JP2021524444A - 医薬品活性成分に適した崩壊性経口錠剤 - Google Patents
医薬品活性成分に適した崩壊性経口錠剤 Download PDFInfo
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- JP2021524444A JP2021524444A JP2020564460A JP2020564460A JP2021524444A JP 2021524444 A JP2021524444 A JP 2021524444A JP 2020564460 A JP2020564460 A JP 2020564460A JP 2020564460 A JP2020564460 A JP 2020564460A JP 2021524444 A JP2021524444 A JP 2021524444A
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- sugar alcohol
- tablet according
- oral tablet
- particles
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Abstract
Description
i)粒子集団及び少なくとも1種の香料成分を含み、粒子集団が直接圧縮性(DC)及び非直接圧縮性(非DC)糖アルコール粒子を含む崩壊性経口錠剤を得る工程と、
ii)咀嚼により錠剤を崩壊させ、それにより、錠剤中の複数の離散した非DC領域により、香料のバーストを生じさせる工程と
を含む方法に関する。
2層錠剤の調製
上のTable 1A(表1)及び1B(表2)並びに2(表3)に示されている組成物をそれぞれ、実施例1〜12、13〜24及び25〜36に概説されているとおりの組成物を有する2層錠剤に加工する。言い換えると、実施例1〜12は、Table 1A(表1)及び1B(表2)による第1の層を備え、第2層が主にDCマルチトールをベースとする2層錠剤である。実施例13〜24では、第2の層は主にDCキシリトールをベースとする。実施例25〜36では、第2の層は主に、Table 2(表3)に示されているとおりのDCイソマルトをベースとする。
HPC:ヒドロキシプロピルセルロース。Ashland社製のKlucel Nutra D
非DCキシリトール:Dupont社製のXivia C
非顆粒化ソルビトール:Cargill社製のPharmSorbidex
非DCイソマルト:Beneo Paltinit社製のIsomalt GS
非DCマンニトール:Roquette社製のPearlitol
非DCマルチトール:Roquette社製のMaltisorb. P200
非DCエリトリトール:Cargill社製のZerose 16952
DCエリトリトール - Cargill社製のZerose 16966
DCキシリトール - Dupont社製のXylitab 200
DCイソマルト - Beneo Paltinit社製のIsomalt DC 101
DCマンニトール - Roquette社製のPearlitol SD200
DCマルチトール - Roquette社製のSweetpearl 300 DC
DCイソマルト - Beneo Paltinit社製のIsomalt DC 101
非DCエリトリトール:Cargill社製のZerose 16952
HPC:ヒドロキシプロピルセルロース。Ashland社製のKlucel Nutra D
DC CaCO3:Scora社製のScoralite 97 PVP
各実施例39〜41では、原料を1600ミクロン篩で篩い掛けし、次いで、Table 3B(表5)の例示の組成物に従って適正量に秤量する。
ISX2は、ソルビトール実施例14を指し、
ISX3は、非DCイソマルト実施例15を指し、
ISX4は、非DCエリトリトール実施例16を指し、
ISX5は、非DCマンニトール実施例17を指し、
ISX6は、非DCマルチトール実施例18を指す。
ODT錠剤を含む2層錠剤の調製
種々の濃度の非DC糖アルコールを含む調製
種々の濃度の非DC糖アルコールを含む調製
上のTable 4(表7)、4B(表8)、5(表9)及び6(表10)に示されている組成物をそれぞれ、実施例42〜50及び43Bに概説されているとおりの組成物で2層錠剤に加工する。
HPC:ヒドロキシプロピルセルロース。Ashland社製のKlucel Nutra D
非DCキシリトール:Dupont社製のXivia C
非顆粒化ソルビトール:Cargill社製のPharmSorbidex
非DCイソマルト:Beneo Paltinit社製のIsomalt GS
非DCマンニトール:Roquette社製のPearlitol
非DCマルチトール:Roquette社製のMaltisorb. P200
非DCエリトリトール:Cargill社製のZerose 16952
DCエリトリトール - Cargill社製のZerose 16966
DCキシリトール - Dupont社製のXylitab 200
DCイソマルト - Beneo Paltinit社製のIsomalt DC 101
DCマンニトール - Roquette社製のPearlitol SD200
DCマルチトール - Roquette社製のSweetpearl 300 DC
DC CaCO3:Scora社製のScoralite 97 PVP
Pearlitol Flashは、Roquette社の商標である。
微結晶質セルロース(MCC): FMC社製のAvicel PH-105
クロスポビドン:BASF社製のKollidon CL-SF
上の2層実施例42〜50及び43Bをウォータリング作用に関して、試験パネルが時間-強度評価構成(time-intensity evaluation set-up)で評価した。ウォータリング作用は、試験パネルにより知覚されるウォータリング作用、すなわち、経口投与及び試験開始の際のウォータリング作用の全体的な印象である。
異なる粒径分布を有する粉末の調製
非DCキシリトール:Dupont社製のXivia C
非DCイソマルト:Beneo Paltinit社製のIsomalt GS
非DCエリトリトール:Cargill社製のZerose 16952
上の粉末実施例51〜59が試験パネルにより、経口投与の際に生成した唾液の合計質量に関して評価された。
画分を、再現可能な値が得られるように、中断せずに連続的な手順で試験した。粉末1.0gの画分を容器に秤量した。この試験では、試験者は、試験が開始される前に唾液を嚥下するように指示され、試験中は嚥下を許されなかった。粉末を舌の舌先1/3に置き、頭部を正面に保持し、試験中は嚥下を許されなかった。試験者は、1分当たり約60回の頻度で粉末を咀嚼した。60秒後に、生成した唾液を収集し、唾液の質量を記録した。新たな試験を行う前に、口腔を水ですすぎ、次の試験の前に4分の時間間隔を守った。一連の2回の試験が試験者で行われた。
第1に、これらの結果は明らかに、唾液生成について、非DCエリトリトール(実施例59)が、非DCキシリトール(実施例56)と比較して、非DCイソマルト(実施例53)よりも更に良好な最良の結果をもたらしたことを示す。非DCエリトリトールは試験期間中の唾液の合計生成量については最良の結果を示したが、キシリトール及びイソマルトの結果は両方とも、非常に有利なレベルであったことが特記される。
第2に、これらの結果はまた非常に有利なことに、3種の非DC糖アルコールのすべてについて、500ミクロン超の粒径が、500ミクロン未満と比較して、唾液生成について特に有利であることを示す。500ミクロン超の粒径分布を有する非DCエリトリトール(実施例58)で最良の結果が得られ、キシリトールはより低い値(実施例55)であり、イソマルトが最も低かったが(実施例52)、まだ非常に有利な値であった。
種々の糖アルコールを有する粉末の調製
非DCキシリトール:Dupont社製のXivia C
非DCイソマルト:Beneo Paltinit社製のIsomalt GS
非DCエリトリトール:Cargill社製のZerose 16952
上の粉末実施例60〜62が試験パネルにより、経口投与の際に生成する唾液の合計質量に関して評価された。
粉末1.0gの画分を容器に秤量した。この試験では、8人の試験者は、試験が開始される前に唾液を嚥下するように指示された。粉末を舌の舌先1/3に置き、頭部を正面に保持し、試験中は嚥下を許されなかった。試験者は、1分当たり約60回の頻度で粉末を咀嚼した。60秒後に、生成した唾液を収集し、唾液の質量を記録した。新たな試験を行う前に、口腔を水ですすぎ、次の試験の前に4分の時間間隔を守った。一連の2回の試験が試験者で行われた。したがって、合計16の試験サンプルが各原料粉末について生じた。各試験者に、6つのサンプルを試験シリーズで試験させた。各試験シリーズ間に少なくとも30分の間隔が求められた。
非DCイソマルト:Beneo Paltinit社製のIsomalt GS
非DCエリトリトール:Cargill社製のZerose 16952
上の粉末実施例63〜66が試験パネルにより、経口投与の際に生成した唾液の合計質量に関して評価された。
粉末1.0gの画分を容器に秤量した。この試験では、8人の試験者は、試験が開始される前に唾液を嚥下するように指示された。粉末を舌の舌先1/3に置き、頭部を正面に保持し、試験中は嚥下を許されなかった。試験者は、1分当たり約60回の頻度で粉末を咀嚼した。60秒後に、生成した唾液を収集し、唾液の質量を記録した。新たな試験を行う前に、口腔を水ですすぎ、次の試験の前に4分の時間間隔を守った。一連の2回の試験が試験者で行われた。したがって、合計16の試験サンプルが各原料粉末について生じた。各試験者に、6つのサンプルを試験シリーズで試験させた。各試験シリーズ間に少なくとも30分の間隔が求められた。
第1に、これらの結果は非常に有利なことに、2種の非DC糖アルコールについて、500ミクロン超の粒径が、500ミクロン未満と比較して特に有利であることを示す。500ミクロン超の粒径分布を有する非DCエリトリトール(実施例66)で最良の結果が得られ、イソマルトが最も低かったが(実施例64)、まだ許容可能な値であった。
第2に、結果は、唾液の生成が非DCイソマルトと比較して非DCエリトリトールで最高であったことを示した。
CaCO3を含む2層錠剤の調製
歯みがき剤を含む2層錠剤の調製
クリーンラベル/天然成分を含む2層錠剤の調製
20 経口錠剤
21 上部モジュール
22 下部モジュール
30 経口錠剤
31 上部モジュール
32 下部モジュール
33 中間モジュール
40 部分、最終経口錠剤
41 非DC糖アルコール粒子、非DC粒子
42 DC粒子
51 非DC粒子
52 DC粒子
60 錠剤
61 非DC糖アルコール粒子
62 DC粒子、DC糖アルコール粒子
63 DC粒子、DC糖アルコール粒子
Claims (96)
- 粒子集団及び少なくとも1種の香料成分を含む、医薬品活性成分に適した崩壊性経口錠剤であって、前記粒子集団が、直接圧縮性(DC)及び非直接圧縮性(非DC)糖アルコール粒子を含み、前記非DC粒子が、錠剤に複数の離散した非DC領域を与え、前記非DC領域が、前記錠剤の咀嚼の際に前記少なくとも1種の香料成分のバーストをもたらす、経口錠剤。
- 前記非DC糖アルコール粒子が錠剤化の前に顆粒化されていない、請求項1に記載の経口錠剤。
- 前記非DC糖アルコール粒子が、本質的に糖アルコールからなる、請求項1又は2に記載の経口錠剤。
- 前記非DC糖アルコール粒子が、糖アルコールからなる、請求項1から3のいずれか一項に記載の経口錠剤。
- 香料を前記錠剤の1〜10質量%の量で含む、請求項1から4のいずれか一項に記載の経口錠剤。
- 咀嚼の開始から20秒以内に前記香料の少なくとも50質量%を放出するように設計されている、請求項1から5のいずれか一項に記載の経口錠剤。
- 前記少なくとも1種の香料成分のバーストが、咀嚼の際に、肺への香料のバーストを伴う、請求項1から6のいずれか一項に記載の経口錠剤。
- 前記少なくとも1種の香料成分のバーストが、咀嚼の際に、鼻腔への香料のバーストを伴う、請求項1から7のいずれか一項に記載の経口錠剤。
- 前記少なくとも1種の香料成分が揮発性香料を含む、請求項1から8のいずれか一項に記載の経口錠剤。
- 咀嚼の開始から20秒以内に崩壊するように設計されている、請求項1から9のいずれか一項に記載の経口錠剤。
- 咀嚼中に前記非DC糖アルコール粒子により促進される唾液分泌が、その結果生じる甘味料の溶解と組み合わされることで、バーストを得る、請求項1から10のいずれか一項に記載の経口錠剤。
- インビボでの咀嚼から20秒以内に崩壊するように設計されており、この際、前記インビボでの咀嚼が、少なくとも10人の個体からなる咀嚼パネルにより、1分当たり60回の咀嚼速度での咀嚼で実施される、請求項1から11のいずれか一項に記載の経口錠剤。
- 前記粒子集団が、第1のモジュールに錠剤化され、第2のモジュールに錠剤化されている第2の粒子集団と組み合わされている、請求項1から12のいずれか一項に記載の経口錠剤。
- 前記粒子集団が第1のモジュールに錠剤化されており、第2のモジュールに錠剤化されている第2の粒子集団と組み合わされており、前記第2のモジュールが非DC糖アルコール粒子を含まない、請求項1から13のいずれか一項に記載の経口錠剤。
- 前記粒子集団が第1のモジュールに錠剤化されており、第2のモジュールに錠剤化されている第2の粒子集団と組み合わされており、前記第2のモジュールが組成において前記第1のモジュールとは異なる、請求項1から14のいずれか一項に記載の経口錠剤。
- 前記粒子集団が第1のモジュールに錠剤化されており、第2のモジュールに錠剤化されている第2の粒子集団と組み合わされており、前記第2のモジュールが経口崩壊錠剤(ODT)である、請求項1から15のいずれか一項に記載の経口錠剤。
- 前記非DC領域が前記錠剤又は前記錠剤の少なくとも1つのモジュールに均等に分布している、請求項1から16のいずれか一項に記載の経口錠剤。
- 一連の少なくとも10個の前記錠剤が、前記非DC粒子を10%未満の相対標準偏差(RSD)で変動する量で含む、請求項1から17のいずれか一項に記載の経口錠剤。
- 前記非DC領域が前記錠剤又は前記錠剤の少なくとも1つのモジュールに均質に分布している、請求項1から18のいずれか一項に記載の経口錠剤。
- 前記錠剤がチュアブル錠である、請求項1から19のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子の少なくとも20質量%が500μm超の粒径を有する、請求項1から20のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子の少なくとも30質量%が500μm超の粒径を有する、請求項1から21のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子の少なくとも40質量%が500μm超の粒径を有する、請求項1から22のいずれか一項に記載の経口錠剤。
- 前記粒子集団の少なくとも10質量%が250μm未満の粒径を有し、前記粒子集団の少なくとも30質量%が500μm超の粒径を有する、請求項1から23のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子の少なくとも10質量%が250μm未満の粒径を有する、請求項1から24のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子の少なくとも5質量%が250μm未満の粒径を有する、請求項1から25のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子が、エリトリトール、マルチトール、キシリトール、イソマルト、ラクチトール、マンニトール、及びそれらの組合せの非DC粒子から選択される、請求項1から26のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子が、エリトリトール、マルチトール、キシリトール、イソマルト、及びそれらの組合せの非DC粒子から選択される、請求項1から27のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子が、エリトリトール、マルチトール、キシリトール、及びそれらの組合せの非DC粒子から選択される、請求項1から28のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子が非DCエリトリトール粒子である、請求項1から29のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子が非DCキシリトール粒子である、請求項1から30のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子が非DCイソマルト粒子である、請求項1から31のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子を前記錠剤の少なくとも10質量%の量で含む、請求項1から32のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子を前記錠剤の少なくとも20質量%の量で含む、請求項1から33のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコール粒子を前記錠剤の少なくとも30質量%の量で含む、請求項1から34のいずれか一項に記載の経口錠剤。
- 前記第1のモジュールが、前記非DC糖アルコール粒子を前記第1のモジュールの少なくとも30質量%の量で含む、請求項1から35のいずれか一項に記載の経口錠剤。
- 前記第1のモジュールが、前記非DC糖アルコール粒子を前記第1のモジュールの少なくとも40質量%の量で含む、請求項1から36のいずれか一項に記載の経口錠剤。
- 前記DC糖アルコール粒子が、ソルビトール、エリトリトール、キシリトール、ラクチトール、マルチトール、マンニトール、イソマルト、及びそれらの組合せのDC粒子から選択される糖アルコールを含む、請求項1から37のいずれか一項に記載の経口錠剤。
- 前記DC糖アルコール粒子を前記錠剤の少なくとも10質量%の量で含む、請求項1から38のいずれか一項に記載の経口錠剤。
- 前記DC糖アルコール粒子を前記錠剤の少なくとも20質量%の量で含む、請求項1から39のいずれか一項に記載の経口錠剤。
- 前記DC糖アルコール粒子を前記錠剤の少なくとも30質量%の量で含む、請求項1から40のいずれか一項に記載の経口錠剤。
- 前記第1のモジュールが、前記DC糖アルコール粒子を前記第1のモジュールの少なくとも30質量%の量で含む、請求項1から41のいずれか一項に記載の経口錠剤。
- 前記第2のモジュールが、DC糖アルコール粒子を前記第2のモジュールの少なくとも50質量%の量で含む、請求項1から42のいずれか一項に記載の経口錠剤。
- 前記第2のモジュールが、DC糖アルコール粒子を前記第2のモジュールの少なくとも70質量%の量で含む、請求項1から43のいずれか一項に記載の経口錠剤。
- 前記第2のモジュールが、DC糖アルコール粒子を前記第2のモジュールの少なくとも90質量%の量で含む、請求項1から44のいずれか一項に記載の経口錠剤。
- 前記錠剤の脆砕性が、3%未満、例えば2%未満、例えば1.5%未満であり、脆砕性が、欧州薬局方9.1、試験方法2.9.7.に従って、Pharma Test社製の医薬品脆砕性テスターPTF 10Eを使用することにより測定される、請求項1から45のいずれか一項に記載の経口錠剤。
- 前記DC糖アルコール粒子の部分を形成している結合剤以外の1種又は複数の結合剤を、前記錠剤の0.1〜6質量%の量で含む、請求項1から46のいずれか一項に記載の経口錠剤。
- 前記錠剤の噛み砕き耐性が、60N超、例えば70N超、例えば80N超、例えば90N超、例えば100N超、例えば110N超、例えば130N超、例えば150N超であり、前記錠剤の噛み砕き耐性が、300N未満、例えば250N未満、例えば200N未満であり、前記噛み砕き耐性が、欧州薬局方9.1、試験方法2.9.8.に従って、医薬品噛み砕き耐性テスターモデルPharma Test type PTB 311を使用することにより決定される、請求項1から47のいずれか一項に記載の経口錠剤。
- 0.2から1.2の間の前記非DC糖アルコール粒子と前記DC糖アルコール粒子との間の質量比を有する、請求項1から48のいずれか一項に記載の経口錠剤。
- 0.3から1.0の間の前記非DC糖アルコール粒子と前記DC糖アルコール粒子との間の質量比を有する、請求項1から49のいずれか一項に記載の経口錠剤。
- 0.3から0.7の間の前記非DC糖アルコール粒子と前記DC糖アルコール粒子との間の質量比を有する、請求項1から50のいずれか一項に記載の経口錠剤。
- 前記非DC領域が、誘導唾液生成をもたらす、請求項1から51のいずれか一項に記載の経口錠剤。
- 非DC糖アルコール粒子を含まない錠剤と比較して、前記錠剤の咀嚼の際の唾液生成が誘導される、請求項1から52のいずれか一項に記載の経口錠剤。
- 前記離散した領域がDC糖アルコール粒子をベースとする錠剤と比較して、前記錠剤の咀嚼の際の唾液生成が誘導される、請求項1から53のいずれか一項に記載の経口錠剤。
- 咀嚼の開始から30秒以内に唾液1.5mL超を生成する、請求項1から54のいずれか一項に記載の経口錠剤。
- 咀嚼の開始から30から90秒の期間内に唾液1.5mL超を生成する、請求項1から55のいずれか一項に記載の経口錠剤。
- 咀嚼の開始から90から180秒の期間内に唾液1.5mL超を生成する、請求項1から56のいずれか一項に記載の経口錠剤。
- 咀嚼の開始から180から300秒の期間内に唾液1.5mL超を生成する、請求項1から57のいずれか一項に記載の経口錠剤。
- 少なくとも1種の粘度調整剤を更に含む、請求項1から58のいずれか一項に記載の経口錠剤。
- 前記少なくとも1種の粘度調整剤が、アルギン酸ナトリウム、ペクチン、カラゲナン、ザンサンガム、アラビアゴム及びそれらの混合物からなる群から選択される、請求項1から59のいずれか一項に記載の経口錠剤。
- 水和すると正の表面電荷を有するゲルを形成する少なくとも1種の粘稠剤と、水和すると負の表面電荷を有するゲルを形成する少なくとも1種の粘稠剤とを更に含む、請求項1から60のいずれか一項に記載の経口錠剤。
- 活性成分を含む、請求項1から61のいずれか一項に記載の経口錠剤。
- 経口投与の際に唾液で水和した場合にエマルジョンを形成する自己乳化系を含む、請求項1から62のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、1種又は複数の乳化剤及び1種又は複数の油担体を含む、請求項1から63のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、1種又は複数の乳化剤、1種又は複数の油担体及び1種又は複数の溶解剤を含む、請求項1から64のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、1種又は複数の乳化剤、1種又は複数の油担体、1種又は複数の溶解剤及び1種又は複数の溶媒を含む、請求項1から65のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、1種又は複数の乳化剤及び1種又は複数の溶媒を含む、請求項1から66のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、乳化及び溶解特性の両方を有する1種又は複数の乳化剤を含む、請求項1から67のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、乳化剤及び担体の両方として作用する1種又は複数の乳化剤を含む、請求項1から68のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、乳化剤、担体及び溶解剤の両方として作用する1種又は複数の乳化剤を含む、請求項1から69のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、1種又は複数の脂肪酸、1種又は複数のグリセロール、1種又は複数のワックス、1種又は複数のフラボノイド類及び1種又は複数のテルペン類を含む、請求項1から70のいずれか一項に記載の経口錠剤。
- 前記自己乳化系が、6より大きい、好ましくは8〜18のHLB値を有する1種又は複数の乳化剤を含む、請求項1から71のいずれか一項に記載の経口錠剤。
- 前記1種又は複数の乳化剤が、PEG-35ヒマシ油、PEG-6オレオイルグリセリド、PEG-6リノレオイルグリセリド、PEG-8カプリル酸/カプリン酸グリセリド、モノラウリン酸ソルビタン、モノオレイン酸ソルビタン、モノラウリン酸ポリオキシエチレン(20)ソルビタン、モノステアリン酸ポリオキシエチレン(60)ソルビタン、モノオレイン酸ポリオキシエチレン(80)ソルビタン、ラウロイルポリオキシル-32グリセリド、ステアロイルポリオキシル-32グリセリド、ステアリン酸ポリオキシル-32、モノラウリン酸プロピレングリコール、ジラウリン酸プロピレングリコール、並びにそれらの混合物及び組合せからなる群から選択される、請求項1から72のいずれか一項に記載の経口錠剤。
- 前記1種又は複数の乳化剤が、PEG-35ヒマシ油を含む、請求項1から73のいずれか一項に記載の経口錠剤。
- 前記油担体が、天然脂肪酸;カプリル酸(C8)及びカプリン酸(C10)の中鎖トリグリセリド;カプリル酸(C8)及びカプリン酸(C10)のプロピレングリコールエステル;主にリノール酸(C18:2)及びオレイン酸(C18:1)のモノ-、ジ-及びトリグリセリド;脂肪酸18:1シス-9;天然脂肪酸;オレイン酸(C18:1)のモノ-、ジ-及びトリグリセリド、並びにそれらの混合物及び組合せからなる群から選択される、請求項1から74のいずれか一項に記載の経口錠剤。
- 前記1種又は複数の溶媒が、ジオレイン酸ポリグリセリル-3、1,2-プロパンジオール、ポリエチレングリコール300、ポリエチレングリコール400、ジエチレングリコールモノエチルエーテル、並びにそれらの混合物及び組合せからなる群から選択される、請求項1から75のいずれか一項に記載の経口錠剤。
- 前記1種又は複数の溶解剤が、ラウロイルポリオキシル-32グリセリド;ステアロイルポリオキシル-32グリセリド;ステアリン酸ポリオキシル-32;酸化エチレン(80)及び酸化プロピレン(27)の合成コポリマー;ポリビニルカプロラクタム-酢酸ポリビニル-ポリエチレングリコールグラフトコポリマー;アルファ-、ベータ-又はガンマシクロデキストリン及びその誘導体;ピープロテイン(グロブリン、アルブミン、グルテリンタンパク質);並びにそれらの混合物及び組合せからなる群から選択される、請求項1から76のいずれか一項に記載の経口錠剤。
- 医薬品活性成分を含む、請求項1から77のいずれか一項に記載の経口錠剤。
- 医薬品活性成分及び経口投与の際に唾液で水和するとエマルジョンを形成する自己乳化系を含む、請求項1から78のいずれか一項に記載の経口錠剤。
- ニコチン及び経口投与の際に唾液で水和するとエマルジョンを形成する自己乳化系を含む、請求項1から79のいずれか一項に記載の経口錠剤。
- 活性成分とオレイン酸等の脂肪酸との間の親油性会合を含む、請求項1から80のいずれか一項に記載の経口錠剤。
- ガム基剤を含む粒子を含み、咀嚼されると水不溶性構成成分を含有する凝集性残留物になるように設計されている、請求項1から81のいずれか一項に記載の経口錠剤。
- ガム基剤を含む粒子を含有し、前記ガム基剤が、少なくとも5質量%のエラストマーを含む、請求項1から82のいずれか一項に記載の経口錠剤。
- ガム基剤を含有しない、請求項1から83のいずれか一項に記載の経口錠剤。
- 天然に存在する成分から本質的になる、請求項1から84のいずれか一項に記載の経口錠剤。
- ステビオシド等の天然高強度甘味料を含む、請求項1から85のいずれか一項に記載の経口錠剤。
- 前記非DC糖アルコールが非DCショ糖等の非DC糖である、請求項1から86のいずれか一項に記載の経口錠剤。
- 粒子集団を含む医薬品活性成分に適した崩壊性経口錠剤であって、前記粒子集団が直接圧縮性(DC)及び非直接圧縮性(非DC)糖アルコール粒子を含み、前記錠剤が咀嚼20秒以内に液体になるように設計されている、崩壊性経口錠剤。
- 粒子集団を含む医薬品活性成分に適した崩壊性経口錠剤であって、前記粒子集団が直接圧縮性(DC)及び非直接圧縮性(非DC)糖アルコール粒子を含み、前記錠剤が咀嚼20秒以内に溶解するように設計されている、崩壊性経口錠剤。
- 請求項1から87のいずれか一項の記載に従って構成されている、請求項88又は89に記載の崩壊性経口錠剤。
- 香料のバーストを得る方法であって、
i)粒子集団及び少なくとも1種の香料成分を含み、前記粒子集団が、直接圧縮性(DC)及び非直接圧縮性(非DC)糖アルコール粒子を含む崩壊性経口錠剤を得る工程と、
ii)咀嚼により前記錠剤を崩壊させ、それにより、前記錠剤中の複数の離散した非DC領域により、香料のバーストを生じさせる工程と
を含む方法。 - 前記錠剤が請求項1から90のいずれか一項の記載により構成されている、請求項91に記載の方法。
- 粒子集団及び少なくとも1種の香料成分を含み、前記粒子集団が、直接圧縮性(DC)及び非直接圧縮性(非DC)糖アルコール粒子を含む、香料のバーストを得るための崩壊性経口製品。
- 粉末である、請求項93に記載の崩壊性経口製品。
- パウチである、請求項93に記載の崩壊性経口製品。
- 請求項1から88のいずれか一項の記載により構成されている、請求項93から95のいずれか一項に記載の崩壊性経口製品。
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JP7475286B2 (ja) | 2024-04-26 |
AU2019269881A1 (en) | 2020-10-22 |
AU2019269881B2 (en) | 2022-08-04 |
US11058633B2 (en) | 2021-07-13 |
CN112118833B (zh) | 2023-03-03 |
EP3793531A1 (en) | 2021-03-24 |
CA3096339A1 (en) | 2019-11-21 |
CN112118833A (zh) | 2020-12-22 |
CA3096339C (en) | 2023-08-29 |
US20210106534A1 (en) | 2021-04-15 |
US20190350847A1 (en) | 2019-11-21 |
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US20210290530A1 (en) | 2021-09-23 |
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