JP4994570B2 - 胃保持制御ドラッグデリバリーシステム - Google Patents
胃保持制御ドラッグデリバリーシステム Download PDFInfo
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- JP4994570B2 JP4994570B2 JP2003516487A JP2003516487A JP4994570B2 JP 4994570 B2 JP4994570 B2 JP 4994570B2 JP 2003516487 A JP2003516487 A JP 2003516487A JP 2003516487 A JP2003516487 A JP 2003516487A JP 4994570 B2 JP4994570 B2 JP 4994570B2
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- JP
- Japan
- Prior art keywords
- delivery system
- drug delivery
- gastric retention
- core
- controlled drug
- 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 - Fee Related
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- AFWBFAMUEOVLFX-UHFFFAOYSA-N trimethyl-[2-[6-[2-(trimethylazaniumyl)ethoxycarbonylamino]hexylcarbamoyloxy]ethyl]azanium;dibromide Chemical compound [Br-].[Br-].C[N+](C)(C)CCOC(=O)NCCCCCCNC(=O)OCC[N+](C)(C)C AFWBFAMUEOVLFX-UHFFFAOYSA-N 0.000 description 1
- GXPHKUHSUJUWKP-UHFFFAOYSA-N troglitazone Chemical compound C1CC=2C(C)=C(O)C(C)=C(C)C=2OC1(C)COC(C=C1)=CC=C1CC1SC(=O)NC1=O GXPHKUHSUJUWKP-UHFFFAOYSA-N 0.000 description 1
- 229960001641 troglitazone Drugs 0.000 description 1
- GXPHKUHSUJUWKP-NTKDMRAZSA-N troglitazone Natural products C([C@@]1(OC=2C(C)=C(C(=C(C)C=2CC1)O)C)C)OC(C=C1)=CC=C1C[C@H]1SC(=O)NC1=O GXPHKUHSUJUWKP-NTKDMRAZSA-N 0.000 description 1
- LQCLVBQBTUVCEQ-QTFUVMRISA-N troleandomycin Chemical compound O1[C@@H](C)[C@H](OC(C)=O)[C@@H](OC)C[C@@H]1O[C@@H]1[C@@H](C)C(=O)O[C@H](C)[C@H](C)[C@H](OC(C)=O)[C@@H](C)C(=O)[C@@]2(OC2)C[C@H](C)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)OC(C)=O)[C@H]1C LQCLVBQBTUVCEQ-QTFUVMRISA-N 0.000 description 1
- 229960005041 troleandomycin Drugs 0.000 description 1
- 229960003688 tropisetron Drugs 0.000 description 1
- UIVFDCIXTSJXBB-ITGUQSILSA-N tropisetron Chemical compound C1=CC=C[C]2C(C(=O)O[C@H]3C[C@H]4CC[C@@H](C3)N4C)=CN=C21 UIVFDCIXTSJXBB-ITGUQSILSA-N 0.000 description 1
- 229960000497 trovafloxacin Drugs 0.000 description 1
- WVPSKSLAZQPAKQ-CDMJZVDBSA-N trovafloxacin Chemical compound C([C@H]1[C@@H]([C@H]1C1)N)N1C(C(=CC=1C(=O)C(C(O)=O)=C2)F)=NC=1N2C1=CC=C(F)C=C1F WVPSKSLAZQPAKQ-CDMJZVDBSA-N 0.000 description 1
- 229960002655 tubocurarine chloride Drugs 0.000 description 1
- PRBORDFJHHAISJ-UHFFFAOYSA-N tybamate Chemical compound CCCCNC(=O)OCC(C)(CCC)COC(N)=O PRBORDFJHHAISJ-UHFFFAOYSA-N 0.000 description 1
- 229960002560 tybamate Drugs 0.000 description 1
- 229960004371 urofollitropin Drugs 0.000 description 1
- 210000004291 uterus Anatomy 0.000 description 1
- 229940093257 valacyclovir Drugs 0.000 description 1
- 229960004699 valsartan Drugs 0.000 description 1
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 description 1
- 229960003165 vancomycin Drugs 0.000 description 1
- MYPYJXKWCTUITO-LYRMYLQWSA-N vancomycin Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-N 0.000 description 1
- MYPYJXKWCTUITO-UHFFFAOYSA-N vancomycin Natural products O1C(C(=C2)Cl)=CC=C2C(O)C(C(NC(C2=CC(O)=CC(O)=C2C=2C(O)=CC=C3C=2)C(O)=O)=O)NC(=O)C3NC(=O)C2NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(CC(C)C)NC)C(O)C(C=C3Cl)=CC=C3OC3=CC2=CC1=C3OC1OC(CO)C(O)C(O)C1OC1CC(C)(N)C(O)C(C)O1 MYPYJXKWCTUITO-UHFFFAOYSA-N 0.000 description 1
- 229960003819 vecuronium Drugs 0.000 description 1
- BGSZAXLLHYERSY-XQIGCQGXSA-N vecuronium Chemical compound N1([C@@H]2[C@@H](OC(C)=O)C[C@@H]3CC[C@H]4[C@@H]5C[C@@H]([C@@H]([C@]5(CC[C@@H]4[C@@]3(C)C2)C)OC(=O)C)[N+]2(C)CCCCC2)CCCCC1 BGSZAXLLHYERSY-XQIGCQGXSA-N 0.000 description 1
- 229960004688 venlafaxine Drugs 0.000 description 1
- PNVNVHUZROJLTJ-UHFFFAOYSA-N venlafaxine Chemical compound C1=CC(OC)=CC=C1C(CN(C)C)C1(O)CCCCC1 PNVNVHUZROJLTJ-UHFFFAOYSA-N 0.000 description 1
- PJDFLNIOAUIZSL-UHFFFAOYSA-N vigabatrin Chemical compound C=CC(N)CCC(O)=O PJDFLNIOAUIZSL-UHFFFAOYSA-N 0.000 description 1
- 229960005318 vigabatrin Drugs 0.000 description 1
- UGGWPQSBPIFKDZ-KOTLKJBCSA-N vindesine Chemical compound C([C@@H](C[C@]1(C(=O)OC)C=2C(=CC3=C([C@]45[C@H]([C@@]([C@H](O)[C@]6(CC)C=CCN([C@H]56)CC4)(O)C(N)=O)N3C)C=2)OC)C[C@@](C2)(O)CC)N2CCC2=C1N=C1[C]2C=CC=C1 UGGWPQSBPIFKDZ-KOTLKJBCSA-N 0.000 description 1
- 229960004355 vindesine Drugs 0.000 description 1
- GBABOYUKABKIAF-GHYRFKGUSA-N vinorelbine Chemical compound C1N(CC=2C3=CC=CC=C3NC=22)CC(CC)=C[C@H]1C[C@]2(C(=O)OC)C1=CC([C@]23[C@H]([C@]([C@H](OC(C)=O)[C@]4(CC)C=CCN([C@H]34)CC2)(O)C(=O)OC)N2C)=C2C=C1OC GBABOYUKABKIAF-GHYRFKGUSA-N 0.000 description 1
- 229960002066 vinorelbine Drugs 0.000 description 1
- 229960001729 voglibose Drugs 0.000 description 1
- 229960005080 warfarin Drugs 0.000 description 1
- PJVWKTKQMONHTI-UHFFFAOYSA-N warfarin Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=CC=C1 PJVWKTKQMONHTI-UHFFFAOYSA-N 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
- 229960000833 xylometazoline Drugs 0.000 description 1
- 229960004010 zaleplon Drugs 0.000 description 1
- HUNXMJYCHXQEGX-UHFFFAOYSA-N zaleplon Chemical compound CCN(C(C)=O)C1=CC=CC(C=2N3N=CC(=C3N=CC=2)C#N)=C1 HUNXMJYCHXQEGX-UHFFFAOYSA-N 0.000 description 1
- ARAIBEBZBOPLMB-UFGQHTETSA-N zanamivir Chemical compound CC(=O)N[C@@H]1[C@@H](N=C(N)N)C=C(C(O)=O)O[C@H]1[C@H](O)[C@H](O)CO ARAIBEBZBOPLMB-UFGQHTETSA-N 0.000 description 1
- 229960001028 zanamivir Drugs 0.000 description 1
- 229960002555 zidovudine Drugs 0.000 description 1
- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 description 1
- MWLSOWXNZPKENC-SSDOTTSWSA-N zileuton Chemical compound C1=CC=C2SC([C@H](N(O)C(N)=O)C)=CC2=C1 MWLSOWXNZPKENC-SSDOTTSWSA-N 0.000 description 1
- 229960005332 zileuton Drugs 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
- XRASPMIURGNCCH-UHFFFAOYSA-N zoledronic acid Chemical compound OP(=O)(O)C(P(O)(O)=O)(O)CN1C=CN=C1 XRASPMIURGNCCH-UHFFFAOYSA-N 0.000 description 1
- 229960004276 zoledronic acid Drugs 0.000 description 1
- 229960001360 zolmitriptan Drugs 0.000 description 1
- UTAZCRNOSWWEFR-ZDUSSCGKSA-N zolmitriptan Chemical compound C=1[C]2C(CCN(C)C)=CN=C2C=CC=1C[C@H]1COC(=O)N1 UTAZCRNOSWWEFR-ZDUSSCGKSA-N 0.000 description 1
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- 229960002911 zonisamide Drugs 0.000 description 1
- UBQNRHZMVUUOMG-UHFFFAOYSA-N zonisamide Chemical compound C1=CC=C2C(CS(=O)(=O)N)=NOC2=C1 UBQNRHZMVUUOMG-UHFFFAOYSA-N 0.000 description 1
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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Description
制御ドラッグデリバリーシステムは、有効成分の治療有効血中濃度が確立できるように身体に薬物を送達し、この血中濃度がいったん達成されると、該システムは、身体が薬物を排出する速度と同じ速度で身体に薬物を送達することによって、長期間一定の血中濃度を維持しつづける。従来の投与剤形に関連する血中濃度における山と谷を回避することによって、制御ドラッグデリバリーシステムは、悪影響あるいは副作用の発生率を低下させる。非常に重要に制御されたドラッグデリバリーシステムは、服用頻度を減少させて、服薬および特定の投与処方へのコンプライアンスという点で、患者に簡便さをもたらす。
(a)薬物、高膨潤性ポリマーおよびガス発生剤を含む制御放出コア(該コアは、長期間、胃腸液中でその物理的完全性を維持しながら、迅速に膨潤し、浮遊を達成する能力がある);および
(b)コア内のものと同じ薬物および医薬的に許容しうる賦形剤を含む速放性コーティング組成物(ここで、コーティング組成物は、システムが胃腸液中で薬物の二相性放出を提供するようにコアを取り囲む);
を含む胃保持制御ドラッグデリバリーシステムを提供することである。
本発明のさらに別の目的は、バクロフェンのための胃保持制御ドラッグデリバリーシステムを提供することである。
(a)薬物、高膨潤性ポリマーおよびガス発生剤を含む制御放出コア(該コアは、長期間、胃腸液中でその物理的完全性を維持しながら、迅速に膨潤し、浮遊を達成する能力がある);および
(b)コア内のものと同じ薬物および医薬的に許容しうる賦形剤を含む速放性コーティング組成物(ここで、コーティング組成物は、システムが胃腸液中で薬物の二相性放出を提供するようにコアを取り囲む);
を含む胃保持制御ドラッグデリバリーシステムを提供する。
本発明はさらに、制御放出コアが、少なくとも元の体積の2倍に迅速に膨潤し、長期間、胃腸液中でその物理的完全性を維持する能力がある胃保持制御ドラッグデリバリーシステムを提供する。
また本発明は、バクロフェンまたはその医薬的に許容しうる塩を含む胃保持制御ドラッグデリバリーシステムを提供する。
(a)薬物、高膨潤性ポリマーおよびガス発生剤を含む制御放出コア(該コアは、長期間、胃腸液中でその物理的完全性を維持しながら、迅速に膨潤し、浮遊を達成する能力がある);および
(b)コア内のものと同じ薬物および医薬的に許容しうる賦形剤を含む速放性コーティング組成物(ここで、コーティング組成物は、システムが胃腸液中で薬物の二相性放出を提供するようにコアを取り囲む);
を含む胃保持制御ドラッグデリバリーシステムを提供する。
アルコール中毒薬の例は、クラゼペート、クロロジアゼポキシド、ジアゼパム、ジスルフィラム、ヒドロキシジン、ナルトレキソンおよびそれらの塩である。
麻酔薬の例は、アドレナリン、ブピバカイン、クロロプロカイン、デスフルラン、エチドカイン、レボブピバカイン、リドカイン、ミダゾラム、プロポフォル、ロピバカインおよびそれらの塩である。
フラダフィバン、ガベキセート、イロプロスト、イスボグレル、ラミフィバン、ラモテプラーゼ、レフラダフィバン、レピルジン、レボシメンダン、レキシパファント、メラガトラン、ナファグレル、ナファモストサト、ニゾフェノンン、オルビフィバン、オザグレル、パミコグレル、パルナパリン、キノベンダン、レテプラーゼ、サルポグラレーテ、サチグレール、シルテプラーゼ、シメンダン、チクロピジン、バピプロスト、チロフィバン、キセミロフィバン、Y20811およびそれらの塩である。
ドーパミン受容体アゴニストの例は、アマンタジン、カベルゴリン、フェノルドパム、ペルゴリド、プラミペザル、ロピニロールおよびそれらの塩である。
子宮内膜症管理薬の例は、ダナゾール、ゴセレリン、リュープロリド、ナファレリン、ノルエチンドロンおよびそれらの塩である。
勃起不全療法に用いる薬物の例は、アルプロスタジル、シルデナフィル、ヨヒンビンおよびそれらの塩である。
胃腸薬の例は、アロセトロン、ビサコジル、サリチル酸ビスマス、セレコキシブ、ジフォキシン、ジフェノキシレート、ドクセート、ファモチジン、グリコピロレート、インフリキシマブ、ランソプラゾール、ロペラミド、メタクロプラミド、ニザチジン、オメプラゾール、パントプラゾール、ラベプラゾール、ラニチジン、シメチコン、スクラルフェートおよびそれらの塩である。
免疫調節剤および免疫抑制剤の例は、アザチオプリン、セフチゾキシン、シクロスポリン、ダクリツマブ、グラチラメル、免疫グロブリン、インターフェロン、レフルノミド、レバミゾール、ミコフェノレート、マウソマナブ、フタリドミド、リバビリン、シロリマスおよびそれらの塩である。
偏頭痛製剤用薬物の例は、アセタミノフェン、ジヒドロエルゴタミン、ジバルプロエクックス、エルゴタミン、プロプラノロール、リサトリプタン、スミトリプタン、トリメトレキセートおよびそれらの塩である。
バクロフェンは、約15mg〜約80mgの量で本発明システムに用いることができる。本発明の胃保持制御ドラッグデリバリーシステムにおいて、バクロフェンを30mgの量で用いる。本発明システムは、30mg用量のバクロフェンの大部分が、コアに存在し、制御放出剤として利用可能であり、薬物の小部分がコーティングに存在し、速放剤として利用可能であるように設計される。したがって、本発明デリバリーシステムによって、バクロフェンの二相性放出が提供される。
副交感神経作動薬の例は、ベタネコール、ビペリジン、エドロフォニウム、グリコピロレート、ヒヨスカミン、ピロカルピン、タクリン、ヨヒンビンおよびそれらの塩である。
プロスタグランジンの例は、アルプロスタジル、エタノールポジティブプロステノール、ミソプロストールおよびそれらの塩である。
ヒドロキシC1−4アルキルC1−4アルキルセルロース、カルボキシアルキルセルロース、ヒドロキシC1−4アルキルセルロースなどの高膨潤性グレードのセルロースエーテル、好ましくは、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、さらに好ましくは、高粘度グレードのヒドロキシエチルセルロース;
(i)海草から誘導されたアルギン酸塩、カラギーナン、ファーセレラン、(ii)陸生植物から誘導されたグアーゴム、アラビアゴム、トラガカントゴム、カラヤゴム、ローカストギーンゴム、ペクチン、(iii)デキストラン、ジェランガム、ラムサンガム、ウエランガム、キサンタンガムなどの微生物多糖類、および(iv)アルギン酸プロピレングリコール、ヒドロキシプロピルグアーおよびデンプングリコール酸ナトリウムといったような加工デンプンなどの合成または半合成ゴムなどの植物性、動物性、鉱物性または合成ゴム;
架橋ポリビニルピロリドン、架橋カルボキシメチルセルロースナトリウム、カルボキシメチルデンプン、カルボキシメチルナトリウムデンプン、メタクリル酸カリウム−ジビニルベンゼンコポリマー、ポリビニルアルコール、アミロース、架橋アミロース、デンプン誘導体、微結晶セルロースおよびセルロース誘導体、α−、β−およびγ−シクロデキストリンならびにデキストリン誘導体などの超崩壊剤ポリマー;
商品名Carbopol(登録商標)として入手可能な架橋ポリマーなどのアクリル酸ポリマー;
架橋ポリビニルピロリドンまたはクロスポビドンなどのビニルピロリドンポリマー;ビニルピロリドンと酢酸ビニルのコポリマー;またはそれらの混合物。
次の実施例は、本発明の範囲を限定するものではなく、例示として用いるものである。
下記表1のとおり、胃保持制御ドラッグデリバリーシステムを得る。
表1
成分 量(mg/錠)
コア
粒内
バクロフェン 20.0
ラクトース 30.0
ヒドロキシメチルセルロース(HEC 250 H) 400.0
デンプングリコール酸ナトリウム 150.0
重炭酸ナトリウム 40.0
ヒドロキシプロピルメチルセルロース(HPMC K4M) 136.0
粒外
ケイ化微結晶セルロース(Prosolv SMCC 90) 90.0
タルク 24.0
ポリエチレングリコール(PEG 8000) 10.0
ヒドロキシプロピルメチルセルロース(HPMC K4M) 100.0
コーティング
バクロフェン 10.0
ヒドロキシプロピルメチルセルロース(Opadry II) 45.0
表2
時間 0.1N HCl中に放出された薬物%
0 0
1 39
2 44
4 53
6 60
8 66
12 77
下記表3のとおり、胃保持制御ドラッグデリバリーシステムを得る。
表3
成分 量(mg/錠)
コア
粒内
バクロフェン 22.5
マンニトール60 260.0
ヒドロキシメチルセルロース(HEC 250 HX Pharma) 200.0
デンプングリコール酸ナトリウム 250.0
重炭酸ナトリウム 80.0
ヒドロキシプロピルメチルセルロース(HPMC K4M) 4.50
粒外
ケイ化微結晶セルロース(Prosolv SMCC 90) 90.0
タルク 24.0
ポリエチレングリコール(PEG 8000) 10.0
コーティング
バクロフェン 7.5
ヒドロキシプロピルメチルセルロース(HPMC E5) 24.0
タルク 10.0
プロピレングリコール 5.0
二酸化チタン 11.0
表4
時間 0.1N HCl中に放出された薬物%
0 0
1 55
2 63
4 75
6 83
8 91
12 99
下記表5のとおり、本発明の胃保持制御ドラッグデリバリーシステムを得る。
表5
成分 量(mg/錠)
バクロフェン 30.0
ヒドロキシエチルセルロース(Natrosol 250 H) 97.5
デンプングリコール酸ナトリウム 217.5
微結晶セルロース(Avicel PH 101) 435.0
重炭酸ナトリウム 10.0
ポリビニルピロリドン(PVP K-30) 22.0
タルク 9.0
ステアリン酸マグネシウム 9.0
30mgのバクロフェンを含む胃保持制御ドラッグデリバリーシステム(実施例2)の投与後のバクロフェンの薬物動態を調べる。バクロフェンについて、複数回投与および一回投与、非盲検、ランダム化、比較および相互クロスオーバー実験を行う。
薬物動態的評価は、血液サンプリングによって測定されたバクロフェンの血漿レベルに基づく。血液サンプルは、試験薬物の投与前および投与後0.25、0.5、1、1.5、2、2.5、3、4、6、8、12、12.5、13、13.5、14、15、16、20および24時間の時点で得る。
被験者は、絶食後5日間、周囲温度にて、240mlの水とともにバクロフェン(30mg)の胃保持制御放出錠を一回付与された。
種々の時点で採取したサンプルについて、バクロフェンの血漿濃度を決定し、12名のボランティア間で平均した。データを下記表6に示す。血漿濃度対時間のプロフィールを図1に示す。
時間(時間) バクロフェン(30 mg)胃保持制御放出錠の平均血漿濃度(ng/ml)
0 0
0.25 0.97
0.5 12.95
1.0 81.57
1.5 117.42
2.0 141.46
2.5 154.1
3.0 157.67
4.0 172.88
6.0 155.77
8.0 119.55
12.0 67.38
12.5 65.28
13.0 60.20
13.5 57.01
14.0 52.26
15.0 48.18
16.0 40.07
20.0 28.03
24.0 18.87
Claims (14)
- (a)バクロフェン、高膨潤性ポリマーおよびガス発生剤を含む制御放出コア(該コアは、長期間、胃腸液中でその物理的完全性を維持しながら、迅速に膨潤し、浮遊を達成する能力がある);および
(b)バクロフェンおよび医薬的に許容しうる賦形剤を含む速放性コーティング組成物(ここで、コーティング組成物は、システムが胃腸液中で薬物の二相性放出を提供するようにコアを取り囲む);
を含む胃保持制御ドラッグデリバリーシステムであって、
バクロフェンの一日一回投与に適当であるシステム。 - 高膨潤性ポリマーが、超崩壊剤および親水性ポリマーの混合物である請求項1に記載の胃保持制御ドラッグデリバリーシステム。
- 超崩壊剤が、架橋ポリビニルピロリドン、架橋カルボキシメチルナトリウムセルロースおよびデンプングリコール酸ナトリウムから選ばれる請求項2に記載の胃保持制御ドラッグデリバリーシステム。
- デンプングリコール酸ナトリウムを、コアの10重量%〜40重量%の量で用いる請求項3に記載の胃保持制御ドラッグデリバリーシステム。
- 用いる親水性ポリマーが、2%w/vの水溶液において、500 mPas〜120,000 mPasの水溶液粘度を有する高粘度セルロース誘導体である請求項2に記載の胃保持制御ドラッグデリバリーシステム。
- 高粘度セルロース誘導体が、2%w/vの水溶液において、9000 mPas〜30,000 mPasの水溶液粘度を有するヒドロキシエチルセルロースである請求項5に記載の胃保持制御ドラッグデリバリーシステム。
- ヒドロキシエチルセルロースを、コアの15重量%〜30重量%の量で用いる請求項6に記載の胃保持制御ドラッグデリバリーシステム。
- 超崩壊剤がデンプングリコール酸ナトリウムであり、デンプングリコール酸ナトリウム:ヒドロキシエチルセルロースの比率が4:6〜6:4である請求項5に記載の胃保持制御ドラッグデリバリーシステム。
- ガス発生剤が、炭酸塩、重炭酸塩、亜硫酸塩およびその混合物から選ばれる請求項1に記載の胃保持制御ドラッグデリバリーシステム。
- ガス発生剤が、さらに、クエン酸、リンゴ酸、コハク酸、酒石酸、フマル酸、マレイン酸、アスコルビン酸、グルタミン酸またはそれらの塩、ならびにそれらの混合物から選ばれる酸源を含む請求項9に記載の胃保持制御ドラッグデリバリーシステム。
- 用いるガス発生剤が、重炭酸ナトリウムである請求項9に記載の胃保持制御ドラッグデリバリーシステム。
- 重炭酸ナトリウムを、コアの1重量%〜15重量%の量で用いる請求項11に記載の胃保持制御ドラッグデリバリーシステム。
- 制御放出コアが、さらに、浸透性作用剤を含む請求項1に記載の胃保持制御ドラッグデリバリーシステム。
- 浸透性作用剤を、コアの2重量%〜40重量%の量で用いる請求項13に記載の胃保持制御ドラッグデリバリーシステム。
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US20100305208A1 (en) | 2010-12-02 |
US20040180088A1 (en) | 2004-09-16 |
BR0211317A (pt) | 2004-12-14 |
HUP0500795A3 (en) | 2008-04-28 |
MXPA03012041A (es) | 2004-03-26 |
JP2004538301A (ja) | 2004-12-24 |
CN1520286A (zh) | 2004-08-11 |
US7776345B2 (en) | 2010-08-17 |
EP2238975A1 (en) | 2010-10-13 |
HUP0500795A2 (en) | 2007-02-28 |
ATE477795T1 (de) | 2010-09-15 |
US8012496B2 (en) | 2011-09-06 |
CA2452738C (en) | 2011-06-14 |
JP2010090161A (ja) | 2010-04-22 |
EP2238975B1 (en) | 2012-12-05 |
PL370793A1 (en) | 2005-05-30 |
WO2003011255A1 (en) | 2003-02-13 |
EP1411901B1 (en) | 2010-08-18 |
KR20040018394A (ko) | 2004-03-03 |
RU2325152C2 (ru) | 2008-05-27 |
CN1520286B (zh) | 2010-12-01 |
DE60237372D1 (de) | 2010-09-30 |
EP1411901A1 (en) | 2004-04-28 |
ZA200400799B (en) | 2005-07-27 |
ES2398348T3 (es) | 2013-03-15 |
AU2002355686B2 (en) | 2007-11-29 |
CA2452738A1 (en) | 2003-02-13 |
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