JP7216055B2 - 医薬組成物 - Google Patents
医薬組成物 Download PDFInfo
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- JP7216055B2 JP7216055B2 JP2020153832A JP2020153832A JP7216055B2 JP 7216055 B2 JP7216055 B2 JP 7216055B2 JP 2020153832 A JP2020153832 A JP 2020153832A JP 2020153832 A JP2020153832 A JP 2020153832A JP 7216055 B2 JP7216055 B2 JP 7216055B2
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
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- A61K9/2022—Organic macromolecular compounds
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- A61K9/2022—Organic macromolecular compounds
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- A61K47/02—Inorganic compounds
Description
口腔に挿入可能な適当な大きさに切断されるシートに成形する。一実施例において、ウエハは、活性剤、溶媒、結合剤、またはその他の添加剤を水のような溶媒に懸濁させて成形する。所定量の懸濁液をプラスチック用金型内のウェルに入れ、ウェル内で凍結乾燥させ、水を除去してウエハを成形する。
また他の面において、本発明は、高リン血症治療用の薬剤製造における本発明の組成物の用途を提供する。
錠剤軽度及び崩壊時間は、標準ヨーロッパ薬局方の試験法によって測定した。
表1による量/比率のオキシ水酸化鉄懸濁液(EP0 868 125 B1によって製造する)及び賦形剤を混合して、安定化したオキシ水酸化鉄予備混合物を製造した。前記懸濁液を135~200℃の噴射乾燥に適用し、流動性粉末状の予備混合物を得た。前記予備混合物を直接打錠法に適用し、表1に示す組成の錠剤を得た。
実施例2により得られたが、単に50%の分量のみを有する錠剤を矩形状に打錠し、後続して下記表による成分を混合してフィルムコートした(2~5%の重量増加)。
下記表による成分を添加することにより、実施例1eによって得た粉末を、造粒液体としてイソプロパノールを用いた高せん断造粒によって湿潤造粒した。
下記表による成分を混合して乾燥混合物を製造し、次に、サシェまたはスティックパックへの充填に適用した。
下記表による成分を混合して乾燥混合物を製造し、次に、サシェまたはスティックパックへの充填に適用した。
9.6kgFeOOH(6.0kgFeに該当)を表7aに示す量の賦形剤及びアジュバントと一緒に水に懸濁させた。100kgの懸濁液を噴射乾燥に適用させた。得られた粉末の鉄含量を7bに示す。
実施例7a)乃至g)で得られた製品を表9aに示す成分と混合し、得られた混合物の錠剤を成形した。Fe含量、pH3でのFe放出量、及び得られた錠剤のリン酸塩吸着は、表9bに示す。
Claims (30)
- 経口投与の圧縮形態の医薬組成物であって、
オキシ水酸化鉄を、組成物全重量に対して10~80%(w/w)含み、かつ、投与形態当たり300mg~1700mgの量で含み、
蔗糖、デキストリンから選択される少なくとも1つからなる、或いは、蔗糖及び/又はデキストリンと、でんぷんとからなる炭水化物を含み、
オキシ水酸化鉄、蔗糖、でんぷん、崩壊剤、デキストリン及び水の成分の総重量が、組成物全重量の70%(w/w)を超えるものである、医薬組成物。 - オキシ水酸化鉄、蔗糖、でんぷん、崩壊剤及び水の成分の総重量が、組成物全重量の70%(w/w)を超えるものである、請求項1に記載の医薬組成物。
- オキシ水酸化鉄、蔗糖、でんぷん、崩壊剤、デキストリン及び水の成分の総重量が、組成物全重量の90%(w/w)以上である、請求項1に記載の医薬組成物。
- オキシ水酸化鉄、蔗糖、でんぷん、崩壊剤及び水の成分の総重量が、組成物全重量の90%(w/w)以上である、請求項3に記載の医薬組成物。
- 蔗糖及びでんぷんを含む、請求項1~4のいずれかに記載の医薬組成物。
- オキシ水酸化物鉄がベータオキシ水酸化鉄を含む、請求項1~5のいずれかに記載の医薬組成物。
- 組成物全重量に対してオキシ水酸化鉄を30~65%(w/w)含む、請求項1~6のいずれかに記載の医薬組成物。
- 組成物全重量に対して炭水化物を1~50%(w/w)含む、請求項1~7のいずれかに記載の医薬組成物。
- 1つ以上の風味剤、甘味料、味増強剤、及び/又は着色剤をさらに含む、請求項1~8のいずれかに記載の医薬組成物。
- 甘味料が、糖、ポリオール、アスパルテーム、スクラロース、アセスルファミンK、及び/又はサッカリンから選択される天然又は非天然の甘味料であり、
味増強剤が、ネオヘスペリジンジヒドロカルコン、グリシルリジン、グルタミン酸塩等の配糖体から選択される、請求項9に記載の医薬組成物。 - 甘味料を組成物全重量に対して0.01~2.5%(w/w)含み、かつ味増強剤を組成物全重量に対して0.1~10ppm含む、請求項9又は10に記載の医薬組成物。
- 風味剤を組成物全重量に対して0.01~10%(w/w)含む、請求項9に記載の医薬組成物。
- 崩壊剤、流動促進剤、酸化防止剤から選択される1つ以上の賦形剤をさらに含む、請求項1~12のいずれかに記載の医薬組成物。
- 単一の崩壊剤又は2つ以上を組み合わせた崩壊剤を含む、請求項1~13のいずれかに記載の医薬組成物。
- 崩壊剤が、架橋ポリビニルピロリドン、改質デンプン、改質セルロースから選択される、請求項13又は14に記載の医薬組成物。
- 崩壊剤を組成物全重量に対して0.1~10%(w/w)含む、請求物13~15のいずれかに記載の医薬組成物。
- 流動促進剤が、ステアリン酸マグネシウム、コロイド状シリカなどのシリカ誘導体、ケイアルミン酸ナトリウム水和物、コロイド状二酸化ケイ素、滑石及びそれらの混合物から選択される、請求項13に記載の医薬組成物。
- 流動促進剤を組成物全重量に対して0.01~10%(w/w)含む、請求項13又は17に記載の医薬組成物。
- 組成物全重量に対して、オキシ水酸化鉄を10~80%(w/w)含み、1つ以上の前記炭水化物を合計1.0~50%(w/w)含み、1つ以上の賦形剤を合計1.0~50%(w/w)含み、1つ以上の風味剤を合計0.01~10%(w/w)含む、請求項1~18のいずれかに記載の医薬組成物。
- 鉄放出率が、2.5%(w/w)以下である請求項1~19のいずれかに記載の医薬組成物。
- オキシ水酸化鉄が安定化剤で安定化したオキシ水酸化鉄である、請求項1~20のいずれかに記載の医薬組成物。
- 前記経口投与の形態が、完全な嚥下又は崩壊が可能なチュアブル錠又は錠剤から選択される形態である、請求項1~21のいずれかに記載の医薬組成物。
- 高リン血症患者の治療に使用するための請求項1~22のいずれかに記載の医薬組成物。
- 慢性腎不全患者の治療に使用するための請求項1~22のいずれかに記載の医薬組成物。
- 非生体吸収性である請求項1~24のいずれかに記載の医薬組成物。
- 請求項1~25のいずれかに記載の医薬組成物の製造方法であって、直接打錠法又は乾式造粒によって圧縮形態にする製造方法。
- 請求項1~25のいずれかに記載の医薬組成物の製造方法であって、高せん断造粒、流動層造粒又は(乾式)混合によって顆粒の形態にする製造方法。
- 請求項1~25のいずれかに記載の医薬組成物の製造方法であって、オキシ水酸化鉄及び少なくとも1つの賦形剤の圧縮を含む製造方法。
- 請求項1~25のいずれかに記載の圧縮形態の医薬組成物の製造方法であって、最終組成物の全重量に対して少なくとも90%(w/w)の成分を含有する水性懸濁液を製造し、これを噴射乾燥に適用させて流動性粉末を得、これを任意では残りの成分と混合し、次いで打錠して錠剤を得る製造方法。
- 組成物の全重量(フイルムコート錠の場合は錠剤コーティングの重量を除く)に対して、オキシ水酸化鉄を30~65%(w/w)含み、蔗糖を5~30%(w/w)含み、でんぷんを5~30%(w/w)含み、かつ、前記オキシ水酸化鉄を投与形態当たり300mg~1700mgの量で含む圧縮形態の医薬組成物。
Priority Applications (1)
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JP2022177769A JP2023011873A (ja) | 2007-11-16 | 2022-11-07 | 医薬組成物 |
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EP07120837 | 2007-11-16 | ||
EP07120837.5 | 2007-11-16 |
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JP2019016592A Division JP6764959B2 (ja) | 2007-11-16 | 2019-02-01 | 医薬組成物 |
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JP2022177769A Division JP2023011873A (ja) | 2007-11-16 | 2022-11-07 | 医薬組成物 |
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JP2021001192A JP2021001192A (ja) | 2021-01-07 |
JP2021001192A5 JP2021001192A5 (ja) | 2021-07-26 |
JP7216055B2 true JP7216055B2 (ja) | 2023-01-31 |
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JP2010533575A Active JP5466164B2 (ja) | 2007-11-16 | 2008-11-13 | 医薬組成物 |
JP2013257490A Active JP5961601B2 (ja) | 2007-11-16 | 2013-12-12 | 医薬組成物 |
JP2015088748A Active JP6294260B2 (ja) | 2007-11-16 | 2015-04-23 | 医薬組成物 |
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