JP2017536404A - 胃保持性の徐放性懸濁組成物 - Google Patents
胃保持性の徐放性懸濁組成物 Download PDFInfo
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- JP2017536404A JP2017536404A JP2017529675A JP2017529675A JP2017536404A JP 2017536404 A JP2017536404 A JP 2017536404A JP 2017529675 A JP2017529675 A JP 2017529675A JP 2017529675 A JP2017529675 A JP 2017529675A JP 2017536404 A JP2017536404 A JP 2017536404A
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- JP
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- Prior art keywords
- suspension
- sustained release
- sodium
- composition
- gastric retentive
- Prior art date
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K31/13—Amines
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Abstract
Description
(i)有効成分及び1種以上の薬学的に許容される賦形剤を含むコアを調製する工程;
(ii)放出制御ポリマー及び1種以上の薬学的に許容される被覆添加剤を適切な溶媒に溶解/分散させる工程;
(iii)工程(i)のコア上に工程(ii)の被覆組成物を適用する工程;
(iv)1種以上のオスモゲント、1種以上のゲル形成剤、1種以上のガス発生剤、及び薬学的に許容される賦形剤を薬学的に許容される媒体に溶解/分散させて懸濁基剤を形成する工程;並びに、
(v)工程(iii)の被覆コアを工程(iv)の懸濁基剤に分散させて胃保持性の徐放性懸濁組成物を得る工程
を含む、胃保持性の徐放性懸濁組成物の調製方法を提供する。
(A)(i)有効成分及び1種以上の薬学的に許容される賦形剤を含むコアを調製する工程;
(ii)放出制御ポリマー及び1種以上の薬学的に許容される被覆添加剤を適切な溶媒に溶解/分散させる工程;
(iii)工程(i)のコア上に工程(ii)の被覆組成物を適用する工程;
(iv)1種以上の薬学的に許容される賦形剤を工程(iii)の被覆コアと混合して懸濁液用の粉末を得る工程
を含む、懸濁液用の粉末を調製する工程;
(B)1種以上のオスモゲント、1種以上のゲル形成剤、1種以上のガス発生剤、及び薬学的に許容される賦形剤を薬学的に許容される媒体に溶解/分散させることによって懸濁基剤を調製する工程;並びに、
(C)工程(A)の懸濁液用の粉末を工程(B)の懸濁基剤で再構成して胃保持性の徐放性懸濁組成物を得る工程
を含む、胃保持性の徐放性懸濁組成物の調製方法を提供する。
(A)(i)有効成分及び1種以上の薬学的に許容される賦形剤を含むコアを調製する工程;
(ii)放出制御ポリマー及び1種以上の薬学的に許容される被覆添加剤を適切な溶媒に溶解/分散させる工程;
(iii)工程(i)のコア上に工程(ii)の被覆組成物を適用する工程;
(iv)1種以上のオスモゲント、1種以上のゲル形成剤、1種以上のガス発生剤、及び1種以上の薬学的に許容される賦形剤を工程(iii)の被覆コアと混合して懸濁液用の粉末を得る工程
を含む、懸濁液用の粉末を調製する工程;並びに、
(B)工程(A)の懸濁液用の粉末を薬学的に許容される媒体で再構成して胃保持性の徐放性懸濁組成物を得る工程
を含む、胃保持性の徐放性懸濁組成物の調製方法を提供する。
1.メトホルミン塩酸塩及びヒドロキシプロピルメチルセルロースを精製水に溶解した。
2.結晶セルロース(粒)を工程1の溶液で被覆した。
3.エチルセルロース及びセバシン酸ジブチルをアセトン及び精製水の混合物に分散させた。
4.工程2のビーズを工程3の被覆分散液で被覆した。
5.メトホルミン塩酸塩、キシリトール、アルギン酸ナトリウム、アルファ化デンプン、重炭酸ナトリウム、炭酸カルシウム、メチルパラベン、プロピルパラベン、ストロベリーフレーバー、スクラロース、及びコロイド状二酸化ケイ素を混合した。
6.工程4の被覆ビーズを工程5の混合物と混合して懸濁液用の粉末を得た。
7.工程6の懸濁液用の粉末を、必要な時に、必要量の精製水で再構成して胃保持性の徐放性懸濁組成物を形成する。
実施例1によって調製した胃保持性の徐放性懸濁組成物を室温で30日間保管した。インビトロの溶解を、1000mLのリン酸緩衝液(pH6.8)中、37℃で、米国薬局方タイプII装置(100rpm)を使用して、0日及び30日に測定した。放出の検討の結果を第1表に示す。
実施例1に従って調製した懸濁液用の胃保持性の徐放性粉末を必要量の精製水で再構成した。この懸濁液を少なくとも20分間手動で振とうした。次いで、この懸濁液をろ過して、精製水で希釈して、オズモマット030−Dを使用して浸透圧を測定した。
100mLに相当する胃保持性の徐放性懸濁液を実施例1に示された処方に従って調製した。この懸濁液を少なくとも20分間手動で振とうし、次いで、7.5mLの10個の試料を目盛り付の注射器で取り出した。各試料のメトホルミン含量をHPLC法で測定した(インターシルODSカラム(250×4.6mm、5μm);移動相−緩衝液(pH3.5):アセトニトリル(95:5v/v);流速1.5mL/分;UV検出233nm)。結果を第3表に示す。
実施例1によって調製した胃保持性の徐放性懸濁組成物の分析試料を、0日及び室温で30日間保管後に測定した。実施例1によって調製した懸濁液用の粉末(工程6まで)を、加速条件(即ち、40℃/75%R.H.)で1ヶ月間保管した。1ヶ月後、懸濁液用の粉末を必要量の精製水で再構成し、次いで分析試料を0日及び室温で30日間保管後に測定した。メトホルミンの分析試料をHPLC法で測定した(インターシルODSカラム(250×4.6mm、5μm);移動相−緩衝液(pH3.5):アセトニトリル(95:5v/v);流速1.5mL/分;UV検出233nm)。結果を第4表に示す。
メトホルミン塩酸塩、キシリトール、アルギン酸ナトリウム、アルファ化デンプン、重炭酸ナトリウム、炭酸カルシウム、メチルパラベン、プロピルパラベン、ストロベリーフレーバー、スクラロース、及びコロイド状二酸化ケイ素を実施例1の工程5のように混合した。この粉末を必要量の精製水で再構成した。次いで、この懸濁液をろ過して、精製水で希釈して、オズモマット030−Dを使用して浸透圧を測定した。
各種濃度のオスモゲント(塩化ナトリウム)を有する各種の溶液を実施例1A〜1Fによって調製した。これらの溶液の浸透圧をオズモマット030−Dを使用して測定した。
Claims (27)
- 有効成分及び懸濁基剤を含み、少なくとも7日間の保管で、インビトロの溶解放出プロファイルに実質的な変化がないことを特徴とする、胃保持性の徐放性懸濁組成物。
- 前記有効成分が、放出制御ポリマーで被覆された多層コアの形状である、請求項1に記載の胃保持性の徐放性懸濁組成物。
- 前記組成物の浸透圧比が少なくとも約1であることを特徴とする、請求項1に記載の胃保持性の徐放性懸濁組成物。
- 前記懸濁基剤が、高浸透圧環境の作成に関与する、請求項1に記載の胃保持性の徐放性懸濁組成物。
- 前記懸濁基剤がオスモゲントを含む、請求項1に記載の胃保持性の徐放性懸濁組成物。
- 懸濁基剤が更に、ゲル形成剤及びガス発生剤を含む、請求項5に記載の胃保持性の徐放性懸濁組成物。
- 前記組成物が、懸濁液又は懸濁液用の再構成粉末である、請求項1に記載の胃保持性の徐放性懸濁組成物。
- 前記有効成分が不活性粒子上に積層されて、前記コアを形成する、請求項2に記載の胃保持性の徐放性懸濁組成物。
- 前記不活性粒子が、ノンパレイル種子、結晶セルロース(粒)、二塩基性リン酸カルシウムビーズ、マンニトールビーズ、シリカビーズ、酒石酸ペレット、又はワックス系ペレットを含む群から選択される、請求項8に記載の胃保持性の徐放性懸濁組成物。
- 前記ゲル形成剤が、アルギン酸又はその塩、キサンタンガム、グアーガム、ローカストビーンガム、トラガカント、カラギーナン、アカシアガム、アラビアガム、ジェランガム、ペクチンまたはその誘導体、デキストリン、ポリデキストリン、デキストラン、ポリガラクツロ酸、キシラン、アラビノキシラン、アラビノガラクタン、デンプン、ヒドロキシプロピルセルロース、ヒドロキシメチルセルロース、ヒドロキシエチルセルロース、メチルセルロース、カルボキシメチルセルロースナトリウム、ヒドロキシプロピルメチルセルロース、ポリビニルアルコール、ポリビニルピロリドン、キトサン、カルボキシビニルポリマー、ポリエチレングリコール、ポリエチレンオキシド、ゼラチン、及びこれらの混合物を含む群から選択される、請求項6に記載の胃保持性の徐放性懸濁組成物。
- 前記ガス発生剤が、炭酸カリウム、重炭酸カリウム、炭酸ナトリウム、重炭酸ナトリウム、炭酸カルシウム、グリシン炭酸ナトリウム、炭酸マグネシウム、炭酸アルミニウム、亜硫酸ナトリウム、重亜硫酸ナトリウム、メタ亜硫酸ナトリウム、及びこれらの混合物を含む群から選択される、請求項6に記載の胃保持性の徐放性懸濁組成物。
- 前記放出制御ポリマーが、pH依存性ポリマー、pH非依存性ポリマー、又はこれらの混合物を含む群から選択される、請求項2に記載の胃保持性の徐放性懸濁組成物。
- 前記pH依存性ポリマーが、メタクリル酸とメタクリル酸メチルとのコポリマー(例えば、「オイドラギット」(登録商標)L100及び「オイドラギット」(登録商標)S100)、メタクリル酸とアクリル酸エチルとのコポリマー(例えば、「オイドラギット」(登録商標)L100−55及び「オイドラギット」(登録商標)L30D−55)、メタクリル酸ジメチルアミノエチルとメタクリル酸ブチルとメタクリル酸メチルとのコポリマー(例えば、「オイドラギット」(登録商標)E100、「オイドラギット」(登録商標)EPO)、アクリル酸メチルとメタクリル酸とアクリル酸オクチルとのコポリマー、スチレンとアクリル酸とのコポリマー、アクリル酸ブチルとスチレンとアクリル酸とのコポリマー、及びアクリル酸エチル−メタクリル酸コポリマー等のアクリルコポリマー;セルロースアセテートフタレート;セルロースアセテートスクシネート;ヒドロキシプロピルメチルセルロースフタレートのようなヒドロキシアルキルセルロースフタレート;ヒドロキシプロピルメチルセルロースアセテートスクシネート等のヒドロキシアルキルセルロースアセテートスクシネート;ビニルアセテートフタレート;ビニルアセテートスクシネート;セルロースアセテートトリメリテート;ポリビニルアセテートフタレート、ポリビニルアルコールフタレート、ポリビニルブチラートフタレート、およびポリビニルアセトアセタールフタレート等のポリビニル誘導体;ゼイン;シェラック;又はこれらの混合物を含む群から選択される、請求項12に記載の胃保持性の徐放性懸濁組成物。
- 前記pH非依存性ポリマーが、エチルセルロース、メチルセルロース、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、ヒドロキシエチルメチルセルロース、ヒドロキシプロピルメチルセルロース、及びカルボキシメチルセルロース等のセルロースポリマー;メタクリル酸コポリマー等のアクリルコポリマー(例えば、「オイドラギット」(登録商標)RS、「オイドラギット」(登録商標)RL、「オイドラギット」(登録商標)NE30D);セルロースアセテート;ポリエチレン誘導体(例えば、ポリエチレングリコール及びポリエチレンオキシド);ポリビニルアルコール;ポリビニルアセテート;ガム(例えば、グアーガム、ローカストビーンガム、トラガカント、カラギーナン、アルギン酸、アカシアガム、アラビアガム、ジェランガム、及びキサンタンガム);トリグリセリド;ワックス(例えば、「コンプリトール」(登録商標)、「ルブリタブ」(登録商標)、及び「ゲルシア」(登録商標));脂質;脂肪酸若しくはそれらの塩/誘導体;ポリビニルアセテートとポリビニルピロリドンとの混合物(例えば、「コリドン」(登録商標)SR);又はこれらの混合物を含む群から選択される、請求項12に記載の胃保持性の徐放性懸濁組成物。
- 前記オスモゲントが、キシリトール、マンニトール、ソルビトール、アラビノース、リボース、キシロース、グルコース、フルクトース、マンノース、ガラクトース、スクロース、マルトース、ラクトース、デキストロース、及びラフィノース等の炭水化物;塩化マグネシウム、硫酸マグネシウム、硫酸カリウム、塩化リチウム、塩化ナトリウム、塩化カリウム、リン酸水素リチウム、リン酸水素ナトリウム、リン酸水素カリウム、リン酸二水素リチウム、リン酸二水素ナトリウム、リン酸二水素カリウム、及び三塩基性リン酸ナトリウム等の無機酸の水溶性塩;酢酸ナトリウム、酢酸カリウム、コハク酸マグネシウム、安息香酸ナトリウム、クエン酸ナトリウム、及びアスコルビン酸ナトリウム等の有機酸の水溶性塩;グリシン、ロイシン、アラニン、メチオニン等の水溶性アミノ酸;尿素若しくはその誘導体;プロピレングリコール;グリセリン;又はこれらの混合物を含む群から選択される、請求項5に記載の胃保持性の徐放性懸濁組成物。
- 前記有効成分が、メトホルミン、アシクロビル、ガバペンチン、プレガバリン、トリメタジジン、ファロペネム(feropenem)、カルビドーパ、レボドパ、メチルドーパ、べラパミル、プロプラノロール、カルベジロール、アテノロール、アルブテロール、ピルブテロール、ニフェジピン、ニモジピン、ニカルジピン、アムロジピン、プラゾシン、アロプリノール、メトプロロール、オクスプレノロール、バクロフェン、スマトリプタン、ベナゼプリル、エナラプリル、リシノプリル、カプトプリル、キナプリル、モエキシプリル(moxipril)、インドラプリル、オリンダプリル、レチナプリル、スピラプリル、シラザプリル、ペリンドプリル、ラミプリル、ゾフェノプリル、ホシノプリル、ニトロフラントイン、バラシクロビル、アジスロマイシン、イノシン、ジダノシン、プラノベクス、トリバビリン、ビダラビン、シンバスタチン、プラバスタチン、アトルバスタチン、ロバスタチン、セレギリン、ミダゾラム、炭酸リチウム、シメチジン、ラニチジン、ファモチジン、ニザチジン、ビフェンチジン、ニフェンチジン、ロキサチジン、制酸薬(例えば、炭酸マグネシウム、炭酸アルミニウム、水酸化アルミニウム、酸化マグネシウムおよびスクラルファート)、カルベノキソロン(carbenoloxalone)、ミソプロストール、ピレンゼピン、テレンゼピン、ビスマス塩、メトロニダゾール、シプロフロキサシン、アモキシシリン、セファレキシン、アスコルビン酸、葉酸、ビタミンE、フロセミド、トピラミド(topiramide)、ヒドロクロロチアジド、オルリスタット、アルフゾシン、アミオダロン、セリプロロール、クロルプロチキセン、シプロヘプタジン、ダサチニブ、デシプラミン、ジピリダモール、ジソピラミド、ドネペジル、ハロペリドール、ヒドララジン、イマチニブ、エトポシド、リドカイン、マプロチリン、ミフェプリストン、ニロチニブ、オルフェナドリン、パリペリドン、プラモキシン、プロシクリジン、プロメタジン、プロパフェノン、シロドシン、テラゾシン、チオリダジン、トリヘキシフェニジル、トリメトプリム、プロゲステロン、タクロリムス、エストラジオール、ブデソニド、ノルゲストレル、アレンドロネート、ベタメタゾン、ビペリデン、エルゴタミン、エストラムスチン、メルファラン、メトスクシミド、ミトタン、フェノキシベンザミン、アミロリド、アザチオプリン、ブロモクリプチン、クロルプロパミド、クロルタリドン、コルチゾン、ダナゾール、ジフルニサル、フェノフィブラート、フルドロコルチゾン、イスラジピン、ロペラミド、マプロチリン、メチルテストステロン、ナブメトン、ノルトリプチリン、オクスカルバゼピン、ピロキシカム、プロベネシド、プロピルチオウラシル、タモキシフェン、トリアゾラム、トリヘキシフェニジル、トリミプラミン、カルシトニン、ブトコナゾール、エコナゾール、アムリノン、アロキシプリン、アミノグルテチミド、アステミゾール、ベクロメタゾン、ベンドロフルアジド、ベキサフィブラート(bexafibrate)、ベザフィブラート、ブロモアゼパン、ブスルファン、カンプトテシン、カルビマゾール、シンナリジン、シサプリド、クラブラン酸、クリオキノール、クロフィブラート、クロチアゼパム、シクリジン、ダロジピン、デコキナート、デキサナビノール、デキストロプロポキシフェン(dextropropyoxyphene)、ジクマロール、ジヒドロコデイン、ドンペリドン、エトプロパジン、フェンブフェン、フェンフルラミン、フルナリジン、フルニトラゼパム、フルオプロマジン、フルペンチキソール、グリクラジド、イミダプリル(imidopril)、リスリド、マジンドール、メクロフェナム酸、メフェナム酸、メペンゾラート、メサラジン、メタクアロン、メチセルギド、ミアンセリン、ネオスチグミン、ニクマロン、ニトラゼパム、ノルエチステロン、オクスプレノロール(oxprenolon)、オキシフェンサイクリミン、パラメタジオン、フェニンジオン、フェニルブタゾン、ピゾチフェン、プロブコール、プロピシリン、ピランテル、スルファジアジン、スルファフラゾール、スルファメラジン、スルファピリジン、スルファサラジン、スルフィンピラゾン、スルピリド、テルフェナジン、ゾピクロン、ザレプロン、カルシウム、鉄、炭酸リチウムまたはクエン酸リチウム、炭酸カルシウムまたはクエン酸カルシウム、リボフラビン、カプトプリル、ピルブテロール、ビスマスサブサリチラート、ビスマスサブシトラート、ミソプロストール、5−フルオロウラシル、ドキソルビシン、マイトマイシン、セムスチン、シスプラチン、メトトレキサート、クラリスロマイシン、メチルナルトレキソン、アバカビル硫酸塩、ラミブジン、ジドブジン、アセタゾラミド、アセトアミノフェン、アルベンダゾール、アモキシシリン/クラブラン酸カリウム、アンプレナビル、アルテスナート、アトバコン、プログアニル塩酸塩、アトラクリウムベシラート、硫酸バリウム、プロピオン酸ベクロメタゾン、吉草酸ベタメタゾン、ビスマスサブサリチラート、ブプロピオン、カルバマゼピン、カスポファンギン酢酸塩、セファクロル、セファゾリン、セフタジジム、セフロキシム、クロラムブシル、クロロキン、クロルプロマジン、プロピオン酸クロベタゾール、コトリモキサゾール、デキストロアンフェタミン、ダイオキシン、ジヒドロキシアルテミシニン、ドキシサイクリン、エポプロステノール、プロピオン酸フルチカゾン、グリタゾン、ヒドロタルサイト、ヒドロコドン、ヒドロクロロチアジド、トリアムテレン、ラモトリギン、炭酸リチウム、ロメフロキサシン(lomefloxacine)、ロサルタンカリウム、メルカプトプリン、メフロキン、メサラジン、モルヒネ、ムピロシンカルシウムクリーム、ナブメトン、ナラトリプタン、ノルフロキサシン、オフロキサシン(ofloxacine)、オンダンセトロン塩酸塩、オキシコナゾール硝酸塩、オキシコドン、パロキセチン塩酸塩、ペフロキサシン(pefioxacine)、ピロキシカム、プラゾシン(prazodin)、プロクロルペラジン、プロサクリジン塩酸塩、ピリメタミン、レパグリニド、ロフェコキシブ、ロピニロール塩酸塩、ロシグリタゾンマレイン酸塩、サルメテロール、プロピオン酸フルチカゾン、重炭酸ナトリウム、スピロノラクトン、スクシニルコリンクロリド、タペンタドール、チオグアニン、塩酸トポテカン、トラマドール、トラニルシプロミン硫酸塩、オキシバートナトリウム、イソトレチノイン、グアイフェネシン、デクスメチルフェニデート、メチルフェニデート、ラノラジン、又はトリフルオペラジンを含む群から選択される、請求項1に記載の胃保持性の徐放性懸濁組成物。
- 前記組成物が更に、懸濁剤、固結防止剤、湿潤剤、保存剤、緩衝剤、香味料、抗酸化剤、及びキレート剤を含む群から選択される1種以上の薬学的に許容される賦形剤を含む、請求項1〜16のいずれか1項に記載の胃保持性の徐放性懸濁組成物。
- (i)有効成分及び1種以上の薬学的に許容される賦形剤を含むコアを調製する工程;
(ii)放出制御ポリマー及び1種以上の薬学的に許容される被覆添加剤を適切な溶媒に溶解/分散させる工程;
(iii)工程(i)のコア上に工程(ii)の被覆組成物を適用する工程;
(iv)1種以上のオスモゲント、1種以上のゲル形成剤、1種以上のガス発生剤、及び薬学的に許容される賦形剤を薬学的に許容される媒体に溶解/分散させて懸濁基剤を形成する工程;並びに、
(v)工程(iii)の被覆コアを工程(iv)の懸濁基剤に分散させて胃保持性の徐放性懸濁組成物を得る工程
を含む、請求項1に記載の胃保持性の徐放性懸濁組成物の調製方法。 - (A)(i)有効成分及び1種以上の薬学的に許容される賦形剤を含むコアを調製する工程;
(ii)放出制御ポリマー及び1種以上の薬学的に許容される被覆添加剤を適切な溶媒に溶解/分散させる工程;
(iii)工程(i)のコア上に工程(ii)の被覆組成物を適用する工程;
(iv)1種以上の薬学的に許容される賦形剤を工程(iii)の被覆コアと混合して懸濁液用の粉末を得る工程
を含む懸濁液用の粉末を調製する工程;
(B)1種以上のオスモゲント、1種以上のゲル形成剤、1種以上のガス発生剤、及び薬学的に許容される賦形剤を薬学的に許容される媒体に溶解/分散させることによって懸濁基剤を調製する工程;並びに、
(C)工程(A)の懸濁液用の粉末を工程(B)の懸濁基剤で再構成して胃保持性の徐放性懸濁組成物を得る工程
を含む、請求項1に記載の胃保持性の徐放性懸濁組成物の調製方法。 - (A)(i)有効成分及び1種以上の薬学的に許容される賦形剤を含むコアを調製する工程;
(ii)放出制御ポリマー及び1種以上の薬学的に許容される被覆添加剤を適切な溶媒に溶解/分散させる工程;
(iii)工程(i)のコア上に工程(ii)の被覆組成物を適用する工程;
(iv)1種以上のオスモゲント、1種以上のゲル形成剤、1種以上のガス発生剤、および1種以上の薬学的に許容される賦形剤を工程(iii)の被覆コアと混合して懸濁液用の粉末を得る工程
を含む懸濁液用の粉末を調製する工程;並びに、
(B)工程(A)の懸濁液用の粉末を薬学的に許容される媒体で再構成して胃保持性の徐放性懸濁組成物を得る工程
を含む、 請求項1に記載の胃保持性の徐放性懸濁組成物の調製方法。 - 有効成分を含む胃保持性の徐放性懸濁組成物の調製のための懸濁基剤の使用であって、該組成物が、少なくとも7日間の保管で、インビトロの溶解放出プロファイルに実質的な変化がないことを特徴とする、使用。
- 前記有効成分が、放出制御ポリマーで被覆された多層コアの形状である、請求項21の懸濁基剤の使用。
- 前記組成物の浸透圧比が少なくとも約1であることを特徴とする、請求項21の懸濁基剤の使用。
- 前記懸濁基剤が、高浸透圧環境の作成に関与する、請求項21の懸濁基剤の使用。
- 前記懸濁基剤がオスモゲントを含む、請求項21の懸濁基剤の使用。
- 前記懸濁基剤が更に、ゲル形成剤及びガス発生剤をさらに含む、請求項25の懸濁基剤の使用。
- 前記組成物が、懸濁液又は懸濁液用の再構成粉末である、請求項21の懸濁基剤の使用。
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US20180008539A1 (en) | 2018-01-11 |
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MX2017007299A (es) | 2017-08-25 |
RU2017123366A3 (ja) | 2019-01-10 |
EP3226839A1 (en) | 2017-10-11 |
RU2017123366A (ru) | 2019-01-10 |
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