JP2022500490A - 送達装置における放出制御製剤 - Google Patents
送達装置における放出制御製剤 Download PDFInfo
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- JZRWCGZRTZMZEH-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N JZRWCGZRTZMZEH-UHFFFAOYSA-N 0.000 description 1
- YFNCATAIYKQPOO-UHFFFAOYSA-N thiophanate Chemical compound CCOC(=O)NC(=S)NC1=CC=CC=C1NC(=S)NC(=O)OCC YFNCATAIYKQPOO-UHFFFAOYSA-N 0.000 description 1
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- OHKOGUYZJXTSFX-KZFFXBSXSA-N ticarcillin Chemical compound C=1([C@@H](C(O)=O)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)C=CSC=1 OHKOGUYZJXTSFX-KZFFXBSXSA-N 0.000 description 1
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- IEDVJHCEMCRBQM-UHFFFAOYSA-N trimethoprim Chemical compound COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 IEDVJHCEMCRBQM-UHFFFAOYSA-N 0.000 description 1
- 229960001082 trimethoprim Drugs 0.000 description 1
- 229960003842 virginiamycin Drugs 0.000 description 1
- 235000019373 virginiamycin Nutrition 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
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- 229940045997 vitamin a Drugs 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- 235000012431 wafers Nutrition 0.000 description 1
- 238000003466 welding Methods 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
- 229960002555 zidovudine Drugs 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
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Abstract
Description
・ルーメン液に対して実質的に不浸透性の本体であって、バレルと、少なくとも1つの出口と、バレル内の少なくとも1つのマトリックスと、を備える、本体と、
・バレル内のマトリックスの列を少なくとも1つの出口に付勢するように適合された本体内の圧縮機構と、
・ルーメンの保持を支援するための、本体に依存する少なくとも1つの可変外形装置と、を備え、
バレル内の少なくとも1つのマトリックスは、少なくとも1つの有効成分と、非イオン性ポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマーと、を含む。
・ルーメン液に対して実質的に不浸透性の本体であって、バレルと、少なくとも1つの出口と、バレル内の少なくとも1つのマトリックスと、を備える、本体と、
・バレル内のマトリックスの列を少なくとも1つの出口に付勢するように適合された本体内の圧縮機構と、
・ルーメンの保持を支援するための、本体から依存する少なくとも1つの可変外形装置と、を備え、
バレル内の少なくとも1つのマトリックスは、少なくとも1つの有効成分と、非イオン性ポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマーと、を含み、アニオン性ポリマーは、ポリエチレングリコールのブロックポリマーである。
・ルーメン液に対して実質的に不浸透性の本体であって、バレルと、少なくとも1つの出口と、バレル内の少なくとも1つのマトリックスと、を備える、本体と、
・バレル内のマトリックスの列を少なくとも1つの出口に付勢するように適合された本体内の圧縮機構と、
・ルーメンの保持を支援するための、本体から依存する少なくとも1つの可変外形装置と、を備え、
バレル内の少なくとも1つのマトリックスは、少なくとも1つの有効成分と、非イオン性ポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマーと、を含み、アニオン性ポリマーは、長鎖アルキル酸エステルを含む。
・ルーメン液に対して実質的に不浸透性の本体であって、バレルと、少なくとも1つの出口と、バレル内の少なくとも1つのマトリックスと、を備える、本体と、
・バレル内のマトリックスの列を少なくとも1つの出口に付勢するように適合された本体内の圧縮機構と、
・ルーメンの保持を支援するための、本体から依存する少なくとも1つの可変外形装置と、を備え、
バレル内の少なくとも1つのマトリックスは、少なくとも1つの有効成分と、非イオン性ポリオールポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマーと、を含む。
・ルーメン液に対して実質的に不浸透性の本体であって、バレルと、少なくとも1つの出口と、バレル内の少なくとも1つのマトリックスと、を備える、本体と、
・バレル内のマトリックスの列を少なくとも1つの出口に付勢するように適合された本体内の圧縮機構と、
・ルーメンの保持を支援するための、本体から依存する少なくとも1つの可変外形装置と、を備え、
バレル内の少なくとも1つのマトリックスは、少なくとも1つの有効成分と、
a)非イオン性ポリオールポリマー、
b)長鎖アルキル酸エステルを含む架橋アニオン性ポリマー、
c)ポリエチレングリコールのブロックポリマーである架橋アニオン性ポリマー、および
d)(a)〜(c)の任意の組み合わせから選択される少なくとも1つのポリマーと、を含む。
・ルーメン液に対して実質的に不浸透性の本体であって、バレルと、少なくとも1つの出口と、バレル内の少なくとも1つのマトリックスと、を備える、本体と、
・バレル内のマトリックスの列を少なくとも1つの出口に付勢するように適合された本体内の圧縮機構と、
・ルーメンの保持を支援するための、本体から依存する少なくとも1つの可変外形装置と、を備え、
バレル内の少なくとも1つのマトリックスは、少なくとも1つの有効成分と、
a)非イオン性ポリマーであって、
i)非イオン性ポリオールポリマーと、
ii)非イオン性ポリエチレンオキシドホモポリマーと、
iii)約0.9〜約700万の分子量を有する非イオン性ポリエチレンオキシドホモポリマーと、
iv)約7,500cPを超える粘度を有する非イオン性ポリエチレンオキシドホモポリマーと、
v)容易に架橋される非イオン性ポリエチレンオキシドホモポリマーと、を含む非イオン性ポリマー、または
b)架橋アニオン性ポリマーであって、
vi)長鎖アルキル酸エステルを含む架橋アニオン性ポリマーと、
vii)ポリエチレングリコールのブロックポリマーである架橋アニオン性ポリマーと、
viii)アニオン性ポリ(アクリル酸)インターポリマー(コポリマー)と、
ix)ポリアルコールのアリルエステルと架橋したアクリル酸インターポリマーと、
x)非水溶性のアニオン性アクリル酸インターポイマーと、
xi)約45,000cPを超える粘度を有するアニオン性アクリル酸インターポリマーと、
xii)重合プロセスがベンゼンフリーであるポリマーと、
xiii)使用した重合溶媒が酢酸エチルもしくはシクロヘキサン、またはそれらの組み合わせを含む共溶媒であるポリマーと、
xiv)実質的にベンゼンフリーである非イオン性アクリル酸インターポリマーと、
xv)非イオン性アクリル酸インターポリマーと、を含む架橋アニオン性ポリマー、または
c)(i)〜(xv)の任意の組み合わせから選択される、少なくとも1つのポリマーと、を含む。
p)
q)長鎖アルキル酸エステルを含む架橋アニオン性ポリマー、
r)ポリエチレングリコールのブロックポリマーである架橋アニオン性ポリマー、
s)(a)〜(c)の任意の組み合わせ、の特性のいずれか1つ以上を有する。
・少なくとも1つの有効成分、および非イオン性ポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマー、および任意選択で1つ以上の賦形剤を含む混合物を顆粒にすることと、
・顆粒を乾燥させることと、
・顆粒をふるいに通すことと、
・顆粒を少なくとも1つのマトリックスに錠剤化することと、
・少なくとも1つのマトリックスをルーメン内装置の本体内に装填することと、を含む。
本発明は、ルーメン内装置に関し、ルーメン内装置は、ルーメン液に対して実質的に不浸透性の本体であって、バレルと、少なくとも1つの出口と、バレル内の少なくとも1つのマトリックスと、を備える本体と、
バレル内の少なくとも1つのマトリックスは、少なくとも1つの有効成分と、非イオン性ポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマーと、を含む。
加重構成要素は、例えば、本体の残りの部分を作製するために使用される材料よりも高密度の材料から作製された本体の領域であり得る。したがって、加重構成要素は、ルーメン内装置がルーメン腔の底に留まることを確実にして、逆流を回避することができる。
本発明のルーメン内装置は、少なくとも1つのマトリックスを備える。少なくとも1つのマトリックスは、1つ以上の有効成分と、1つ以上のポリマーおよび賦形剤とを、治療有効量の1つ以上の有効成分を非ヒト動物、好ましくは反芻動物に送達することを可能にする比率で備え得る。
本発明者らは、ルーメン内装置における少なくとも1つのマトリックスからの栄養的または薬学的有効成分(複数可)の放出速度および/または放出の直線性が、マトリックス内の1つ以上のポリマー、好ましくは非イオン性および架橋アニオン性ポリマーからなる群から選択される1つ以上のポリマーを使用して調整または制御され得ることを、有利に発見した。
((最終重量(膨潤後)−初期重量(膨潤前)/初期重量(膨潤前))×100%
・陰イオン性ポリ(アクリル酸)インターポリマー(コポリマー)。
・ポリアルコールのアリルエステルで架橋されたアクリル酸インターポリマー。
・陰イオン性アクリル酸インターポリマーは非水溶性である。
・粘度が約45,000cPを超えるアニオン性アクリル酸インターポリマー。
・重合プロセスがベンゼンフリーであるように形成される。
・重合溶媒が酢酸エチルとシクロヘキサンを含む共溶媒であるように形成される。
・陰イオン性アクリル酸インターポリマーは、本質的にベンゼンフリーである。
・陰イオン性アクリル酸インターポリマーは、Carbopol Ultrez 10である。
・非イオン性ポリエチレンオキシドホモポリマー。
・非イオン性ポリエチレンオキシドホモポリマーの分子量は、約0.9〜700万である。
・非イオン性ポリエチレンオキシドホモポリマーの粘度は、約7,500超である。
・非イオン性ポリエチレンオキシドホモポリマーは、容易に架橋される。
本発明のルーメン内装置内の少なくとも1つのマトリックスは、治療量の1つ以上の有効成分を送達する。有効成分(複数可)は、ルーメン内装置から送達され、例えば胃腸管において局所作用を有し得、および/または微生物もしくは酵素環境を含むルーメン内で活性を有し得、および/または体循環に吸収されて、例えば主要な臓器や組織を含む他の体のコンパートメントに治療反応を与え得る。
1つ以上の有効成分およびポリマーを含む少なくとも1つのマトリックスは、いくつかの賦形剤をさらに含み得る。好適な賦形剤の例には、充填剤、希釈剤、潤滑剤、界面活性剤、流動促進剤、ゲル形成剤、結合剤、および安定剤、あるいはそれらの組み合わせが含まれ得るが、これらに限定されない。
いくつかの実施形態では、本発明は、本明細書に記載されるようなルーメン内装置を製造する方法を提供する。
・少なくとも1つの有効成分、および非イオン性ポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマー、および任意選択で本明細書に記載の1つ以上の賦形剤を含む混合物を顆粒にすることと、
・顆粒を乾燥させることと、
・顆粒をふるいに通すことと、
・顆粒を少なくとも1つのマトリックスに錠剤化/圧縮することと、
・少なくとも1つのマトリックスをルーメン内装置の本体内に装填することと、を含む、方法。
少なくとも1つのマトリックスおよびルーメン内装置は、共に使用される場合、治療有効量の範囲の有効成分、例えば駆虫薬を、非ヒト動物、好ましくは反芻動物に送達することができる。ルーメン内装置は、ルーメン内装置の一端の少なくとも1つの出口を通って拡散させることにより、活性物質をルーメンに送達することができる。
試料マトリックスの実験室規模のバッチは、
・42%w/w有効成分(モネンシンナトリウム)と、
・44%w/wショ糖脂肪酸エステルと、
・1.5%w/wステアリン酸マグネシウムと、
・0.5%w/wコロイド状二酸化ケイ素と、
・表1に記したポリマーと、乳糖一水和物と、を含有して製造された。
特注の240Lステンレス鋼タンクを使用して、製剤を評価した。このモデルは、ミネラル濃度および/またはイオン相互作用の変化に対する本明細書に記載の製剤の感受性を試験する。
Claims (26)
- ルーメン内装置であって、
ルーメン液に対して実質的に不浸透性の本体であって、バレルと、少なくとも1つの出口と、前記バレル内の少なくとも1つのマトリックスと、を備える、本体と、
前記バレル内のマトリックスの列を前記少なくとも1つの出口に付勢するように適合された前記本体内の圧縮機構と、
ルーメンの保持を支援するための、前記本体に依存する少なくとも1つの可変外形装置と、を備え、
前記バレル内の前記少なくとも1つのマトリックスは、少なくとも1つの有効成分と、非イオン性ポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマーと、を含む、ルーメン内装置。 - 前記非イオン性ポリマーはホモポリマーである、請求項1に記載のルーメン内装置。
- 前記非イオン性ポリマーは、ポリエチレンオキシドポリマーおよびポリビニルピロリドンからなる群から選択される、請求項1または2に記載のルーメン内装置。
- 前記ポリビニルピロリドンは、35,000〜60,000g/molL−1の範囲の分子量を有する、請求項3に記載のルーメン内装置。
- 前記ポリエチレンオキシドポリマーは、800,000〜7,250,000g/molL−1の範囲の分子量を有する、請求項3に記載のルーメン内装置。
- 前記ポリエチレンオキシドポリマーは、5,000〜15,000cPの範囲の粘度を有する、請求項5に記載のルーメン内装置。
- 前記架橋アニオン性ポリマーは、モノマーの総数と比較して、遊離アニオン基を有する65%未満のモノマーを含む、請求項1に記載のルーメン内装置。
- 前記架橋アニオン性ポリマーは、ポリアクリル酸またはポリアクリル酸誘導体である、請求項1または7に記載のルーメン内装置。
- 前記架橋アニオン性ポリマーは、アリルスクロースまたはアリルペンタエリスリトールで架橋されている、請求項1、7または8のいずれか一項に記載のルーメン内装置。
- 前記架橋アニオン性ポリマーは、40,000〜67,000cPの範囲の粘度を有する、請求項1または7〜9のいずれか一項に記載のルーメン内装置。
- 前記架橋アニオン性ポリマーは、ポリエチレングリコールと長鎖アルキル酸エステルとのブロックコポリマーを含む、請求項1または7〜10のいずれか一項に記載のルーメン内装置。
- 反芻動物を治療する方法で使用するための、請求項1〜11のいずれか一項に記載のルーメン内装置。
- 前記治療方法は、前記反芻動物のルーメン内のpHおよびイオン効果に左右されない、請求項12に記載のルーメン内装置。
- 前記治療方法は、前記反芻動物の食餌の変化に起因するpHおよびイオン効果に左右されない、請求項13に記載のルーメン内装置。
- 少なくとも1つの有効成分または有益な成分は、抗生物質、抗真菌剤、抗ウイルス剤、ステロイドホルモン、抗ヒスタミン剤、代謝調節剤、例えば、ルーメンメタン阻害剤/調節剤、生産性調節剤、コルチコステロイド、抗甲状腺剤、例えば駆虫薬などの寄生虫駆除剤(外部寄生虫駆除剤および/または内部寄生虫駆除剤)、非ステロイド性抗炎症剤、栄養活性物質、ルーメン発酵調整剤、またはそれらの組み合わせからなる群から選択される、請求項1〜14のいずれか一項に記載のルーメン内装置。前記少なくとも1つの有効成分は寄生虫駆除剤である、先の請求項のいずれか一項に記載のルーメン内装置。
- 前記少なくとも1つの有効成分は寄生虫駆除剤である、請求項1〜15のいずれか一項に記載のルーメン内装置。
- 前記寄生虫駆除剤は、ベンズイミダゾール、イミダゾチアゾール、テトラヒドロピリミジン、大環状ラクトン、サリチルアニリド、置換フェノール、芳香族アミド、イソキノリン、アミノアセトニトリルおよびスピロインドール、またはそれらの組み合わせからなる群から選択される駆虫薬である、請求項9に記載のルーメン内装置。
- 治療を必要とする反芻動物を治療する方法であって、請求項1〜17のいずれか一項に記載のルーメン内装置を前記反芻動物に投与することを含む、方法。
- 前記治療方法は、前記反芻動物のルーメン内のpHおよびイオン効果に左右されない、請求項18に記載の方法。
- 前記治療方法は、前記反芻動物の食餌の変化に起因するpHおよびイオン効果に左右されない、請求項19に記載の方法。
- 有効濃度の少なくとも1つの有効成分を、それを必要とする反芻動物に送達するための、請求項1〜17のいずれか一項に記載の放出制御ルーメン内装置の使用。
- 前記有効濃度は、前記反芻動物の前記ルーメン内のpHおよびイオン効果に左右されない、請求項21に記載の使用。
- 前記有効濃度は、前記反芻動物の食餌の変化に起因するpHおよびイオン効果に左右されない、請求項22に記載の使用。
- 前記反芻動物は、ウシ、ヤギ、ヒツジおよびシカからなる群から選択される、請求項18〜20のいずれか一項に記載の方法または請求項21〜23のいずれか一項に記載の使用。
- 請求項1〜17のいずれか一項に記載の制御送達ルーメン内装置を組み立てる方法であって、
少なくとも1つの有効成分と、非イオン性ポリマーおよび架橋アニオン性ポリマーからなる群から選択される少なくとも1つのポリマーと、任意選択で1つ以上の賦形剤と、を含む混合物を顆粒にすることと、
前記顆粒を乾燥させることと、
前記顆粒をふるいに通すことと、
前記顆粒を少なくとも1つのマトリックスに錠剤化することと、
前記少なくとも1つのマトリックスをルーメン内装置の本体内に装填することと、を含む、方法。 - 本明細書の任意の実施例を参照して、および添付の図面のうちのいずれか1つ以上を参照して、または参照せずに、実質的に本明細書に記載される、請求項1〜25のいずれか一項に記載のルーメン内装置、方法または使用。
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- 2019-09-10 CA CA3112369A patent/CA3112369A1/en active Pending
- 2019-09-10 WO PCT/NZ2019/050120 patent/WO2020055271A1/en unknown
- 2019-09-10 JP JP2021537435A patent/JP2022500490A/ja active Pending
- 2019-09-10 EP EP19860409.2A patent/EP3849525A4/en active Pending
- 2019-09-10 AU AU2019338076A patent/AU2019338076A1/en active Pending
- 2019-09-10 CN CN201980073735.8A patent/CN113329740A/zh active Pending
- 2019-09-10 US US17/275,109 patent/US20220054809A1/en active Pending
- 2019-09-10 BR BR112021004458-2A patent/BR112021004458A2/pt unknown
- 2019-09-10 MX MX2021002855A patent/MX2021002855A/es unknown
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BR112021004458A2 (pt) | 2021-05-25 |
US20220054809A1 (en) | 2022-02-24 |
CA3112369A1 (en) | 2020-03-19 |
EP3849525A4 (en) | 2022-06-08 |
AU2019338076A1 (en) | 2021-05-20 |
WO2020055271A1 (en) | 2020-03-19 |
MX2021002855A (es) | 2021-08-16 |
EP3849525A1 (en) | 2021-07-21 |
CN113329740A (zh) | 2021-08-31 |
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