JP2018517676A5 - - Google Patents
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- JP2018517676A5 JP2018517676A5 JP2017555543A JP2017555543A JP2018517676A5 JP 2018517676 A5 JP2018517676 A5 JP 2018517676A5 JP 2017555543 A JP2017555543 A JP 2017555543A JP 2017555543 A JP2017555543 A JP 2017555543A JP 2018517676 A5 JP2018517676 A5 JP 2018517676A5
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- 239000000825 pharmaceutical preparation Substances 0.000 claims description 42
- 239000008194 pharmaceutical composition Substances 0.000 claims description 23
- 239000007884 disintegrant Substances 0.000 claims description 22
- 239000002245 particle Substances 0.000 claims description 22
- 150000001875 compounds Chemical class 0.000 claims description 15
- 229920000233 poly(alkylene oxides) Polymers 0.000 claims description 13
- 239000007788 liquid Substances 0.000 claims description 10
- 229920002472 Starch Polymers 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 7
- 235000019698 starch Nutrition 0.000 claims description 7
- 229920000881 Modified starch Polymers 0.000 claims description 6
- 238000009472 formulation Methods 0.000 claims description 6
- 150000004676 glycans Polymers 0.000 claims description 6
- 229920001282 polysaccharide Polymers 0.000 claims description 6
- 239000005017 polysaccharide Substances 0.000 claims description 6
- 150000004804 polysaccharides Polymers 0.000 claims description 6
- 238000000338 in vitro Methods 0.000 claims description 5
- 235000019426 modified starch Nutrition 0.000 claims description 5
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 5
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 5
- 239000000126 substance Substances 0.000 claims description 5
- KWTSXDURSIMDCE-QMMMGPOBSA-N (S)-amphetamine Chemical compound C[C@H](N)CC1=CC=CC=C1 KWTSXDURSIMDCE-QMMMGPOBSA-N 0.000 claims description 4
- 239000001913 cellulose Substances 0.000 claims description 4
- 229920002678 cellulose Polymers 0.000 claims description 4
- 235000010980 cellulose Nutrition 0.000 claims description 4
- 238000006011 modification reaction Methods 0.000 claims description 4
- 230000003364 opioid Effects 0.000 claims description 4
- 238000002360 preparation method Methods 0.000 claims description 4
- 239000008213 purified water Substances 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- 239000011780 sodium chloride Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 239000002775 capsule Substances 0.000 claims description 3
- DUGOZIWVEXMGBE-UHFFFAOYSA-N Adhd patch Chemical compound C=1C=CC=CC=1C(C(=O)OC)C1CCCCN1 DUGOZIWVEXMGBE-UHFFFAOYSA-N 0.000 claims description 2
- 229940025084 Amphetamine Drugs 0.000 claims description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N HCl Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 2
- LLPOLZWFYMWNKH-CMKMFDCUSA-N Hydrocodone Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)CC(=O)[C@@H]1OC1=C2C3=CC=C1OC LLPOLZWFYMWNKH-CMKMFDCUSA-N 0.000 claims description 2
- WVLOADHCBXTIJK-YNHQPCIGSA-N Hydromorphone Chemical compound O([C@H]1C(CC[C@H]23)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O WVLOADHCBXTIJK-YNHQPCIGSA-N 0.000 claims description 2
- 229960001344 Methylphenidate Drugs 0.000 claims description 2
- BQJCRHHNABKAKU-KBQPJGBKSA-N Morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims description 2
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycontin Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims description 2
- UQCNKQCJZOAFTQ-ISWURRPUSA-N Oxymorphone Chemical compound O([C@H]1C(CC[C@]23O)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O UQCNKQCJZOAFTQ-ISWURRPUSA-N 0.000 claims description 2
- KWGRBVOPPLSCSI-WCBMZHEXSA-N Pseudoephedrine Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WCBMZHEXSA-N 0.000 claims description 2
- 229960003908 Pseudoephedrine Drugs 0.000 claims description 2
- KWTWDQCKEHXFFR-SMDDNHRTSA-N Tapentadol Chemical compound CN(C)C[C@H](C)[C@@H](CC)C1=CC=CC(O)=C1 KWTWDQCKEHXFFR-SMDDNHRTSA-N 0.000 claims description 2
- TVYLLZQTGLZFBW-ZBFHGGJFSA-N Tramadol Chemical compound COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-ZBFHGGJFSA-N 0.000 claims description 2
- 229960004380 Tramadol Drugs 0.000 claims description 2
- 150000001252 acrylic acid derivatives Chemical class 0.000 claims description 2
- 229960002734 amfetamine Drugs 0.000 claims description 2
- 238000009835 boiling Methods 0.000 claims description 2
- -1 dexamethylphenidate Chemical compound 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims description 2
- 238000010438 heat treatment Methods 0.000 claims description 2
- 229960000240 hydrocodone Drugs 0.000 claims description 2
- 229910000041 hydrogen chloride Inorganic materials 0.000 claims description 2
- 229960001410 hydromorphone Drugs 0.000 claims description 2
- 239000011159 matrix material Substances 0.000 claims description 2
- 229960005181 morphine Drugs 0.000 claims description 2
- 229930014694 morphine Natural products 0.000 claims description 2
- 229960002085 oxycodone Drugs 0.000 claims description 2
- 229960005118 oxymorphone Drugs 0.000 claims description 2
- 239000002831 pharmacologic agent Substances 0.000 claims description 2
- 238000000638 solvent extraction Methods 0.000 claims description 2
- 229960005126 tapentadol Drugs 0.000 claims description 2
- 230000000144 pharmacologic effect Effects 0.000 claims 1
- 235000018102 proteins Nutrition 0.000 description 6
- 102000004169 proteins and genes Human genes 0.000 description 6
- 108090000623 proteins and genes Proteins 0.000 description 6
- 229940032147 Starch Drugs 0.000 description 5
- 239000008107 starch Substances 0.000 description 5
- 239000003349 gelling agent Substances 0.000 description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M NaHCO3 Chemical group [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-M acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 2
- 229960001681 Croscarmellose Sodium Drugs 0.000 description 1
- 229920002785 Croscarmellose sodium Polymers 0.000 description 1
- 229960000913 Crospovidone Drugs 0.000 description 1
- 235000010469 Glycine max Nutrition 0.000 description 1
- 240000007842 Glycine max Species 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinylpyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 229940005550 Sodium alginate Drugs 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid Chemical group OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- 239000005018 casein Substances 0.000 description 1
- 235000021240 caseins Nutrition 0.000 description 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 1
- 229920001888 polyacrylic acid Polymers 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- MSXHSNHNTORCAW-UHFFFAOYSA-M sodium 3,4,5,6-tetrahydroxyoxane-2-carboxylate Chemical compound [Na+].OC1OC(C([O-])=O)C(O)C(O)C1O MSXHSNHNTORCAW-UHFFFAOYSA-M 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229920003109 sodium starch glycolate Polymers 0.000 description 1
- 229940079832 sodium starch glycolate Drugs 0.000 description 1
- 239000008109 sodium starch glycolate Substances 0.000 description 1
Description
３つ全てのカプセル剤のｉｎ ｖｉｔｒｏ放出プロファイルを図４に示す。
なお、本願は、特許請求の範囲に記載の発明に関するものであるが、他の態様として以下も包含し得る。
１．薬理活性化合物、ポリアルキレンオキシドおよび崩壊剤を含む多数の粒子を含む改変防止医薬製剤であって、
上記薬理活性化合物は、上記ポリアルキレンオキシドおよび崩壊剤を含むマトリックス中に分散しており、
上記崩壊剤の含有量は、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として、５．０重量％超であり、
上記ポリアルキレンオキシドの含有量は、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として、少なくとも２５重量％であり、
上記製剤は、ｉｎ ｖｉｔｒｏ条件下で、欧州薬局方に従った薬理活性化合物の即時放出を提供する、
改変防止医薬製剤。
２．少なくとも３００Ｎの破壊強度を有する、請求項１に記載の医薬製剤。
３．（ｉ）もとのままであるかまたは手動で粉砕されたかのいずれかである医薬製剤を、２つのスプーンにより、５ｍｌの精製水中に調剤し、
（ｉｉ）該液体をその沸点まで加熱し、
（ｉｉｉ）該液体を、さらなる精製水の添加なしに、蓋をした容器中で５分間沸騰させ、（ｉｖ）当該熱い液体を注射器中に抜き取り、そして
（ｖ）注射器内の液体に含まれる薬理活性化合物の量を決定した場合に、
注射器により残部から分離できる調製物の液体部分が、上記製剤に元々含まれていた薬理活性化合物の１０重量％以下であるような、溶媒抽出に対する耐性を示す、請求項１または２に記載の医薬製剤。
４．上記崩壊剤が多糖類、デンプン類、デンプン誘導体、セルロース誘導体、アクリレート類、ポリビニルピロリドン類およびガス放出物質からなる群から選択される、請求項１〜３のいずれか１つに記載の医薬製剤。
５．上記崩壊剤が多糖類であるかまたは多糖類を含む、請求項１〜４のいずれか１つに記載の医薬製剤。
６．上記多糖類が、ダイズから得られた多糖類混合物またはアルギン酸ナトリウムである、請求項５に記載の医薬製剤。
７．上記崩壊剤がデンプンであるかまたはデンプンを含む、請求項１〜６のいずれか１つに記載の医薬製剤。
８．上記デンプンが標準デンプンまたはアルファー化デンプンである、請求項７に記載の医薬製剤。
９．上記崩壊剤がデンプン誘導体であるかまたはデンプン誘導体を含む、請求項１〜８のいずれか１つに記載の医薬製剤。
１０．上記デンプン誘導体がデンプングリコール酸ナトリウムまたはカルボキシメチルデンプンナトリウムである、請求項９に記載の医薬製剤。
１１．上記崩壊剤がセルロース誘導体であるかまたはセルロース誘導体を含む、請求項１〜１０のいずれか１つに記載の医薬製剤。
１２．上記セルロース誘導体がクロスカルメロースナトリウムである、請求項１１に記載の医薬製剤。
１３．上記崩壊剤がアクリレートであるかまたはアクリレートを含む、請求項１〜１２のいずれか１つに記載の医薬製剤。
１４．上記アクリレートがカーボポールである、請求項１３に記載の医薬製剤。
１５．上記崩壊剤がポリビニルピロリドンであるかまたはポリビニルピロリドンを含む、請求項１〜１４のいずれか１つに記載の医薬製剤。
１６．上記ポリビニルピロリドンがクロスポビドンである、請求項１５に記載の医薬製剤。
１７．上記崩壊剤がガス放出物質であるかまたはガス放出物質を含む、請求項１〜１６のいずれか１つに記載の医薬製剤。
１８．上記ガス放出物質が重炭酸ナトリウムである、請求項１７に記載の医薬製剤。
１９．上記崩壊剤がタンパク質またはタンパク質誘導体であるかあるいはタンパク質またはタンパク質誘導体を含む、請求項１〜１８のいずれか１つに記載の医薬製剤。
２０．上記タンパク質またはタンパク質誘導体が架橋カゼインである、請求項１９に記載の医薬製剤。
２１．上記崩壊剤の含有量が、上記粒子の全重量を基準として少なくとも１０重量％である、請求項１〜２０のいずれか１つに記載の医薬製剤。
２２．上記崩壊剤の含有量が、上記粒子の全重量を基準として１５±５．０重量％の範囲内である、請求項１〜２１のいずれか１つに記載の医薬製剤。
２３．上記崩壊剤の含有量が、上記粒子の全重量を基準として２０±５．０重量％の範囲内である、請求項１〜２１のいずれか１つに記載の医薬製剤。
２４．上記崩壊剤の含有量が、上記粒子の全重量を基準として２５±５．０重量％の範囲内である、請求項１〜２１のいずれか１つに記載の医薬製剤。
２５．上記ポリアルキレンオキシドが少なくとも５００，０００ｇ／ｍｏｌの重量平均分子量を有する、請求項１〜２４のいずれか１つに記載の医薬製剤。
２６．上記ポリアルキレンオキシドの含有量が、上記粒子の全重量を基準として少なくとも４０重量％である、請求項１〜２５のいずれか１つに記載の医薬製剤。
２７．上記ポリアルキレンオキシドの含有量が、上記粒子の全重量を基準として少なくとも４５重量％である、請求項２６に記載の医薬製剤。
２８．上記ポリアルキレンオキシドの含有量が、上記粒子の全重量を基準として少なくとも５０重量％である、請求項２７に記載の医薬製剤。
２９．医薬製剤に含まれるポリアルキレンオキシドの全含有量が上記粒子中に含まれる、請求項１〜２８のいずれか１つに記載の医薬製剤。
３０．ｉｎ ｖｉｔｒｏ条件下で、６００ｍｌ ０．１Ｍ ＨＣｌ（ｐＨ １）において７５ｒｐｍで３０分後に、上記製剤に元々含まれていた薬理活性成分の少なくとも９０重量％が放出されるような放出プロファイルを提供する、請求項１〜２９のいずれか１つに記載の医薬製剤。
３１．追加的にゲル化剤を含む、請求項１〜３０のいずれか１つに記載の医薬製剤。
３２．上記ゲル化剤が多糖類である、請求項３１に記載の医薬製剤。
３３．上記ゲル化剤の含有量が、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として少なくとも１．０重量％である、請求項３１または３２に記載の医薬製剤。
３４．上記薬理活性化合物がオピオイドである、請求項１〜３３のいずれか１つに記載の医薬製剤。
３５．上記オピオイドが、オキシコドン、ヒドロコドン、オキシモルフォン、ヒドロモルフォン、モルヒネ、トラマドール、タペンタドール、セブラノパドールおよびそれらの生理学的に許容可能な塩からなる群から選択される、請求項３４に記載の医薬製剤。
３６．上記薬理活性化合物が興奮薬である、請求項１〜３５のいずれか１つに記載の医薬製剤。
３７．上記興奮薬が、アンフェタミン、デキサンフェタミン、メチルフェニデート、デキサメチルフェニデート、プソイドエフェドリンおよびそれらの生理学的に許容可能な塩からなる群から選択される、請求項３６に記載の医薬製剤。
３８．上記薬理活性化合物の含有量が、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として少なくとも５．０重量％である、請求項１〜３７のいずれか１つに記載の医薬製剤。
３９．上記粒子がホットメルト押出される、請求項１〜３８のいずれか１つに記載の医薬製剤。
４０．上記粒子がフィルムコーティングされている、請求項１〜３９のいずれか１つに記載の医薬製剤。
４１．錠剤またはカプセル剤である、請求項１〜４０のいずれか１つに記載の医薬製剤。
なお、本願は、特許請求の範囲に記載の発明に関するものであるが、他の態様として以下も包含し得る。
１．薬理活性化合物、ポリアルキレンオキシドおよび崩壊剤を含む多数の粒子を含む改変防止医薬製剤であって、
上記薬理活性化合物は、上記ポリアルキレンオキシドおよび崩壊剤を含むマトリックス中に分散しており、
上記崩壊剤の含有量は、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として、５．０重量％超であり、
上記ポリアルキレンオキシドの含有量は、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として、少なくとも２５重量％であり、
上記製剤は、ｉｎ ｖｉｔｒｏ条件下で、欧州薬局方に従った薬理活性化合物の即時放出を提供する、
改変防止医薬製剤。
２．少なくとも３００Ｎの破壊強度を有する、請求項１に記載の医薬製剤。
３．（ｉ）もとのままであるかまたは手動で粉砕されたかのいずれかである医薬製剤を、２つのスプーンにより、５ｍｌの精製水中に調剤し、
（ｉｉ）該液体をその沸点まで加熱し、
（ｉｉｉ）該液体を、さらなる精製水の添加なしに、蓋をした容器中で５分間沸騰させ、（ｉｖ）当該熱い液体を注射器中に抜き取り、そして
（ｖ）注射器内の液体に含まれる薬理活性化合物の量を決定した場合に、
注射器により残部から分離できる調製物の液体部分が、上記製剤に元々含まれていた薬理活性化合物の１０重量％以下であるような、溶媒抽出に対する耐性を示す、請求項１または２に記載の医薬製剤。
４．上記崩壊剤が多糖類、デンプン類、デンプン誘導体、セルロース誘導体、アクリレート類、ポリビニルピロリドン類およびガス放出物質からなる群から選択される、請求項１〜３のいずれか１つに記載の医薬製剤。
５．上記崩壊剤が多糖類であるかまたは多糖類を含む、請求項１〜４のいずれか１つに記載の医薬製剤。
６．上記多糖類が、ダイズから得られた多糖類混合物またはアルギン酸ナトリウムである、請求項５に記載の医薬製剤。
７．上記崩壊剤がデンプンであるかまたはデンプンを含む、請求項１〜６のいずれか１つに記載の医薬製剤。
８．上記デンプンが標準デンプンまたはアルファー化デンプンである、請求項７に記載の医薬製剤。
９．上記崩壊剤がデンプン誘導体であるかまたはデンプン誘導体を含む、請求項１〜８のいずれか１つに記載の医薬製剤。
１０．上記デンプン誘導体がデンプングリコール酸ナトリウムまたはカルボキシメチルデンプンナトリウムである、請求項９に記載の医薬製剤。
１１．上記崩壊剤がセルロース誘導体であるかまたはセルロース誘導体を含む、請求項１〜１０のいずれか１つに記載の医薬製剤。
１２．上記セルロース誘導体がクロスカルメロースナトリウムである、請求項１１に記載の医薬製剤。
１３．上記崩壊剤がアクリレートであるかまたはアクリレートを含む、請求項１〜１２のいずれか１つに記載の医薬製剤。
１４．上記アクリレートがカーボポールである、請求項１３に記載の医薬製剤。
１５．上記崩壊剤がポリビニルピロリドンであるかまたはポリビニルピロリドンを含む、請求項１〜１４のいずれか１つに記載の医薬製剤。
１６．上記ポリビニルピロリドンがクロスポビドンである、請求項１５に記載の医薬製剤。
１７．上記崩壊剤がガス放出物質であるかまたはガス放出物質を含む、請求項１〜１６のいずれか１つに記載の医薬製剤。
１８．上記ガス放出物質が重炭酸ナトリウムである、請求項１７に記載の医薬製剤。
１９．上記崩壊剤がタンパク質またはタンパク質誘導体であるかあるいはタンパク質またはタンパク質誘導体を含む、請求項１〜１８のいずれか１つに記載の医薬製剤。
２０．上記タンパク質またはタンパク質誘導体が架橋カゼインである、請求項１９に記載の医薬製剤。
２１．上記崩壊剤の含有量が、上記粒子の全重量を基準として少なくとも１０重量％である、請求項１〜２０のいずれか１つに記載の医薬製剤。
２２．上記崩壊剤の含有量が、上記粒子の全重量を基準として１５±５．０重量％の範囲内である、請求項１〜２１のいずれか１つに記載の医薬製剤。
２３．上記崩壊剤の含有量が、上記粒子の全重量を基準として２０±５．０重量％の範囲内である、請求項１〜２１のいずれか１つに記載の医薬製剤。
２４．上記崩壊剤の含有量が、上記粒子の全重量を基準として２５±５．０重量％の範囲内である、請求項１〜２１のいずれか１つに記載の医薬製剤。
２５．上記ポリアルキレンオキシドが少なくとも５００，０００ｇ／ｍｏｌの重量平均分子量を有する、請求項１〜２４のいずれか１つに記載の医薬製剤。
２６．上記ポリアルキレンオキシドの含有量が、上記粒子の全重量を基準として少なくとも４０重量％である、請求項１〜２５のいずれか１つに記載の医薬製剤。
２７．上記ポリアルキレンオキシドの含有量が、上記粒子の全重量を基準として少なくとも４５重量％である、請求項２６に記載の医薬製剤。
２８．上記ポリアルキレンオキシドの含有量が、上記粒子の全重量を基準として少なくとも５０重量％である、請求項２７に記載の医薬製剤。
２９．医薬製剤に含まれるポリアルキレンオキシドの全含有量が上記粒子中に含まれる、請求項１〜２８のいずれか１つに記載の医薬製剤。
３０．ｉｎ ｖｉｔｒｏ条件下で、６００ｍｌ ０．１Ｍ ＨＣｌ（ｐＨ １）において７５ｒｐｍで３０分後に、上記製剤に元々含まれていた薬理活性成分の少なくとも９０重量％が放出されるような放出プロファイルを提供する、請求項１〜２９のいずれか１つに記載の医薬製剤。
３１．追加的にゲル化剤を含む、請求項１〜３０のいずれか１つに記載の医薬製剤。
３２．上記ゲル化剤が多糖類である、請求項３１に記載の医薬製剤。
３３．上記ゲル化剤の含有量が、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として少なくとも１．０重量％である、請求項３１または３２に記載の医薬製剤。
３４．上記薬理活性化合物がオピオイドである、請求項１〜３３のいずれか１つに記載の医薬製剤。
３５．上記オピオイドが、オキシコドン、ヒドロコドン、オキシモルフォン、ヒドロモルフォン、モルヒネ、トラマドール、タペンタドール、セブラノパドールおよびそれらの生理学的に許容可能な塩からなる群から選択される、請求項３４に記載の医薬製剤。
３６．上記薬理活性化合物が興奮薬である、請求項１〜３５のいずれか１つに記載の医薬製剤。
３７．上記興奮薬が、アンフェタミン、デキサンフェタミン、メチルフェニデート、デキサメチルフェニデート、プソイドエフェドリンおよびそれらの生理学的に許容可能な塩からなる群から選択される、請求項３６に記載の医薬製剤。
３８．上記薬理活性化合物の含有量が、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として少なくとも５．０重量％である、請求項１〜３７のいずれか１つに記載の医薬製剤。
３９．上記粒子がホットメルト押出される、請求項１〜３８のいずれか１つに記載の医薬製剤。
４０．上記粒子がフィルムコーティングされている、請求項１〜３９のいずれか１つに記載の医薬製剤。
４１．錠剤またはカプセル剤である、請求項１〜４０のいずれか１つに記載の医薬製剤。
Claims (15)
- 薬理活性化合物、ポリアルキレンオキシドおよび崩壊剤を含む多数の粒子を含む改変防止医薬製剤であって、
上記薬理活性化合物は、上記ポリアルキレンオキシドおよび崩壊剤を含むマトリックス中に分散しており、
上記崩壊剤の含有量は、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として、５．０重量％超であり、
上記ポリアルキレンオキシドの含有量は、上記医薬製剤の全重量を基準としておよび／または上記粒子の全重量を基準として、少なくとも２５重量％であり、
上記製剤は、ｉｎ ｖｉｔｒｏ条件下で、欧州薬局方に従った薬理活性化合物の即時放出を提供する、
改変防止医薬製剤。 - 少なくとも３００Ｎの破壊強度を有する、請求項１に記載の医薬製剤。
- （ｉ）もとのままであるかまたは手動で粉砕されたかのいずれかである医薬製剤を、２つのスプーンにより、５ｍｌの精製水中に調剤し、
（ｉｉ）該液体をその沸点まで加熱し、
（ｉｉｉ）該液体を、さらなる精製水の添加なしに、蓋をした容器中で５分間沸騰させ、（ｉｖ）当該熱い液体を注射器中に抜き取り、そして
（ｖ）注射器内の液体に含まれる薬理活性化合物の量を決定した場合に、
注射器により残部から分離できる調製物の液体部分が、上記製剤に元々含まれていた薬理活性化合物の１０重量％以下であるような、溶媒抽出に対する耐性を示す、請求項１または２に記載の医薬製剤。 - 上記崩壊剤が多糖類、デンプン類、デンプン誘導体、セルロース誘導体、アクリレート類、ポリビニルピロリドン類およびガス放出物質からなる群から選択される、請求項１〜３のいずれか１つに記載の医薬製剤。
- 上記崩壊剤の含有量が、上記粒子の全重量を基準として少なくとも１０重量％である、請求項１〜４のいずれか１つに記載の医薬製剤。
- 上記崩壊剤の含有量が、各々の場合に上記粒子の全重量を基準として１５±５．０重量％、２０±５．０重量％または２５±５．０重量％の範囲内である、請求項１〜５のいずれか１つに記載の医薬製剤。
- 上記ポリアルキレンオキシドが少なくとも５００，０００ｇ／ｍｏｌの重量平均分子量を有する、請求項１〜６のいずれか１つに記載の医薬製剤。
- 上記ポリアルキレンオキシドの含有量が、上記粒子の全重量を基準として少なくとも４０重量％である、請求項１〜７のいずれか１つに記載の医薬製剤。
- ｉｎ ｖｉｔｒｏ条件下で、６００ｍｌ ０．１Ｍ ＨＣｌ（ｐＨ １）において７５ｒｐｍで３０分後に、上記製剤に元々含まれていた薬理活性成分の少なくとも９０重量％が放出されるような放出プロファイルを提供する、請求項１〜８のいずれか１つに記載の医薬製剤。
- 上記薬理活性化合物がオピオイドである、請求項１〜９のいずれか１つに記載の医薬製剤。
- 上記オピオイドが、オキシコドン、ヒドロコドン、オキシモルフォン、ヒドロモルフォン、モルヒネ、トラマドール、タペンタドール、セブラノパドールおよびそれらの生理学的に許容可能な塩からなる群から選択される、請求項１０に記載の医薬製剤。
- 上記薬理活性化合物が興奮薬である、請求項１〜１１のいずれか１つに記載の医薬製剤。
- 上記興奮薬が、アンフェタミン、デキサンフェタミン、メチルフェニデート、デキサメチルフェニデート、プソイドエフェドリンおよびそれらの生理学的に許容可能な塩からなる群から選択される、請求項１２に記載の医薬製剤。
- 上記粒子がホットメルト押出される、請求項１〜１３のいずれか１つに記載の医薬製剤。
- 錠剤またはカプセル剤である、請求項１〜１４のいずれか１つに記載の医薬製剤。
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| PCT/EP2016/058981 WO2016170097A1 (en) | 2015-04-24 | 2016-04-22 | Tamper-resistant dosage form with immediate release and resistance against solvent extraction |
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- 2016-04-22 CA CA2983642A patent/CA2983642A1/en not_active Abandoned
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-
2018
- 2018-05-02 HK HK18105689.5A patent/HK1246173A1/zh unknown
- 2018-08-29 US US16/116,282 patent/US20180369237A1/en not_active Abandoned
-
2020
- 2020-05-11 US US16/871,150 patent/US20200276188A1/en not_active Abandoned
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