BR0213861A - Processo para a preparação de composições de ribavirina de carga elevada, de dissolução rápida - Google Patents
Processo para a preparação de composições de ribavirina de carga elevada, de dissolução rápidaInfo
- Publication number
- BR0213861A BR0213861A BR0213861-1A BR0213861A BR0213861A BR 0213861 A BR0213861 A BR 0213861A BR 0213861 A BR0213861 A BR 0213861A BR 0213861 A BR0213861 A BR 0213861A
- Authority
- BR
- Brazil
- Prior art keywords
- ribavirin
- composition
- compositions
- granulation
- preparation
- Prior art date
Links
- IWUCXVSUMQZMFG-AFCXAGJDSA-N Ribavirin Chemical compound N1=C(C(=O)N)N=CN1[C@H]1[C@H](O)[C@H](O)[C@@H](CO)O1 IWUCXVSUMQZMFG-AFCXAGJDSA-N 0.000 title abstract 14
- 229960000329 ribavirin Drugs 0.000 title abstract 14
- HZCAHMRRMINHDJ-DBRKOABJSA-N ribavirin Natural products O[C@@H]1[C@H](O)[C@@H](CO)O[C@H]1N1N=CN=C1 HZCAHMRRMINHDJ-DBRKOABJSA-N 0.000 title abstract 14
- 239000000203 mixture Substances 0.000 title abstract 11
- 238000000034 method Methods 0.000 title abstract 3
- 238000002360 preparation method Methods 0.000 title abstract 2
- 238000005469 granulation Methods 0.000 abstract 3
- 230000003179 granulation Effects 0.000 abstract 3
- 239000007884 disintegrant Substances 0.000 abstract 2
- 239000000945 filler Substances 0.000 abstract 2
- 238000002156 mixing Methods 0.000 abstract 2
- 238000004566 IR spectroscopy Methods 0.000 abstract 1
- 239000002775 capsule Substances 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 239000008240 homogeneous mixture Substances 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
- 238000005550 wet granulation Methods 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
- A61K9/14—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
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—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
- A61K9/14—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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Virology (AREA)
- Gastroenterology & Hepatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Saccharide Compounds (AREA)
Abstract
"PROCESSO PARA A PREPARAçãO DE COMPOSIçõES DE RIBAVIRINA DE CARGA ELEVADA, DE DISSOLUçãO RáPIDA". A presente invenção refere-se a uma composição de ribavirina de carga elevada, de dissolução rápida a qual é essencialmente livre de formas polimórficas de ribavirina, a referida composição é preparada por um processo compreendendo: (a) misturar ribavirina, pelo menos um desintegrante e /ou pelo menos uma carga para formar uma mistura homogênea; (b) granular a mistura na presença de água para formar uma granulação; (c) secar a granulação; e (d) misturar pelo menos um desintegrante e /ou pelo menos um lubrificante com a granulação para produzir uma composição de ribavirina, onde a referida composição de ribavirina compreende pelo menos 80 por cento em peso de ribavirina, com base no peso total da composição. As composições de ribavirina preparadas pelo processo de granulação úmida da invenção são de fluxo livre e têm adequada densidade de carga para processamento em cápsulas. Além disso, as composições de ribavirina contêm pelo menos 80 por cento em peso de ribavirina. Além disso, as composições de ribavirina são substancialmente livres de formas polimórficas de ribavirina, isto é, não existe nenhum sinal de alteração polimórfica na ribavirina tal como determinado pela espectrofotometria de infravermelho.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US33685301P | 2001-11-02 | 2001-11-02 | |
| PCT/US2002/034899 WO2003039517A1 (en) | 2001-11-02 | 2002-10-31 | Process for preparing quick dissolving, high loading ribavirin compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR0213861A true BR0213861A (pt) | 2004-12-21 |
Family
ID=23317956
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR0213861-1A BR0213861A (pt) | 2001-11-02 | 2002-10-31 | Processo para a preparação de composições de ribavirina de carga elevada, de dissolução rápida |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US20030104050A1 (pt) |
| EP (1) | EP1443911A1 (pt) |
| JP (1) | JP2005511587A (pt) |
| KR (1) | KR20050042035A (pt) |
| CN (1) | CN1585631A (pt) |
| AU (1) | AU2002350082B9 (pt) |
| BR (1) | BR0213861A (pt) |
| CA (1) | CA2465159A1 (pt) |
| HR (1) | HRP20040384A2 (pt) |
| HU (1) | HUP0402364A2 (pt) |
| IL (1) | IL161697A0 (pt) |
| MX (1) | MXPA04004181A (pt) |
| NO (1) | NO20042143L (pt) |
| PL (1) | PL368550A1 (pt) |
| RU (1) | RU2004116821A (pt) |
| WO (1) | WO2003039517A1 (pt) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6720000B2 (en) | 2001-03-19 | 2004-04-13 | Three Rivers Pharmaceutical, Llc | Process for producing wet ribavirin pellets |
| US7538094B2 (en) * | 2002-09-19 | 2009-05-26 | Three Rivers Pharmacueticals, Llc | Composition containing ribavirin and use thereof |
| CZ298224B6 (cs) * | 2003-04-29 | 2007-07-25 | Pliva Istrazivanje I Razvoj D.O.O. | Farmaceutická kompozice obsahující jako úcinnou látku ribavirin a zpusob její výroby |
| MY144631A (en) * | 2004-05-24 | 2011-10-14 | Nycomed Pharma As | Particulate comprising a calcium-containing compound and a sugar alcohol |
| WO2006002365A2 (en) * | 2004-06-24 | 2006-01-05 | Angiotech International Ag | Microparticles with high loadings of a bioactive agent |
| US7723310B2 (en) * | 2004-10-18 | 2010-05-25 | Three Rivers Pharmaceuticals, Llc | Large dose ribavirin formulations |
| US20060110479A1 (en) * | 2004-11-24 | 2006-05-25 | Mitra Shankar K | Natural composition for curing hepatitis-B, methods for making the same and pharmaceutical formulations thereof |
| US8202546B2 (en) | 2005-08-04 | 2012-06-19 | Vertical Pharmaceuticals, Inc. | Nutritional supplement for use under physiologically stressful conditions |
| US8263137B2 (en) | 2005-08-04 | 2012-09-11 | Vertical Pharmaceuticals, Inc. | Nutritional supplement for women |
| US7901710B2 (en) | 2005-08-04 | 2011-03-08 | Vertical Pharmaceuticals, Inc. | Nutritional supplement for use under physiologically stressful conditions |
| AU2007338751A1 (en) * | 2006-12-21 | 2008-07-03 | Mallinckrodt Inc. | Composition of and method for preparing orally disintegrating tablets containing a high dose of pharmaceutically active ingredients |
| US8202996B2 (en) * | 2007-12-21 | 2012-06-19 | Bristol-Myers Squibb Company | Crystalline forms of N-(tert-butoxycarbonyl)-3-methyl-L-valyl-(4R)-4-((7-chloro-4-methoxy-1-isoquinolinyl)oxy)-N- ((1R,2S)-1-((cyclopropylsulfonyl)carbamoyl)-2-vinylcyclopropyl)-L-prolinamide |
| WO2010062996A2 (en) * | 2008-11-28 | 2010-06-03 | Adamas Pharmaceuticals, Inc. | Ribavirin composition |
| EP2295037A1 (en) | 2009-09-11 | 2011-03-16 | Ratiopharm GmbH | Pharmaceutical formulation containing Ribavirin |
| WO2011154772A1 (es) * | 2010-06-08 | 2011-12-15 | Laboratorio De Diagnostico Gam, S.A. | Composición veterinaria oral para salmónidos que comprende 1-beta-d-ribofuranosil-1h-1,2,4-triazol-3-carboxamida y el uso para el tratamiento de la anemia infecciosa del salmón (isa) en salmónidos |
| EP3307327A1 (en) * | 2015-06-09 | 2018-04-18 | Commonwealth Scientific and Industrial Research Organisation | Antiviral conjugates of polyanionic polymer and antiviral drug |
| CN106806345B (zh) * | 2015-11-27 | 2020-10-13 | 北京科信必成医药科技发展有限公司 | 一种利巴韦林掩味颗粒及其制备方法 |
| CN108464972A (zh) * | 2018-07-02 | 2018-08-31 | 福州大学 | 一种含有斯诺普利的抗肺动脉高压口服片剂及其制备方法 |
| KR20230011359A (ko) | 2020-06-18 | 2023-01-20 | 엑스더블유파마 리미티드 | 수용성 활성 약제 성분의 제어 방출 과립화물 |
| JP7751638B2 (ja) | 2020-10-05 | 2025-10-08 | エックスダブリューファーマ リミテッド | ガンマ-ヒドロキシ酪酸誘導体の調節放出組成物 |
| CN113304114B (zh) * | 2021-06-08 | 2022-06-10 | 药大制药有限公司 | 一种利巴韦林颗粒及其制备方法 |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3277520A (en) * | 1963-06-18 | 1966-10-11 | Fuji Denki Kogyo Kabushiki Kai | Method and apparatus for making spherical granules |
| US3798209A (en) * | 1971-06-01 | 1974-03-19 | Icn Pharmaceuticals | 1,2,4-triazole nucleosides |
| US3927216A (en) * | 1971-06-01 | 1975-12-16 | Icn Pharmaceuticals | 1,2,4-Triazol E-3-carboxamides for inhibiting virus infections |
| US4211771A (en) * | 1971-06-01 | 1980-07-08 | Robins Ronald K | Treatment of human viral diseases with 1-B-D-ribofuranosyl-1,2,4-triazole-3-carboxamide |
| US3976545A (en) * | 1973-03-12 | 1976-08-24 | Icn Pharmaceuticals, Inc. | 1,2,4-Triazol E-3-carboxamides as antiviral agents |
| US3948885A (en) * | 1973-03-19 | 1976-04-06 | Icn Pharmaceuticals, Inc. | 5-Hydroxyl-1,2,3-triazole-4-carboxamide nucleoside |
| US4138547A (en) * | 1977-12-22 | 1979-02-06 | Icn Pharmaceuticals, Inc. | Process for preparing 1,2,4-triazole nucleosides |
| US4439453A (en) * | 1980-12-22 | 1984-03-27 | Monsanto Company | Directly compressible acetaminophen granulation |
| GB9009861D0 (en) * | 1990-05-02 | 1990-06-27 | Glaxo Group Ltd | Chemical compounds |
| US5405837A (en) * | 1993-05-18 | 1995-04-11 | Indiana University Foundation | Method for the treatment of neoplastic disease utilizing tiazofurin and ribavirin |
| US5908621A (en) * | 1995-11-02 | 1999-06-01 | Schering Corporation | Polyethylene glycol modified interferon therapy |
| CA2329474C (en) * | 1995-11-02 | 2002-02-26 | Schering Corporation | Continuous low-dose cytokine infusion therapy |
| US6150337A (en) * | 1996-01-23 | 2000-11-21 | Icn Pharmaceuticals, Inc. | Specific modulation of Th1/Th2 cytokine expression by Ribavirin in activated T-lymphocytes |
| US5767097A (en) * | 1996-01-23 | 1998-06-16 | Icn Pharmaceuticals, Inc. | Specific modulation of Th1/Th2 cytokine expression by ribavirin in activated T-lymphocytes |
| EP1027359B9 (en) * | 1996-10-16 | 2003-09-17 | Ribapharm, Inc. | Monocyclic l-nucleosides, analogs and uses thereof |
| US6172046B1 (en) * | 1997-09-21 | 2001-01-09 | Schering Corporation | Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection |
| US6472373B1 (en) * | 1997-09-21 | 2002-10-29 | Schering Corporation | Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection |
| US5914128A (en) * | 1997-12-22 | 1999-06-22 | Schering Corporation | Orally administrable solid dosage form |
| ZA9811726B (en) * | 1997-12-22 | 1999-06-21 | Schering Corp | Orally administrable solid ribavirin dosage forms and process for making them |
| US5916594A (en) * | 1997-12-22 | 1999-06-29 | Schering Corporation | Process of making solid ribavirin dosage forms |
| US20030104048A1 (en) * | 1999-02-26 | 2003-06-05 | Lipocine, Inc. | Pharmaceutical dosage forms for highly hydrophilic materials |
| US6541014B2 (en) * | 2000-10-13 | 2003-04-01 | Advancis Pharmaceutical Corp. | Antiviral product, use and formulation thereof |
| US6720000B2 (en) * | 2001-03-19 | 2004-04-13 | Three Rivers Pharmaceutical, Llc | Process for producing wet ribavirin pellets |
-
2002
- 2002-10-31 KR KR1020047006543A patent/KR20050042035A/ko not_active Withdrawn
- 2002-10-31 CA CA002465159A patent/CA2465159A1/en not_active Abandoned
- 2002-10-31 WO PCT/US2002/034899 patent/WO2003039517A1/en not_active Ceased
- 2002-10-31 HR HR20040384A patent/HRP20040384A2/hr not_active Application Discontinuation
- 2002-10-31 HU HU0402364A patent/HUP0402364A2/hu unknown
- 2002-10-31 CN CNA028222172A patent/CN1585631A/zh active Pending
- 2002-10-31 IL IL16169702A patent/IL161697A0/xx unknown
- 2002-10-31 RU RU2004116821/15A patent/RU2004116821A/ru not_active Application Discontinuation
- 2002-10-31 MX MXPA04004181A patent/MXPA04004181A/es unknown
- 2002-10-31 AU AU2002350082A patent/AU2002350082B9/en not_active Ceased
- 2002-10-31 BR BR0213861-1A patent/BR0213861A/pt not_active IP Right Cessation
- 2002-10-31 JP JP2003541808A patent/JP2005511587A/ja active Pending
- 2002-10-31 PL PL02368550A patent/PL368550A1/xx not_active Application Discontinuation
- 2002-10-31 US US10/285,188 patent/US20030104050A1/en not_active Abandoned
- 2002-10-31 EP EP02786613A patent/EP1443911A1/en not_active Withdrawn
-
2004
- 2004-05-25 NO NO20042143A patent/NO20042143L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| KR20050042035A (ko) | 2005-05-04 |
| AU2002350082B9 (en) | 2006-08-31 |
| RU2004116821A (ru) | 2005-04-20 |
| MXPA04004181A (es) | 2005-01-25 |
| IL161697A0 (en) | 2004-09-27 |
| JP2005511587A (ja) | 2005-04-28 |
| AU2002350082B2 (en) | 2006-07-20 |
| CN1585631A (zh) | 2005-02-23 |
| NO20042143L (no) | 2004-05-25 |
| US20030104050A1 (en) | 2003-06-05 |
| EP1443911A1 (en) | 2004-08-11 |
| PL368550A1 (en) | 2005-04-04 |
| WO2003039517A1 (en) | 2003-05-15 |
| HUP0402364A2 (hu) | 2005-02-28 |
| CA2465159A1 (en) | 2003-05-15 |
| HRP20040384A2 (en) | 2005-08-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE A 6A, 7A E 8A ANUIDADES. |
|
| B08K | Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette] |
Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2099 DE 29/03/2011. |