JP5712148B2 - プロトンポンプ阻害剤、nsaid及び緩衝剤を含む剤形 - Google Patents
プロトンポンプ阻害剤、nsaid及び緩衝剤を含む剤形 Download PDFInfo
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- JP5712148B2 JP5712148B2 JP2012001163A JP2012001163A JP5712148B2 JP 5712148 B2 JP5712148 B2 JP 5712148B2 JP 2012001163 A JP2012001163 A JP 2012001163A JP 2012001163 A JP2012001163 A JP 2012001163A JP 5712148 B2 JP5712148 B2 JP 5712148B2
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- Prior art keywords
- nsaid
- proton pump
- pharmaceutical composition
- pump inhibitor
- buffer
- 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.)
- Expired - Lifetime
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- 229920002981 polyvinylidene fluoride Polymers 0.000 description 1
- 229960004063 propylene glycol Drugs 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 229960004157 rabeprazole Drugs 0.000 description 1
- YREYEVIYCVEVJK-UHFFFAOYSA-N rabeprazole Chemical compound COCCCOC1=CC=NC(CS(=O)C=2NC3=CC=CC=C3N=2)=C1C YREYEVIYCVEVJK-UHFFFAOYSA-N 0.000 description 1
- 230000008707 rearrangement Effects 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 239000008159 sesame oil Substances 0.000 description 1
- 235000011803 sesame oil Nutrition 0.000 description 1
- HELHAJAZNSDZJO-OLXYHTOASA-L sodium L-tartrate Chemical compound [Na+].[Na+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O HELHAJAZNSDZJO-OLXYHTOASA-L 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 229940001593 sodium carbonate Drugs 0.000 description 1
- 235000017550 sodium carbonate Nutrition 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 229960001790 sodium citrate Drugs 0.000 description 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- 239000001433 sodium tartrate Substances 0.000 description 1
- 229960002167 sodium tartrate Drugs 0.000 description 1
- 235000011004 sodium tartrates Nutrition 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229960000894 sulindac Drugs 0.000 description 1
- MLKXDPUZXIRXEP-MFOYZWKCSA-N sulindac Chemical compound CC1=C(CC(O)=O)C2=CC(F)=CC=C2\C1=C/C1=CC=C(S(C)=O)C=C1 MLKXDPUZXIRXEP-MFOYZWKCSA-N 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- 229960001017 tolmetin Drugs 0.000 description 1
- UPSPUYADGBWSHF-UHFFFAOYSA-N tolmetin Chemical compound C1=CC(C)=CC=C1C(=O)C1=CC=C(CC(O)=O)N1C UPSPUYADGBWSHF-UHFFFAOYSA-N 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- 229960000281 trometamol Drugs 0.000 description 1
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Description
PPI/NSAIDの薬物適合性
各種NSAIDをランソプラゾールまたはランソプラゾール及び緩衝剤と組み合わせて成分の適合性を調べた。混合物を室温及び40℃/75%の相対湿度下に置いた。サンプルを最初に、上記した貯蔵条件で2週間後に試験した。結果を所与成分の理論量の%として下表1に示す。
顆粒剤及び錠剤中の物質適合性
本実施例では、PPI及び各種NSAIDの顆粒を作成し、顆粒形態での各物質の相互適合性を調べた。下表2に示す成分を含有する顆粒を作成した。
PPI、NSAID及び緩衝剤を含む錠剤及びその溶解
実施例2の顆粒Aを実施例2の顆粒E、FまたはGと一緒に用いて錠剤を作成した。30mgのランソプラゾールに加えて81mgのアスピリン、250mgのナプロキセンまたは20mgのピロキシカムを含有する錠剤が得られるように顆粒を秤量した。各種顆粒を混合した後成分を錠剤に圧縮した。顆粒を1/4または1/2トンの圧力で錠剤に圧縮して、溶解時に成分を迅速に遊離するであろう錠剤を形成した。
Claims (6)
- アンギナ、大動脈・肺動脈シャント閉塞、結腸直腸癌、食道癌、結腸癌、冠動脈疾患、痴呆、月経困難症、心筋梗塞、関節リウマチ、骨関節炎、疼痛、血小板血症、術後血栓塞栓症、虚血、滑液嚢炎、認識低下、発熱、痛風、筋骨格疾患、軟部組織損傷及び心膜炎からなる群から選択される状態を治療するための医薬組成物であって、
(a)水酸化マグネシウム及び炭酸カルシウムから選択される水不溶性緩衝剤、
(b)非ステロイド系抗炎症剤(NSAID)を含む顆粒、及び
(c)プロトンポンプ阻害剤を含む顆粒、ここで、前記プロトンポンプ阻害剤は、腸溶コーティングされず、NSAIDから胃腸管を保護する、
を含み、腸溶コーティングを含まず、上記(b)及び(c)の顆粒を圧縮した形状で含む医薬組成物。 - 非ステロイド系抗炎症剤がアスピリンである請求の範囲第1項に記載の医薬組成物。
- プロトンポンプ阻害剤がランソプラゾールである請求の範囲第2項に記載の医薬組成物。
- アスピリンを50〜100mgの量含む請求の範囲第3項に記載の医薬組成物。
- アンギナ、大動脈・肺動脈シャント閉塞、結腸直腸癌、食道癌、結腸癌、冠動脈疾患、痴呆、月経困難症、心筋梗塞、関節リウマチ、骨関節炎、疼痛、卒中、血小板血症、術後血栓塞栓症、虚血、滑液嚢炎、認識低下、発熱、痛風、筋骨格疾患、軟部組織損傷及び心膜炎からなる群から選択される状態を1つ以上有する患者の治療用医薬製造のための、水酸化マグネシウム及び炭酸カルシウムから選択される水不溶性緩衝剤、腸溶コーティングされていないプロトンポンプ阻害剤及び非ステロイド系抗炎症剤を含む非腸溶コーティング医薬組成物の使用。
- NSAID治療から胃腸管を保護するための医薬の製造のための、水酸化マグネシウム及び炭酸カルシウムから選択される水不溶性緩衝剤及びプロトンポンプ阻害剤と組み合わせた、NSAIDの使用であって、プロトンポンプ阻害剤は腸溶コーティングされておらず、NSAID、プロトンポンプ阻害剤及び緩衝剤は、単一の非腸溶コーティング医薬組成物を含む、使用。
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Application Number | Priority Date | Filing Date | Title |
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US10/325,338 US20040121004A1 (en) | 2002-12-20 | 2002-12-20 | Dosage forms containing a PPI, NSAID, and buffer |
US10/325,338 | 2002-12-20 |
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JP2004565359A Division JP5620622B2 (ja) | 2002-12-20 | 2003-12-11 | プロトンポンプ阻害剤、nsaid及び緩衝剤を含む剤形 |
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JP2012001163A Expired - Lifetime JP5712148B2 (ja) | 2002-12-20 | 2012-01-06 | プロトンポンプ阻害剤、nsaid及び緩衝剤を含む剤形 |
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AT (1) | ATE427747T1 (ja) |
CA (1) | CA2506930C (ja) |
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US20030235628A1 (en) * | 2001-09-19 | 2003-12-25 | Rajneesh Taneja | Methods and pharmaceutical formulations for protecting pharmaceutical compounds from acidic environments |
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2002
- 2002-12-20 US US10/325,338 patent/US20040121004A1/en not_active Abandoned
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- 2003-12-11 PL PL375900A patent/PL213637B1/pl unknown
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CA2506930A1 (en) | 2004-07-22 |
US20040121004A1 (en) | 2004-06-24 |
EP1594499B1 (en) | 2009-04-08 |
CA2506930C (en) | 2011-10-11 |
ATE427747T1 (de) | 2009-04-15 |
JP2012107021A (ja) | 2012-06-07 |
MXPA05006629A (es) | 2005-09-30 |
JP2006514049A (ja) | 2006-04-27 |
PL213637B1 (pl) | 2013-04-30 |
JP5620622B2 (ja) | 2014-11-05 |
EP1594499A1 (en) | 2005-11-16 |
ES2325502T3 (es) | 2009-09-07 |
US20090074863A1 (en) | 2009-03-19 |
WO2004060372A1 (en) | 2004-07-22 |
PL375900A1 (en) | 2005-12-12 |
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