NOVEL LIQUID COMPOSITION WITH ENHANCED STABILITY
PROBLEM TO BE SOLVED: To provide a stable liquid composition with good texture, which is prevented from causing precipitation of a pharmaceutical agent such as guaifenesin, the composition comprising a mixture of polyethylene glycol, polyvinylpyrrolidone, and propylene glycol, alone or in combinatio...
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Zusammenfassung: | PROBLEM TO BE SOLVED: To provide a stable liquid composition with good texture, which is prevented from causing precipitation of a pharmaceutical agent such as guaifenesin, the composition comprising a mixture of polyethylene glycol, polyvinylpyrrolidone, and propylene glycol, alone or in combination with an additional pharmaceutical agent, such as phenylephrine.SOLUTION: The present invention provides a liquid oral pharmaceutical composition comprising: 0.1 w/v% to 20 w/v% of polyvinyl pyrrolidone; 5 w/v% to 70 w/v% of polyethylene glycol; 1 w/v% to 30 w/v% propylene glycol; 1 w/v% to 10 w/v% guaifenesin; and 0.01 w/v% to 1.0 w/v% of phenylephrine. The composition further comprises one or more pharmaceutical agents selected from analgesics, decongestants, expectorants, antitussives, antipyretics, anti-inflammatory agents, cough suppressants, and antihistamines. The composition causes no visible precipitation of guaifenesin at least 62 days at 4°C.SELECTED DRAWING: None
【課題】ポリエチレングリコール、ポリビニルピロリドン、およびプロピレングリコールの混合物において、単独での、またはフェニレフリンなどの追加の医薬剤と組み合わせた、グアイフェネシンなどの医薬剤の沈澱が阻止され口あたりの良い安定な液体組成物の提供。【解決手段】0.1w/v%〜20w/v%のポリビニルピロリドン;5w/v%〜70w/v%のポリエチレングリコール;1w/v%〜30w/v%のプロピレングリコール;1w/v%〜10w/v%のグアイフェネシン;および0.01w/v%〜1.0w/v%のフェニレフリンを含む液体経口医薬組成物であって、さらに、鎮痛薬、うっ血除去薬、去痰薬、鎮咳薬、解熱薬、抗炎症剤、咳止め、および抗ヒスタミン剤から選択される1種または複数の医薬剤を含み、ここで、4℃で少なくとも62日間グアイフェネシンの沈澱が目視されない組成物。【選択図】なし |
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