JP6031599B2 - 長期放出性、濫用抑止特性薬学的組成物 - Google Patents
長期放出性、濫用抑止特性薬学的組成物 Download PDFInfo
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Description
本願は、2012年7月12日に出願された米国仮特許出願第61/670,751号明細書および2013年3月15日に出願された米国仮特許出願第61/790,463号明細書の利益を主張し、本明細書においてその全体およびU.S.が組み込まれる。
本開示は、一般に、活性成分の長期放出を提供し、濫用抑止特性を有する薬学的組成物に関する。
2008年に、米国における12歳以上の集団の中で鎮痛剤を医療以外で使用することは、違法薬物の中で、大麻に次いで2番目に広く行き渡っていることが報告された。処方箋医薬品の濫用は、大衆の中での慢性疼痛のより積極的な処置に起因して、オピオイド投与形態の入手可能性が増した結果として起こっている。濫用者数の増加、入手可能性の増大、そしてアヘン剤の破壊的/嗜癖性の可能性から、処方箋医薬の濫用は、公衆衛生に関わる問題になっている。
本開示は、少なくとも1種の活性な医薬成分(API)またはその薬学的に受容可能な塩、少なくとも1種の親水性プラストマー、必要に応じて少なくとも1種の親水性エラストマー、および少なくとも1種の潮解性可塑剤を含む、中身に手を加えられないようになっている長期放出物を提供する。本明細書で開示される薬学的組成物は、上記APIの長期放出を提供し、濫用抑止特性を有する。
(項目1)
薬学的組成物であって、該組成物は、少なくとも1種の活性な医薬成分(API)またはその薬学的に受容可能な塩、少なくとも1種の親水性プラストマー、必要に応じて、少なくとも1種の親水性エラストマー、および少なくとも1種の潮解性可塑剤を含む、薬学的組成物。
(項目2)
前記組成物は、前記APIの長期放出を提供し、濫用抑止特性を有する、項目1に記載の薬学的組成物。
(項目3)
前記親水性プラストマーは、セルロースエーテル、ポリアルキレンオキシド、ポリアルキレングリコール、ポリオレフィンアルコール、ポロビニルラクタム、ポリカルボン酸、ポリサッカリド、ポリペプチド、またはこれらの組み合わせであり、そして前記薬学的組成物の約10重量%〜約90重量%の量で存在する、項目1または2のいずれかに記載の薬学的組成物。
(項目4)
前記親水性プラストマーは、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、ポリエチレンオキシド、またはこれらの組み合わせである、前述の項目のいずれか1項に記載の薬学的組成物。
(項目5)
前記親水性エラストマーは、アクリレートポリマー、メタクリレートポリマー、またはこれらの組み合わせであり、存在する場合、前記薬学的組成物の約0.5重量%〜約40重量%の量で存在する、前述の項目のいずれか1項に記載の薬学的組成物。
(項目6)
前記親水性エラストマーは、カルボマー、ポリカルボフィル、またはこれらの組み合わせである、前述の項目のいずれか1項に記載の薬学的組成物。
(項目7)
前記潮解性可塑剤は、有機酸、糖アルコール、有機酸および/または糖アルコールならびに液体可塑剤の共処理混合物、またはこれらの組み合わせであり、そして前記薬学的組成物のうちの約2重量%〜約50重量%の量で存在する、前述の項目のいずれか1項に記載の薬学的組成物。
(項目8)
前記組成物は、固体投与形態であり、必要に応じて、フィルムコーティングを含む、前述の項目のいずれか1項に記載の薬学的組成物。
(項目9)
前記組成物が約12分間粉砕されて、粒子を形成した後、該粒子のうちの約30%より多く、または60%より多くは、約250ミクロンより大きい平均直径を有する、前述の項目のいずれか1項に記載の薬学的組成物。
(項目10)
前記親水性プラストマーは、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロースおよびポリエチレンオキシドを含み、そして前記組成物の約50重量%〜約80重量%の量で存在し;必要に応じた親水性エラストマーは、存在する場合、カルボマーであり、そして前記組成物の0.5重量%〜約10重量%の量で存在し;そして前記潮解性可塑剤は、クエン酸およびソルビトールを含み、前記組成物の約10重量%〜約30重量%の量で存在する、前述の項目のいずれか1項に記載の薬学的組成物。
(項目11)
前記APIは、オキシコドン、オキシモルホン、ヒドロコドン、ヒドロモルホン、コデイン、またはモルフィンである、前述の項目のいずれか1項に記載の薬学的組成物。
(項目12)
前述の項目のいずれか1項に記載の固体投与形態を調製するためのプロセスであって、該プロセスは、
a)前記API、前記親水性プラストマー、前記必要に応じた親水性エラストマー、および前記潮解性可塑剤を含む混合物を形成する工程であって、ここで該混合物は、粉末、粒状物、または固体投与単位である、工程;
b)(a)の混合物に加湿して、加湿した粉末、加湿した粒状物、または加湿した固体投与単位を形成する工程;
c)必要に応じて、(b)の加湿した粉末または加湿した粒状物を処理した固体投与単位へと形成する工程;
d)必要に応じて、(b)の加湿した固体投与単位または(c)の処理した固体投与単位を被覆して、被覆した固体投与単位を形成する工程;ならびに
e)(b)の加湿した固体投与単位、(c)の処理した固体投与単位、または(d)の被覆した固体投与単位を加熱して、該固体投与形態を形成する工程、
を包含する、プロセス。
(項目13)
前記加湿する工程(b)は、前記潮解性可塑剤が潮解を受けるような温度および相対湿度で起こる、項目12に記載のプロセス。
(項目14)
25℃での前記相対湿度は、約40%〜約100%である、項目13に記載のプロセス。
(項目15)
前記加熱する工程(e)は、約50℃より高い温度で起こる、項目12〜14のいずれか1項に記載のプロセス。
本開示の他の局面および繰り返しは、以下でより詳細に記載される。
本開示は、活性な医薬成分の長期放出を提供し、濫用抑止特性を有する、固体投与薬学的組成物を提供する。長期放出の濫用抑止性薬学的組成物を作製するための方法もまた、提供される。本明細書で開示される薬学的組成物は、少なくとも1種の親水性プラストマー、必要に応じて少なくとも1種の親水性エラストマー、および少なくとも1種の潮解性可塑剤を含む。本発明の出願人は、親水性ポリマーが、上記ポリマーを含む組成物の加湿によって、潮解性可塑剤で可塑化され得ることを発見した。湿気のある環境下で、上記潮解性可塑剤は、大気から水分を吸収して、液体になり、それによって、上記可塑剤が上記親水性ポリマーを効率的に可塑化することを可能にする。次いで、上記加湿された組成物は、過剰な水分を除去し、上記親水性ポリマーを硬化させるために、加熱される。得られた組成物は、微細粒子へと破砕されたりすり粉砕されたりするのに耐えるように、十分な硬度および弾性を有する。
(I)薬学的組成物
(a)組成物の成分
(i)親水性プラストマー
(ii)親水性エラストマー
(iii)潮解性可塑剤
(iv)必要に応じた調節因子
(v)API
;ビタミン;ミネラル;ならびにこれらの組み合わせ。
(vi)必要に応じた賦形剤
(vii)必要に応じたフィルム被覆
(b)投与形態
(c)組成物のインビトロ放出特性
(d)組成物の濫用抑止特性
(e)例示的実施形態
(II)固体投与薬学的組成物を調製するためのプロセス
(a)混合物の形成
(b)混合物の加湿
(c)固体投与単位の必要に応じた形成
(d)固体投与単位の必要に応じた被覆
(e)固体投与単位の加熱
(f)プロセスの反復
(実施例1:プロトタイプ#1の調製)
(実施例2:プロトタイプ#2の調製)
(実施例3:プロトタイプ#1および#2からのオキシコドンのインビトロ放出)
(実施例5:プロトタイプ処方物を加湿する効果)
(実施例8:プロトタイプ#3の力プロフィール)
(実施例9:オキシモルホン処方物)
Claims (17)
- 薬学的組成物であって、該組成物は、濫用の可能性を有する少なくとも1種の活性な医薬成分(API)またはその薬学的に受容可能な塩、各々約20,000ダルトン〜約2,000,000ダルトンの平均分子量を有する少なくとも2種の親水性プラストマー、カルボマー、ポリカルボフィル、またはこれらの組み合わせから選択される少なくとも1種の親水性エラストマー、および有機酸、糖アルコール、有機酸および/または糖アルコールならびに液体可塑剤の共処理混合物、またはこれらの組み合わせから選択される少なくとも1種の潮解性可塑剤を含み、該薬学的組成物は、該APIの長期放出を提供し、破砕、粉砕、または微粉化したときに粒子を形成することによって濫用を抑止し、そして、該薬学的組成物を約12分間粉砕したときに該粒子の約30%より多くが約250ミクロンより大きい平均直径を有する、薬学的組成物。
- 前記親水性プラストマーは、セルロースエーテル、ポリアルキレンオキシド、ポリアルキレングリコール、ポリオレフィンアルコール、ポリビニルラクタム、ポリカルボン酸、ポリサッカリド、ポリペプチド、またはこれらの組み合わせであり、そして前記薬学的組成物の約10重量%〜約90重量%の量で存在する、請求項1に記載の薬学的組成物。
- 前記親水性プラストマーは、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、ポリエチレンオキシド、またはこれらの組み合わせである、請求項2に記載の薬学的組成物。
- 前記親水性エラストマーは、前記薬学的組成物の約0.5重量%〜約40重量%の量で存在する、請求項1〜3のいずれか1項に記載の薬学的組成物。
- 前記潮解性可塑剤は、クエン酸、クエン酸とソルビトールとの組み合わせ、またはクエン酸とソルビトールおよびグリセロールの共処理混合物との組み合わせであり、そして前記薬学的組成物のうちの約2重量%〜約50重量%の量で存在する、請求項1〜4のいずれか1項に記載の薬学的組成物。
- 前記組成物は、固体投与形態である、請求項1〜5のいずれか1項に記載の薬学的組成物。
- 前記固体投与形態がフィルムコーティングを含む、請求項6に記載の薬学的組成物。
- 前記粒子のうちの60%より多くは、約250ミクロンより大きい平均直径を有する、請求項1〜7のいずれか1項に記載の薬学的組成物。
- 前記薬学的組成物が、約10mL未満の適切な溶媒と接触したときに粘性の混合物またはゲルを形成することによって、濫用を抑止する、請求項1〜8のいずれか1項に記載の薬学的組成物。
- 前記親水性プラストマーは、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロースおよびポリエチレンオキシドを含み、そして前記組成物の約50重量%〜約80重量%の量で存在し;前記親水性エラストマーは、カルボマーであり、そして前記組成物の0.5重量%〜約10重量%の量で存在し;そして前記潮解性可塑剤は、クエン酸およびソルビトールを含み、前記組成物の約10重量%〜約30重量%の量で存在する、請求項1〜9のいずれか1項に記載の薬学的組成物。
- 前記APIは、オキシコドン、オキシモルホン、ヒドロコドン、ヒドロモルホン、コデイン、またはモルフィンである、請求項1〜10のいずれか1項に記載の薬学的組成物。
- 請求項1〜11のいずれか1項に記載の薬学的組成物の固体投与形態を調製するためのプロセスであって、該プロセスは、
a)前記API、前記親水性プラストマー、前記必要に応じた親水性エラストマー、および前記潮解性可塑剤を含む混合物を形成する工程であって、ここで該混合物は、粉末、粒状物、または固体投与単位である、工程;
b)(a)の混合物に加湿して、加湿した粉末、加湿した粒状物、または加湿した固体投与単位を形成する工程;ならびに
c)(b)の加湿した固体投与単位を加熱して、該固体投与形態を形成する工程、
を包含する、プロセス。 - 工程(b)の後に、
i)(b)の前記加湿した粉末または前記加湿した粒状物を処理した固体投与単位へと形成する工程;および
ii)(i)の該処理した固体投与単位を加熱して、前記固体投与単位を形成する工程、
をさらに包含する、請求項12に記載のプロセス。 - 工程(b)または工程(i)の後に、
1)(b)の前記加湿した固体投与単位または(i)の前記処理した固体投与単位を被覆して、被覆した固体投与単位を形成する工程;および
2)(1)の該被覆した固体投与単位を加熱して、前記固体投与単位を形成する工程、
をさらに包含する、請求項12または13に記載のプロセス。 - 前記加湿する工程(b)は、前記潮解性可塑剤が潮解を受けるような温度および相対湿度で起こる、請求項12〜14のいずれか1項に記載のプロセス。
- 25℃での前記相対湿度は、約40%〜約100%である、請求項15に記載のプロセス。
- 前記加熱する工程(c)、(ii)、または(2)は、約50℃より高い温度で起こる、請求項12〜16のいずれか1項に記載のプロセス。
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CA2877774A1 (en) | 2014-01-16 |
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IL236648A0 (en) | 2015-02-26 |
IL236648B (en) | 2019-09-26 |
US20170143699A1 (en) | 2017-05-25 |
BR112015000320B1 (pt) | 2023-03-07 |
JP2015525764A (ja) | 2015-09-07 |
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ES2698611T3 (es) | 2019-02-05 |
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