BRPI0606119A2 - preparações injetáveis de diclofenaco e seus sais farmaceuticamente aceitáveis - Google Patents
preparações injetáveis de diclofenaco e seus sais farmaceuticamente aceitáveisInfo
- Publication number
- BRPI0606119A2 BRPI0606119A2 BRPI0606119-2A BRPI0606119A BRPI0606119A2 BR PI0606119 A2 BRPI0606119 A2 BR PI0606119A2 BR PI0606119 A BRPI0606119 A BR PI0606119A BR PI0606119 A2 BRPI0606119 A2 BR PI0606119A2
- Authority
- BR
- Brazil
- Prior art keywords
- diclofenac
- pharmaceutically acceptable
- injectable
- acceptable salts
- water
- Prior art date
Links
- DCOPUUMXTXDBNB-UHFFFAOYSA-N diclofenac Chemical compound OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl DCOPUUMXTXDBNB-UHFFFAOYSA-N 0.000 title abstract 5
- 238000002360 preparation method Methods 0.000 title abstract 3
- 150000003839 salts Chemical class 0.000 title abstract 2
- 229960001259 diclofenac Drugs 0.000 title 1
- 238000002347 injection Methods 0.000 abstract 3
- 239000007924 injection Substances 0.000 abstract 3
- 239000000243 solution Substances 0.000 abstract 2
- 239000003513 alkali Substances 0.000 abstract 1
- 239000003963 antioxidant agent Substances 0.000 abstract 1
- 239000000872 buffer Substances 0.000 abstract 1
- 239000006184 cosolvent Substances 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000007972 injectable composition Substances 0.000 abstract 1
- 238000001990 intravenous administration Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000003755 preservative agent Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K9/08—Solutions
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
PREPARAçõES INJETáVEIS DE DICLOFENACO E SEUS SAIS FARMACEUTICAMENTE ACEITáVEIS. A presente invenção fornece formulações injetáveis de sais de diclofenaco solúveis em água em doses únicas ou menores do que 2 mL, que causam significativamente menos dor no local da injeção e podem ser administradas via intradeltólde, em adição a via intraglútea e intravenosa lenta. Mais especificamente as preparações injetáveis contém 75 mg a 100 mg de sais de diclofenaco solúveis em água, em cerca de 1 mL de solução de injeção sem elevar significativamente a viscosidade da solução de injeção sem o uso de surfactantes. As formulações são ajustadas em pH 6 a 10 contendo até 100 mg de sal de diclofenaco em um meio compreendido de água, junto com um ou mais cosolvente(s)/solubilizante(s), antioxidantes, conservantes, buffers, álcali e estabilizantes.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN96MU2005 | 2005-02-01 | ||
| IN96/MUM/2005 | 2005-02-01 | ||
| PCT/IN2006/000033 WO2006095363A2 (en) | 2005-02-01 | 2006-01-30 | Injectable preparations of diclofenic and its pharmaceutically acceptable salts |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BRPI0606119A2 true BRPI0606119A2 (pt) | 2009-06-02 |
| BRPI0606119B1 BRPI0606119B1 (pt) | 2019-05-07 |
| BRPI0606119B8 BRPI0606119B8 (pt) | 2021-05-25 |
Family
ID=36953757
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0606119A BRPI0606119B8 (pt) | 2005-02-01 | 2006-01-30 | preparações injetáveis de diclofenaco e seus sais farmaceuticamente aceitáveis |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US8809393B2 (pt) |
| EP (1) | EP1848419B1 (pt) |
| JP (1) | JP2008528572A (pt) |
| KR (1) | KR101226121B1 (pt) |
| CN (1) | CN101123957B (pt) |
| AP (1) | AP2888A (pt) |
| AU (2) | AU2006221633B2 (pt) |
| BR (1) | BRPI0606119B8 (pt) |
| CA (1) | CA2596031C (pt) |
| DK (1) | DK1848419T3 (pt) |
| EA (1) | EA013616B1 (pt) |
| ES (1) | ES2392097T3 (pt) |
| IL (1) | IL184697A (pt) |
| MX (1) | MX2007009312A (pt) |
| NZ (1) | NZ554779A (pt) |
| PL (1) | PL1848419T3 (pt) |
| PT (1) | PT1848419E (pt) |
| UA (1) | UA93365C2 (pt) |
| WO (1) | WO2006095363A2 (pt) |
| ZA (1) | ZA200705729B (pt) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009155315A (ja) * | 2007-12-26 | 2009-07-16 | Fujiyakuhin Co Ltd | 注射剤 |
| WO2013005226A1 (en) * | 2011-07-04 | 2013-01-10 | Zota Health Care Ltd | A novel combined pharmaceutical composition containing diclofenac and methods of making and using the same |
| US20140187635A1 (en) * | 2012-12-28 | 2014-07-03 | Themis Medicare Limited | Diclofenac compositions |
| US20140275261A1 (en) | 2013-03-15 | 2014-09-18 | Dr. Reddy's Laboratories, Inc. | Diclofenac parenteral compositions |
| CN103432132B (zh) * | 2013-08-31 | 2015-01-21 | 西南大学 | 甲磺酸普立地诺双氯芬酸钠注射液及其制备方法 |
| WO2016170401A1 (en) * | 2015-04-20 | 2016-10-27 | Umedica Laboratories Pvt. Ltd | Novel injectable composition of diclofenac sodium |
| WO2021048748A1 (en) | 2019-09-09 | 2021-03-18 | Ftf Pharma Private Limited | Pharmaceutical formulations comprising diclofenac |
Family Cites Families (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE8200488L (sv) | 1982-01-29 | 1983-07-30 | Svenska Flaektfabriken Ab | Arreteringsanordning, serskilt for forankring av till- och franluftventiler i ventilationskanaler |
| DE3328401A1 (de) | 1983-08-05 | 1985-02-21 | Merckle GmbH, 7902 Blaubeuren | Injizierbare loesung zur behandlung von entzuendungen |
| DE3446873A1 (de) * | 1984-12-21 | 1986-07-10 | Merckle Gmbh | Fluessige diclofenac-zubereitungen |
| DE3613799C1 (de) | 1986-04-24 | 1987-09-03 | Nattermann A & Cie | Verwendung von Glycofurol zum Verfluessigen von Arzneimittelzubereitungen fuer das Abfuellen in Weichgelatinekapseln |
| JP3219096B2 (ja) | 1990-05-10 | 2001-10-15 | ニコメド ファーマ エイエス | ｎ―グリコフロール類及びｎ―エチレングリコール類を含有する医薬製剤 |
| US5389681A (en) | 1992-10-22 | 1995-02-14 | Ciba-Geigy Corporation | Parenteral solutions for diclofenac salts |
| ZA949182B (en) | 1993-12-02 | 1995-07-26 | South African Druggists Ltd | Pharmaceutical composition |
| US5554650A (en) * | 1994-07-28 | 1996-09-10 | Southern Research Institute | Antiphlogistic, analgesic, antipyretic injection preparation |
| GB9502695D0 (en) | 1995-02-11 | 1995-03-29 | Glaxo Spa | Pharmaceutical composition |
| US5747058A (en) | 1995-06-07 | 1998-05-05 | Southern Biosystems, Inc. | High viscosity liquid controlled delivery system |
| JP2000515852A (ja) | 1996-06-25 | 2000-11-28 | グラクソ、グループ、リミテッド | Ｈｉｖの治療に使用するためのｖｘ４７８、ジドブジン、ｆｔｃおよび／または３ｔｃを含んでなる組合わせ |
| US5853263A (en) * | 1996-08-15 | 1998-12-29 | Accrued, Inc. | System for installing raised road markers |
| US6846495B2 (en) * | 1999-01-11 | 2005-01-25 | The Procter & Gamble Company | Compositions having improved delivery of actives |
| DE10105576C1 (de) * | 2001-02-07 | 2002-08-08 | Underberg Kg | Flasche mit im Boden ausgebildeten Griffmulden |
| IN192711B (pt) | 2002-01-22 | 2004-05-15 | Ketan Rajnibhai Patel | |
| CH694034A8 (de) | 2002-12-12 | 2004-08-31 | Mepha Ag | Diclofenac-Kalium-Injektionsloesung. |
| KR100612070B1 (ko) * | 2003-02-12 | 2006-08-11 | 알앤피코리아주식회사 | 용출률이 향상된 난용성 약제의 용매 시스템 및 이를 함유한 제약학적 제제 |
| JP2006514119A (ja) * | 2003-02-12 | 2006-04-27 | アール アンド ピー コリア カンパニー リミテッド | 溶解率が向上した難溶性薬剤の溶媒系 |
| CN1557290A (zh) | 2004-01-19 | 2004-12-29 | 江苏扬子江药业集团有限公司 | 复方双氯芬酸钾注射液制剂 |
| JP2007528384A (ja) | 2004-03-10 | 2007-10-11 | シモダ、バイオテック（プロプライエタリー）リミテッド | 安定な注射可能なジクロフェナク組成物 |
| CN1279897C (zh) | 2004-04-30 | 2006-10-18 | 济南百诺医药科技开发有限公司 | 含有双氯芬酸盐和利多卡因的冻干制剂及其制备方法 |
| ITMI20041245A1 (it) | 2004-06-22 | 2004-09-22 | Ibsa Inst Biochimique Sa | Composizioni farmaceutiche iniettabnili comprendenti diclofenac sodico e b-ciclodestrina |
-
2006
- 2006-01-30 UA UAA200708877A patent/UA93365C2/ru unknown
- 2006-01-30 EP EP06745197A patent/EP1848419B1/en not_active Expired - Lifetime
- 2006-01-30 US US11/883,331 patent/US8809393B2/en active Active
- 2006-01-30 AP AP2007004101A patent/AP2888A/xx active
- 2006-01-30 JP JP2007552812A patent/JP2008528572A/ja active Pending
- 2006-01-30 PL PL06745197T patent/PL1848419T3/pl unknown
- 2006-01-30 ES ES06745197T patent/ES2392097T3/es not_active Expired - Lifetime
- 2006-01-30 WO PCT/IN2006/000033 patent/WO2006095363A2/en not_active Ceased
- 2006-01-30 AU AU2006221633A patent/AU2006221633B2/en not_active Ceased
- 2006-01-30 CN CN2006800034355A patent/CN101123957B/zh not_active Expired - Fee Related
- 2006-01-30 BR BRPI0606119A patent/BRPI0606119B8/pt not_active IP Right Cessation
- 2006-01-30 EA EA200701645A patent/EA013616B1/ru not_active IP Right Cessation
- 2006-01-30 NZ NZ554779A patent/NZ554779A/en not_active IP Right Cessation
- 2006-01-30 MX MX2007009312A patent/MX2007009312A/es active IP Right Grant
- 2006-01-30 KR KR1020077019888A patent/KR101226121B1/ko not_active Expired - Fee Related
- 2006-01-30 PT PT06745197T patent/PT1848419E/pt unknown
- 2006-01-30 DK DK06745197.1T patent/DK1848419T3/da active
- 2006-01-30 CA CA2596031A patent/CA2596031C/en not_active Expired - Lifetime
-
2007
- 2007-07-12 ZA ZA200705729A patent/ZA200705729B/xx unknown
- 2007-07-18 IL IL184697A patent/IL184697A/en not_active IP Right Cessation
-
2009
- 2009-10-29 AU AU2009233594A patent/AU2009233594A1/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| US20080153914A1 (en) | 2008-06-26 |
| ES2392097T3 (es) | 2012-12-04 |
| IL184697A (en) | 2014-02-27 |
| EP1848419A2 (en) | 2007-10-31 |
| BRPI0606119B8 (pt) | 2021-05-25 |
| EP1848419B1 (en) | 2012-07-25 |
| AU2009233594A1 (en) | 2009-11-19 |
| PT1848419E (pt) | 2012-10-31 |
| AP2888A (en) | 2014-05-31 |
| KR101226121B1 (ko) | 2013-01-25 |
| PL1848419T3 (pl) | 2012-12-31 |
| AU2006221633B2 (en) | 2009-07-30 |
| UA93365C2 (ru) | 2011-02-10 |
| US8809393B2 (en) | 2014-08-19 |
| JP2008528572A (ja) | 2008-07-31 |
| AP2007004101A0 (en) | 2007-08-31 |
| CN101123957B (zh) | 2010-12-08 |
| WO2006095363A3 (en) | 2006-12-14 |
| MX2007009312A (es) | 2008-03-10 |
| EA200701645A1 (ru) | 2008-02-28 |
| EA013616B1 (ru) | 2010-06-30 |
| KR20070107091A (ko) | 2007-11-06 |
| NZ554779A (en) | 2011-02-25 |
| CA2596031C (en) | 2013-02-19 |
| AU2006221633A1 (en) | 2006-09-14 |
| IL184697A0 (en) | 2007-12-03 |
| DK1848419T3 (da) | 2012-11-05 |
| WO2006095363A2 (en) | 2006-09-14 |
| CN101123957A (zh) | 2008-02-13 |
| WO2006095363B1 (en) | 2007-02-01 |
| CA2596031A1 (en) | 2006-09-14 |
| ZA200705729B (en) | 2008-08-27 |
| BRPI0606119B1 (pt) | 2019-05-07 |
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Legal Events
| Date | Code | Title | Description |
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| B25G | Requested change of headquarter approved |
Owner name: TROIKAA PHARMACEUTICALS LTD. (IN) Free format text: SEDE ALTERADA CONFORME SOLICITADO NA PETICAO NO 016080000660/RS DE 30/01/2008. |
|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
| B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
| B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 07/05/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 07/05/2019, OBSERVADAS AS CONDICOES LEGAIS |
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| B16C | Correction of notification of the grant [chapter 16.3 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/01/2006 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF |
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| B21F | Lapse acc. art. 78, item iv - on non-payment of the annual fees in time |
Free format text: REFERENTE A 18A ANUIDADE. |
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| B24J | Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12) |
Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2759 DE 21-11-2023 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013. |