JP2017529399A - 発泡組成物及びそれを製造する方法 - Google Patents
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Abstract
Description
以下の用語説明は、本開示をよりよく説明し、本開示の実施において当業者を導くために提供される。本明細書で使用する場合、「含む(comprising)」は、「含むがこれらに限定されない(including but not limited to)」ことを意味し、単数形「1つ(種)の(a)」若しくは「1つ(種)の(an」又は「その(the)」は、文脈上明らかに別段の指定がない限り、複数の指示対象を含む。「又は」という用語は、文脈上明らかに別段の指示がない限り、記述された択一的要素のうちの単一の要素又は2つ以上の要素の組合せを指す。
本開示は、多孔性発泡組成物、より詳細には顆粒に関する。組成物は、1つ又は複数の重要な属性、例えば自由流動能力、圧縮性、多孔度、相当量の二酸化炭素保持及び機械的強度を有する。顆粒の形態の発泡組成物は、それ自体を使用することができ、使用する前に他の添加剤と混合することができ、又は例えば、所望の機械的強度、有効性及び急速な崩壊時間を有する発泡錠を形成するのに好適である。一部の実施形態では、本開示の顆粒の形態の多孔性発泡組成物は、投入ブレンドの多孔度よりも少なくとも50%大きい多孔度を有し、投入ブレンドの二酸化炭素(CO2)含有量の全て又は実質的に全てを保持する。本明細書において、投入ブレンドに対する発泡組成物の多孔度は、相対多孔度と称される。相対多孔度は、相対かさ多孔度又は相対タップ多孔度のいずれかとして測定されうる。「投入ブレンドのCO2含有量の全て又は実質的に全て」という用語は、投入ブレンドのCO2含有量の少なくとも90%を意味し、組成物、詳細には顆粒のパーセント相対保持CO2含有率としても表される。
多様な用途における組成物の使用に寄与する改善された特性を示す多孔性発泡組成物の実施形態が、本明細書に開示される。一部の実施形態では、多孔性発泡組成物は、酸及び塩基を含む投入ブレンドを使用して形成することができる。一部の実施形態では、多孔性発泡組成物は、投入ブレンドの多孔度よりも少なくとも50%大きい多孔度を有する。一部の実施形態では、多孔性発泡組成物は、投入ブレンドの少なくとも90%の保持二酸化炭素含有率を有する。顆粒の多孔度の増加を、顆粒の他の特性を損なうことなく達成できることが観察された。
SEI=SEI機械的+SEI熱的
酸溶融パーセント=SEI/Em×100……(1)
(式中、酸の完全溶融に必要とされるエネルギー(Em)は、投入ブレンド及びその成分の示差走査熱量測定(DSC)サーモグラムから得ることができる)。
P=2πNτ/60,000……(2)
(式中、P=出力(kW)
N=スクリュー速度(rpm)
τ=トルク(Nm))
SEI機械的=出力(kW)/スループット又は供給速度(kg/h)……(3)
(式中、SEI機械的は、二軸スクリュー加工機の機械的比エネルギー投入量(kWh/kg)である)。
本明細書に開示された組成物、方法及び加工機の実施形態は、重要な属性、例えば従来の類似の発泡組成物と比較してより高い多孔度及びより高い二酸化炭素含有量を有する発泡組成物の生産を実現する。これらの多孔性発泡組成物は、加工添加剤を使用して更に加工して、例えば、改善された機械的強度を示し、且つ一般に60秒未満の急速な崩壊時間も示す発泡錠を形成することができる。
特許請求された方法の実施形態を使用して形成された多孔性発泡組成物、詳細には顆粒の水分含有率、保持CO2含有率、崩壊時間、多孔度、かさ密度及びタップ密度、並びに他の特性を決定するための例が、本明細書に記載される。いくつかの例は、従来方法と比較して、本開示の組成物及び方法を使用することの利益を強調する。
相対保持CO2含有率(%)=(顆粒中のCO2の観測質量(g)×100)/投入ブレンド中のCO2の観測質量(g)
かさ密度=質量(m)/かさ体積(V0)
タップ密度=質量(m)/タップ体積(Vt)
相対かさ多孔度%=((顆粒1gのかさ比体積-投入ブレンド1gのかさ比体積)×100)/投入ブレンド1gのかさ比体積
(式中、顆粒1gのかさ比体積=1/顆粒のかさ密度、及び
投入ブレンド1gのかさ比体積=1/投入ブレンドのかさ密度)
相対タップ多孔度%=((顆粒1gのタップ比体積-投入ブレンド1gのタップ比体積)×100)/投入ブレンド1gのタップ比体積
(式中、顆粒1gのタップ比体積=1/顆粒のタップ密度
投入ブレンド1gのタップ比体積=1/投入ブレンドのタップ密度)
本開示による多孔性発泡組成物の調製:
4つの実験を実施して、異なる酸を含む例示的な顆粒を形成した。例示的な顆粒を形成するために使用した成分を下記に挙げる。
相対保持CO2含有率%=(顆粒中のCO2の観測質量(g)×100)/投入ブレンド中のCO2の観測質量(g)
相対保持CO2含有率%=(1.36×100)/1.43=95.10
顆粒1gのかさ比体積=1/顆粒のかさ密度
投入ブレンド1gのかさ比体積=1/投入ブレンドのかさ密度
相対かさ多孔度%=((顆粒1gのかさ比体積-投入ブレンド1gのかさ比体積)×100)/投入ブレンド1gのかさ比体積
顆粒1gのかさ比体積=1/0.389=2.570
投入ブレンド1gのかさ比体積=1/0.680=1.470
相対かさ多孔度%=(2.57-1.47×100)/1.47=74.81
顆粒1gのタップ比体積=1/顆粒のタップ密度
投入ブレンド1gのタップ比体積=1/投入ブレンドのタップ密度
相対タップ多孔度%=((顆粒1gのタップ比体積-投入ブレンド1gのタップ比体積)×100)/投入ブレンド1gのタップ比体積
顆粒1gのタップ比体積=1/0.555=1.801
投入ブレンド1gのタップ比体積=1/1.137=0.879
相対タップ多孔度%=(1.801-0.879×100)/0.879=104.86
例示的な発泡錠の調製
実施例1に記載した4つの実験において得られた例示的な顆粒1〜4を、乾燥減量が0.5w/w%になるまで45℃に維持した。乾燥した顆粒を、ASTMメッシュ20番篩に通した。上記の工程からの顆粒を、20mm丸平面はす縁ツーリングを備えた単一ステーションの卓上Inweka打錠機(Ahmedabad、インド)を使用して、2.5グラムの質量の錠剤に圧縮した。次いで、錠剤を評価して、その特性を決定した。4つの実験において得られた錠剤の特性を、下記のTable 5(表6)に要約した。
APIを含む発泡錠の調製
3つの実験を実施して、API-アスピリン、N-アセチル-L-システイン(NAC)及びセフィキシムを含む発泡錠を形成した。発泡錠を形成するために使用した成分を下記に示す。
積極的に添加される造粒剤として溶融性結合剤を使用することによる発泡顆粒の調製
1つの例では、積極的に添加される結合剤を使用して顆粒を形成する方法を使用して、錠剤を製造した。この例における錠剤を形成するために使用した成分を下記に示す。
溶融している酸の一部及び溶融していない酸の一部の組合せを含む無水酸成分と、カーボネート官能基を含み、酸成分と反応して二酸化炭素を形成することが可能である無水塩基成分とを含む顆粒状組成物であって、無水酸成分及び無水塩基成分が、1:9から9:1の範囲の質量比で存在する、積極的に添加される造粒剤を含まない、組成物。
202 取入れゾーン
204 造粒開始ゾーン
206 造粒完了ゾーン
208 出口
Claims (35)
- 溶融している酸の一部及び溶融していない酸の一部の組合せを含む無水酸成分と、
カーボネート官能基を含み、酸成分と反応して二酸化炭素を形成することが可能である無水塩基成分と
を含む顆粒状組成物であって、
無水酸成分及び無水塩基成分が1:9から9:1の範囲の質量比で存在し、組成物が、積極的に添加される造粒剤を含まない、組成物。 - 抗感染症薬、抗細菌薬、抗ヒスタミン薬、鬱血除去薬、抗炎症薬、抗寄生虫薬、抗ウイルス薬、抗真菌薬、殺アメーバ薬、殺トリコモナス剤、鎮痛薬、抗関節炎薬、抗喘息薬、抗凝固薬、抗けいれん薬、抗鬱薬、抗糖尿病薬、抗新生物薬、抗精神病薬、降圧薬、去痰薬、電解質、緩下薬、植物性医薬品、筋弛緩薬、利尿薬、又はそれらの組合せからなる群から選択される医薬活性作用物質を更に含む、請求項1に記載の組成物。
- 酸及び塩基を含む投入ブレンドから、投入ブレンドを二軸スクリュー加工機において造粒することによって形成された多孔性発泡組成物であって、in situ造粒剤によって形成された顆粒を含み、in situ造粒剤が酸の一部であり、前記酸の一部が、造粒中に溶融する酸の一部である、多孔性発泡組成物。
- 投入ブレンドの多孔度よりも少なくとも50%大きい多孔度を有する、請求項3に記載の多孔性発泡組成物。
- 投入ブレンドの少なくとも90%の保持二酸化炭素含有率を有する、請求項3に記載の多孔性発泡組成物。
- 積極的に添加される造粒剤を含有しない、又は含まない、請求項3に記載の多孔性発泡組成物。
- 投入ブレンドの酸及び塩基の一方又は両方が、無水である、請求項3に記載の多孔性発泡組成物。
- 投入ブレンドが、組成物の0.5w/w%未満の水分含有率を有する、請求項3に記載の多孔性発泡組成物。
- 酸が、クエン酸、酒石酸、アジピン酸、リンゴ酸、又はそれらの組合せからなる群から選択される、請求項3に記載の多孔性発泡組成物。
- 投入ブレンドが、医薬、食品、獣医学、栄養補助、園芸、家庭、料理、殺虫、農業、化粧、除草、工業、洗浄、製菓及び着香用の作用物質、又はそれらの組合せからなる群から選択される1種又は複数の成分を更に含む、請求項3に記載の多孔性発泡組成物。
- 酸及び塩基を含む投入ブレンドから、投入ブレンドを二軸スクリュー加工機において造粒することによって形成された多孔性発泡組成物であって、in situ造粒剤によって形成された顆粒を含み、in situ造粒剤が酸の一部であり、前記酸の一部が、造粒中に溶融する酸の一部である、多孔性発泡組成物と、1種又は複数の任意選択の加工添加剤とを含む、経口固体剤形。
- 投入ブレンドの酸及び塩基の一方又は両方が、無水である、請求項11に記載の経口固体剤形。
- 多孔性発泡組成物が、投入ブレンドの多孔度よりも少なくとも50%大きい多孔度を有する、請求項11に記載の経口固体剤形。
- 多孔性発泡組成物が、投入ブレンドの少なくとも90%の保持二酸化炭素含有率を有する、請求項11に記載の経口固体剤形。
- 酸が、クエン酸、酒石酸、アジピン酸、リンゴ酸、又はそれらの組合せからなる群から選択される、請求項11に記載の経口固体剤形。
- 医薬、食品、獣医学、栄養補助、園芸、家庭、料理、殺虫、農業、化粧、除草、工業、洗浄、製菓及び着香用の作用物質、又はそれらの組合せからなる群から選択される1種又は複数の成分を更に含む、請求項11に記載の経口固体剤形。
- 発泡錠、経口投与用散剤、又はそれらの組合せからなる群から選択される、請求項11に記載の経口固体剤形。
- 発泡錠が、速崩錠又は口腔内崩壊錠である、請求項17に記載の経口固体剤形。
- 発泡錠が、約25℃±5℃の室温で、水中で20から90秒の崩壊時間を有する、請求項17に記載の経口固体剤形。
- 発泡錠が、少なくとも3Kpの硬度を有する、請求項17に記載の経口固体剤形。
- 多孔性発泡顆粒を調製するための方法であって、
酸及び塩基を含む投入ブレンドを二軸スクリュー加工機に供給する工程と、
in situ造粒剤として機能するように、酸の一部のみを溶融させる工程と、
投入ブレンドを造粒して顆粒を形成する工程と、
任意選択で、二軸スクリュー加工機から顆粒を回収する工程と
を含む、方法。 - 酸の一部のみの溶融が、二軸スクリュー加工機の造粒開始ゾーンにおいて、材料の停滞なしに達成され、造粒開始ゾーンが、搬送エレメントから本質的になる、請求項21に記載の方法。
- 酸の一部のみの溶融が、二軸スクリュー加工機内における短い滞留時間を保つことによって達成される、請求項21に記載の方法。
- 造粒開始ゾーンが、酸の一部のみの溶融を引き起こすのに十分な温度に維持される、請求項21に記載の方法。
- 二軸スクリュー加工機が、共回転二軸スクリュー押出機である、請求項21に記載の方法。
- 二軸スクリュー加工機から回収された顆粒が、投入ブレンドの多孔度よりも少なくとも50%大きい多孔度を有する、請求項21に記載の方法。
- 二軸スクリュー加工機から回収された顆粒が、投入ブレンドの少なくとも90%の保持二酸化炭素含有率を有する、請求項21に記載の方法。
- 多孔性発泡顆粒を調製するための二軸スクリュー加工機であって、
酸及び塩基を含む投入ブレンドを受け入れるための取入れゾーンと、
in situ造粒剤として機能するように、酸の一部のみを溶融させるための造粒開始ゾーンと、
投入ブレンドを造粒するための造粒完了ゾーンと、
顆粒を吐出するための出口と
を含む、二軸スクリュー加工機。 - 造粒開始ゾーンが、搬送エレメントから本質的になる、請求項28に記載の二軸スクリュー加工機。
- 造粒開始ゾーンが、造粒開始ゾーンを酸の一部のみを溶融させるのに十分な温度に維持する加熱エレメントを含む、請求項28に記載の二軸スクリュー加工機。
- 造粒完了ゾーンが、搬送エレメントから本質的になる、請求項28に記載の二軸スクリュー加工機。
- 造粒完了ゾーンが、造粒開始ゾーンの温度よりも低い温度に維持される、請求項28に記載の二軸スクリュー加工機。
- 造粒開始ゾーン及び造粒完了ゾーンの間に遷移ゾーンを更に含み、遷移ゾーンが、造粒開始ゾーンの温度よりも低く、且つ造粒完了ゾーンの温度よりも高い温度に維持される、請求項28に記載の二軸スクリュー加工機。
- 共回転二軸スクリュー押出機である、請求項28に記載の二軸スクリュー加工機。
- 酸及び塩基を含む多孔性発泡顆粒であって、顆粒を調製するために使用される投入ブレンドの多孔度よりも少なくとも50%大きい多孔度を有し、投入ブレンドの二酸化炭素の少なくとも90%を保持する、多孔性発泡顆粒。
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US20220192973A1 (en) | 2022-06-23 |
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AU2015316552C1 (en) | 2018-08-23 |
AU2018203085B2 (en) | 2019-12-19 |
JP6566450B2 (ja) | 2019-08-28 |
AU2018203085A1 (en) | 2018-05-24 |
JP7010890B2 (ja) | 2022-01-26 |
CA3018828A1 (en) | 2016-03-24 |
KR102193599B1 (ko) | 2020-12-21 |
WO2016042372A1 (en) | 2016-03-24 |
CN106714783A (zh) | 2017-05-24 |
KR20170071500A (ko) | 2017-06-23 |
JP2019163335A (ja) | 2019-09-26 |
JP2018138553A (ja) | 2018-09-06 |
EP3193843A1 (en) | 2017-07-26 |
CA2961445A1 (en) | 2016-03-24 |
RU2706727C2 (ru) | 2019-11-20 |
US11576855B2 (en) | 2023-02-14 |
JP6748138B2 (ja) | 2020-08-26 |
AU2015316552B2 (en) | 2018-05-24 |
CA3018828C (en) | 2021-05-11 |
RU2017110025A (ru) | 2018-10-17 |
BR112017005362A2 (pt) | 2018-01-23 |
AU2015316552A1 (en) | 2017-05-04 |
RU2017110025A3 (ja) | 2018-10-17 |
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