JP2006517928A - 高用量のコンドロイチン硫酸を用いた膀胱炎の処置 - Google Patents
高用量のコンドロイチン硫酸を用いた膀胱炎の処置 Download PDFInfo
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Abstract
Description
本発明は、間質性膀胱炎および関連する膀胱の状態を含む膀胱炎の処置に有用な治療薬および方法に関する。
間質性膀胱炎は、尿の刺激原により誘発される不快および痛みを伴う膀胱の状態であり、排尿の切迫および頻度の増加を引き起こす。その原因が十分に解明されていないために、有用な処置の開発は、ほとんどが経験的な取り組みに従ってきた。これらの取り組みは、幾らかの有用な治療薬および処置を生じる以上の成果を上げなかった。Sant and La Rockにより非特許文献1に記載されたように、現在の治療には薬物療法を含み、ジメチルスルフォキシドの膀胱内使用がFDAにより認められている唯一の治療である。さらに様々な他の薬剤が、単独またはDMSOと組み合わせたいずれかで間質性膀胱炎の症状を処置するために使用されている。そのような薬剤には、オキシクロロセンナトリウム(Clorpactin)、ヘパリン、ヒアルロン酸、ステロイド、重炭酸ナトリウム、硝酸銀、ペントサンポリ硫酸ナトリウム、クロモリンナトリウム、リドカインおよびドキソルビシンを含む。多くのこれら薬剤は経口的に送達され得るが、単剤療法、併用療法または順次療法のいずれかとして点滴注入により送達される時、ウレセリウム(urethelium)のGAG表層で最も効果的となり得る。これら薬剤および治療は、膀胱の粘膜内層を標的とし、そして疼痛、頻尿(frequency)および切迫性の症状の軽減を提供する。しかしこれらの治療の中で継続して軽減を提供できるものはほとんどない。
今、膀胱炎および膀胱および尿管の関連状態に罹患している患者は、コンドロイチン硫酸の点滴注入用量が200mgを上回る時、コンドロイチン硫酸の処置に、より迅速に応答することが分かった。200mgに近い用量が、膀胱の内層を飽和するために十分であり、故に十分なコンドロイチン硫酸を沈積または吸着して、膀胱内層のすべての可能な侵食部位を保護すると予想された。しかし今、驚くべきことには、膀胱炎の症状からのさらに迅速な軽減が、コンドロイチン硫酸の点滴注入用量を200mgを越えて増やした時に実現できることが分かった。さらに、より高用量のコンドロイチン硫酸の投与は、膀胱炎治療の他の従来の状態にはほとんど無反応であるような膀胱炎が大変重症な患者に軽減を提供することが分かった。
(1)少なくとも250mg、例えば250mg〜飽和の範囲の、高度に精製された等級のコンドロイチン硫酸の単位用量、および
(2)患者に耐容され、そして処置する膀胱表面積に触れさせるために十分な用量の製薬学的に許容され得る水性担体、
を含んでなる滅菌された水性組成物を含む。
詳細な説明および好適な態様
膀胱炎は特に膀胱で起こるが、それらは尿道を含む尿管、および小嚢点滴注入の投与経路により処置に暴露される他の粘膜表面でも起こるので、本発明の組成物および方法は、種々の状態の膀胱炎の処置および評価に有用である。この経路により、滅菌カテーテルは尿道を介して膀胱に配置され、そして処置溶液がカテーテルを介して供給される。次いで溶液は排泄する前に少なくとも30分間以上、膀胱内に保持される。処置することができる膀胱炎の状態には、特に間質性膀胱炎、および本コンドロイチン硫酸処置が使用される時に生じると考えられる粘膜の完全性およびバリア機能の強化に応答する膀胱炎の他の状態および関連する膀胱の状態を含む。これらには放射線が誘導する膀胱炎、化学物質が誘導する膀胱炎、例えば化学療法から生じる膀胱炎および出血性膀胱炎、ならびにより一般的には膀胱炎のGAG−欠損形および慢性の尿路感染症から生じるGAG−欠損を含む。
(1)少なくとも250mgの単位用量のコンドロイチン硫酸および水性賦形剤を含んでなる第1滅菌溶液;および
(2)本発明の処置法に従い、その使用を教示する印刷された使用説明書
を組み合わせて含んでなるキットが提供される。
外観:白色からわずかにホフホワイトの高度に吸湿性の固体粉末
純度(無水基準):>98.0%
1%水中のpH:5.5〜7.5
比旋光度(4%水中):−20から−30度
窒素(無水基準):2.5〜3.5%
硫黄(無水基準):5.0〜7.0%
硫酸灰(無水基準):21〜29%
重金属:<20ppm
塩化物:<0.1%
タンパク質(無水基準):<1.0%
発熱物質:発熱物質は含まない
平均分子量:10,000〜40,000ダルトン
このCSは、以下の成分をブレンドすることにより20.0mg/mL溶液として配合される:
処方量
成分 (mLあたり)
Naコンドロイチン硫酸(無水物として) 20.0mg
塩化ナトリウム、USP 8.5mg
二塩基性リン酸ナトリウム7H2O、USP 0.42mg
一塩基性リン酸ナトリウム2H2O、USP 0.04mg
注入用滅菌水、USP または
潅注用滅菌水 USP 十分量 として 容量とする
調合については、約20mLの注入用水、USPを集め、そして必要量(2%溶液を作成するために、上記のmLあたりの処方量の20倍)の塩化ナトリウムを加え、そして完全に溶解するまで(最低15分間)混合する。次いで必要量の一塩基性および二塩基性リン酸ナトリウムを加え、そして完全に溶解するまで(最低15分間)混合する。次いで必要量のコンドロイチン硫酸ナトリウムを加え、そして完全に溶解するまで(水和には最低4時間)混合する。必要ならばpHを7.2 0.1にINの水酸化ナトリウム(WFI、USP中)で、または1N リン酸(WFI、USP中)で調整する。次いで最終容量とするために十分量の注入用滅菌水、USPを加え、そして完全に混合する。この方法は単に緩衝液の容量を変え、かつ/またはCSおよび他の記載した成分の量を変えることにより、異なる単位用量のCSを生成するためにも適すると考えられる。このように本方法により、10〜40mL、例えば20mLのようなCS製剤が提供され、製剤は250、300、350、400、600、800、1,000および1,200mgのCSを含有する。
Claims (9)
- 組成物が250mg〜1200mgの量のコンドロイチン硫酸および10mL〜100mLの容量の水性賦形剤を含んでなる、患者の膀胱への点滴注入に適合した製薬学的組成物。
- 水性賦形剤が10mL〜40mLの容量で存在する、請求項2に記載の製薬学的組成物。
- コンドロイチン硫酸が350mg〜600mgの量で存在する、請求項3に記載の製薬学的組成物。
- 20mLの水性賦形剤中に400mgのコンドロイチン硫酸を含んでなる、請求項1に記載の製薬学的組成物。
- 400mgのコンドロイチン硫酸および20mLの水性賦形剤からなる滅菌コンドロイチン硫酸溶液の状態である製薬学的組成物。
- 水性賦形剤がリン酸緩衝化生理食塩水である請求項1ないし5のいずれか1項に記載の製薬学的組成物。
- 塩化カリウム溶液の点滴注入で、罹患している患者に1または複数の膀胱炎の症状が現れる、膀胱炎および関連状態から選択される膀胱または尿管状態に罹患している患者を処置するための、請求項1ないし6のいずれか1項に記載の製薬学的組成物の調製におけるコンドロイチン硫酸の使用。
- 膀胱炎の処置のための請求項1ないし6のいずれか1項に記載の製薬学的組成物の調製におけるコンドロイチン硫酸の使用。
- 間質性膀胱炎の処置のための請求項8に記載のコンドロイチン硫酸の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/367,970 US20040161476A1 (en) | 2003-02-19 | 2003-02-19 | Cystitis treatment with high dose chondroitin sulfate |
US10/367,970 | 2003-02-19 | ||
PCT/CA2004/000244 WO2004073584A2 (en) | 2003-02-19 | 2004-02-18 | Cystitis treatment with high dose chondroitin sulfate |
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JP2006517928A true JP2006517928A (ja) | 2006-08-03 |
JP4778888B2 JP4778888B2 (ja) | 2011-09-21 |
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JP2006501424A Expired - Fee Related JP4778888B2 (ja) | 2003-02-19 | 2004-02-18 | 高用量のコンドロイチン硫酸を用いた膀胱炎の処置 |
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US (5) | US20040161476A1 (ja) |
EP (2) | EP1603578B1 (ja) |
JP (1) | JP4778888B2 (ja) |
CN (1) | CN1758920B (ja) |
AU (1) | AU2004212650B2 (ja) |
CA (1) | CA2515512C (ja) |
CY (1) | CY1116069T1 (ja) |
DE (1) | DE14189577T9 (ja) |
DK (1) | DK1603578T3 (ja) |
ES (1) | ES2527664T3 (ja) |
HK (2) | HK1085136A1 (ja) |
IL (2) | IL170309A (ja) |
PT (1) | PT1603578E (ja) |
SI (1) | SI1603578T1 (ja) |
WO (1) | WO2004073584A2 (ja) |
Cited By (2)
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KR20170098942A (ko) * | 2015-01-09 | 2017-08-30 | 세이가가쿠 고교 가부시키가이샤 | 콘드로이틴 황산 유도체 및 방광 질환 처치제 |
JP2019529645A (ja) * | 2016-09-16 | 2019-10-17 | グリコロジクス、エルエルシー | プロテオグリカン模倣物としての硫酸化グリコサミノグリカン生体材料 |
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US20040161476A1 (en) | 2003-02-19 | 2004-08-19 | Hahn Sungtack Samuel | Cystitis treatment with high dose chondroitin sulfate |
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WO2005072751A1 (en) * | 2004-01-28 | 2005-08-11 | The Regents Of The University Of California | Novel interstitial therapy for immediate symptom relief and chronic therapy in interstitial cystitis |
ITMI20061030A1 (it) * | 2006-05-26 | 2007-11-27 | Altergon Sa | Nuova composizione comprendente glicosamminoglicani a viscosita' controllata e uso di tale composizione nella terapuia della cistite cronica |
US20090023637A1 (en) * | 2006-08-30 | 2009-01-22 | Parsons C Lowell | Methods for detecting and treating interstitial cystitis |
DE102006060953A1 (de) * | 2006-12-12 | 2008-08-07 | Farco-Pharma Gmbh | Pharmazeutische Zubereitung für die Behandlung entzündlicher Erkrankungen des Urogenitaltraktes |
US8404655B2 (en) * | 2007-05-18 | 2013-03-26 | University Of Florida Research Foundation, Inc. | Inhibition of palmitoyl acyl transferase expression and/or activity for the regulation of antiproliferative factor activity |
US9849086B2 (en) * | 2012-03-19 | 2017-12-26 | Nanologix Research, Inc. | Method and composition for treating cystitis |
DE202017103288U1 (de) | 2017-05-12 | 2018-05-16 | Farco-Pharma Gmbh | Zusammensetzung für die Behandlung entzündlicher Erkrankungen des Urogenitaltraktes in Form einer hochdosierten Wirkstoffkombination |
ES2769059T3 (es) | 2017-05-12 | 2020-06-24 | Farco Gmbh | Composición de instilación de la vejiga que contiene sulfato de condonitina (20 mg/ml), ácido hialurónico (16 mg/ml) y buffer de fosfato (pH 6,1 a 7,9) con mayor estabilidad de almacenamiento para el tratamiento de la cistitis |
DE202017103289U1 (de) | 2017-05-12 | 2018-05-16 | Farco-Pharma Gmbh | Zusammensetzung für die Behandlung entzündlicher Erkrankungen des Urogenitaltraktes in Form einer Wirkstoffkombination |
ES2775673T3 (es) * | 2017-05-12 | 2020-07-27 | Farco Gmbh | Composición para el tratamiento de enfermedades inflamatorias del tracto urogenital que contiene sulfato de condonita (4,5 mg/ml), ácido hialurónico (16 mg/ml) y tampón de fosfato (pH 6,1 a 7,9) con mayor estabilidad de almacenamiento para tratar la cistitis |
DE202017104675U1 (de) | 2017-06-13 | 2018-06-14 | Farco-Pharma Gmbh | Zusammensetzung mit lokalanästhetischer Wirkung und deren Verwendung |
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WO2022246405A1 (en) * | 2021-05-18 | 2022-11-24 | Karuna Therapeutics, Inc. | Methods for treating central nervous system disorders with muscarinic receptor activation and antipsychotics |
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- 2004-02-18 EP EP04711966.4A patent/EP1603578B1/en not_active Revoked
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- 2004-02-18 DE DE14189577.1T patent/DE14189577T9/de active Active
- 2004-02-18 EP EP14189577.1A patent/EP2857024A1/en not_active Ceased
- 2004-02-18 PT PT47119664T patent/PT1603578E/pt unknown
- 2004-02-18 SI SI200432205T patent/SI1603578T1/sl unknown
- 2004-02-18 ES ES04711966.4T patent/ES2527664T3/es not_active Expired - Lifetime
- 2004-02-18 AU AU2004212650A patent/AU2004212650B2/en not_active Ceased
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2015
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
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KR20170098942A (ko) * | 2015-01-09 | 2017-08-30 | 세이가가쿠 고교 가부시키가이샤 | 콘드로이틴 황산 유도체 및 방광 질환 처치제 |
KR102512431B1 (ko) * | 2015-01-09 | 2023-03-22 | 세이가가쿠 고교 가부시키가이샤 | 콘드로이틴 황산 유도체 및 방광 질환 처치제 |
KR20230047193A (ko) * | 2015-01-09 | 2023-04-06 | 세이가가쿠 고교 가부시키가이샤 | 콘드로이틴 황산 유도체 및 방광 질환 처치제 |
KR102655779B1 (ko) * | 2015-01-09 | 2024-04-05 | 세이가가쿠 고교 가부시키가이샤 | 콘드로이틴 황산 유도체 및 방광 질환 처치제 |
JP2019529645A (ja) * | 2016-09-16 | 2019-10-17 | グリコロジクス、エルエルシー | プロテオグリカン模倣物としての硫酸化グリコサミノグリカン生体材料 |
US11975019B2 (en) | 2016-09-16 | 2024-05-07 | Glycologix, Inc. | Sulfated glycosaminoglycan biomaterials as proteoglycan mimics |
Also Published As
Publication number | Publication date |
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AU2004212650A1 (en) | 2004-09-02 |
CN1758920A (zh) | 2006-04-12 |
CN1758920B (zh) | 2010-05-26 |
CA2515512A1 (en) | 2004-09-02 |
JP4778888B2 (ja) | 2011-09-21 |
CA2515512C (en) | 2012-07-10 |
US20100292182A1 (en) | 2010-11-18 |
ES2527664T3 (es) | 2015-01-28 |
WO2004073584A2 (en) | 2004-09-02 |
DE14189577T9 (de) | 2020-12-10 |
SI1603578T1 (sl) | 2015-04-30 |
US20040161476A1 (en) | 2004-08-19 |
US20120058969A1 (en) | 2012-03-08 |
CY1116069T1 (el) | 2017-02-08 |
US8334276B2 (en) | 2012-12-18 |
HK1209037A1 (en) | 2016-03-24 |
EP1603578A2 (en) | 2005-12-14 |
IL238811A0 (en) | 2015-06-30 |
US20060194757A1 (en) | 2006-08-31 |
US8778908B2 (en) | 2014-07-15 |
US7772210B2 (en) | 2010-08-10 |
HK1085136A1 (en) | 2006-08-18 |
IL170309A (en) | 2015-11-30 |
PT1603578E (pt) | 2014-12-11 |
IL238811A (en) | 2017-03-30 |
US20130143839A1 (en) | 2013-06-06 |
WO2004073584A3 (en) | 2005-01-27 |
EP1603578B1 (en) | 2014-10-29 |
US8084441B2 (en) | 2011-12-27 |
DE14189577T1 (de) | 2019-10-17 |
DK1603578T3 (en) | 2015-01-19 |
EP2857024A1 (en) | 2015-04-08 |
AU2004212650B2 (en) | 2009-07-23 |
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