JP6371463B2 - 即時放出性乱用抑止性液体充填剤形 - Google Patents
即時放出性乱用抑止性液体充填剤形 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
Description
本出願は、2014年7月17日出願の米国仮出願第62/025,878号に基づく優先権を主張するものであり、その開示内容が全体にわたって参照により本明細書に組み込まれる。
本発明の種々の態様を以下に列挙する。
1.
(a)乱用されやすい活性物質、
(b)約30,000ダルトン〜約40,000ダルトンの間の平均分子量を有する第1のポリエチレングリコール(PEG)、及び
(c)約3000ダルトン〜約4000ダルトンの間の平均分子量を有する第2のPEG
を含む即時放出性乱用抑止性カプセル剤であって、
第1のPEG対第2のPEGの比が約1:4w/w未満である、即時放出性乱用抑止性カプセル剤。
2.
第1のPEG及び第2のPEGが、合わせて剤形の少なくとも約60wt%である、上記1に記載のカプセル剤。
3.
内容物の少なくとも80%が水及びアルコールの両方に可溶である、上記1に記載のカプセル剤。
4.
活性物質が酒石酸水素ヒドロコドンである、上記1に記載のカプセル剤。
5.
活性物質がオキシコドンHClである、上記1に記載のカプセル剤。
6.
FD&C青色1号、FD&C黄色6号及びFD&C赤色40号を含む灰色染料をさらに含む、上記1に記載のカプセル剤。
7.
染料が乱用に対する視覚的抑止性をもたらす、上記6に記載のカプセル剤。
8.
第1のPEG対第2のPEGの比が約1:7w/w〜約1:11w/wの間である、上記1に記載のカプセル剤。
9.
第1のPEGが約35,000ダルトンの平均分子量を有し、第2のPEGが約3350ダルトンの平均分子量を有する、上記1に記載のカプセル剤。
10.
カプセル剤が少なくとも約2.5wt%の活性物質を含む、上記1に記載のカプセル剤。
11.
カプセル剤が、活性物質、第1のPEG及び第2のPEGを含む加熱均質化懸濁液でカプセルボディを充填することにより調製される、上記1に記載のカプセル剤。
12.
(a)乱用されやすい活性物質、及び
(b)約6200ダルトン〜約7800ダルトンの間の重量平均分子量を有するPEG
を含む即時放出性乱用抑止性カプセル剤。
13.
カプセル剤が、少なくとも約60wt%のPEGを含む、上記12に記載のカプセル剤。
14.
活性物質が酒石酸水素ヒドロコドンである、上記12に記載のカプセル剤。
15.
活性物質がオキシコドンHClである、上記12に記載のカプセル剤。
16.
(a)乱用されやすい活性物質、
(b)約60℃以上の融点を有する第1のPEG、及び
(c)約57℃以下の融点を有する第2のPEG
を含む即時放出性乱用抑止性カプセル剤であって、
カプセルの内容物が40℃/相対湿度75%で固体であり、投与又は溶出試験後45分以内に活性成分の少なくとも75%がカプセルから放出される、即時放出性乱用抑止性カプセル剤。
17.
第1のPEG及び第2のPEGが、合わせてカプセル剤の少なくとも約60wt%である、上記16に記載のカプセル剤。
18.
活性物質が酒石酸水素ヒドロコドンである、上記16に記載のカプセル剤。
19.
活性物質がオキシコドンHClである、上記16に記載のカプセル剤。
20.
少なくとも1種の乱用されやすい活性物質を含む即時放出性乱用抑止性カプセル剤の製造方法であって、
(a)(i)少なくとも1種の乱用されやすい活性物質、
(ii)約30,000ダルトン〜約40,000ダルトンの間の平均分子量を有する第1のPEG、及び
(iii)約3000ダルトン〜約4000ダルトンの間の平均分子量を有する第2のPEG
の均質化懸濁液を調製するステップ、並びに
(b)均質化懸濁液をカプセルボディに充填してカプセル剤を製造するステップ
を含み、
第1のPEG対第2のPEGの比が約1:4w/w未満である、方法。
21.
第1のPEG及び第2のPEGが、合わせてカプセル剤の少なくとも約60wt%である、上記20に記載の方法。
22.
活性物質が酒石酸水素ヒドロコドンである、上記20に記載の方法。
23.
活性物質がオキシコドンHClである、上記20に記載の方法。
24.
カプセル剤が、カプセルボディをカプセルキャップと接合させることにより形成される、上記20に記載の方法。
25.
治療有効量の上記1に記載のカプセル剤を、それを必要とする対象に投与するステッ
プを含む、痛みを治療する方法。
[実施例1]
即時放出性ADF液体充填カプセル剤についての最初の試験及び評価実験は、APIをPEG中に懸濁し、これを重量により硬ゼラチンカプセルに充填し、次いでこれが室温で蝋状物質に凝固することに基づいていた。これらの実験の一部では、C-II麻薬の代わりにトレーサー薬物としてアセトアミノフェン(APAP)を使用した。オキシコドンHCl及びAPAPはともに、脱気水に可溶である。プールされた酒石酸水素ヒドロコドン及びアセトアミノフェン錠剤についてのUSPモノグラフは、0.1N HCl中で30分で両薬物が80%(Q)+10%を放出することを規定しており、両方が即時放出可能であることを示している。結果として、APAPが実験における使用可能な代替物であることが予期された。
PEG35000を含む即時放出性ADF液体充填カプセル剤
各種の量のPEG1450及びPEG35000を含むさらなる即時放出性ADFオキシコドンHCl液体充填カプセル製剤の溶出率、ADF特性及び溶融温度を評価した。アセトアミノフェン(APAP)をオキシコドンHClについてのトレーサー薬物として使用した。下記の表3に処方を示す。APAPの目標量はカプセルあたり30mg、目標充填重量は100mg(バッチ番号92)又は200mg(バッチ番号93〜94)であった。カプセルはAPAPを30%w/w(バッチ番号92)又は15%w/w(バッチ番号93〜94)含んでいた。サイズ3不透明硬ゼラチンカプセルを使用した。
染料の評価
多数の染料を、静脈内乱用を抑止する可能性について評価した。各種濃度のFD&C青色2号、緑色(FD&C青色2号及びFD&C黄色5号)、FD&C黄色5号、FD&C赤色40号及び灰色染料(FD&C青色1号、FD&C黄色6号、FD&C赤色40号)を、95%エタノール5%精製水(190プルーフ)溶液にこれらを溶解させ、溶液をシリンジフィルターに通すことにより評価した。シリンジ濾過後、染料溶液を色強度について視覚的に評価し、0が無色を示し5が濃く顕著な色を示す0〜5のスケールで等級付けした。下記の表7に示す通り、青色及び緑色染料は低濃度、例えば0.25%w/wで最も高い色強度を示した。濾過前後の灰色染料溶液をそれぞれ図2A及び2Bに示す。灰色染料は特に顕著且つより魅力的でなかった。染料抽出後の許容されるカラースケール判定は、5を最高レベルの色とする1〜5のスケールで4以上である。
即時放出性ADFオキシコドンHCl液体充填カプセル
オピオイド製品の乱用者はしばしば、活性成分のより急速な放出を促進するために、製品に混ぜ物をする。製品は咀嚼及び嚥下、破砕及び吸入、又は、水若しくはアルコールで(破砕するかそのままかのいずれかで)抽出して、静脈内投与に使用可能であるか精製された製品の吹送のために乾燥可能である溶液を生成することができる。製品に混ぜ物をすることにより、製品そのままの摂取により実現されうるよりも急速な活性物質の送達が可能になる。この急速な開始、高度の曝露には、陶酔感、薬物嗜好、及びより高い乱用可能性が伴う。
即時放出性液体充填カプセルPEG製剤の乱用抑止特性
一実施形態において、即時放出性薬物製品を「乱用抑止性」と判断する少なくとも3つの決定要因、すなわち、すりつぶしに対する抵抗性、抽出時の純度、及び抽出後の視覚的評価がある。消化管への溶出率を増大させるために、摂取前に製品の表面積を増大させるように、剤形の切断を行うことができる。すりつぶし又は抽出の効率を増大させるために切断を使用することもできる。しかし、切断単独では、製剤を乱用可能にするには十分でない。鼻腔の血管に即時放出させるために吹送する(鼻から吸引する)目的で、切断よりも効率的に製品の粒径を低下させるために、剤形のすりつぶしを行うことができる。すりつぶしに使用される、容易に入手可能な道具は市販のコーヒーグラインダーである。一実施形態において、薬物製品は、パン内の%物質(500μm以下)が50%以下であれば乱用抑止性であるとみなされる。すりつぶされると経鼻吹送に利用可能な物質(500μm以下)を1剤形ベースで50%以下生ずる剤形は、乱用抑止性であるとみなされる。本研究の目的は、オキシコドンHClの様々な剤形のすりつぶし可能性を決定することであった。テクスチャー解析は、医薬製品の物理的特性を測定するための、医薬製品の機械的試験である。薬物製品を経鼻乱用(吹送)に好適な粒径にすりつぶす目的で、市販のコーヒーグラインダー(Mr. Coffee)を模すためにRetsch Knife Mill GRINDOMIX GM200(TE96)を利用した。500マイクロメートル(μm)粒径ふるい(35メッシュ)を利用するATM L3P Sonic Sifter(TE47)を利用して、粒径解析を実施した。本研究の目的のためには、直径500μm未満の粒子は全て経鼻乱用に好適であるとみなされる。直径500μm超の粒子は全て鼻腔の血管により十分に吸収されないことが一般的に受容されている。
Claims (23)
- (a)乱用されやすい活性物質、
(b)約30,000ダルトン〜約40,000ダルトンの間の平均分子量を有する第1のポリエチレングリコール(PEG)、及び
(c)約3000ダルトン〜約4000ダルトンの間の平均分子量を有する第2のPEG
を含む即時放出性乱用抑止性カプセル剤であって、
第1のPEG対第2のPEGの比が約1:4w/w未満である、即時放出性乱用抑止性カプセル剤。 - 第1のPEGが約35,000ダルトンの平均分子量を有し、第2のPEGが約3350ダルトンの平均分子量を有する、請求項1に記載のカプセル剤。
- 第1のPEG及び第2のPEGが、合わせて剤形の少なくとも約60wt%である、請求項1又は2に記載のカプセル剤。
- 内容物の少なくとも80%が水及びアルコールの両方に可溶である、請求項1又は2に記載のカプセル剤。
- 活性物質が酒石酸水素ヒドロコドンである、請求項1又は2に記載のカプセル剤。
- 活性物質がオキシコドンHClである、請求項1又は2に記載のカプセル剤。
- FD&C青色1号、FD&C黄色6号及びFD&C赤色40号を含む灰色染料をさらに含む、請求項1又は2に記載のカプセル剤。
- 染料が乱用に対する視覚的抑止性をもたらす、請求項7に記載のカプセル剤。
- 第1のPEG対第2のPEGの比が約1:7w/w〜約1:11w/wである、請求項1又は2に記載のカプセル剤。
- カプセル剤が少なくとも約2.5wt%の活性物質を含む、請求項1又は2に記載のカプセル剤。
- カプセル剤が、活性物質、第1のPEG及び第2のPEGを含む加熱均質化懸濁液でカプセルボディを充填することにより調製される、請求項1又は2に記載のカプセル剤。
- (a)乱用されやすい活性物質、
(b)約60〜65℃の融点を有する第1のPEG、及び
(c)約53〜57℃の融点を有する第2のPEG
を含む即時放出性乱用抑止性カプセル剤であって、
カプセルの内容物が40℃/相対湿度75%で固体であり、投与又は溶出試験後45分以内に活性成分の少なくとも75%がカプセルから放出される、即時放出性乱用抑止性カプセル剤。 - 第1のPEG及び第2のPEGが、合わせてカプセル剤の少なくとも約60wt%である、請求項12に記載のカプセル剤。
- 活性物質が酒石酸水素ヒドロコドンである、請求項12に記載のカプセル剤。
- 活性物質がオキシコドンHClである、請求項12に記載のカプセル剤。
- 少なくとも1種の乱用されやすい活性物質を含む即時放出性乱用抑止性カプセル剤の製造方法であって、
(a)(i)少なくとも1種の乱用されやすい活性物質、
(ii)約30,000ダルトン〜約40,000ダルトンの間の平均分子量を有する第1のPEG、及び
(iii)約3000ダルトン〜約4000ダルトンの間の平均分子量を有する第2のPEG
の均質化懸濁液を調製するステップ、並びに
(b)均質化懸濁液をカプセルボディに充填してカプセル剤を製造するステップ
を含み、
第1のPEG対第2のPEGの比が約1:4w/w未満である、方法。 - 第1のPEG及び第2のPEGが、合わせてカプセル剤の少なくとも約60wt%である、請求項16に記載の方法。
- 活性物質が酒石酸水素ヒドロコドンである、請求項16に記載の方法。
- 活性物質がオキシコドンHClである、請求項16に記載の方法。
- カプセル剤が、カプセルボディをカプセルキャップと接合させることにより形成される、請求項16に記載の方法。
- 第1のPEGが約35,000ダルトンの平均分子量を有し、第2のPEGが約3350ダルトンの平均分子量を有する、請求項16に記載の方法。
- (a)乱用されやすい活性物質、
(b)約30,000ダルトン〜約40,000ダルトンの平均分子量を有する第1のポリエチレングリコール(PEG)、及び
(c)約3000ダルトン〜約4000ダルトンの平均分子量を有する第2のPEG
を含み、第1のPEG対第2のPEGの比が約1:4w/w未満である、痛みを治療するための即時放出性乱用抑止性カプセル剤。 - 第1のPEGが約35,000ダルトンの平均分子量を有し、第2のPEGが約3350ダルトンの平均分子量を有する、請求項22に記載のカプセル剤。
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CA264736A (en) | 1926-10-05 | S. Goulet William | Rotary engine | |
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2015
- 2015-07-07 EP EP15821947.7A patent/EP3169315B1/en active Active
- 2015-07-07 WO PCT/US2015/039336 patent/WO2016010771A1/en active Application Filing
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EP3169315A4 (en) | 2018-03-21 |
ES2809458T3 (es) | 2021-03-04 |
WO2016010771A1 (en) | 2016-01-21 |
JP2017521448A (ja) | 2017-08-03 |
EP3169315B1 (en) | 2020-06-24 |
EP3169315A1 (en) | 2017-05-24 |
AU2015290098B2 (en) | 2018-11-01 |
AU2015290098A1 (en) | 2017-01-19 |
US9707184B2 (en) | 2017-07-18 |
DK3169315T3 (da) | 2020-08-10 |
CA2955229A1 (en) | 2016-01-21 |
US20170340574A1 (en) | 2017-11-30 |
CA2955229C (en) | 2020-03-10 |
US20160015650A1 (en) | 2016-01-21 |
JP2018197241A (ja) | 2018-12-13 |
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