BRPI0113539B8 - processo para a preparação de composições farmacêuticas para uso com formulações de gelatina macia - Google Patents
processo para a preparação de composições farmacêuticas para uso com formulações de gelatina maciaInfo
- Publication number
- BRPI0113539B8 BRPI0113539B8 BRPI0113539A BR0113539A BRPI0113539B8 BR PI0113539 B8 BRPI0113539 B8 BR PI0113539B8 BR PI0113539 A BRPI0113539 A BR PI0113539A BR 0113539 A BR0113539 A BR 0113539A BR PI0113539 B8 BRPI0113539 B8 BR PI0113539B8
- Authority
- BR
- Brazil
- Prior art keywords
- active ingredient
- pharmaceutically active
- soft gelatin
- concentration
- pharmaceutical compositions
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 4
- 108010010803 Gelatin Proteins 0.000 title abstract 2
- 238000009472 formulation Methods 0.000 title abstract 2
- 229920000159 gelatin Polymers 0.000 title abstract 2
- 239000008273 gelatin Substances 0.000 title abstract 2
- 235000019322 gelatine Nutrition 0.000 title abstract 2
- 235000011852 gelatine desserts Nutrition 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 5
- 238000000034 method Methods 0.000 abstract 3
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 abstract 2
- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 abstract 2
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 abstract 1
- CMWTZPSULFXXJA-UHFFFAOYSA-N Naproxen Natural products C1=C(C(C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-UHFFFAOYSA-N 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 239000000945 filler Substances 0.000 abstract 1
- 239000007903 gelatin capsule Substances 0.000 abstract 1
- 229960001680 ibuprofen Drugs 0.000 abstract 1
- 229960000905 indomethacin Drugs 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 229960002009 naproxen Drugs 0.000 abstract 1
- CMWTZPSULFXXJA-VIFPVBQESA-N naproxen Chemical compound C1=C([C@H](C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-VIFPVBQESA-N 0.000 abstract 1
- 229960005489 paracetamol Drugs 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
- A61K9/4858—Organic compounds
-
- 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
- A61K9/485—Inorganic compounds
-
- 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)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
"processo para a preparação de composições farmacêuticas para uso com formulações de gelatina macia". a invenção revelada aqui é um processo para aumentar a concentração conseguível de um ingrediente farmaceuticamente ativo relativamente à viscosidade da composição de preenchimento para unidades de dosagem. o processo é particularmente útil na preparação de cápsulas de gelatina macia contendo ibuprofeno, naproxeno, indometacina, e acetaminofeno, como o ingrediente farmaceuticamente ativo. como um resultado do processo, quantidades menores dos ingredientes da composição outros que o ingrediente farmaceuticamente ativo são necessárias para conseguir a mesma dosagem terapeuticamente eficaz, aumentando desse modo de modo significativamente a concentração do ingrediente farmaceuticamente ativo resultando tanto em uma redução no total do volume de preenchimento e no tamanho da unidade de dosagem ou num aumento na concentração do ingrediente farmaceuticamente ativo por forma de dosagem.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/649,947 US6387400B1 (en) | 2000-08-29 | 2000-08-29 | Process for preparing pharmaceutical compositions for use with soft gelatin formulations |
| PCT/US2001/026711 WO2002017855A2 (en) | 2000-08-29 | 2001-08-28 | Process for preparing pharmaceutical compositions for use with soft gelatin formulations |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BR0113539A BR0113539A (pt) | 2003-07-15 |
| BRPI0113539B1 BRPI0113539B1 (pt) | 2017-05-09 |
| BRPI0113539B8 true BRPI0113539B8 (pt) | 2021-05-25 |
Family
ID=24606884
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0113539A BRPI0113539B8 (pt) | 2000-08-29 | 2001-08-28 | processo para a preparação de composições farmacêuticas para uso com formulações de gelatina macia |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US6387400B1 (pt) |
| EP (1) | EP1365749B1 (pt) |
| JP (1) | JP4990474B2 (pt) |
| KR (1) | KR100634571B1 (pt) |
| CN (1) | CN1237959C (pt) |
| AT (1) | ATE353009T1 (pt) |
| AU (2) | AU2431702A (pt) |
| BR (1) | BRPI0113539B8 (pt) |
| CA (1) | CA2419993C (pt) |
| CY (1) | CY1106542T1 (pt) |
| CZ (1) | CZ299449B6 (pt) |
| DE (2) | DE01984557T1 (pt) |
| DK (1) | DK1365749T3 (pt) |
| ES (1) | ES2206081T3 (pt) |
| HK (1) | HK1056326A1 (pt) |
| HU (1) | HU229381B1 (pt) |
| MX (1) | MXPA03001762A (pt) |
| NO (1) | NO333369B1 (pt) |
| PL (1) | PL200398B1 (pt) |
| PT (1) | PT1365749E (pt) |
| SI (1) | SI1365749T1 (pt) |
| TW (1) | TW589199B (pt) |
| WO (1) | WO2002017855A2 (pt) |
| ZA (1) | ZA200301007B (pt) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4226846B2 (ja) * | 2002-06-07 | 2009-02-18 | キャタレント・ジャパン株式会社 | 口腔内で崩壊可能なソフトカプセル剤 |
| EP1684732A2 (en) * | 2003-11-12 | 2006-08-02 | Ranbaxy Laboratories Limited | Ibuprofen-containing soft gelatin capsules |
| US9241902B2 (en) * | 2003-12-17 | 2016-01-26 | R.P. Scherer Technologies, Llc | Chewable soft capsules containing ungelatinized starch |
| US20050137262A1 (en) * | 2003-12-22 | 2005-06-23 | Hu Patrick C. | Highly concentrated pourable aqueous solutions of potassium ibuprofen, their preparation and their uses |
| WO2005063219A2 (en) * | 2003-12-23 | 2005-07-14 | Ranbaxy Laboratories Limited | Ibuprofen-containing soft gelatin capsules |
| CN1909891A (zh) * | 2004-01-09 | 2007-02-07 | 惠氏公司 | 药用组合物的微乳液 |
| US20050249802A1 (en) * | 2004-05-06 | 2005-11-10 | The Procter & Gamble Company | Softgel encapsulated pharmaceutical compositions comprising concentrated active ingredients |
| WO2005123133A1 (en) * | 2004-06-18 | 2005-12-29 | Ranbaxy Laboratories Limited | A process for preparing ibuprofen soft gelatin capsules |
| BRPI0512900A (pt) | 2004-06-30 | 2008-04-15 | Albemarle Corp | composição farmacêutica compreendendo de ibuprofeno, processo de preparação dos gránulos enriquecidos em ibuprofeno e os gránulos secos feitos por este processo |
| US20060088590A1 (en) * | 2004-10-22 | 2006-04-27 | Banner Pharmacaps, Inc. | Non-blooming gelatin and non-gelatin formulations |
| US8231896B2 (en) * | 2004-11-08 | 2012-07-31 | R.P. Scherer Technologies, Llc | Non-gelatin soft capsule system |
| US20070053868A1 (en) | 2005-03-08 | 2007-03-08 | Banner Pharmacaps, Inc. | Solvent system for enhancing the solubility of pharmaceutical agents |
| US20080269334A1 (en) * | 2005-09-19 | 2008-10-30 | Albemarle Corporation | Highly Concentrated Pourable Aqueous Solutions Of Potassium Ibuprofen, Their Preparation And Their Use |
| CN100404031C (zh) * | 2006-03-13 | 2008-07-23 | 浙江万联药业有限公司 | 含葡萄糖酸锌、布洛芬和马来酸氯苯那敏的软胶囊组合物 |
| US9629809B2 (en) | 2008-07-21 | 2017-04-25 | Si Group, Inc. | High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms |
| CN102099017A (zh) * | 2008-07-21 | 2011-06-15 | 雅宝公司 | 高含量布洛芬钠颗粒、其制备及其在制备非泡腾固体剂型中的用途 |
| ES2363964B1 (es) | 2009-11-20 | 2012-08-22 | Gp Pharm, S.A. | Cápsulas de principios activos farmacéuticos y ésteres de ácidos grasos poliinsaturados. |
| CA2690488C (en) | 2010-01-19 | 2013-06-11 | Accucaps Industries Limited | Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof |
| CN104083339A (zh) * | 2014-08-04 | 2014-10-08 | 人福普克药业（武汉）有限公司 | 萘普生钠软胶囊及其制备方法 |
| CN107951857B (zh) * | 2017-11-29 | 2019-12-24 | 浙江安宝药业有限公司 | 布洛芬软胶囊 |
| CA3100314A1 (en) | 2018-05-16 | 2019-11-21 | Bayer Healthcare Llc | High concentration suspension formulation for cold and flu soft gel capsule medications |
| WO2019224832A1 (en) * | 2018-05-25 | 2019-11-28 | Strides Shasun Limited | Process for preparing pharmaceutical compositions resulting in reduction in overall fill volume for use with soft gelatin formulations |
| CN108904465B (zh) * | 2018-10-17 | 2021-02-26 | 石药集团恩必普药业有限公司 | 一种布洛芬药物制剂组合物及其制备方法 |
| CN109820833B (zh) * | 2019-04-01 | 2022-02-01 | 人福普克药业（武汉）有限公司 | 一种快速溶出的布洛芬软胶囊及其制备方法 |
| KR20220004691A (ko) * | 2019-04-26 | 2022-01-11 | 알.피.쉐러 테크놀러지즈 엘엘씨 | 미니 연질 겔 나프록센 조성물 |
| JP2022552223A (ja) * | 2019-10-09 | 2022-12-15 | アール．ピー．シェーラー テクノロジーズ，エルエルシー | 非動物性ソフトゲルカプセル製剤、その調製方法、およびその使用方法 |
| US20220233452A1 (en) * | 2021-01-25 | 2022-07-28 | R.P. Scherer Technologies, Llc | Mini softgel naproxen composition |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2118040A (en) | 1982-02-15 | 1983-10-26 | Hoechst Uk Ltd | Oral anti-diabetic preparation |
| ATE57472T1 (de) | 1984-03-14 | 1990-11-15 | Jerome Corbiere | Verfahren zum loesen von wirksubstanzen und auf diese weise erhaltene arzneimittel. |
| DE3437599A1 (de) | 1984-10-13 | 1986-04-17 | Dolorgiet GmbH & Co KG, 5205 St Augustin | Ibuprofen enthaltende weichgelatinekapseln und verfahren zu ihrer herstellung |
| US5071643A (en) * | 1986-10-17 | 1991-12-10 | R. P. Scherer Corporation | Solvent system enhancing the solubility of pharmaceuticals for encapsulation |
| JP3121080B2 (ja) | 1991-12-19 | 2000-12-25 | アール・ピー・シーラー コーポレイション | カプセル封入用溶液 |
| US5376688A (en) | 1992-12-18 | 1994-12-27 | R. P. Scherer Corporation | Enhanced solubility pharmaceutical solutions |
| CA2281946C (en) * | 1997-03-03 | 2007-08-07 | Sanofi-Synthelabo | Pharmaceutical formulations containing poorly soluble drug substances |
-
2000
- 2000-08-29 US US09/649,947 patent/US6387400B1/en not_active Expired - Lifetime
-
2001
- 2001-08-28 CN CNB01814778XA patent/CN1237959C/zh not_active Expired - Lifetime
- 2001-08-28 HU HU0401224A patent/HU229381B1/hu unknown
- 2001-08-28 AU AU2431702A patent/AU2431702A/xx active Pending
- 2001-08-28 BR BRPI0113539A patent/BRPI0113539B8/pt not_active IP Right Cessation
- 2001-08-28 SI SI200130688T patent/SI1365749T1/sl unknown
- 2001-08-28 DE DE0001365749T patent/DE01984557T1/de active Pending
- 2001-08-28 WO PCT/US2001/026711 patent/WO2002017855A2/en active IP Right Grant
- 2001-08-28 KR KR1020037002971A patent/KR100634571B1/ko active IP Right Grant
- 2001-08-28 EP EP01984557A patent/EP1365749B1/en not_active Expired - Lifetime
- 2001-08-28 MX MXPA03001762A patent/MXPA03001762A/es active IP Right Grant
- 2001-08-28 AT AT01984557T patent/ATE353009T1/de active
- 2001-08-28 CZ CZ20030564A patent/CZ299449B6/cs not_active IP Right Cessation
- 2001-08-28 CA CA002419993A patent/CA2419993C/en not_active Expired - Lifetime
- 2001-08-28 DE DE60126433T patent/DE60126433T2/de not_active Expired - Lifetime
- 2001-08-28 ES ES01984557T patent/ES2206081T3/es not_active Expired - Lifetime
- 2001-08-28 JP JP2002522830A patent/JP4990474B2/ja not_active Expired - Lifetime
- 2001-08-28 PT PT01984557T patent/PT1365749E/pt unknown
- 2001-08-28 PL PL365752A patent/PL200398B1/pl unknown
- 2001-08-28 AU AU2002224317A patent/AU2002224317B2/en not_active Expired
- 2001-08-28 DK DK01984557T patent/DK1365749T3/da active
-
2002
- 2002-01-17 TW TW091100669A patent/TW589199B/zh not_active IP Right Cessation
-
2003
- 2003-02-05 ZA ZA200301007A patent/ZA200301007B/xx unknown
- 2003-02-26 NO NO20030897A patent/NO333369B1/no not_active IP Right Cessation
- 2003-12-03 HK HK03108793A patent/HK1056326A1/xx not_active IP Right Cessation
-
2007
- 2007-04-26 CY CY20071100560T patent/CY1106542T1/el unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B25G | Requested change of headquarter approved |
Owner name: R.P. SCHERER TECHNOLOGIES, INC. (US) Free format text: SEDE ALTERADA CONFORME SOLICITADO NA PETICAO NO 020050106742/RJ DE 30/09/2005. |
|
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B15K | Others concerning applications: alteration of classification |
Free format text: PARA INT.CL: A61K 9/48, A61K 31/167, A61K 31/185, A61K 31/403, A61K 45/00, A61K 47/02, A61K 47/34,A61P 29/00 Ipc: A61K 9/48 (2011.01) Free format text: PARA INT.CL: A61K 9/48, A61K 31/167, A61K 31/185, A61K 31/403, A61K 45/00, A61K 47/02, A61K 47/34, A61P 29/00 Ipc: A61K 9/48 (2011.01) |
|
| B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
| B09B | Patent application refused [chapter 9.2 patent gazette] | ||
| B12B | Appeal against refusal [chapter 12.2 patent gazette] | ||
| 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] | ||
| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] | ||
| B21F | Lapse acc. art. 78, item iv - on non-payment of the annual fees in time | ||
| B21H | Decision of lapse of a patent or of a certificate of addition of invention cancelled [chapter 21.8 patent gazette] | ||
| 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 28/08/2001 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF |
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| B21A | Patent or certificate of addition expired [chapter 21.1 patent gazette] |
Free format text: PATENTE EXTINTA EM 28/08/2021 |