JP6449871B2 - エチレン−酢酸ビニルポリマーを含有する改変防止剤形 - Google Patents
エチレン−酢酸ビニルポリマーを含有する改変防止剤形 Download PDFInfo
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Description
(i)薬理活性成分は、EVAポリマーを含む持続放出マトリックス中に埋め込まれ、および/または
(ii)医薬剤形は、薬理活性成分の持続放出を提供する。
− 本発明による医薬剤形は、モノリスであり、任意の方向に少なくとも2.5mmの伸びを有し;または、多微粒子であり、個々の薬物含有粒子は、任意の方向に少なくとも2.2mmの伸びを有し;あるいは
− 本発明による医薬剤形は、モノリスであり、任意の方向に少なくとも3.0mmの伸びを有し;または、多微粒子であり、個々の薬物含有粒子は、任意の方向に少なくとも2.5mmの伸びを有し;あるいは
− 本発明による医薬剤形は、モノリスであり、任意の方向に少なくとも3.5mmの伸びを有し;または、多微粒子であり、個々の薬物含有粒子は、任意の方向に少なくとも2.8mmの伸びを有し;あるいは
− 本発明による医薬剤形は、モノリスであり、任意の方向に少なくとも4.0mmの伸びを有し;または、多微粒子であり、個々の薬物含有粒子は、任意の方向に少なくとも3.0mmの伸びを有し;あるいは
− 本発明による医薬剤形は、モノリスであり、任意の方向に少なくとも4.5mmの伸びを有し;または、多微粒子であり、個々の薬物含有粒子は、任意の方向に少なくとも3.2mmの伸びを有し;あるいは
− 本発明による医薬剤形は、モノリスであり、任意の方向に少なくとも5.0mmの伸びを有し;または、多微粒子であり、個々の薬物含有粒子は、任意の方向に少なくとも3.5mmもしくは少なくとも4.0mmの伸びを有する。
(i)エチレンおよび酢酸ビニル;または
(ii)エチレンおよびビニルアルコール;または
(ii)エチレン、酢酸ビニルおよびビニルアルコール
から誘導される繰り返し単位を含んでもよい。
(i)持続放出マトリックス材料としてのEVAポリマーであって、ASTM D1238に従って測定された、190℃および2.16kgで52±2g/10分のメルトフローレートを有し、好ましくはEVAポリマーの総重量に対して60±5重量%のエチレン繰り返し単位を含有する、単一のEVAポリマーを含む、EVAポリマー;および
(ii)好ましくは、ポリアルキレンオキシド、架橋アクリルポリマー、ならびにポリ酢酸ビニルおよびポリビニルピロリドンをベースとしたマトリックスからなる群から選択されるポリマーである、追加的な持続放出マトリックス材料;
を含み、
(iii)持続放出マトリックス材料の相対重量含量は、好ましくは、追加的な持続放出マトリックス材料の相対重量含量よりも高い。
− グリセリド、特にモノグリセリド、ジグリセリド、トリグリセリド、
− 脂肪酸の脂肪アルコールとのエステル、および
− パラフィン
からなる群から選択される。
− ステアリン酸マグネシウムおよびステアリン酸;
− ポリオキシエチレングリセロール脂肪酸エステル、例えば、グリセロールのモノ−、ジ−およびトリエステル、ならびに、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の混合物、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ココエート、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シノレート;
− ポリグリコール化グリセリド、例えば「Labrasol」の商品名で知られ市販されているもの;
− 直鎖または分岐鎖であってもよい脂肪アルコール、例えばセチルアルコール、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;ならびに
− 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から選択される。
− 好適な成分が、
− 好適な量で、
− 十分な圧力に、
− 十分な温度で
− 十分な期間
曝露された場合にのみ得ることができる。
破壊強さ[N]=10×医薬剤形/粒子の直径[mm]
(a)全ての成分を混合するステップと、
(b)任意選択で、好ましくはステップ(a)から得られた混合物に熱および/または力を印加することにより、ステップ(a)から得られた混合物を予備成形するステップであって、供給される熱の量は、好ましくは、EVAポリマーおよび持続放出マトリックス材料それぞれをその軟化点まで加熱するのに十分ではないステップと、
(c)熱および力を印加することにより混合物を硬化させ、力の印加中および/またはその前に熱を供給することが可能であり、供給される熱の量は、EVAポリマーおよび持続放出マトリックス材料それぞれを少なくともその軟化点まで加熱するのに十分であり;その後材料を冷却させ、力を除去するステップと、
(d)任意選択で、硬化した混合物を単一化するステップと、
(e)任意選択で、粒子を造形するステップと、
(f)任意選択で、フィルムコーティングを提供するステップと
を含む。
(i)薬理活性成分、エチレン−酢酸ビニル(EVA)ポリマー、および任意選択でさらなる添加剤を混合するステップ;および
(ii)ステップ(i)において得られた混合物を熱成型するステップであって、前記混合物は、加熱と同時に、または加熱の前もしくは後に圧力に供されるステップ
を含む方法に関する。
a)全ての成分が混合されること、
b)得られる混合物が、押出機内で、少なくともEVAポリマーおよび持続放出マトリックス材料それぞれの軟化点まで加熱され、力の印加により押出機の出口開口を通して押し出されること、
c)まだ可塑性の押出し物が単一化され、医薬剤形および粒子のそれぞれに成形されること、または
d)冷却および任意選択で再加熱された単一化押出し物が、医薬剤形および粒子のそれぞれに成形されること
を特徴とする。
− ノンパレイル糖もしくは微結晶セルロースビーズ上の薬物層形成、
− 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
− 湿潤集合体の押出し球状化
を含むいくつかの技術により調製され得ることを認識している。
− 本発明による医薬剤形は、モノリスもしくは多微粒子もしくはMUPS製剤であり;ならびに/または
− 本発明による医薬剤形は、ホットメルト押出され;ならびに/または
− 本発明による医薬剤形は、向精神作用を有する薬理活性成分の持続放出を提供し;ならびに/または
− 向精神作用を有する薬理活性成分は、オピオイドもしくはその生理学的に許容可能な塩であり;ならびに/または
− 薬理活性成分の含量は、医薬剤形の総重量を基準として1〜35重量%の範囲内であり;ならびに/または
− EVAポリマーは、エチレンならびに酢酸ビニルおよび/もしくはビニルアルコールから誘導される繰り返し単位を含み;ならびに/または
− EVAポリマーは、EVAポリマーの総重量に対して60±30重量%、より好ましくは60±5重量%のエチレン繰り返し単位を含有し;ならびに/または
− EVAポリマーは、ASTM D1238に従って測定された、190℃および2.16kgで52±2g/10分のメルトフローレートを有し;ならびに/または
− EVAポリマーの含量は、医薬剤形の総重量に対して、または、医薬剤形が多微粒子である場合は、薬理活性成分を含有する粒子の総重量に対して45〜70重量%の範囲内であり;ならびに/または
− 薬理活性成分は、持続放出マトリックス材料としてのEVAポリマーおよび追加的な持続放出マトリックス材料を含有する持続放出マトリックス中に埋め込まれ;
− 追加的な持続放出マトリックス材料の含量は、持続放出マトリックスの総重量に対して5〜30重量%の範囲内であり;ならびに/または
− 追加的な持続放出マトリックス材料は、少なくとも5,000,000g/molの重量平均分子量を有するポリアルキレンオキシド、好ましくはポリエチレンオキシドであり;または
− 追加的な持続放出マトリックス材料は、ポリビニルピロリドンおよびポリ酢酸ビニルの混合物であり、前記混合物は、USPおよび欧州薬局方モノグラフ「ポビドン」に記載される方法に従い、テトラヒドロフラン中1%の溶液中で測定された60〜65の範囲内のK値を有し、ポリ酢酸ビニルとポリビニルピロリドンとの間の重量比は、4.5:1〜3.5:1の範囲内であり;または
− 追加的な持続放出マトリックス材料は、Brookfield RVT、20rpm、スピンドル番号5、25℃、および0.5重量%でpH7.3〜7.8に中性化して測定された4,000〜11,000mPa・sの粘度を有する、アリルペンタエリスリトールで架橋したアニオン性アクリルポリマー、好ましくはポリアクリル酸ポリマーである。
材料
Elvax(登録商標)40W エチレン−酢酸ビニルコポリマー(40重量%酢酸ビニルコモノマー)
Elvax(登録商標)40L−03 エチレン−酢酸ビニルコポリマー(40重量%酢酸ビニルコモノマー)
Elvax(登録商標)220W エチレン−酢酸ビニルコポリマー(28重量%酢酸ビニルコモノマー)
Elvax(登録商標)265 エチレン−酢酸ビニルコポリマー(28重量%酢酸ビニルコモノマー)
Elvax(登録商標)660 エチレン−酢酸ビニルコポリマー(12重量%酢酸ビニルコモノマー)
PEO 7 Mio. ポリエチレンオキシド(7 mio)
Kollidon SR ポリ酢酸ビニルおよびポリビニルピロリドンの混合物
Carbopol 71G ペンタエリスリトールのアリルエーテルで架橋したアクリル酸のポリマー
キサンタン グルコース、マンノースおよびグルクロン酸を含む五糖繰り返し単位を含むポリサッカリド
HPMC ヒドロキシプロピルメチルセルロース
Kollicoat IR ポリビニルアルコール−ポリエチレングリコールグラフトコポリマー
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比較例13A:
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.向精神作用を有する薬理活性成分およびエチレン−酢酸ビニル(EVA)ポリマーを含み、溶媒抽出に対する耐性、粉砕に対する耐性、および水性エタノール中の用量ダンピング(dose−dumping)に対する耐性を提供する、改変防止(tamper−resistant)経口医薬剤形。
2.(i)薬理活性成分が、EVAポリマーを含む持続放出マトリックス中に埋め込まれ;および/または
(ii)医薬剤形が、薬理活性成分の持続放出を提供する、上記1に記載の医薬剤形。
3.EVAポリマーが、エチレンならびに酢酸ビニルおよび/またはビニルアルコールから誘導される繰り返し単位を含む、上記1または2に記載の医薬剤形。
4.EVAポリマーが、EVAポリマーの総重量に対して少なくとも50重量%のエチレン繰り返し単位を含有する、上記1〜3のいずれか一つに記載の医薬剤形。
5.EVAポリマーが、EVAポリマーの総重量に対して50〜95重量%のエチレン繰り返し単位を含有する、上記4に記載の医薬剤形。
6.EVAポリマーが、ASTM D1238に従って測定された、190℃および2.16kgで1〜160g/10分の範囲内のメルトフローレートを有する、上記1〜5のいずれか一つに記載の医薬剤形。
7.EVAポリマーの含量が、医薬剤形の総重量に対して20〜80重量%の範囲内である、上記1〜6のいずれか一つに記載の医薬剤形。
8.EVAポリマーの含量が、医薬剤形の総重量に対して少なくとも30重量%である、上記7に記載の医薬剤形。
9.モノリスであり、少なくとも300Nの破壊強さを有し;または、多微粒子であり、個々の粒子の少なくとも一部は、少なくとも300Nの破壊強さを有する、上記1〜8のいずれか一つに記載の医薬剤形。
10.モノリスであり、任意の方向に少なくとも2.0mmの伸びを有し;または、多微粒子であり、個々の薬物含有粒子は、任意の方向に少なくとも2.0mmの伸びを有する、上記1〜9のいずれか一つに記載の医薬剤形。
11.薬理活性成分が、オピオイドまたはその生理学的に許容可能な塩である、上記1〜10のいずれか一つに記載の医薬剤形。
12.ホットメルト押し出しされている、上記1〜11のいずれか一つに記載の医薬剤形。
13.改変防止経口医薬剤形の製造のための方法であって、
(i)薬理活性成分、エチレン−酢酸ビニル(EVA)ポリマー、および任意選択でさらなる添加剤を混合するステップ;および
(ii)ステップ(i)において得られた混合物を熱成型するステップであって、前記混合物は、加熱と同時に、または加熱の前もしくは後に圧力に供されるステップ
を含む方法。
14.改変防止医薬剤形が、上記1〜12のいずれか一つに記載されている、上記13に記載の方法。
15.上記13または14に記載の方法により得ることができる、改変防止経口医薬剤形。
Claims (11)
- 向精神作用を有する薬理活性成分およびエチレン−酢酸ビニル(EVA)ポリマーを含み、溶媒抽出に対する耐性、粉砕に対する耐性、および水性エタノール中の用量ダンピング(dose−dumping)に対する耐性を提供する、改変防止(tamper−resistant)経口医薬剤形であって、EVAポリマーの含量が、医薬剤形の総重量に対して20〜80重量%の範囲内であり、前記医薬剤形がホットメルト押し出しされている、
改変防止経口医薬剤形。 - (i)薬理活性成分が、EVAポリマーを含む持続放出マトリックス中に埋め込まれ;および/または
(ii)医薬剤形が、薬理活性成分の持続放出を提供する、請求項1に記載の医薬剤形。 - EVAポリマーが、エチレンならびに酢酸ビニルおよび/またはビニルアルコールから誘導される繰り返し単位を含む、請求項1または2に記載の医薬剤形。
- EVAポリマーが、EVAポリマーの総重量に対して少なくとも50重量%のエチレン繰り返し単位を含有する、請求項1〜3のいずれか一つに記載の医薬剤形。
- EVAポリマーが、EVAポリマーの総重量に対して50〜95重量%のエチレン繰り返し単位を含有する、請求項4に記載の医薬剤形。
- EVAポリマーが、ASTM D1238に従って測定された、190℃および2.16kgで1〜160g/10分の範囲内のメルトフローレートを有する、請求項1〜5のいずれか一つに記載の医薬剤形。
- EVAポリマーの含量が、医薬剤形の総重量に対して少なくとも30重量%である、請求項1〜6のいずれか一つに記載の医薬剤形。
- モノリスであり、少なくとも300Nの破壊強さを有し;または、多微粒子であり、個々の粒子の少なくとも一部は、少なくとも300Nの破壊強さを有する、請求項1〜7のいずれか一つに記載の医薬剤形。
- モノリスであり、任意の方向に少なくとも2.0mmの伸びを有し;または、多微粒子であり、個々の薬物含有粒子は、任意の方向に少なくとも2.0mmの伸びを有する、請求項1〜8のいずれか一つに記載の医薬剤形。
- 薬理活性成分が、オピオイドまたはその生理学的に許容可能な塩である、請求項1〜9のいずれか一つに記載の医薬剤形。
- 請求項1〜10のいずれか一つに記載の改変防止経口医薬剤形の製造のための方法であって、
(i)薬理活性成分、エチレン−酢酸ビニル(EVA)ポリマー、および任意選択でさらなる添加剤を混合するステップ;および
(ii)ステップ(i)において得られた混合物を熱成型するステップであって、前記混合物は、加熱と同時に、または加熱の前もしくは後に圧力に供されるステップ
を含む方法。
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US9770514B2 (en) | 2013-09-03 | 2017-09-26 | ExxPharma Therapeutics LLC | Tamper-resistant pharmaceutical dosage forms |
WO2015048597A1 (en) | 2013-09-30 | 2015-04-02 | Daya Drug Discoveries, Inc. | Prevention of illicit methamphetamine manufacture from pseudoephedrine using food flavor excipients |
WO2015065547A1 (en) | 2013-10-31 | 2015-05-07 | Cima Labs Inc. | Immediate release abuse-deterrent granulated dosage forms |
US10744131B2 (en) | 2013-12-31 | 2020-08-18 | Kashiv Biosciences, Llc | Abuse-resistant drug formulations |
CA2938699A1 (en) | 2014-02-05 | 2015-08-13 | Kashiv Pharma Llc | Abuse-resistant drug formulations with built-in overdose protection |
US20160089439A1 (en) | 2014-09-28 | 2016-03-31 | Satara Pharmaceuticals, LLC | Prevention of Illicit Manufacutre of Methamphetamine from Pseudoephedrine Using Food Flavor Excipients |
EA035434B1 (ru) | 2015-04-24 | 2020-06-15 | Грюненталь Гмбх | Защищенная от применения не по назначению лекарственная форма с немедленным высвобождением и устойчивостью к экстракции растворителями |
US20170112766A1 (en) | 2015-04-24 | 2017-04-27 | Grünenthal GmbH | Tamper-resistant dosage form with immediate release and resistance against solvent extraction |
US20170296476A1 (en) | 2016-04-15 | 2017-10-19 | Grünenthal GmbH | Modified release abuse deterrent dosage forms |
-
2014
- 2014-07-10 MX MX2016000330A patent/MX368846B/es active IP Right Grant
- 2014-07-10 WO PCT/EP2014/064830 patent/WO2015004245A1/en active Application Filing
- 2014-07-10 JP JP2016524828A patent/JP6449871B2/ja active Active
- 2014-07-10 EP EP14738499.4A patent/EP3019157A1/en not_active Withdrawn
- 2014-07-10 CA CA2917136A patent/CA2917136C/en not_active Expired - Fee Related
- 2014-07-10 KR KR1020167003584A patent/KR20160031526A/ko not_active Application Discontinuation
- 2014-07-10 CN CN201480050307.0A patent/CN105682643B/zh not_active Expired - Fee Related
- 2014-07-10 BR BR112016000194A patent/BR112016000194A8/pt not_active Application Discontinuation
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CN105682643A (zh) | 2016-06-15 |
JP2016526567A (ja) | 2016-09-05 |
MX2016000330A (es) | 2016-05-09 |
BR112016000194A8 (pt) | 2019-12-31 |
IL243277B (en) | 2020-05-31 |
AU2014289187B2 (en) | 2019-07-11 |
CA2917136A1 (en) | 2015-01-15 |
CN105682643B (zh) | 2019-12-13 |
EA201600100A1 (ru) | 2016-07-29 |
WO2015004245A1 (en) | 2015-01-15 |
CA2917136C (en) | 2022-05-31 |
US10624862B2 (en) | 2020-04-21 |
AU2014289187A1 (en) | 2016-02-04 |
EP3019157A1 (en) | 2016-05-18 |
US20150017250A1 (en) | 2015-01-15 |
KR20160031526A (ko) | 2016-03-22 |
NZ715801A (en) | 2021-07-30 |
MX368846B (es) | 2019-10-18 |
EA032465B1 (ru) | 2019-05-31 |
US20200197327A1 (en) | 2020-06-25 |
IL243277A0 (en) | 2016-02-29 |
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