JP2018526414A - 乱用抑止性の即放性製剤を用いた経口過剰摂取に対する保護 - Google Patents
乱用抑止性の即放性製剤を用いた経口過剰摂取に対する保護 Download PDFInfo
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Abstract
Description
好ましくは単一の製剤は、生理学的条件下で薬理活性成分aの速い放出を、より好ましくは即時放出を提供し;そして
薬理活性成分aの少なくとも一部分は、薬理活性成分aが埋め込まれているポリマーマトリックスを含む1つまたは複数の粒子Aに含有される、
医薬製剤に関する。
−20個の粒子A1;
−3個の粒子A2と組み合わせた2個の粒子A1;
−1個の粒子A3と組み合わせた1個の粒子A2;または
−1個の粒子A3と組み合わせた6個の粒子A1、
により達成することができる。
(i)薬理活性成分aは向精神効果を有し;および/または
(ii)任意選択的に存在する薬理活性成分bは、WHOによるATC分類[M01A]、[M01C]、[N02B]および[N02C]から選択される。
(i)単一の製剤が、製剤に元々含まれていた薬理活性成分aの、少なくとも30重量%、または少なくとも31重量%、または少なくとも32重量%、または少なくとも33重量%、または少なくとも34重量%、または少なくとも35重量%、または少なくとも36重量%、または少なくとも37重量%、または少なくとも38重量%、または少なくとも39重量%、または少なくとも40重量%を放出しており;および/または
(ii)10個の製剤の集合が、10個の製剤の集合に元々含まれていた薬理活性成分aの全含有量の、25重量%以下、または24重量%以下、または23重量%以下、または22重量%以下、または21重量%以下、または20重量%以下、または19重量%以下、または18重量%以下、または17重量%以下、または16重量%以下、または15重量%以下を放出している、
ような薬理活性成分aのin vitro放出プロファイルを提供する。
(i)単一の製剤が、製剤に元々含まれていた薬理活性成分aのうちのXmgを放出しており;および
(ii)n個の製剤の集合が、n個の製剤の集合に元々含まれていた薬理活性成分aのうちのYmgを放出しており;
ここで、Y/nはXの50%以下であり、好ましくはXの45%以下であり、より一層好ましくはXの40%以下であり、さらに一層好ましくはXの35%以下であり、最も好ましくはXの30%以下であり;そして、nは、2〜10、好ましくは5〜10の整数、より好ましくは10である、
ような薬理活性成分aのin vitro放出プロファイルを提供する。
(i)単一の製剤が、製剤に元々含まれていた薬理活性成分bのうちのVmgを放出しており;および
(ii)n個の製剤の集合が、n個の製剤の集合に元々含まれていた薬理活性成分bのうちのWmgを放出しており;
ここで、W/nはVの50%以下であり、好ましくはVの45%以下であり、より一層好ましくはVの40%以下であり、さらに一層好ましくはVの35%以下であり、最も好ましくはVの30%以下であり;そして、nは、2〜10、好ましくは5〜10の整数、より好ましくは10である、
ような薬理活性成分bのin vitro放出プロファイルを提供する。
−適切な構成成分が
−適切な量で、
−十分な圧力に、
−十分な温度で、
−十分な期間にわたって
曝露されたときにおいてのみ、得ることができる。
−20〜600の範囲内の総数に達し;および/または
−実質的に同一の成分混合物から製造され;および/または
−実質的に同一のサイズ、形状、重量および組成を有し;および/または
−円筒状の形状を有し;および/または
−実質的に同一の破壊強度を有し;
−少なくとも300Nの破壊強度を有し;および/または
−0.1mg〜5mgの範囲内の平均の個々重量を有し;および/または
−10mg〜500mgの範囲内の全重量を有し;および/または
−製剤の全重量を基準として10重量%〜80重量%の範囲内の全含有量に達し;および/または
−それら自体が改変防止性であって、その結果それらが製剤の残りの構成成分から分離された後にも改変防止性を提供し;および/または
−製剤に含まれる薬理活性成分aの全量を含有し;および/または
−実質的に同一の薬理活性成分a含有量を有し;および/または
−実質的に同一のin vitro放出プロファイルを示し;および/または
−in vitro条件下で30分後に、製剤に元々含まれていた薬理活性成分aの少なくとも80重量%を放出しており;および/または
−ホットメルト押出により熱成形される、
粒子Aの集合を、本発明の製剤は含む。
−ステアリン酸マグネシウムおよびステアリン酸;
−モノグリセリド類、ジグリセリド類、トリグリセリド類およびそれらの混合物を含む、脂肪酸のグリセリド類;好ましくはC6〜C22脂肪酸のグリセリド類;特に好ましくは、C16〜C22脂肪酸の部分グリセリド類、例えばグリセロールベヘネート、グリセロールパルミトステアレートおよびグリセロールモノステアレートである;
−グリセロールのモノ−、ジ−およびトリエステルと、200〜4000g/molの範囲内の分子量を有するマクロゴールのジ−およびモノエステル、例えば、マクロゴールグリセロールカプリロカプレート、マクロゴールグリセロールラウレート、マクロゴールグリセロールオココエート(macrogolglycerolococoate)、マクロゴールグリセロールリノレート、マクロゴール−20−グリセロールモノステアレート、マクロゴール−6−グリセロールカプリロカプレート、マクロゴールグリセロールオレエート、マクロゴールグリセロールステアレート、マクロゴールグリセロールヒドロキシステアレートおよびマクロゴールグリセロールリジノレエートの混合物などの、ポリオキシエチレングリセロール脂肪酸エステル;
−公知の商標名「Labrasol」として市販されているものなどの、ポリグリコール化グリセリド類;
−セチルアルコール、ステアリルアルコール、セチルステアリルアルコール、2−オクチルドデカン−1−オールおよび2−ヘキシルデカン−1−オールなどの、直鎖状または分岐鎖状であり得る脂肪アルコール類;
−10,000〜60,000g/molの間の分子量を有するポリエチレングリコール;および
−天然半合成または合成ロウ、好ましくは少なくとも50℃、より好ましくは60℃の軟化点を有するロウ、特にカルナウバロウおよびミツロウ。
(a)全ての成分を混合すること;
(b)任意選択的に、ステップ(a)から得られた混合物を、好ましくは熱及び/又は力をステップ(a)から得られた混合物に加えることによって、予備成形すること、ここで、供給される熱の量は、好ましくは、ポリアルキレンオキシドをその軟化点まで加熱するのに十分ではない;
(c)熱及び力を加えることによって混合物を硬化させること、ここで、力を加える間及び/又は力を加える前および/または後に熱を供給することが可能であり、供給される熱の量は、ポリアルキレンオキシドを少なくともその軟化点まで加熱するのに十分なものである;そして、その後、材料を冷却させ、力を除去する
(d)任意選択的に、硬化した混合物を単体化すること;および
(e)任意選択的に、フィルムコーティングを施すこと。
a)全成分を混合すること、
b)得られた混合物を押出機中で、少なくともポリアルキレンオキシドの軟化点まで加熱し、力を適用することによって押出機の出口オリフィスを通して押出すること、
c)さらに可塑性の押出物を単体化し、粒子(単数または複数)の形態にすること、又は
d)冷却され且つ任意選択で再加熱された単一化押出物を粒子(単数または複数)の形態にすること。
・ノンパレイル糖または微結晶セルロースビーズ上での薬物の層状化、
・噴霧乾燥、
・噴霧凝固、
・回転造粒(rotogranulation)、
・ホットメルト押出、
・低融点材料の球状化、または
・湿塊の押出−球状化。
ヒドロコドンとアセトアミノフェンとの組み合わせを含む錠剤を、以下から製造した
−ヒドロコドンを含むホットメルト押出されたペレット(薬理活性成分aを含む粒子A);
−アセトアミノフェン(薬理活性成分b)を含む顆粒;および
−粉末。
同一用量のヒドロコドンおよびアセトアミノフェンを含み、以下の定性的な組成を有する市販の錠剤(Norco(登録商標)、Watson Pharma)を比較のために試験した:
本発明の例1に従って、5mgヒドロコドン+325mgアセトアミノフェンを含む以下の表に要約するホットメルト押出したペレット、顆粒および粉末を含む錠剤を製造した:
比較の目的のために、同一用量のヒドロコドンおよび300mgアセトアミノフェンを含む市販製品(Vicodin(登録商標),AbbVie Inc.)を試験した。
本発明の例1および2に従って、以下の組成を有するペレットを製造し、保護コーティング(Opadry(登録商標))でコーティングした:
比較目的のために、同一用量のアンフェタミン硫酸塩を含む市販の錠剤(Evekeo(登録商標),Arbor Pharmaceuticals)を試験した。
Claims (68)
- 全体で治療用量を超える用量の薬理活性成分aを含む複数の製剤の偶然のもしくは意図的な同時投与後の薬理活性成分aの過剰摂取の予防に使用するための、薬理活性成分aと少なくとも200,000g/molの平均分子量を有するポリアルキレンオキシドを含むポリマーマトリックスとを含む医薬製剤であって;薬理活性成分aの少なくとも一部分が、薬理活性成分aが埋め込まれている上記ポリマーマトリックスを含む1つまたは複数の粒子Aに含まれる、医薬製剤。
- 欧州薬局方に従う25rpmで900mLの0.1M HClにおいて37℃のin vitro条件下で、30分後に、
(i)単一の製剤が、製剤に元々含まれていた薬理活性成分aの少なくとも30%を放出しており;および/または
(ii)10個の製剤の集合が、10個の製剤の集合に元々含まれていた薬理活性成分aの全体含有量の25重量%以下を放出している、
請求項1に記載の製剤。 - 製剤におけるポリアルキレンオキシドの含有量が少なくとも25mgである、請求項1または2に記載の医薬製剤。
- 製剤におけるポリアルキレンオキシドの含有量が少なくとも50mgである、請求項3に記載の医薬製剤。
- 製剤におけるポリアルキレンオキシドの含有量が少なくとも65mgである、請求項3または4に記載の医薬製剤。
- 上記ポリアルキレンオキシドがポリエチレンオキシドである、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が1,000,000g/mol〜15,000,000g/molの範囲の平均分子量を有する、請求項1〜7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、粒子(単数または複数)Aの全重量を基準として、少なくとも30重量%である、請求項1〜8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、粒子(単数または複数)Aの全重量を基準として、少なくとも35重量%である、請求項9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、粒子(単数または複数)Aの全重量を基準として、少なくとも40重量%である、請求項10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、粒子(単数または複数)Aの全重量を基準として、少なくとも45重量%である、請求項11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、粒子(単数または複数)Aの全重量を基準として、少なくとも50重量%である、請求項12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、粒子(単数または複数)Aの全重量を基準として、25〜80重量%の範囲内である、請求項1〜13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、粒子(単数または複数)Aの全重量を基準として、50±20重量%の範囲内である、請求項14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、粒子(単数または複数)Aの全重量を基準として、50±10重量%の範囲内である、請求項15に記載の医薬製剤。
- 上記の1つまたは複数の粒子Aが少なくとも300Nの破壊強度を有する、請求項1〜16のいずれか1つに記載の製剤。
- 上記の1つまたは複数の粒子Aが少なくとも400Nの破壊強度を有する、請求項17に記載の製剤。
- 上記の1つまたは複数の粒子Aが少なくとも500Nの破壊強度を有する、請求項18に記載の製剤。
- 上記の1つまたは複数の粒子Aが20〜600の範囲内の総数になる、請求項1〜19のいずれか1つに記載の製剤。
- 上記の1つまたは複数の粒子Aが、同一の成分混合物から作られ、および/または実質的に同一のサイズ、形状、重量および組成のものである、請求項1〜20のいずれか1つに記載の製剤。
- 上記の1つまたは複数の粒子Aが、0.1mg〜5mgの範囲内の平均の個々重量を有する、請求項1〜21のいずれか1つに記載の製剤。
- 上記の1つまたは複数の粒子Aが、10mg〜500mgの範囲内の全重量を有する、請求項1〜22のいずれか1つに記載の製剤。
- 上記の1つまたは複数の粒子Aが、製剤の全重量を基準として、少なくとも10重量%の全含有量である、請求項1〜23のいずれか1つに記載の製剤。
- 上記の1つまたは複数の粒子Aが、製剤の全重量を基準として、少なくとも20重量%の全含有量である、請求項24に記載の製剤。
- 上記の1つまたは複数の粒子Aが、製剤の全重量を基準として、少なくとも25重量%の全含有量である、請求項25に記載の医薬製剤。
- 上記の1つまたは複数の粒子Aが、それら自身が改変防止性であり、その結果それらが製剤の残りの構成成分から分離された後にも改変防止性を付与する、請求項1〜26のいずれか1つに記載の製剤。
- 上記の1つまたは複数の粒子Aが、製剤に含まれる薬理活性成分aの全量を含む、請求項1〜27のいずれか1つに記載の製剤。
- 上記の1つまたは複数の粒子Aがホットメルト押出により熱成形される、請求項1〜28のいずれか1つに記載の製剤。
- 欧州薬局方に従う25rpmで900mLの0.1M HClにおいて37℃のin vitro条件下で、
(i)単一の製剤が、製剤に元々含まれていた薬理活性成分aのうちのXmgを放出しており;および
(ii)10個の製剤の集合が、上記の10個の製剤の集合に元々含まれていた薬理活性成分aのうちのYmgを放出しており;
Y/10がXの50%以下である、
請求項1〜29のいずれか1つに記載の医薬製剤。 - 薬理活性成分aは向精神作用を有する、請求項1〜30のいずれか1つに記載の医薬製剤。
- 薬理活性成分aは、鎮痛薬、興奮薬、麻酔薬およびトランキライザーからなる群から選択される、請求項1〜31のいずれか1つに記載の医薬製剤。
- 薬理活性成分aがオピオイド類から選択される、請求項1〜32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33に記載の医薬製剤。
- 薬理活性成分aが興奮薬から選択される、請求項1〜32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、デキサメチルフェニデート、アトモキセチン、カフェイン、エフェドリン、フェニルプロパノールアミン、フェニレフリン、フェンカンファミン、フェノゾロン、フェネチリン、メチレンジオキシメタンフェタミン(MDMA)、メチレンジオキシピロバレロン(MDPV)、プロリンタン、リスデキサンフェタミン、メフェドロン、メタンフェタミン、メチルフェニデート、モダフィニル、ニコチン、ぺモリン、フェニルプロパノールアミン、プロピルヘキセドリン、ジメチルアミルアミン、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35に記載の医薬製剤。
- 薬理活性成分aの含有量が、粒子(単数または複数)Aの全重量を基準として、少なくとも0.5重量%である、請求項1〜36のいずれか1つに記載の医薬製剤。
- 薬理活性成分aの含有量が、粒子(単数または複数)Aの全重量を基準として、最大で20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。
- 薬理活性成分aの含有量が、粒子(単数または複数)Aの全重量を基準として、最大で15重量%である、請求項38に記載の医薬製剤。
- カプセル剤である、請求項1〜39のいずれか1つに記載の医薬製剤。
- スプリンクルカプセル剤である、請求項40に記載の医薬製剤。
- 上記カプセル剤が、緩い充填の形態で上記粒子および全ての添加剤を含む、請求項40または41に記載の医薬製剤。
- 上記カプセル剤が、層の形態で上記粒子および全ての添加剤を含む、請求項40または41に記載の医薬製剤。
- 錠剤である、請求項1〜39のいずれか1つに記載の医薬製剤。
- 上記錠剤が、外側マトリックス材料において粒子(単数または複数)Aを均一な分布で含む、請求項44に記載の医薬製剤。
- 上記錠剤が、マントル錠剤の形態で粒子(単数または複数)Aを含む、請求項44に記載の医薬製剤。
- 薬理活性成分aとは異なる薬理活性成分bを追加的に含む、請求項1〜46のいずれか1つに記載の医薬製剤。
- 薬理活性成分bが向精神作用を示さない、請求項47に記載の医薬製剤。
- 薬理活性成分bが、WHOによるATC分類[M01A]、[M01C]、[N02B]および[N02C]から選択される、請求項47または48に記載の医薬製剤。
- −薬理活性成分aが、オキシコドン、オキシモルフォン、ヒドロコドン、ヒドロモルフォン、モルヒネ、タペンタドール、トラマドール、ブプレノルフィン、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;そして
−上記の第二の薬理活性成分がイブプロフェン、アセトアミノフェン、ジクロフェナク、アセチルサリチル酸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47〜49のいずれか1つに記載の医薬製剤。 - 第二の薬理活性成分bが粒子(単数または複数)Aの外側に位置する、請求項47〜50のいずれか1つに記載の医薬製剤。
- 1日1回、1日2回、1日3回または1日3回より頻繁な投与のために適合されている、請求項1〜51のいずれか1つに記載の医薬製剤。
- 粒子(単数または複数)Aが崩壊剤を含む、請求項1〜52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、粒子(単数または複数)Aの全重量を基準として、5.0重量%より多い、請求項53に記載の医薬製剤。
- 上記崩壊剤の含有量が、粒子(単数または複数)Aの全重量を基準として、20±15重量%の範囲内である、請求項53または54に記載の医薬製剤。
- 上記崩壊剤の含有量が、粒子(単数または複数)Aの全重量を基準として、20±10重量%の範囲内である、請求項55に記載の医薬製剤。
- 上記崩壊剤が、デンプン、デンプン誘導体、セルロース誘導体およびガス放出物質からなる群から選択される、請求項53〜56のいずれか1つに記載の医薬製剤。
- −上記デンプンが天然デンプンおよびアルファー化デンプンから選択され;または
−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であり;または
−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57に記載の医薬製剤。 - ポリアルキレンオキシドと崩壊剤との相対重量比が8:1〜1:5の範囲内である、請求項53〜58のいずれか1つに記載の医薬製剤。
- 粒子(単数または複数)Aが酸化防止剤を含む、請求項1〜59のいずれか1つに記載の医薬製剤。
- 上記酸化防止剤が、アスコルビン酸、ブチル化ヒドロキシアニソール(BHA)、ブチル化ヒドロキシトルエン(BHT)、アスコルビン酸の塩、モノチオグリセロール、亜リン酸、ビタミンC、ビタミンEおよびそれらの誘導体、安息香酸コニフェリル、ノルジヒドログアヤレチン酸、ガロイル没食子酸エステル(gallus acid esters)および重亜硫酸ナトリウムからなる群から選択される、請求項60に記載の医薬製剤。
- ワックス成分を含まない、請求項1〜61のいずれか1つに記載の医薬製剤。
- 上記ワックス成分が、脂肪酸エステル類、グリセロール脂肪酸エステル類、脂肪グリセリド誘導体、ワックス類および脂肪アルコール類を含む、請求項62に記載の医薬製剤。
- 粒子(単数または複数)Aが、薬理活性成分を含む活性な薬学的層も、5より大きいpHで水に不溶性であり、5未満のpHで水に可溶性であるpH感受性ポリマーを含むpH感受性フィルムを含む層も含まない、請求項1〜63のいずれか1つに記載の医薬製剤。
- 薬理活性成分aで治療可能である疾患、障害または状態の治療においてさらに使用するための、請求項1〜64のいずれか1つに記載の医薬製剤。
- 上記疾患、障害または状態が疼痛である、請求項65に記載の医薬製剤。
- 全体で治療用量を超える用量の薬理活性成分aを含む複数の製剤の偶然のもしくは意図的な同時投与後の薬理活性成分aの過剰摂取の予防のための、請求項1〜66のいずれか1つに記載の医薬製剤の使用。
- 請求項1〜66のいずれか1つに記載の医薬製剤の提供を含む、全体で治療用量を超える用量の薬理活性成分aを含む複数の製剤の偶然のもしくは意図的な同時投与後の薬理活性成分aの過剰摂取の予防のための方法。
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2016
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- 2016-09-09 AU AU2016319203A patent/AU2016319203A1/en not_active Abandoned
- 2016-09-09 CA CA2998259A patent/CA2998259A1/en not_active Abandoned
- 2016-09-09 EP EP16763260.3A patent/EP3346991A1/en not_active Withdrawn
- 2016-09-09 WO PCT/EP2016/071287 patent/WO2017042325A1/en active Search and Examination
- 2016-09-09 US US15/260,643 patent/US10842750B2/en active Active
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2020
- 2020-11-02 US US17/086,702 patent/US20210046009A1/en not_active Abandoned
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CA2998259A1 (en) | 2017-03-16 |
AU2016319203A1 (en) | 2018-02-22 |
US10842750B2 (en) | 2020-11-24 |
WO2017042325A1 (en) | 2017-03-16 |
EP3346991A1 (en) | 2018-07-18 |
US20210046009A1 (en) | 2021-02-18 |
US20170071862A1 (en) | 2017-03-16 |
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