JP5689458B2 - グルコサミンを包含する栄養補助食品を安定化させる方法 - Google Patents
グルコサミンを包含する栄養補助食品を安定化させる方法 Download PDFInfo
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- JP5689458B2 JP5689458B2 JP2012510976A JP2012510976A JP5689458B2 JP 5689458 B2 JP5689458 B2 JP 5689458B2 JP 2012510976 A JP2012510976 A JP 2012510976A JP 2012510976 A JP2012510976 A JP 2012510976A JP 5689458 B2 JP5689458 B2 JP 5689458B2
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- Prior art keywords
- glucosamine
- granule
- composition
- binder
- disintegrant
- Prior art date
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- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 title claims description 108
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- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
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Description
グルコサミンHCL、クロスカルメロースナトリウム、および2.8%w/wを包含する顆粒を、ハイシアーミキサーおよび流動床乾燥器を用いて調製した。
炭酸カルシウム、クロスカルメロースナトリウム、ポビドン、および21%w/wの水を包含する顆粒を、ハイシアーミキサーおよび流動床乾燥器を用いて調製した。
実施例1および実施例2の顆粒を混合し、錠剤に圧縮した。2つの別に形成された顆粒を含有する最終的な剤形に対して安定性試験を行った。40℃および75℃の相対湿度で3カ月間保存した後に保持されたグルコサミンのパーセンテージは、およそ100%であり、グルコサミン分解産物は検出されなかった。グルコサミンHCLおよび炭酸カルシウムを共に造粒した錠剤と比較すると、40℃および75℃の相対湿度で3カ月間保存した後に保持されたグルコサミンのパーセンテージは、およそ80%未満であった。したがって、グルコサミンを第1の顆粒において造粒し、炭酸カルシウムを第2の顆粒において造粒し、顆粒をその後に混合して錠剤に圧縮する、顆粒の調製によって、安定性が向上し分解が少ない剤形が得られる。
湿気およびpHの効果を評価するために、圧縮および被覆された錠剤を、1)炭酸カルシウムと共造粒したカルシウムおよびグルコサミン、(CGC)、高水分量、高pH、2)炭酸カルシウムと共造粒したグルコサミン、(CGC)、低水分量、高pH、3)炭酸カルシウムと別に造粒したグルコサミン(SG)、低水分量、低pH、という、製造手順の変化を用いて調製した。全ての組合せを、製造の直後のグルコサミンの有効性について分析した。次に、錠剤を40℃/75%RHで保存し、様々な時点で安定性について評価した。試料を、修正された、安定性を示すための文献に記載されている方法を用いて、グルコサミンについて分析した。
Claims (4)
- (a)グルコサミン、第1の崩壊剤、および第1の結合剤を包含する第1の顆粒組成物を提供するステップ、ならびに(b)カルシウム、第2の崩壊剤、および第2の結合剤を包含する第2の顆粒組成物を提供し、第1の顆粒および第2の顆粒を混合するステップを包含する、グルコサミンおよびカルシウムを包含する組成物を製造するための方法であって、前記組成物が、向上したおよび/または増強された貯蔵安定性を有する方法。
- (a)グルコサミン、第1の崩壊剤、および第1の結合剤を包含する第1の顆粒組成物を提供するステップ、ならびに(b)カルシウム、第2の崩壊剤、および第2の結合剤を包含する第2の顆粒組成物を提供し、第1の顆粒および第2の顆粒を混合するステップを包含する、グルコサミンおよびカルシウムを包含する組成物を製造するための方法であって、第1の顆粒が、本質的に乾燥した状態で形成され、さらに、前記組成物が、向上したおよび/または増強された貯蔵安定性を有する方法。
- (a)グルコサミン、第1の崩壊剤、および第1の結合剤を包含する第1の顆粒組成物を提供するステップであって、第1の顆粒のpHが7以下であるステップ、ならびに(b)少なくとも1つのビタミン、ミネラル、または活性原料、第2の崩壊剤、および第2の結合剤を包含する第2の顆粒組成物を提供し、第1の顆粒および第2の顆粒を混合するステップを包含する、グルコサミンおよび少なくとも1つのビタミンまたは少なくとも1つのミネラルを包含する組成物を製造するための方法であって、前記組成物が、向上したおよび/または増強された貯蔵安定性を有する方法。
- (a)グルコサミン、第1の崩壊剤、および第1の結合剤を包含する第1の顆粒組成物を提供するステップであって、第1の顆粒のpHが7以下であるステップ、ならびに(b)少なくとも1つのビタミン、ミネラル、または活性原料、第2の崩壊剤、および第2の結合剤を包含する第2の顆粒組成物を提供し、第1の顆粒および第2の顆粒を混合するステップを包含する、グルコサミンおよび少なくとも1つのビタミンまたは少なくとも1つのミネラルを包含する組成物を製造するための方法であって、第1の顆粒が、本質的に乾燥した状態で形成され、さらに、前記組成物が、向上したおよび/または増強された貯蔵安定性を有する方法。
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US17788809P | 2009-05-13 | 2009-05-13 | |
US61/177,888 | 2009-05-13 | ||
PCT/US2010/034525 WO2010141191A1 (en) | 2009-05-13 | 2010-05-12 | Method to stabilize a dietary supplement comprising glucosamine |
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EP (1) | EP2429500B1 (ja) |
JP (1) | JP5689458B2 (ja) |
AR (1) | AR076576A1 (ja) |
CA (1) | CA2758812C (ja) |
DK (1) | DK2429500T3 (ja) |
ES (1) | ES2534312T3 (ja) |
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JP5740633B2 (ja) * | 2011-06-03 | 2015-06-24 | 株式会社東洋新薬 | 錠剤の製造方法及び錠剤 |
EP3176222A1 (en) * | 2015-12-01 | 2017-06-07 | Omya International AG | Method for the production of granules comprising surface-reacted calcium carbonate |
JP7334025B2 (ja) * | 2017-06-30 | 2023-08-28 | 小林製薬株式会社 | グルコサミンがカルシウム化合物で被覆されている経口組成物 |
TWI827577B (zh) | 2018-01-12 | 2024-01-01 | 南韓商梅堤梅蒂製藥有限公司 | 治療慢性發炎疾病的方法 |
BE1029004B1 (nl) * | 2021-01-11 | 2022-08-16 | Kori Gcv | Nieuw farmaceutische formuleringen, op basis van eenvoudige metabolieten, te gebruiken bij degeneratieve aandoeningen van het zenuwstelsel, bij virale infecties en bij tumorale aandoeningen |
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US2410417A (en) * | 1944-03-04 | 1946-11-05 | Lever Brothers Ltd | Vitamin and mineral dietary supplement and method of making |
DE1792346C3 (de) | 1968-08-22 | 1980-10-23 | Rotta Research Laboratorium S.P.A., San Fruttuoso Di Monza, Mailand (Italien) | Pharmazeutisches Präparat für die Behandlung von degenerativen Gelenkerkrankungen |
IT1044707B (it) | 1968-10-26 | 1980-04-21 | Rotta Research Lab | Procedimento per la preparazione di sali di glucosanina e preparati farmaceutici comprendenti detti sali di glucosamina come agenti attivi |
IT1148050B (it) | 1981-04-30 | 1986-11-26 | Rotta Research Lab | Composto stabile della glucosamina solfato procedimento per la sua preparazione e composizioni farmaceutiche contenenti tale composto |
US4582709A (en) * | 1985-02-08 | 1986-04-15 | Warner-Lambert Company | Chewable mineral supplement |
DE3532081A1 (de) | 1985-09-09 | 1987-03-12 | Orion Yhtymae Oy | Mischsalze von glucosaminsulfat und verfahren zu ihrer herstellung |
US4786510A (en) * | 1987-07-02 | 1988-11-22 | The Procter & Gamble Company | Calcium-iron mineral supplements |
CA2035841C (en) | 1990-02-22 | 1996-02-13 | Harry B. Demopoulos | Storage-stable glucosamine sulphate oral dosage forms and methods for their manufacture |
US5364845C1 (en) | 1993-03-31 | 2002-09-10 | Nutramax Lab Inc | Glusosamine chondroitin and manganese composition for the protection and repair of connective tissue |
US6492349B1 (en) | 1993-03-31 | 2002-12-10 | Nutramax Laboratories, Inc. | Aminosugar and glycosaminoglycan composition for the treatment and repair of connective tissue |
GB9414045D0 (en) * | 1994-07-12 | 1994-08-31 | Berwind Pharma Service | Moisture barrier film coating composition, method, and coated form |
US5840715A (en) | 1995-12-11 | 1998-11-24 | Inholtra Investment Holdings & Trading, N.V. | Dietary regimen of nutritional supplements for relief of symptoms of arthritis |
US5916565A (en) | 1996-03-08 | 1999-06-29 | In Clover, Inc. | Product and method for treating joint disorders in vertebrates |
US5922692A (en) | 1998-03-11 | 1999-07-13 | Marino; Richard P. | Concentration of glycosaminoglycans and precursors thereto in food products |
JP2001064159A (ja) | 1999-08-25 | 2001-03-13 | Shionogi & Co Ltd | 複合顆粒剤 |
US6358526B1 (en) | 2000-08-16 | 2002-03-19 | Rexall Sundown | Method of making tablets and tablet compositions produced therefrom |
TR201909238T4 (tr) * | 2004-03-29 | 2019-07-22 | Wyeth Llc | Multi-vitamin ve mineral besin takviyeleri. |
AR061093A1 (es) * | 2006-05-12 | 2008-08-06 | Drug Tech Corp | Composiciones de calcio |
CA2587805C (en) * | 2007-04-25 | 2014-02-18 | The Procter & Gamble Company | Improved vitamin d content uniformity in pharmaceutical dosage forms |
WO2008136016A1 (en) | 2007-05-08 | 2008-11-13 | Medreich Limited | A stable controlled release oral solid dosage form composition and a process thereof |
CN101801351B (zh) * | 2007-07-19 | 2012-12-12 | 武田药品工业株式会社 | 包含阿格列汀和盐酸二甲双胍的固体制剂 |
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AR076576A1 (es) | 2011-06-22 |
JP2012526835A (ja) | 2012-11-01 |
TW201043640A (en) | 2010-12-16 |
US20100291240A1 (en) | 2010-11-18 |
ES2534312T3 (es) | 2015-04-21 |
EP2429500B1 (en) | 2015-01-14 |
US9592202B2 (en) | 2017-03-14 |
CA2758812C (en) | 2015-03-31 |
DK2429500T3 (en) | 2015-03-09 |
CA2758812A1 (en) | 2010-12-09 |
EP2429500A1 (en) | 2012-03-21 |
WO2010141191A1 (en) | 2010-12-09 |
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