JP2009514786A - 腎結石及び骨粗鬆症の処置のためのクエン酸カリウムカルシウムの粉末混合物 - Google Patents
腎結石及び骨粗鬆症の処置のためのクエン酸カリウムカルシウムの粉末混合物 Download PDFInfo
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Abstract
Description
本願は、2005年7月15日に出願された米国特許出願第11/183,140号への優先権を主張する。
腎結石形成の予防に関する代謝試験
計18名の腎結石を有さない閉経後の女性は、代謝病棟にて一定の規定食を維持しながら、無作為順で選択された4相の試験を受けた。それぞれ2週間続く4相は、クエン酸カリウム(Urocit−K(登録商標))20mEqを1日2回、クエン酸カルシウム(Citracal(登録商標))400mgカルシウムを1日2回、クエン酸カリウムとクエン酸カルシウムの両方を同量、及びプラセボから構成されていた。各相の最後の2日間、生化学因子及び結石危険因子のために、尿を採取し、24時間畜尿した。併用治療によって与えられるカルシウム及びカリウムの量は、本発明の目的の所望の用量とほぼ同量であったことから、この代謝試験からクエン酸カリウム及びクエン酸カルシウムを使用する併用治療は、本発明により具体化される通り、クエン酸カリウムカルシウムを使用する治療と同等である。
骨量減少予防に関する代謝試験
実施例1に記載した同一対象が関与する同一試験において、クエン酸カリウム、クエン酸カルシウム、及びこれら2つの併用の骨代謝に対する効果を試験した。各2週間の相の最後の2日間に、カルシウム代謝、アルカリ添加物、及び骨代謝指標を評価するために、血清及び24時間尿の検体を採取した。
クエン酸カリウムカルシウムを使用する処置の従うべき条件
高肉食: 一般的に体重制限のために行われるAtkinsダイエット等の動物性高タンパク規定食の消費は、腎結石及び骨量減少の危険性を高める可能性がある。一定の規定食を取る対象で慎重に実施した試験において、Atkinsダイエットは、著しい酸性負荷、2倍近くもの尿中カルシウム、並びに尿中pHの低下(尿をより酸性にする)及びクエン酸塩(カルシウム結石形成の阻止因子)の減少をもたらすことが示された(Reddy, et al., 2002, Amer. J. Kid. Dis., 40:265−274)。従って、尿は、結石形成塩に関してより過飽和になり、尿酸及びシュウ酸カルシウム結石の形成をより起りやすくした。同時に、尿中カルシウムが増加しても、腸内カルシウム吸収が変化しなかったため、カルシウムバランスはより負に変化した。
粉末混合物の調製
クエン酸カリウムカルシウムの6種類の粉末混合物を調製した。これらの組成物を表3に提示する。カルシウムは炭酸カルシウムとして用意した。同量のクエン酸を加えることによって、炭酸カルシウムは、クエン酸と反応させることによって水又は胃液に溶解し、可溶性のクエン酸カルシウムを形成することができた。カリウムはクエン酸カリウムとして用意した。炭酸カルシウム、クエン酸、及びクエン酸カリウムを事前に混合したものを水に溶解させると、結果として生じる水溶液製剤は、市販のクエン酸カルシウム及びクエン酸カリウムの通常の単回用量によって供給される(即ち、それぞれカルシウム20mEq(400mg)及びカリウム20mEq)のと同量のカルシウム及びカリウムの単回用量を送達した。製剤Aは、カルシウム及びカリウム陽イオン(40mEq)の総量を中和させるために、総量のクエン酸塩(40mEq)のみを含有した。従って、250cc中の各用量は、20mmolカリウム、10mmolカルシウム、及び1.33mmolクエン酸塩(40mEqが3価によって分割される)をもたらしたため、製剤Aのモル比は2:1:1.33であった。製剤Aの化学成分は、実施例1及び2に記載したクエン酸カルシウムとクエン酸カリウムを組み合わせた処置の単回用量と同一であった。
粉末製剤、並びにクエン酸カルシウム及びクエン酸カリウムの市販の錠剤製剤からのカリウム、カルシウム及びクエン酸塩の同一放出
製剤Aを、100mEqの塩酸を含有する250mLの水に溶解した。同じ酸性水に、Citracalの錠剤2個(クエン酸カルシウム、1錠剤当たり200mgカルシウム、Mission Pharmacal Co.、米国テキサス州サンアントニオ)及びUrocit−Kの錠剤2個(クエン酸カリウム、1錠剤当たり10mEq、Mission Pharmacal、米国テキサス州サンアントニオ)を添加し、錠剤が分解し、両方の塩が完全に溶解するまで1時間攪拌した。
製剤A〜Fの溶解度及び風味
Claims (27)
- クエン酸カリウム、クエン酸、並びに炭酸カルシウム、水酸化カルシウム、酸化カルシウム、及びこれらの任意の組み合わせからなる群から選択される成分の混合物を含む、組成物。
- 前記混合物が粉末混合物である、請求項1に記載の組成物。
- 該クエン酸カリウムが、約10mEq〜約40mEqのレベルであり、該炭酸カルシウムが、約10mEq〜約40mEqのレベルであり、クエン酸が、約20mEq〜約100mEqのレベルである、請求項1に記載の組成物。
- 前記組成物が、約20mEqのクエン酸カリウム、約20mEqの炭酸カルシウム、及び約20mEqのクエン酸を含む、請求項1に記載の組成物。
- 更にクエン酸の形態で0.17〜1.34mEqのクエン酸塩を有する、請求項4に記載の組成物。
- 更に甘味料を含む、請求項1に記載の組成物。
- 前記甘味料が人工甘味料である、請求項6に記載の組成物。
- 該組成物が溶液の形態である、請求項1に記載の組成物。
- 該溶液が水溶液である、請求項8に記載の組成物。
- 該組成物が懸濁液の形態である、請求項1に記載の組成物。
- クエン酸カリウム、炭酸カルシウム、及びクエン酸を含み、水に溶解すると、カリウム、カルシウム及びクエン酸塩の水溶液を、2:1:1.33〜2:1:2.67の範囲のカリウム:カルシウム:クエン酸塩のモル比でもたらす、粉末混合物。
- 該クエン酸カリウムが、約10mEq〜約40mEqのレベルであり、該炭酸カルシウムが、約10mEq〜約40mEqのレベルであり、クエン酸が、約20mEq〜約100mEqのレベルである、請求項11に記載の粉末混合物。
- 約20mEqのクエン酸カリウム、約20mEqの炭酸カルシウム、及び約20mEqのクエン酸を含む、請求項12に記載の粉末混合物。
- 更にクエン酸の形態で0.17〜1.34mEqのクエン酸塩を有する、請求項12に記載の粉末混合物。
- 2:1:1.33のカリウム:カルシウム:クエン酸塩のモル比を有する、請求項11に記載の粉末混合物。
- 動物における骨粗鬆症若しくは腎結石又はその両方を処置又は予防する方法であって、クエン酸カリウム、クエン酸、並びに炭酸カルシウム、水酸化カルシウム、酸化カルシウム、及びこれらの任意の組み合わせからなる群から選択される成分の混合物を含む組成物の投与を含み、前記組成物が、2:1:1.33〜2:1:2.67の範囲のカリウム:カルシウム:クエン酸塩のモル比を有する、方法。
- 該動物がヒトである、請求項16に記載の方法。
- 該ヒトが閉経後の女性である、請求項17に記載の方法。
- 前記投与が経口投与を含む、請求項16に記載の方法。
- 該動物が慢性下痢症候群を呈する、請求項16に記載の方法。
- 該組成物が、2:1:1.33のカリウム:カルシウム:クエン酸塩のモル比を有する、請求項16に記載の方法。
- 動物における骨粗鬆症若しくは腎結石又はその両方を処置又は予防する方法であって、2:1:1.33〜2:1:2.67の範囲のカリウム:カルシウム:クエン酸塩のモル比を有する、クエン酸カリウム及びクエン酸カルシウムの混合物を含む組成物の投与を含む、方法。
- 該動物がヒトである、請求項22に記載の方法。
- 該ヒトが閉経後の女性である、請求項23に記載の方法。
- 前記投与が経口投与を含む、請求項22に記載の方法。
- 該動物が慢性下痢症候群を呈する、請求項22に記載の方法。
- 該組成物が、2:1:1.33のカリウム:カルシウム:クエン酸塩のモル比を有する、請求項22に記載の方法。
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PCT/US2006/027398 WO2007011740A2 (en) | 2005-07-15 | 2006-07-13 | A powder mix of potassium calcium citrate for the treatment of kidney stones and osteoporosis |
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WO2015120272A1 (en) * | 2014-02-06 | 2015-08-13 | University Of Houston System | Organic acids as growth inhibitors of pathological calcification and uses thereof |
US10285961B2 (en) | 2014-02-06 | 2019-05-14 | University Of Houston System | Organic acids as agents to dissolve calcium minerals in pathological calcification and uses thereof |
CN104069125B (zh) * | 2014-07-16 | 2017-02-08 | 华南理工大学 | 一种用于泌尿系磷酸盐结石的溶石剂及其制备方法 |
WO2016159897A1 (en) * | 2015-04-01 | 2016-10-06 | Ay Doğan | Potassium citrate suspension |
WO2019035989A1 (en) * | 2017-08-17 | 2019-02-21 | The Board Of Regents Of The University Of Texas System | PREVENTION OF CALCIUM OXALATE RENAL CALCULATIONS BY POTASSIUM HYDROXYCITRATE |
IT202200021258A1 (it) * | 2022-10-14 | 2024-04-14 | Neilos S R L | “Composizione nutraceutica o farmaceutica per il benessere renale” |
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US4888182A (en) * | 1983-04-11 | 1989-12-19 | Board Of Regents Of The University Of Texas System | Compositions and methods of treating calcium renal stones |
US4772467A (en) * | 1985-02-19 | 1988-09-20 | Board Of Regents, U T Systems | Osteoporosis inhibition by dietary calcium supplementation |
US4722847A (en) * | 1986-05-07 | 1988-02-02 | The Procter & Gamble Company | Fruit juice beverages and juice concentrates nutritionally supplemented with calcium |
US4871554A (en) * | 1987-08-12 | 1989-10-03 | Coca-Cola Company | Calcium fortified food product |
US5128374A (en) * | 1987-08-28 | 1992-07-07 | The Procter & Gamble Company | Use of calcium citrate malate for the treatment of osteoporosis and related disorders |
ES2061394B1 (es) * | 1993-02-05 | 1995-06-16 | Robert S A Lab | Procedimiento de fabricacion de un granulado de citrato potasico con cesion retardada. |
US6680305B1 (en) * | 1993-06-04 | 2004-01-20 | Biotime, Inc. | Physiologically acceptable aqueous solutions and methods for their use |
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US6599544B2 (en) * | 2000-01-26 | 2003-07-29 | American Micronutrients, Inc. | Calcium enrichment composition and method for producing the same |
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US7507421B2 (en) * | 2002-04-30 | 2009-03-24 | Unibar Corporation | Hydroxycitric acid salt composition and method of making |
US6833146B2 (en) * | 2002-07-08 | 2004-12-21 | Unilab Pharmatech, Ltd. | Powered beverage mix with rapidly dissolving calcium |
US7138151B2 (en) * | 2002-11-22 | 2006-11-21 | Unilab Pharmatech, Ltd. | Calcium-fortified acidic beverages |
US20040185119A1 (en) * | 2003-02-26 | 2004-09-23 | Theuer Richard C. | Method and compositions for treating gastric hyperacidity while diminishing the likelihood of producing vitamin deficiency |
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