) | EG26027A (es) |
| ES (2) | ES2291749T5 (es) |
| HR (1) | HRP20041013B1 (es) |
| IL (2) | IL164956A (es) |
| JO (1) | JO2663B1 (es) |
| MX (1) | MXPA04010866A (es) |
| MY (1) | MY143550A (es) |
| NO (1) | NO329690B1 (es) |
| NZ (2) | NZ555514A (es) |
| PA (1) | PA8580601A1 (es) |
| PE (1) | PE20040416A1 (es) |
| PL (1) | PL212072B1 (es) |
| PT (2) | PT1596870E (es) |
| RU (1) | RU2315603C2 (es) |
| SG (1) | SG174628A1 (es) |
| SI (2) | SI1790347T1 (es) |
| TW (1) | TWI342215B (es) |
| UY (1) | UY27942A1 (es) |
| WO (1) | WO2004056373A1 (es) |
| ZA (1) | ZA200408822B (es) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20090029312A (ko) | 2002-05-10 | 2009-03-20 | 에프. 호프만-라 로슈 아게 | 골다공증 치료 및 예방용 비스포스폰산 |
| AU2004275569B2 (en) * | 2003-09-29 | 2011-04-21 | Cipla Limited | Pharmaceutical formulation with improved stability |
| JP4559431B2 (ja) * | 2004-08-23 | 2010-10-06 | 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 | 固体及び結晶イバンドロネートナトリウム及びその調製方法 |
| KR100908529B1 (ko) * | 2005-02-01 | 2009-07-20 | 에프. 호프만-라 로슈 아게 | 이반드로네이트 다형체 에이 |
| US20070191315A1 (en) * | 2006-02-16 | 2007-08-16 | Bengt Bergstrom | Method for administering ibandronate |
| DE102006012866B4 (de) | 2006-03-19 | 2009-04-09 | Uic Gmbh | Verfahren zur Abtrennung leichtflüchtiger Komponenten aus einem Stoffgemisch sowie Vorrichtung zur Durchführung dieses Verfahrens |
| GB0616794D0 (en) | 2006-08-24 | 2006-10-04 | Arrow Int Ltd | Solid dosage form |
| WO2008026907A1 (es) * | 2006-08-29 | 2008-03-06 | Espinosa Abdala Leopoldo De Je | Composición farmacéutica que comprende ibandronato y vitamina d3 para el tratamiento de osteoporosis |
| US20080139514A1 (en) * | 2006-11-29 | 2008-06-12 | Subhash Pandurang Gore | Diphosphonic acid pharmaceutical compositions |
| WO2009018834A1 (en) * | 2007-08-06 | 2009-02-12 | Pharmathen S.A. | Pharmaceutical composition containing bisphosphonate and method for the preparation thereof |
| KR20100014090A (ko) * | 2008-08-01 | 2010-02-10 | 동화약품주식회사 | 벤즈아미딘 유도체 또는 이의 염, 및 비스포스포네이트를 포함하는 골다공증의 예방 또는 치료용 약학 조성물 |
| US20160016982A1 (en) | 2009-07-31 | 2016-01-21 | Thar Pharmaceuticals, Inc. | Crystallization method and bioavailability |
| KR101813728B1 (ko) | 2009-07-31 | 2017-12-29 | 그뤼넨탈 게엠베하 | 결정화 방법 및 생체이용률 |
| US9169279B2 (en) | 2009-07-31 | 2015-10-27 | Thar Pharmaceuticals, Inc. | Crystallization method and bioavailability |
| CN102000094B (zh) * | 2010-09-27 | 2013-03-27 | 天津南开允公医药科技有限公司 | 一种含有伊班膦酸的药物组合物及制备工艺 |
| KR101244414B1 (ko) * | 2010-11-05 | 2013-03-18 | 주식회사 바이오파마티스 | 고함량 이반드론산 함유 골다공증 예방 또는 치료용 조성물 및 이의 제조방법 |
| US9340565B2 (en) | 2010-11-24 | 2016-05-17 | Thar Pharmaceuticals, Inc. | Crystalline forms |
| WO2012093974A1 (en) | 2011-01-06 | 2012-07-12 | Mahmut Bilgic | Improved bisphosphonate formulations |
| US9854831B2 (en) * | 2012-01-20 | 2018-01-02 | Altria Client Services Llc | Oral product |
| WO2017208070A1 (en) | 2016-05-31 | 2017-12-07 | Grünenthal GmbH | Bisphosphonic acid and coformers with lysin, glycin, nicotinamide for treating psoriatic arthritis |
| EP4082535A1 (en) | 2017-12-08 | 2022-11-02 | F. Hoffmann-La Roche AG | Pharmaceutical formulation |
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