JP2007051109A - 圧縮成型製剤 - Google Patents
圧縮成型製剤 Download PDFInfo
- Publication number
- JP2007051109A JP2007051109A JP2005238577A JP2005238577A JP2007051109A JP 2007051109 A JP2007051109 A JP 2007051109A JP 2005238577 A JP2005238577 A JP 2005238577A JP 2005238577 A JP2005238577 A JP 2005238577A JP 2007051109 A JP2007051109 A JP 2007051109A
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- Prior art keywords
- compression
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- tablet
- molded
- disintegrant
- Prior art date
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- Granted
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Abstract
【解決手段】 崩壊剤と2種類以上のケイ酸類を含有した圧縮成型製剤およびケイ酸類の少なくとも1種類を付着させた崩壊剤と、別の種類のケイ酸類を含有する圧縮成型製剤。
【選択図】 なし
Description
クラリスロマイシン819.6g、乳糖200M26.4g、ノイシリンUFL−2
20.0gおよびPVP K−30 16.0gに精製水400mLを添加して攪拌造粒機にて造粒を行った。
コリドンCL100gとアエロジル200 60gを攪拌造粒機を用いて10分間混合した。この混合物16gと試料例1の顆粒221.5gをV型混合機にて20分間混合し、この混合顆粒にステアリン酸マグネシウム3.5gを加え、更に5分間混合した。次いで、この混合物をロータリー打錠機により、打錠圧600kgfの条件で打錠して1錠当たり240mgの錠剤を得た。
試料例1の顆粒221.5g、コリドンCL10gおよびアエロジル2006gをV型混合機にて20分間混合した。その後、この混合顆粒にステアリン酸マグネシウム3.5gを加え、更に5分間混合した。次いで、この混合物をロータリー打錠機により、打錠圧600kgfの条件で打錠して1錠当たり240mgの錠剤を得た。
実施例1および比較例1で製した錠剤を用い、溶出試験機で錠剤の崩壊を観察した。なお、崩壊試験の条件は下記の通りである。
試 験 液: McIlvain buffer pH3.0
パドル回転数: 50rpm
試験液の量: 900mL
腸溶性顆粒の調製:
(1)ランソプラゾール600g、クムライト(水酸化アルミニウム・炭酸水素ナトリウム共沈物)100gおよび乳糖200M(乳糖)200gを20%エタノール水溶液
2160gに加え、懸濁液を得た。
圧縮成型錠剤の調製:
コリドンCL(クロスポビドン:平均粒子径 約50μm)10g、ノイシリンUFL2(メタケイ酸アルミン酸マグネシウム:平均粒子径 約1.6μm)5gおよびアドソリダー101(軽質無水ケイ酸:平均粒子径 約3μm)5gを50%エタノールを用いて乳鉢で造粒した。得られた顆粒15gに、参考例1で調製した腸溶製顆粒50gおよびフローラック100(乳糖)35gを添加し、良く混合した。この顆粒を、オイルプレスを用い、1500kgfで打錠して、1錠当たり200mgの圧縮成型錠剤を得た。
コリドンCL(クロスポビドン)10gおよびノイシリンUFL2(メタケイ酸アルミン酸マグネシウム)5gを、50%エタノールを用いて乳鉢で造粒した。得られた顆粒11.25gに、参考例1で調製した腸溶製顆粒50gおよびフローラック100(乳糖)38.75gを添加し、良く混合した。この顆粒をオイルプレスを用い、1500kgfで打錠して、1錠当たり200mgの圧縮成型錠剤を得た。
コリドンCL(クロスポビドン)10gおよびアドソリダー101(軽質無水ケイ酸)5gを、50%エタノールを用いて乳鉢で造粒した。得られた顆粒11.25gに、参考例1で調製した腸溶製顆粒50gおよびフローラック100(乳糖)38.75gを添加し、良く混合した。この顆粒を、オイルプレスを用い、1500kgfで打錠して、1錠当たり200mgの圧縮成型錠剤を得た。
実施例2、比較例2および比較例3で得られた錠剤について、硬度と口腔内での崩壊時間を測定した。その結果を表1に示す。なお、硬度は、及び口腔内での崩壊時間は、下記の方法により、それぞれ測定した。
硬度計(錠剤破壊試験装置:富山産業)を用いて測定した。
口腔内での崩壊時間:
口腔内に錠剤を投入し、錠剤が無くなる時間を測定した。
コリドンCL(クロスポビドン)120g、ノイシリンUFL2(メタケイ酸アルミン酸マグネシウム)60gおよびアドソリダー101(軽質無水ケイ酸)60gをハイスピードミキサー(攪拌造粒機)に投入し、50%エタノール400mLで造粒した。この造粒物150gに、フローラック100(乳糖)350gおよび腸溶性顆粒500gを添加し、V型混合機で20分間混合後、ステアリン酸マグネシウム5gを添加し、更に5分間混合した。この顆粒を用い、1錠300mgになるように圧縮力500kgfで打錠し、圧縮成型錠剤を得た。
コリドンCL(クロスポビドン)120g、ノイシリンUFL2(メタケイ酸アルミン酸マグネシウム)60gおよびアドソリダー101(軽質無水ケイ酸)60gをハイスピードミキサー(攪拌造粒機)に投入し、50%エタノール400mLで造粒した。この造粒物100gに、フローラック100(乳糖)245g、ノイシリンSG2(メタケイ酸アルミン酸マグネシウム:平均粒子径 約120μm)150gおよび腸溶性顆粒500gを添加し、V型混合機で20分間混合後、ステアリン酸マグネシウム5gを添加し、更に5分間混合した。この顆粒を用い、1錠300mgになるように圧縮力500kgfで打錠し、圧縮成型錠剤を得た。
コリドンCL(クロスポビドン)120g、ノイシリンUFL2(メタケイ酸アルミン酸マグネシウム)60gおよびアドソリダー101(軽質無水ケイ酸)60gをハイスピードミキサー(攪拌造粒機)に投入し、50%エタノール400mLで造粒した。この造粒物160gに、フローラック100(乳糖)410g、ノイシリンSG2(メタケイ酸アルミン酸マグネシウム)220gおよび腸溶性顆粒1000gを添加し、V型混合機で20分間混合後、ステアリン酸マグネシウム9gを添加し、更に5分間混合した。この顆粒を用い、1錠270mgになるように圧縮力500kgfで打錠し、圧縮成型錠剤を得た。
コリドンCL(クロスポビドン)150g、ノイシリンUFL2(メタケイ酸アルミン酸マグネシウム)75gおよびアドソリダー101(軽質無水ケイ酸)75gをハイスピードミキサー(攪拌造粒機)に投入し、50%エタノール500mLで造粒、さらにフローラック100(乳糖)438gを投入し、50%エタノール80mLで造粒した。この造粒物492gに、ノイシリンSG2(メタケイ酸アルミン酸マグネシウム)300gおよび腸溶性顆粒1000g添加し、V型混合機で20分間混合後、ステアリン酸マグネシウム9gを添加し、更に5分間混合した。この顆粒を用い、1錠270mgになるように圧縮力500kgfで打錠し、圧縮成型錠剤を得た。
コリドンCL(クロスポビドン)150gおよびアドソリダー101(軽質無水ケイ酸)75gをハイスピードミキサー(攪拌造粒機)に投入し、50%エタノール300mLで造粒した。この造粒物150gに、フローラック100(乳糖)650g、ノイシリンSG2(メタケイ酸アルミン酸マグネシウム)200gおよび腸溶性顆粒1000gを添加し、V型混合機で20分間混合した。この顆粒を用い、1錠300mgになるように圧縮力500kgfで打錠し、圧縮成型錠剤を得た。
コリドンCL(クロスポビドン)150gおよびアドソリダー101(軽質無水ケイ酸)75gをハイスピードミキサー(攪拌造粒機)に投入し、50%エタノール300mLで造粒した。この造粒物150gに、ノイシリンSG2(メタケイ酸アルミン酸マグネシウム)850gおよび腸溶性顆粒1000g添加し、V型混合機で20分間混合した。この顆粒を用い、1錠300mgになるように圧縮力500kgfで打錠し、圧縮成型錠剤を得た。
トレハロース(トレハロース)160gおよびノイシリンUFL2(メタケイ酸アルミン酸マグネシウム)16gを水1000mLに混合・懸濁させた混合液を凍結乾燥した。この凍結乾燥品135g、コリドンCL(クロスポビドン)303gおよびノイシリンUFL2(メタケイ酸アルミン酸マグネシウム)153gをハイスピードミキサー(攪拌造粒機)に投入し、精製水200mLで造粒した。この造粒物394gに、フローラック100(乳糖)606gおよび腸溶性顆粒1000gを添加し、V型混合機で20分間混合した。この顆粒を用い、1錠300mgになるように圧縮力500kgfで打錠し、圧縮成型錠剤を得た。
乳糖200M(乳糖)100gおよびアビセルPH101(結晶セルロース)25gを水600mLに混合・懸濁させた混合液を凍結乾燥した。この凍結乾燥品75g、コリドンCL(クロスポビドン)150gおよびアドソリダー101(軽質無水ケイ酸)75gをハイスピードミキサー(攪拌造粒機)に投入し、80%エタノール300mLで造粒した。この造粒物200gに、フローラック100(乳糖)580g、ノイシリンSG2(メタケイ酸アルミン酸マグネシウム)200gおよび腸溶性顆粒1000g添加し、V型混合機で20分間混合後、ステアリン酸マグネシウム20gを添加し、更に5分間混合した。この顆粒を用い、1錠300mgになるように圧縮力500kgfで打錠し、圧縮成型錠剤を得た。
実施例3ないし10で得られた錠剤について、その硬度と口腔内での崩壊時間を測定した。その結果を表2に示す。
制酸剤口腔内速崩錠:
(1)コリドンCL(クロスポビドン)120g、ノイシリンUFL2(メタケイ酸アルミン酸マグネシウム)60gおよびアドソリダー101(軽質無水ケイ酸)60gを、ハイスピードミキサー(攪拌造粒機)に投入し、50%エタノール400mLで造粒した。この造粒物100gに、フローラック100(乳糖)245gおよびノイシリンSG2(メタケイ酸アルミン酸マグネシウム)150gを添加して速崩ユニットを製造した。
試験例10で得られた錠剤(制酸製剤)について、その硬度と口腔内での崩壊時間を測定した。その結果を表3に示す。
デキストリン(パインデックス#100:松谷化学工業(株)製)5gを300mLの精製水に溶解させた。この溶解液を使用して、沈降炭酸カルシウム(平均粒子径 11.75μm:備北粉化工業(株)製)500gを流動層にて造粒をした。この造粒物252.5gにDマンニトール(パーテックM−200:メルク(株)製)212.5g、クロスポビドン(コリドンCL:BASF武田ビタミン(株)製)25gおよびアスパルテーム(アスパルテーム:味の素(株)製)5gを添加してV型混合機で20分間混合した。混合後、ステアリン酸マグネシウム(ステアリン酸マグネシウム:太平化学産業(株)製)5gを更に加え、5分間混合した。このようにして打錠用顆粒を製造した。この打錠用顆粒を10mmの杵を用いロータリー打錠機にて圧縮圧750kgfで圧縮成型し、1錠当たり500mgの圧縮成型錠剤を得た。
沈降炭酸カルシウムの平均粒子径を4.80μmにした以外は実施例12と同様にして圧縮成型錠剤を製造した。
沈降炭酸カルシウムの平均粒子径を2.49μmにした以外は実施例12と同様にして圧縮成型錠剤を製造した。
デキストリン5gを300mLの精製水に溶解させた。この溶解液を使用して、沈降炭酸カルシウム500gを流動層にて造粒をした。この造粒物252.5gにDマンニトール212.5g、クロスポビドン25g、アスパルテーム5gを添加してV型混合機で20分間混合した。混合後、ステアリン酸マグネシウム5gを更に加え、5分間混合した。このようにして打錠用顆粒を製造した。この打錠用顆粒を10mmの杵を用いロータリー打錠機にて圧縮圧750kgfで圧縮成型し、1錠当たり500mgの圧縮成型錠剤を得た。
実施例12〜14及び比較例4に従って製造した口腔内速崩錠について下記の方法の試験を実施した。その結果を表4に示す。
口腔内に錠剤を投入し、錠剤が無くなる時間を測定した。
口腔内での錠剤の様子:
口腔内に錠剤を含み、崩壊していく段階での芯の有無、ざらつき感等を確認した。
Claims (15)
- 崩壊剤と2種以上のケイ酸類を含有してなる圧縮成型製剤。
- ケイ酸類が、それぞれメタケイ酸アルミン酸塩、ケイ酸カルシウム、ケイ酸マグネシウム、軽質無水ケイ酸および含水二酸化ケイ素よりなる群から選択されたものである請求項1記載の圧縮成型製剤。
- 崩壊剤がカルボキシメチルスターチナトリウムまたはクロスポビドンである請求項1若しくは2記載の圧縮成型製剤。
- 崩壊剤がクロスポビドンである請求項1ないし3の何れかの項記載の圧縮成型製剤。
- 口腔内で速やかに崩壊するものである、請求項1ないし4の何れかの項記載の圧縮成型製剤。
- ケイ酸類の少なくとも1種が付着された崩壊剤と、少なくとも1種の他のケイ酸類とを含有する請求項1ないし5の何れかの項記載の圧縮成型製剤。
- 2種以上のケイ酸類のうち、少なくとも1種のケイ酸塩がアルカリもしくはアルカリ土類金属の塩の形態である請求項1ないし6の何れかの項記載の圧縮成型製剤。
- 2種以上のケイ酸類として、少なくともメタケイ酸アルミン酸塩と無水ケイ酸を含有する請求項1ないし7の何れかの項記載の圧縮成型製剤。
- 更に糖類を含有する請求項1ないし8の何れかの項記載の圧縮成型製剤。
- 糖類が、糖アルコールである請求項9記載の圧縮成型製剤。
- 糖類が、非晶質の糖類である請求項9または10記載の圧縮成型製剤。
- 非晶質の糖類が、凍結乾燥により得られた糖である請求項11記載の圧縮成型製剤。
- 更に、薬効成分を含有させた請求項1ないし12の何れかの項記載の圧縮成型製剤。
- 有効成分から若しくは有効成分を含有した組成物から形成された平均粒子径が4μm以上の顆粒を圧縮成型して得られる口腔内速崩錠。
- 有効成分が、無機塩である請求項14記載の口腔内速崩錠。
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JP2010202579A (ja) * | 2009-03-03 | 2010-09-16 | Sawai Pharmaceutical Co Ltd | アカルボースを含有する口腔内崩壊剤 |
JP2011241181A (ja) * | 2010-05-19 | 2011-12-01 | Takada Seiyaku Kk | クエチアピンフマル酸塩含有経口用錠剤 |
JP2012530778A (ja) * | 2009-06-25 | 2012-12-06 | ジン ヤン ファーム カンパニー リミテッド | ロサルタンカルボン酸を含有する薬学組成物及びその製造方法 |
JPWO2011081199A1 (ja) * | 2009-12-28 | 2013-05-13 | ニプロ株式会社 | 品質が向上した経口剤 |
JP2020055755A (ja) * | 2018-09-28 | 2020-04-09 | 日本ケミファ株式会社 | 腸溶性製剤 |
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JP2010202579A (ja) * | 2009-03-03 | 2010-09-16 | Sawai Pharmaceutical Co Ltd | アカルボースを含有する口腔内崩壊剤 |
JP2012530778A (ja) * | 2009-06-25 | 2012-12-06 | ジン ヤン ファーム カンパニー リミテッド | ロサルタンカルボン酸を含有する薬学組成物及びその製造方法 |
JPWO2011081199A1 (ja) * | 2009-12-28 | 2013-05-13 | ニプロ株式会社 | 品質が向上した経口剤 |
JP5933268B2 (ja) * | 2009-12-28 | 2016-06-08 | ニプロ株式会社 | 品質が向上した経口剤 |
JP2016138134A (ja) * | 2009-12-28 | 2016-08-04 | ニプロ株式会社 | 品質が向上した経口製剤 |
JP2011241181A (ja) * | 2010-05-19 | 2011-12-01 | Takada Seiyaku Kk | クエチアピンフマル酸塩含有経口用錠剤 |
JP2020055755A (ja) * | 2018-09-28 | 2020-04-09 | 日本ケミファ株式会社 | 腸溶性製剤 |
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