JP6559912B2 - 放出制御剤形 - Google Patents
放出制御剤形 Download PDFInfo
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- JP6559912B2 JP6559912B2 JP2018557785A JP2018557785A JP6559912B2 JP 6559912 B2 JP6559912 B2 JP 6559912B2 JP 2018557785 A JP2018557785 A JP 2018557785A JP 2018557785 A JP2018557785 A JP 2018557785A JP 6559912 B2 JP6559912 B2 JP 6559912B2
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Description
本開示では以下の定義を使用する。
一態様において、本開示は、経口投与用の固体医薬剤形を提供する。一実施形態において、剤形は、コンパートメントを形成する基材を含み、基材が、少なくとも第1の部分および第2の部分を含み、第1の部分が、第2の部分に動作可能に連結している。剤形は、コンパートメントに詰め込まれている薬物内容物を含む。剤形は、基材と動作可能に連結され、水または体液と接触すると、第1および第2の部分を分離して、コンパートメントを開き、薬物内容物を放出することができるリリーサーも含む。
本明細書に開示される放出制御剤形は、いずれかの適切な方法を利用して製造することができる。いくつかの実施形態において、剤形は三次元プリンティング(3Dプリンティング)を利用して製造される。
Claims (16)
- コンパートメントを形成する基材であって、少なくとも第1の部分および第2の部分を含み、第1の部分が、第2の部分に動作可能に連結しており、第1の部分および第2の部分は水または体液に対して透過性ではない基材と、
コンパートメントに詰め込まれている薬物内容物と、
基材と動作可能に連結され、水または体液と接触すると、第1および第2の部分を分離して、薬物内容物を放出することができるリリーサーと
を含む固体医薬剤形であって、
コンパートメントは、リリーサーで密封されているアパーチャーを有する、固体医薬剤形。 - リリーサーが、ヒドロゲルを含む、請求項1に記載の剤形。
- 基材が、熱成形性材料から作製されている、請求項1に記載の剤形。
- 熱成形性材料が、ポリビニルカプロラクタム−ポリビニルアセテート−ポリエチレングリコールグラフトコポリマー57/30/13、ポリビニルピロリドン−co−ビニルアセテート(PVP−VA)、ポリビニルピロリドン−ポリビニルアセテートコポリマー(PVP−VA)60/40、ポリビニルピロリドン(PVP)、ポリビニルアセテート(PVAc)とポリビニルピロリドン(PVP)80/20、ポリエチレングリコール−ポリビニルアルコールグラフトコポリマー25/75、kollicoat IR−ポリビニルアルコール60/40、ポリビニルアルコール(PVAまたはPV−OH)、ポリ(ビニルアセテート)(PVAc)、ポリ(ブチルメタクリレート−co−(2−ジメチルアミノエチル)メタクリレート−co−メチルメタクリレート)1:2:1、ポリ(ジメチルアミノエチルメタクリレート−co−メタクリル酸エステル)、ポリ(エチルアクリレート−co−メチルメタクリレート−co−トリメチルアンモニオエチルメタクリレートクロリド)、ポリ(メチルアクリレート−co−メチルメタクリレート−co−メタクリル酸)7:3:1、ポリ(メタクリル酸−co−メチルメタクリレート)1:2、ポリ(メタクリル酸−co−エチルアクリレート)1:1、ポリ(メタクリル酸−co−メチルメタクリレート)1:1、ポリ(エチレンオキシド)(PEO)、ポリ(エチレングリコール)(PEG)、多分岐状ポリエステルアミド、ヒドロキシプロピルメチルセルロースフタレート、ヒプロメロースフタレート、ヒドロキシプロピルメチルセルロースまたはヒプロメロース(HMPC)、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またはヒプロメロースアセテートスクシネート(HPMCAS)、ポリ(ラクチド−co−グリコリド)(PLGA)、カルボマー、ポリ(エチレン−co−ビニルアセテート)、エチレン−ビニルアセテートコポリマー、ポリエチレン(PE)、およびポリカプロラクトン(PCL)、Eudragit RS PO、クエン酸トリエチル(TEC)ならびにそれらの組合せからなる群から選択される、請求項3に記載の剤形。
- 基材が、角柱または円柱の形状をとる、請求項1に記載の剤形。
- コンパートメントが、角柱または円柱の形状をとる、請求項1に記載の剤形。
- 薬物内容物が、医薬品有効成分(API)を含む、請求項1に記載の剤形。
- APIが、局所麻酔薬、抗てんかん薬および抗痙攣薬、抗アルツハイマー病薬、鎮痛薬、抗痛風薬、抗高血圧薬、抗不整脈薬、利尿薬、肝疾患処置薬、膵疾患処置薬、抗ヒスタミン薬、抗アレルギー薬、グルココルチコイド薬、性ホルモン薬および避妊薬、血糖降下薬、抗骨粗鬆症薬、抗生物質、スルホンアミド、キノロン、ならびに他の合成抗細菌薬、抗結核薬、抗ウイルス薬、抗新生物薬、免疫モジュレーター、ならびに化粧料有効物質からなる群から選択される、請求項7に記載の剤形。
- 薬物内容物が、APIと結合している添加物をさらに含む、請求項7に記載の剤形。
- 添加物が、カカオバター、ポリエチレングリコール(PEG)、スクロース、グルコース、ガラクトース、フルクトース、キシロースラクトース、マルトース、トレハロース、ソルビトール、マンニトール、マルトデキストリン、ラフィノース、スタキオース、フラクトオリゴ糖、ポリビニルピロリドン−ポリビニルアセテートコポリマー(PVP−VA)60/40、ヒドロキシルプロピルセルロース(HPC)、クエン酸トリエチル(TEC)およびそれらの組合せからなる群から選択される水溶性材料から作製されている、請求項9に記載の剤形。
- 第1のコンパートメントを形成する第1の基材であって、少なくとも第1の部分および第2の部分を含み、第1の部分が、第2の部分に動作可能に連結しており、第1の部分および第2の部分は水または体液に対して透過性ではない第1の基材と、
第1のコンパートメントに詰め込まれている第1の薬物内容物と、
第1の基材と動作可能に連結され、水または体液と接触すると、第1および第2の部分を分離して、第1の薬物内容物を放出することができる第1のリリーサーであって、第1のコンパートメントは、第1のリリーサーで密封されている第1のアパーチャーを有する第1のリリーサーと、
第2のコンパートメントを形成する第2の基材であって、少なくとも第3の部分および第4の部分を含み、第3の部分が、第4の部分に動作可能に連結しており、第3の部分および第4の部分は水または体液に対して透過性ではない第2の基材と、
第2のコンパートメントに詰め込まれている第2の薬物内容物と、
第2の基材と動作可能に連結され、水と接触すると、第3および第4の部分を分離して、第2の薬物内容物を放出することができる第2のリリーサーあって、第2のコンパートメントは、第2のリリーサーで密封されている第2のアパーチャーを有する第2のリリーサーと
を含む固体医薬剤形であって、
第1の基材が、第2の基材と動作可能に連結され、
第1のコンパートメントが、第2のコンパートメントから分離されており、
第1および第2の部分が分離されて初めて、第2のリリーサーに水または体液が到達可能になる
固体医薬剤形。 - 第1の薬物内容物が、第2の薬物内容物と同じである、請求項11に記載の剤形。
- 第1の薬物内容物が、第2の薬物内容物と異なる、請求項11に記載の剤形。
- 第1のリリーサーおよび第2のリリーサーが、同じ材料で作製されている、請求項11に記載の剤形。
- 第1のリリーサーが第1の材料で作製され、第2のリリーサーが第2の材料で作製され、ここで、第1の材料が第2の材料と異なる、請求項11に記載の剤形。
- 第2の基材が第1の基材上に積み重なっている、請求項11に記載の剤形。
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US62/332,018 | 2016-05-05 | ||
PCT/US2017/031446 WO2017193099A1 (en) | 2016-05-05 | 2017-05-05 | Controlled release dosage form |
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JP2019520866A JP2019520866A (ja) | 2019-07-25 |
JP6559912B2 true JP6559912B2 (ja) | 2019-08-14 |
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JP2018557785A Active JP6559912B2 (ja) | 2016-05-05 | 2017-05-05 | 放出制御剤形 |
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EP (2) | EP3981392A1 (ja) |
JP (1) | JP6559912B2 (ja) |
KR (1) | KR101965283B1 (ja) |
CN (1) | CN107847398B (ja) |
AU (1) | AU2017261372B2 (ja) |
CA (1) | CA3023278C (ja) |
HK (1) | HK1249728B (ja) |
WO (1) | WO2017193099A1 (ja) |
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2017
- 2017-05-05 KR KR1020187035161A patent/KR101965283B1/ko active IP Right Grant
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HK1249728B (zh) | 2020-01-17 |
WO2017193099A1 (en) | 2017-11-09 |
KR20180135975A (ko) | 2018-12-21 |
US10143626B2 (en) | 2018-12-04 |
CN107847398A (zh) | 2018-03-27 |
JP2019520866A (ja) | 2019-07-25 |
US20180116911A1 (en) | 2018-05-03 |
AU2017261372B2 (en) | 2019-02-14 |
CA3023278C (en) | 2019-04-30 |
KR101965283B1 (ko) | 2019-04-03 |
CN107847398B (zh) | 2019-05-07 |
AU2017261372A1 (en) | 2018-11-22 |
EP3981392A1 (en) | 2022-04-13 |
EP3452003A1 (en) | 2019-03-13 |
EP3452003A4 (en) | 2019-06-26 |
CA3023278A1 (en) | 2017-11-09 |
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