JP2004533999A5 - - Google Patents

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Publication number
JP2004533999A5
JP2004533999A5 JP2002571032A JP2002571032A JP2004533999A5 JP 2004533999 A5 JP2004533999 A5 JP 2004533999A5 JP 2002571032 A JP2002571032 A JP 2002571032A JP 2002571032 A JP2002571032 A JP 2002571032A JP 2004533999 A5 JP2004533999 A5 JP 2004533999A5
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JP
Japan
Prior art keywords
atorvastatin calcium
mixture
active ingredient
adjusting substance
pharmaceutical preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Application number
JP2002571032A
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English (en)
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JP4295988B2 (ja
JP2004533999A (ja
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Priority claimed from SI200100069A external-priority patent/SI20848A/sl
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Publication of JP2004533999A publication Critical patent/JP2004533999A/ja
Publication of JP2004533999A5 publication Critical patent/JP2004533999A5/ja
Application granted granted Critical
Publication of JP4295988B2 publication Critical patent/JP4295988B2/ja
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Claims (3)

  1. アトルバスタチンカルシウムが、微紛したアモルファス形アトルバスタチンカルシウムを含んでなり、
    医薬製剤が、pH3の900mlの0.001M HCl溶液である仮想胃液中に溶解される場合に、アトルバスタチンカルシウムのpKa+1と同じまたはそれ以上のpHに上記溶液の上記pHを上げる特性をもつことを特徴とする、活性成分に上記アトルバスタチンカルシウムを含む医薬製剤、及びpH調整物質。
  2. 上記pH調整物質が、単独投与によって上記HCl溶液のpH値を、pKa+1と同じまたはそれ以上に高くするために、該pH調整物質の量が製剤において調整されることを特徴とする請求項1から3のいずれかに記載の医薬製剤。
  3. (a)微紛したアモルファス形アトルバスタチンカルシウムの形である上記活性成分を、アルカリ化及び/または緩衝剤、賦形剤、結合剤、崩壊剤及び界面活性剤からなる群の少なくとも1つの構成と混合するステップ;
    (b)上記混合体を均質化するステップ;
    (c)上記混合体への追加成分の添加ステップ;
    (d)混合体を再度均一化するステップ;及び
    (e)再度均一化された混合体を投与可能な形に最終処理するステップ
    からなる、活性成分にアトルバスタチンカルシウムを含む医薬製剤の調製のためのプロセス。
JP2002571032A 2001-03-14 2002-03-13 医薬形態のアトルバスタチンカルシウム、その構成物、及びアトルバスタチンカルシウムを含む医薬製剤 Expired - Lifetime JP4295988B2 (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SI200100069A SI20848A (sl) 2001-03-14 2001-03-14 Farmacevtska formulacija, ki vsebuje atorvastatin kalcij
PCT/IB2002/000736 WO2002072073A2 (en) 2001-03-14 2002-03-13 Pharmaceutical formulation comprising atorvastatin calcium

Publications (3)

Publication Number Publication Date
JP2004533999A JP2004533999A (ja) 2004-11-11
JP2004533999A5 true JP2004533999A5 (ja) 2005-06-02
JP4295988B2 JP4295988B2 (ja) 2009-07-15

Family

ID=20432850

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2002571032A Expired - Lifetime JP4295988B2 (ja) 2001-03-14 2002-03-13 医薬形態のアトルバスタチンカルシウム、その構成物、及びアトルバスタチンカルシウムを含む医薬製剤

Country Status (25)

Country Link
US (1) US7030151B2 (ja)
EP (2) EP2263655B1 (ja)
JP (1) JP4295988B2 (ja)
KR (1) KR100905730B1 (ja)
CN (1) CN1630510B (ja)
AT (1) ATE500818T1 (ja)
BG (1) BG66339B1 (ja)
BR (1) BR0207880A (ja)
CA (1) CA2440331C (ja)
CZ (1) CZ306128B6 (ja)
DE (1) DE60239425D1 (ja)
ES (2) ES2361609T3 (ja)
HR (1) HRP20030726B1 (ja)
HU (1) HU230213B1 (ja)
IL (2) IL157534A0 (ja)
ME (1) ME00517B (ja)
MX (1) MXPA03008340A (ja)
PL (2) PL211803B1 (ja)
RS (2) RS51746B (ja)
RU (1) RU2293555C2 (ja)
SI (2) SI20848A (ja)
SK (1) SK287925B6 (ja)
UA (1) UA78201C2 (ja)
WO (1) WO2002072073A2 (ja)
ZA (1) ZA200306575B (ja)

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