JP5475254B2 - イブプロフェン、トラネキサム酸及びケイ酸カルシウムを含有する固形製剤 - Google Patents
イブプロフェン、トラネキサム酸及びケイ酸カルシウムを含有する固形製剤 Download PDFInfo
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- JP5475254B2 JP5475254B2 JP2008165187A JP2008165187A JP5475254B2 JP 5475254 B2 JP5475254 B2 JP 5475254B2 JP 2008165187 A JP2008165187 A JP 2008165187A JP 2008165187 A JP2008165187 A JP 2008165187A JP 5475254 B2 JP5475254 B2 JP 5475254B2
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- Prior art keywords
- tranexamic acid
- ibuprofen
- solid preparation
- calcium silicate
- present
- 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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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 title claims description 56
- 229960001680 ibuprofen Drugs 0.000 title claims description 56
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 title claims description 49
- 229960000401 tranexamic acid Drugs 0.000 title claims description 49
- 239000000378 calcium silicate Substances 0.000 title claims description 28
- 229910052918 calcium silicate Inorganic materials 0.000 title claims description 28
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 title claims description 28
- 239000007787 solid Substances 0.000 title description 52
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- 238000004519 manufacturing process Methods 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 2
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- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 11
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Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
[1] イブプロフェン及びトラネキサム酸を含有する固形製剤であって、
ケイ酸カルシウムを含有することを特徴とする固形製剤。
[2] イブプロフェン及びトラネキサム酸を含有する固形製剤であって、
膨張抑制成分として、ケイ酸カルシウムを含有することを特徴とする固形製剤。
[3] ケイ酸カルシウムを含有してなる、イブプロフェン及びトラネキサム酸を含有する固形製剤のための膨張抑制剤。
[4] イブプロフェン及びトラネキサム酸を含有する固形製剤を製造する方法であって、
ケイ酸カルシウムを添加する工程、
を含むことを特徴とする製造方法。
[5] イブプロフェン及びトラネキサム酸を含有する固形製剤を製造する方法であって、
膨張抑制成分として、ケイ酸カルシウムを添加する工程、
を含むことを特徴とする製造方法。
[6] イブプロフェン及びトラネキサム酸を含有する固形製剤を製造するための、ケイ酸カルシウムの使用(use)。
[7] 膨張抑制された、イブプロフェン及びトラネキサム酸を含有する固形製剤を製造するための、ケイ酸カルシウムの使用(use)。
[8] イブプロフェン及びトラネキサム酸を含有する固形製剤の膨張を抑制するための、ケイ酸カルシウムの使用(use)。
[9] ケイ酸カルシウムを添加することによって、イブプロフェン及びトラネキサム酸を含有する固形製剤の膨張を抑制する方法(method)。
以下に、実施例を用いて本発明をさらに具体的に説明するが、本発明はこれらに限定されるものではない。
実施例1のケイ酸カルシウムを配合しない代わりに結晶セルロース549gを追加で配合し、その他は実施例1と同様にして錠剤を得た。
膨張の評価
実施例1、並びに比較例1で製造した錠剤を1錠ずつガラス瓶(2K規格)に入れ、密栓をした後、40℃の恒温容器に1ヶ月間〜6ヶ月間、又は50℃の恒温容器に1週間〜1ヶ月間保存した。デジタルマイクロメーターで測定した製造直後の錠剤の厚みと保存後の錠剤の厚みから、以下の式(1)で定義される膨張率(%)を算出した。
式中、Dは保存後の錠剤の厚みであり、D0は製造直後の錠剤の厚みである。
また、ケイ酸カルシウムを含まない製剤(比較例1)では、40℃6ヶ月の保存後の膨張率(%)は12.5%、50℃1ヶ月の保存後の膨張率(%)は14.6%と高温保存条件下において、高い膨張率を認めた。その一方で、イブプロフェン及びトラネキサム酸を含有し、かつケイ酸カルシウムを含有する本発明の固形製剤(実施例1)では、40℃6ヶ月の保存後の膨張率(%)は6.1%、50℃1ヶ月の保存後の膨張率(%)は8.1%へと顕著に低減されていた。40℃及び50℃での全期間にわたって、本発明の固形製剤の膨張率は、本発明にかかるケイ酸カルシウムを含まない比較例1の固形製剤の膨張率と比較して、顕著に低減されていた。
Claims (2)
- イブプロフェン及びトラネキサム酸を含有する錠剤であって、ケイ酸カルシウムを錠剤全体に対して0.01〜50質量%含有することを特徴とする錠剤。
- イブプロフェン及びトラネキサム酸を含有する錠剤を製造する方法であって、ケイ酸カルシウムを錠剤全体に対して0.01〜50質量%添加する工程、を含むことを特徴とする製造方法。
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