DK2640363T3 - Farmaceutisk sammensætning med citrat- og bicarbonatsalte, anvendelse deraf til behandling af cystinuri - Google Patents
Farmaceutisk sammensætning med citrat- og bicarbonatsalte, anvendelse deraf til behandling af cystinuri Download PDFInfo
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- DK2640363T3 DK2640363T3 DK11794834.9T DK11794834T DK2640363T3 DK 2640363 T3 DK2640363 T3 DK 2640363T3 DK 11794834 T DK11794834 T DK 11794834T DK 2640363 T3 DK2640363 T3 DK 2640363T3
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- 206010011778 Cystinuria Diseases 0.000 title claims description 15
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 title description 5
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
Landscapes
- Health & Medical Sciences (AREA)
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- Chemical & Material Sciences (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
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- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (15)
1. Fast farmaceutisk sammensætning til oral anvendelse i form af tabletter, omfattende: - en første fast farmaceutisk formulering til oral anvendelse i form af mindst én mikrotablet, hvor mikrotabletten har en størrelse, som ligger i området fra 2 til 4 mm, og består af en kerne, som omfatter mindst ét Krebscyklusforløbersalt som aktivt stof, og af en belægning, som omfatter mindst ét belægningsmiddel, hvor Krebscyklusforløbersaltet er udvalgt blandt fumarater, ma-later, citrater, alpha-cetoglutarater, succinyl-Coenzym A, succinater og oxaloacetat, og - en anden fast farmaceutisk formulering til oral anvendelse i form af mindst én minitablet, hvor minitabletten har en størrelse, som ligger i området fra 2 til 25 mm, og hvor minitabletten består af en kerne, som omfatter mindst ét bicarbonatsalt som aktivt stof og mindst én hydrofil matrice med langvarig frigørelse, og af en belægning, som omfatter mindst ét belægningsmiddel, hvor opløsningen in vitro af den anden formulering i et bufferet opløsningsmiljø med en given pH-værdi i et område mellem 1,3 og 7, med en opløsningsindretning af typen 2, ifølge den Europæiske Farmakopé (Ph. Eur.) 2.9.3 « opløsningstest til faste former », udføres ifølge en pFI-uafhængig kinetik.
2. Sammensætning ifølge det foregående krav, hvor sammensætningen omfatter fra 30 til 70 vægt% af den første formulering og fra 70 til 30 vægt% af den anden formulering i forhold til den samlede vægt af sammensætningen.
3. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor den første formulering omfatter fra 40 til 80 vægt%, fortrinsvis fra 50 til 70 vægt% af Krebscyklusforløbersalt på basis af den samlede vægt af den første formulering, og hvor den anden formulering omfatter fra 40% til 80 vægt%, fortrinsvis fra 50 til 80 vægt% af bicarbonatsalt på basis af den samlede vægt af den anden formulering.
4. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor Krebscyklusforløbersaltet er et citratsalt, der er udvalgt blandt kaliumcitrat, natriumcitrat og magnesiumcitrat, og fortrinsvis er citratsaltet kaliumcitrat.
5. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor den første formulering omfatter fra 0,01 til 5 vægt%, fortrinsvis fra 0,01 til 2 vægt%, særlig foretrukket fra 1,4 til 2,5 vægt%, belægningsmiddel af mikro-tabletten af den første formulering i forhold til den samlede vægt af den første formulering.
6. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor belægningsmidlet af mikrotabletten af den første formulering er udvalgt blandt alginater, carboxyvinylpolymerer, natriumsalte af carboxymethylcellu-lose, cellulosederivater, herunder hydroxypropylmethylcellulose, hydroxypro-pylethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, methylcellu-lose, ethylcellulose, xanthangummi og polyethylenoxid, voks af typen paraffinvoks, bivoks eller Carnaubavoks, copolymerer af ammoniummethacrylat type A og B, som beskrevet i den Europæiske Farmakopé, og polyacrylatdis-persioner af ca. 30% som beskrevet i den Europæiske Farmakopé; og fortrinsvis er belægningsmidlet en ethylcellulosepolymer.
7. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor bicarbonatsaltet er udvalgt blandt kaliumbicarbonat, natriumbicarbonat og magnesiumbicarbonat, og fortrinsvis er bicarbonatsaltet kaliumbicarbonat.
8. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor den anden formulering omfatter fra 1 til 20 vægt%, fortrinsvis fra 1,5 til 3 vægt%, belægningsmiddel af minitabletten af den anden formulering i forhold til den samlede vægt af den anden formulering.
9. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor belægningsmidlet af minitabletten af den anden formulering er udvalgt blandt alginater, carboxyvinylpolymerer, natriumsalte af carboxymethylcellulose, cellulosederivater, herunder hydroxypropylmethylcellulose, hydroxypro-pylethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, methylcellu-lose, ethylcellulose, xanthangummi og polyethylenoxid, voks af typen paraffinvoks, bivoks eller Carnaubavoks, copolymerer af ammoniummethacrylat type A og B, som beskrevet i den Europæiske Farmakopé, og polyacrylatdis- persioner af ca. 30% som beskrevet i den Europæiske Farmakopé; og fortrinsvis er belægningsmidlet en ethylcellulosepolymer.
10. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor den anden formulering omfatter fra 10 til 30 vægt%, fortrinsvis fra 15 til 25 vægt% matrice med langvarig frigørelse af minitabletten af den anden formulering, i forhold til den samlede vægt af den anden formulering, hvor matricen med langvarig frigørelse af den anden formulering fortrinsvis er udvalgt blandt alginater, carboxyvinylpolymerer, natriumsalte af carboxymethylcellu-lose, cellulosederivater, herunder hydroxypropylmethylcellulose, hydroxypro-pylethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, methylcellu-lose, ethylcellulose, og polyacrylatdispersioner af ca. 30% som beskrevet i den Europæiske Farmakopé, og mere fortrinsvis er matricen med langvarig frigørelse en hydroxypropylmethylcellulose.
11. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor den anden formulering er i stand til at frigøre bicarbonatsaltet in vitro i et opløsningsmiljø med renset vand med en pH-værdi på 7 med en opløsningsindretning af type 2, ifølge den Europæiske Farmakopé (Ph. Eur.) 2.9.3 « opløsningstest til faste former », med en rate på højst 50% i 4 timer, højst 75% i 6 timer, og højst 90% i 8 timer.
12. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor den første formulering omfatter fra 55 til 70 vægt% kaliumcitrat, fra 20 til 30 vægt% mikrokristallin cellulose, fra 0,02 til 2 vægt% magnesiumstereat, fra 0,01 til 1 vægt% glycerylbehenat og fra 1 til 3% ethylcellulose i forhold til den samlede vægt af den første formulering.
13. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor den anden formulering omfatter fra 60 til 70 vægt% kaliumbikarbonat, fra 15 til 25 vægt% hypromellose, fra 7 til 17 vægt% mikrokristallin cellulose, fra 1 til 3 vægt% glycerylbehenat og fra 0,01 til 1 vægt% magnesiumstearat og fra 1,5 til 3 vægt% ethylcellulose i forhold til den samlede vægt af den anden formulering.
14. Sammensætning ifølge et hvilket som helst af de foregående krav til anvendelse som medikament.
15. Sammensætning ifølge et hvilket som helst af kravene 1 til 15 til anvendelse som medikament til behandling og/eller forebyggelse af cystinuri.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1059474A FR2967578B1 (fr) | 2010-11-18 | 2010-11-18 | Composition pharmaceutique comportant des sels de citrate et de bicarbonate, et son utilisation pour le traitement de la cystinurie |
| PCT/FR2011/052697 WO2012066257A1 (fr) | 2010-11-18 | 2011-11-18 | Composition pharmaceutique comportant des sels de citrate et de bicarbonate, et son utilisation pour le traitement de la cystinurie |
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| DK2640363T3 true DK2640363T3 (da) | 2015-12-14 |
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| EP (1) | EP2640363B1 (da) |
| JP (1) | JP5879359B2 (da) |
| KR (1) | KR101699581B1 (da) |
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| ES (1) | ES2553424T3 (da) |
| FR (2) | FR2967578B1 (da) |
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| WO (1) | WO2012066257A1 (da) |
| ZA (1) | ZA201303695B (da) |
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| US11273140B2 (en) * | 2013-06-06 | 2022-03-15 | Stefanie A. Seixas-Mikelus | Juice beverage for prevention and treatment of renal stones |
| FR3009496B1 (fr) * | 2013-08-12 | 2016-02-05 | Mohamed Skiba | Formes multiparticulaires a liberation prolongee, procede de leurs preparations et compositions les contenant pour le traitement et/ou prevention de la cyctinurie |
| JP2019504024A (ja) * | 2015-12-22 | 2019-02-14 | インプリミス・ファーマシューティカルズ・インコーポレイテッドImprimis Pharmaceuticals, Inc. | 腎結石を治療する医薬製剤ならびにその製造方法および用法 |
| AU2018285927B2 (en) * | 2017-06-16 | 2023-04-20 | Altibio, Inc. | Modified-release tiopronin compositions, kits and methods for treating cystinuria and related disorders |
| BR112021024952A2 (pt) * | 2019-06-10 | 2022-02-15 | Ponce De Leon Health Designated Activity Company | Composições de liberação sustentada de alfa-cetoglutarato |
| CN118139536A (zh) * | 2021-08-24 | 2024-06-04 | 莱米纳瑞集团公司 | 碳酸氢钠营养补充剂 |
| AU2022333240A1 (en) | 2021-08-24 | 2024-03-28 | Laminaria Group Ab | Sodium bicarbonate nutritional supplement |
| WO2024170643A1 (en) | 2023-02-15 | 2024-08-22 | Laminaria Group Ab | Sodium bicarbonate product for childbirth labor |
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| US3903255A (en) * | 1971-05-17 | 1975-09-02 | Rohm & Haas | Effervescent potassium chloride tablet |
| HU165181B (da) | 1971-11-08 | 1974-07-27 | ||
| US4451454A (en) | 1981-06-16 | 1984-05-29 | Wong Dennis W | Prophylaxis and treatment of thromboembolic disorders in man and in warm-blooded animals with bicarbonate salts of alkali metals |
| GB2130087A (en) | 1982-09-22 | 1984-05-31 | Dr Joachime Helbig | Pharmaceutical oral dosage forms of an active agent capable of forming or releasing bicarbonate ions |
| JPS60197624A (ja) * | 1984-03-21 | 1985-10-07 | Nippon Chemiphar Co Ltd | 尿アルカリ化性食品組成物 |
| CA1326040C (en) | 1989-11-16 | 1994-01-11 | Neill B. Walsdorf | Magnesium-potassium citrate |
| JP2941163B2 (ja) * | 1993-02-19 | 1999-08-25 | 武田薬品工業株式会社 | ペットの尿結石症治療・予防剤および治療方法 |
| US5674529A (en) * | 1995-06-06 | 1997-10-07 | Church & Dwight Co., Inc. | Alkalinizing potassium salt controlled release preparations |
| US5888544A (en) * | 1996-06-20 | 1999-03-30 | Gerhard Gergely | Effervescent system for effervescent tablets and effervescent granules |
| EP1970066A1 (de) * | 2007-03-12 | 2008-09-17 | Medice Arzneimittel Pütter GmbH & Co. KG | Pharmazeutische Zusammensetzung zur Behandlung einer Übersäuerung des Blutes |
-
2010
- 2010-11-18 FR FR1059474A patent/FR2967578B1/fr active Active
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2011
- 2011-11-18 CA CA2816660A patent/CA2816660C/fr active Active
- 2011-11-18 EP EP11794834.9A patent/EP2640363B1/fr active Active
- 2011-11-18 KR KR1020137015579A patent/KR101699581B1/ko active Active
- 2011-11-18 WO PCT/FR2011/052697 patent/WO2012066257A1/fr not_active Ceased
- 2011-11-18 NZ NZ611026A patent/NZ611026A/en unknown
- 2011-11-18 ES ES11794834.9T patent/ES2553424T3/es active Active
- 2011-11-18 AU AU2011331019A patent/AU2011331019B2/en active Active
- 2011-11-18 DK DK11794834.9T patent/DK2640363T3/da active
- 2011-11-18 US US13/988,080 patent/US9636304B2/en active Active
- 2011-11-18 HU HUE11794834A patent/HUE026230T2/en unknown
- 2011-11-18 JP JP2013539318A patent/JP5879359B2/ja active Active
- 2011-11-18 PL PL11794834T patent/PL2640363T3/pl unknown
- 2011-11-18 MX MX2013005482A patent/MX338975B/es active IP Right Grant
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2013
- 2013-05-16 IL IL226373A patent/IL226373A/en active IP Right Grant
- 2013-05-21 ZA ZA2013/03695A patent/ZA201303695B/en unknown
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2021
- 2021-10-27 FR FR21C1049C patent/FR21C1049I2/fr active Active
Also Published As
| Publication number | Publication date |
|---|---|
| AU2011331019A1 (en) | 2013-06-13 |
| US20130236545A1 (en) | 2013-09-12 |
| IL226373A (en) | 2016-04-21 |
| JP2013542975A (ja) | 2013-11-28 |
| IL226373A0 (en) | 2013-07-31 |
| US9636304B2 (en) | 2017-05-02 |
| KR101699581B1 (ko) | 2017-01-24 |
| FR2967578A1 (fr) | 2012-05-25 |
| KR20130119450A (ko) | 2013-10-31 |
| CA2816660C (fr) | 2017-07-04 |
| MX2013005482A (es) | 2013-08-29 |
| HUE026230T2 (en) | 2016-06-28 |
| EP2640363B1 (fr) | 2015-08-26 |
| FR21C1049I2 (fr) | 2022-09-30 |
| ZA201303695B (en) | 2014-07-30 |
| FR2967578B1 (fr) | 2012-12-28 |
| EP2640363A1 (fr) | 2013-09-25 |
| JP5879359B2 (ja) | 2016-03-08 |
| CA2816660A1 (fr) | 2012-05-24 |
| ES2553424T3 (es) | 2015-12-09 |
| WO2012066257A1 (fr) | 2012-05-24 |
| PL2640363T3 (pl) | 2016-01-29 |
| MX338975B (es) | 2016-05-06 |
| FR21C1049I1 (da) | 2021-12-10 |
| NZ611026A (en) | 2014-12-24 |
| AU2011331019B2 (en) | 2016-04-07 |
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