JP2016138126A - 乱用抵抗性医薬組成物、その使用方法および作製方法 - Google Patents
乱用抵抗性医薬組成物、その使用方法および作製方法 Download PDFInfo
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
Abstract
【解決手段】乱用抵抗性経口医薬組成物であって、第1のポリマーを含むバリア層と、第2のポリマーを含み、実質的に該バリア層を包被する、拡散層であって、該バリア層に結合され、該第2のポリマー内に実質的に均質に分配され、かつ該拡散層から消化(GI)管内で拡散する薬物を含む、拡散層と、任意選択で、拡張可能なポリマーを含む拡張層であって、該バリア層によって実質的に包被される、拡張層と、を含む、乱用抵抗性経口医薬組成物を作製する。また、その作製方法およびその使用方法も提供する。
【選択図】図1
Description
マンニトール―90mg
微結晶性セルロース―50mg
カルボポル(登録商標)71G―128mg
ヒドロキシプロピルメチルセルロース、タイプ2910―128mg
(メトセル(商標)K4M CR)
ステアリン酸マグネシウム―4mg
マンニトール―22.5mg
微結晶性セルロース―12.5mg
カルボポル(登録商標)71G―32mg
ヒドロキシプロピルメチルセルロース、タイプ2910―32mg
(メトセル(商標)K4M CR)
ステアリン酸マグネシウム―1mg
マンニトール―135mg
微結晶性セルロース―75mg
カルボポル(登録商標)71G―192mg
ヒドロキシプロピルメチルセルロース、タイプ2910―192mg
(メトセル(商標)K4M CR)
ステアリン酸マグネシウム―6mg
マンニトール―70mg
微結晶性セルロース―50mg
カルボポル(商標)71G―128mg
ヒドロキシプロピルメチルセルロース、タイプ2910―128mg
(メトセル(商標)K4M CR)
クロスカルメロースナトリウム―20mg(AC−DI−SOL(登録商標))
ステアリン酸マグネシウム―4mg
マンニトール―45mg
微結晶性セルロース―25mg
カルボポル(商標)71G―64mg
ヒドロキシプロピルメチルセルロース、タイプ2910―64mg
(メトセル(商標)K4M CR)
ステアリン酸マグネシウム―2mg
拡張層錠剤(実施例4)―370g
ユードラギット(登録商標)NE30D分散体―300g
ステアリン酸カルシウム粉末―15g
シメチコン固体―0.15g
精製水―85g
拡張層錠剤(実施例4)―370g
ユードラギット(登録商標)NE30D分散体―300gステアリン酸カルシウム―15g
シメチコンエマルション固体―0.15g
精製水―85g
拡張層錠剤(実施例5)―400g
ユードラギット(登録商標)NE30D分散体―150g
ステアリン酸カルシウム―5g
シメチコンエマルション固体―0.05g
精製水―28g
拡張層錠剤(実施例3)―600g
ユードラギット(登録商標)NE30D分散体―150g
アエロジル200―5g
拡張層錠剤(実施例2)―400g
ユードラギット(登録商標)NE30D分散体―150g
タルク―15g
精製水―50g
拡張層錠剤(実施例4)―370g
ユードラギット(登録商標)NE30D分散体―200g
ユードラギット(登録商標)RS30D分散体―100g
タルク―25g
精製水―142g
バリアコーティングされた錠剤(実施例7)―475g
塩酸オキシコドン―37g
ユードラギット(登録商標)NE30D分散体―175g
ツィーン(登録商標)80―1.5g
アエロジル(登録商標)200―2.0g
精製水―100g
バリアコーティングされた錠剤(実施例7)―475g
塩酸オキシコドン―37g
ユードラギット(登録商標)NE30D分散体―275g
ステアリン酸カルシウム―6g
シメチコンエマルション固体―0.06g
精製水―34.4g
バリアコーティングされた錠剤(実施例11)―485g
塩酸オキシコドン―74g
ユードラギット(登録商標)NE30D分散体―350g
ツィーン80―2g
ステアリン酸カルシウム―11g
シメチコンエマルション固体―0.11g
精製水―60g
バリアコーティングされた錠剤(実施例8)―450g
塩酸オキシコドン―10g
ユードラギット(登録商標)NE30D分散体―100g
アエロジル200―2g精製水―100g
バリアコーティングされた錠剤(実施例7)―475g
酒石酸水素ヒドロコドン―9.25g
ユードラギット(登録商標)NE30D分散体―155g
アエロジル(登録商標)200粉末―5g
ツィーン80(登録商標)―1.5g
精製水―185g
バリアコーティングされた錠剤(実施例7)―475g
硫酸モルヒネ―55.6g
ユードラギット(登録商標)NE30D分散体―275g
アエロジル200―5.0g
精製水―150g
バリアコーティングされた錠剤(実施例7)―475g
塩酸ヒドロモルフォン―14.8g
ユードラギット(登録商標)NE30D分散体―250g
アエロジル(登録商標)200―5.0g精製水―100g
バリアコーティングされた錠剤(実施例7)―475g
塩酸オキシモルフォン―37g
ユードラギット(登録商標)NE30D分散体―220g
ツィーン(登録商標)80―2.5g
アエロジル(登録商標)200―50g
精製水―100g
バリアコーティングされた錠剤(実施例8)―475g
塩酸デキサメチルフェニデート―10g
ユードラギット(登録商標)NE30D分散体―100g
アエロジル200―1g
精製水―100g
バリアコーティングされた錠剤(実施例10)―450g
ザレプロン―20g
ユードラギット(登録商標)NE30D分散体―100g
アエロジル(登録商標)200―1gツィーン(登録商標)80―5g
精製水―100g
バリアコーティングされた錠剤(実施例9)―695g
塩酸プロプラノロール―80g
ユードラギット(登録商標)NE30D分散体―150g
アエロジル(登録商標)200―5g
ツィーン(登録商標)溶液―1g
精製水―100g
バリアコーティングされた錠剤(実施例6)―475g
塩酸トラマドール―92.6g
ユードラギット(登録商標)NE30D分散体―290g
ツィーン(登録商標)80―0.5g
アエロジル(登録商標)200―5g
精製水―250g
バリアコーティングされた錠剤(実施例8)―450g
オキシコドン拡散コーティング:
塩酸オキシコドン―10gユードラギット(登録商標)NE30D分散体―100g
アエロジル(登録商標)200―1g
精製水―100g
サブコーティング、アセトアミノフェノンコーティングおよびシールコーティング:
5%HPMC溶液サブコーティング―100g
アセトアミノフェノン粉末―2000g
10%HPMC溶液―1000g
精製水―1000g
5%HPMCシールコーティング―100g
バリアコーティングされた錠剤―475g
拡散層コーティング:
塩酸オキシコドン―37g
ユードラギット(登録商標)NE30D分散体―275g
ツィーン(登録商標)80―2.5g
ステアリン酸カルシウム―6g
シメチコン固体―0.06g
精製水―34.4g
持続放出層コーティング:
ユードラギット(登録商標)NE30D分散体―30g
HPMC10%溶液―30g
アエロジル(登録商標)200―2.5g
精製水―66g
拡散層錠剤(実施例13)―600g
オパドライ85Fl8422白色粉末―50g
精製水―250g
バリアコーティングされた錠剤(実施例8)―450g
塩酸オキシコドン―10g
硫酸モルヒネ―20g
ユードラギット(登録商標)NE30D分散体―125g
ツィーン(登録商標)80―1.0g
アエロジル(登録商標)200―2.0g
精製水―100g
バリアコーティングされた錠剤(実施例7)―475g
塩酸オキシコドン―9.3g
硫酸モルヒネ―18.5g
ユードラギット(登録商標)NE30D分散体―275g
ツィーン(登録商標)80―2.0g
アエロジル(登録商標)200―2.5g
精製水―100g
拡張層
マンニトール―52.5mg
微結晶性セルロース―37.5mg
カルボポル71G―96mg
ヒドロキシプロピルメチルセルロース、タイプ2910―96mg
(メトセル(商標)K4M CR)
クロスカルメロースナトリウム―15mg
(AC−DI−SOL(登録商標))
ステアリン酸マグネシウム―3mgHPMCサイズ#2カプセル―60mg
バリア層
ユードラギット(登録商標)NE30D固体―97.3mg
ステアリン酸カルシウム―16.2mg
シメチコンエマルション―0.2mg
精製水― ‐‐‐‐‐
拡散層
塩酸オキシコドン―40mg
ユードラギット(登録商標)NE30D固体―63.5mg
アエロジル(登録商標)200―2.5mg
ツィーン80(登録商標)80―1.5mg
精製水― ‐‐‐‐‐
持続放出コーティング
ユードラギット(登録商標)NE30D固体―15mg
アエロジル(登録商標)200―2.5mg
HPMC E6固体―5mg
精製水― ‐‐‐‐‐
カラーコーティング
オパドライ85Fl 8422粉末―30mg
精製水― ‐‐‐‐‐
拡張層
マンニトール―35mg
微結晶性セルロース―25mg
カルボポル71G―64mg
ヒドロキシプロピルメチルセルロース、タイプ2910―64mg
(メトセル(商標)K4M CR)
クロスカルメロースナトリウム―10mg
(AC−DI−SOL(登録商標))
メトセルE6固体―20mg
精製水― ‐‐‐‐‐
バリア層
ユードラギット(登録商標)NE30D固体―97mg
ユードラギット(登録商標)RS30D固体―32mg
タルク粉末―50mg
精製水― ‐‐‐‐‐
拡散層
塩酸オキシコドン―40mg
ユードラギット(登録商標)NE30D固体―89mg
アエロジル(登録商標)200―2mg
精製水― ‐‐‐‐‐
錠剤処方
アビセルPH102―100mg
アビセルPH200―100mg
ステアリン酸マグネシウム―8mg
カラーコーティング
オパドライ85F18422粉末―30mg
精製水― ‐‐‐‐‐
拡張層
マンニトール―70mg
微結晶性セルロース―50mg
カルボポル71G―128mg
ヒドロキシプロピルメチルセルロース、タイプ2910―128mg(メトセル(商標)K4M CR)
クロスカルメロースナトリウム―20mg
(AC−DI−SOL(登録商標))
ステアリン酸マグネシウム―4mg
バリア層
ユードラギット(登録商標)NE30D固体―97.3mg
ステアリン酸カルシウム―16.2mg
シメチコンエマルション―0.2mg
精製水― ‐‐‐‐‐
拡散層
塩酸オキシコドン―40mg
ユードラギット(登録商標)NE30D固体―89.2mg
アエロジル(登録商標)200―2mg
ツィーン(登録商標)80―2mg
精製水― ‐‐‐‐‐
カラーコーティング
オパドライ85Fl8422粉末―30mg
精製水― ‐‐‐‐‐
Claims (38)
- 経口医薬組成物であって、第1のポリマーを含むバリア層と、第2のポリマーを含み、前記バリア層を実質的に包被する、拡散層であって、前記バリア層に結合され、前記第2のポリマー内に実質的に均質に分配され、かつ前記拡散層から消化(GI)管内で拡散する薬物を含む、拡散層と、を含む、経口医薬組成物。
- 前記医薬組成物が、拡張可能なポリマーを含む拡張層をさらに含み、前記バリア層が、前記拡張層を実質的に包被する、請求項1に記載の医薬組成物。
- 前記拡張層が、剤形の総重量に基づき、5〜90重量%の範囲で存在するポリマーを含む、請求項2に記載の医薬組成物。
- 前記医薬組成物が、前記医薬組成物が物理的に損傷を受け、前記拡張層を含有する前記医薬組成物の粒子が形成され、液体に曝露された際、前記拡張可能な層の拡張可能なポリマーが、前記液体の少なくとも一部を吸収するように構成される、請求項2または3に記載の医薬組成物。
- 前記拡散層が、前記バリア層に物理的に結合される、請求項1〜4のいずれか1項に記載の医薬組成物。
- 前記医薬組成物が、前記医薬組成物が無傷形態で投与される際、前記バリア層の前記第1のポリマーが、GI管で実質的に溶解されないように構成される、請求項1〜5のいずれか1項に記載の医薬組成物。
- 前記拡散層の前記第2のポリマーが、6〜24時間にわたる薬物の時限放出を提供する、請求項1〜6のいずれか1項に記載の医薬組成物。
- 前記医薬組成物が、前記医薬組成物が物理的に損傷を受け、前記拡散層および前記バリア層を含有する前記医薬組成物の粒子が形成される際、前記粒子内の前記拡散層とバリア層との間の結合が実質的に保存されるように構成される、請求項1〜7のいずれか1項に記載の医薬組成物。
- 前記医薬組成物が物理的に損傷を受けた形態で被験体に投与される際、投与後2時間、4時間、8時間、12時間、24時間、および48時間から成る群より選択される時間後に達成されるCmaxおよび/またはAUCが、前記医薬組成物が無傷形態で投与された際に達成されるCmaxおよび/またはAUCと実質的に同一またはそれを下回るように構成される、請求項1〜8のいずれか1項に記載の医薬組成物。
- 前記医薬組成物が、投与後2時間、4時間、8時間、12時間、24時間、および48時間から成る群より選択される時間後に達成されるCmaxおよび/またはAUCが、前記医薬組成物が被験体に無傷形態で投与される際に達成されるCmaxおよび/またはAUCよりも20〜75%下回るように構成される、請求項9に記載の医薬組成物。
- 前記医薬組成物が、追加の放出層を含み、前記追加の放出層が、前記拡散層を実質的に包被する即時放出層であり、前記追加の放出層が、少なくとも1つの追加の薬物を含む、請求項1〜10のいずれか1項に記載の医薬組成物。
- 前記追加の放出層内の前記少なくとも1つの追加の薬物が、アセトアミノフェン、および非ステロイド系抗炎症性薬物から成る群より選択される、請求項11に記載の医薬組成物。
- 治療有効量の薬物を含む経口医薬組成物であって、前記医薬組成物が物理的に損傷を受けた形態で被験体に投与される際、投与後に達成されるCmax/AUCが、乱用を防止するための手段を含まない、物理的に損傷を受けた生物学的に同等な組成物の投与後2時間、4時間、8時間、12時間、24時間、および48時間から成る群より選択される時間後に達成されるCmax/AUCを下回るように構成される、経口医薬組成物。
- 治療有効量の薬物を含む経口医薬組成物であって、前記医薬組成物が物理的に損傷を受けた形態で被験体に投与される際、投与後に達成されるCmaxおよび/またはAUCが、乱用を防止するための手段を含まない、生物学的に同等な組成物の投与後2時間、4時間、8時間、12時間、24時間、および48時間から成る群より選択される時間後に達成されるCmaxおよび/またはAUCを下回るように構成される、経口医薬組成物。
- 治療有効量の薬物を含む経口医薬組成物であって、前記医薬組成物が物理的に損傷を受けた形態で被験体に投与される際、2時間、4時間、8時間、および16時間から成る群より選択される時間内に前記組成物から放出される薬物の速度が、前記医薬組成物が無傷形態で投与される際に放出される薬物の速度と実質的に同一またはそれを下回るように構成される、経口医薬組成物。
- 治療有効量の薬物を含む経口医薬組成物であって、前記医薬組成物が物理的に損傷を受けた形態で被験体に投与される際、2時間、4時間、8時間、および16時間から成る群より選択される時間内に前記組成物から放出される薬物の量が、前記医薬組成物が無傷形態で投与される際に放出される薬物の量と実質的に同一またはそれを下回るように構成される、経口医薬組成物。
- 前記医薬組成物が物理的に損傷を受けた形態で被験体に投与される際、2時間、4時間、8時間、および16時間から成る群より選択される時間内に前記組成物から放出される薬物の量が、前記医薬組成物が無傷形態で投与される際に放出される薬物の量の75%以下となるように構成される、請求項16に記載の医薬組成物。
- 治療有効量の薬物を含む経口医薬組成物であって、前記医薬組成物がアルコールと接触するか、またはアルコールと一緒に消費される際、2時間、4時間、8時間、および16時間から成る群より選択される時間内に前記組成物から放出される薬物の速度が、前記医薬組成物がアルコールと一緒には投与されない場合に放出される薬物の速度と実質的に同一またはそれを下回るように構成される、経口医薬組成物。
- 治療有効量の薬物を含む経口医薬組成物であって、前記医薬組成物が無傷形態で投与される際は、薬物の量の少なくとも50%が8時間後に放出され、前記医薬組成物が物理的に損傷を受けた形態で投与される際は、薬物の量の40%以下が1時間後に放出されるように構成される、経口医薬組成物。
- 前記医薬組成物が物理的に損傷を受けた形態で投与される際、薬物の量の35%以下が15分後に放出される、請求項19に記載の医薬組成物。
- 治療有効量の薬物を含む経口医薬組成物であって、前記医薬組成物が無傷形態で投与される際は、薬物の量の少なくとも90%が1時間後に放出され、前記医薬組成物が物理的に損傷を受けた形態で投与される際は、薬物の量の75%以下が1時間後に放出されるように構成される、経口医薬組成物。
- 前記医薬組成物が、錠剤、カプセル、マイクロタブレット、顆粒、ペレット、トローチ剤、キャンディ、およびコーティングされたカプセルから成る群より選択される医薬剤形である、請求項1〜21のいずれか1項に記載の医薬組成物。
- 前記医薬剤形が錠剤である、請求項22に記載の医薬組成物。
- 前記薬物が、中枢神経系刺激薬および中枢神経系抑制薬から成る群より選択される、請求項1〜23のいずれか1項に記載の医薬組成物。
- 前記薬物が、オピオイド、バルビツール酸、ベンゾジアゼピン、およびアンフェタミンから成る群より選択される、請求項1〜23のいずれか1項に記載の医薬組成物。
- 前記薬物が、アルフェンタニル、アリルプロジン、アルファプロジン、アニレリジン、ベンジルモルヒネ、ベジトラミド、ブプレノルフィン、ブトルファノール、クロニタゼン、コデイン、デソモルヒネ、デキストロモラミド、デゾシン、ジアンプロミド、ジアモルフォン、ジヒドロコデイン、ジヒドロモルヒネ、ジメノキサドール、ジメフェプタノール、ジメチルチアムブテン、ジオキサフェチルブチレート、ジピパノン、エプタゾシン、エトヘプタジン、エチルメチルチアムブテン、エチルモルヒネ、エトニタゼン、ヒドロコドン、ヒドロモルフォン、ヒドロキシペチジン、イソメタドン、ケトベミドン、レボルファノール、レボフェナシルモルファン、ロフェンタニル、メペリジン、メプタジノール、メタゾシン、メタドン、メトポン、モルヒネ、ミロフィン、ナルセイン、ニコモルヒネ、ノルレボルファノール、ノルメタドン、ナロルフィン、ナルブフェン、ノルモルヒネ、ノルピパノン、オピウム、オキシコドン、オキシモルフォン、パパベレタム、ペンタゾシン、フェナドキソン、フェノモルファン、フェナゾシン、フェノペリジン、ピミノジン、ピリトラミド、プロフェプタジン、プロメドール、プロペリジン、プロポキシフェン、スフェンタニル、チリジン、トラマドール、およびこれらの薬学的に許容される塩から成る群より選択される、オピオイドである、請求項25に記載の医薬組成物。
- 前記オピオイドが、オキシコドンまたはその薬学的に許容される塩であり、5mg〜400mgの量で存在する、請求項26に記載の医薬組成物。
- 前記オピオイドが、モルヒネまたはその薬学的に許容される塩であり、15mg〜800mgの量で存在する、請求項26に記載の医薬組成物。
- 前記オピオイドが、ヒドロモルフォンまたはその薬学的に許容される塩であり約1mg〜64mgの量で存在する、請求項26に記載の医薬組成物。
- 前記オピオイドが、ヒドロコドンまたはその薬学的に許容される塩であり、5mg〜400mgの量で存在する、請求項26に記載の医薬組成物。
- 前記オピオイドが、オキシモルフォンまたはその薬学的に許容される塩であり、4mg〜80mgの量で存在する、請求項26に記載の医薬組成物。
- 乱用抵抗性経口医薬組成物を作製する方法であって、バリア層を形成するステップであって、前記バリア層が第1のポリマーを含む、ステップと、拡散層を前記バリア層上に塗布して、前記バリア層を実質的に包被するステップであって、前記拡散層が第2のポリマーと、前記第2のポリマー内に均質に分配される薬物とを含む、ステップと、前記拡散層を前記バリア層に結合するステップと、を含む、方法。
- 前記拡散層を前記バリア層に結合する前記ステップが、物理的結合である、請求項32に記載の方法。
- 乱用抵抗性経口医薬組成物を作製する方法であって、拡張可能なポリマーを含む拡張層を形成するステップと、バリア層を前記拡張層上に塗布して、前記拡張層を実質的に包被するステップであって、前記バリア層が第1のポリマーを含む、ステップと、拡散層を前記バリア層上に塗布して、前記バリア層を実質的に包被するステップであって、前記拡散層は第2のポリマーと、前記第2のポリマー内に均質に分配される薬物と、を含むステップと、前記拡散層を前記バリア層に結合するステップと、を含む、方法。
- 前記拡散層を前記バリア層に結合する前記ステップが、物理的結合である、請求項34に記載の方法。
- 噴霧または乾燥コーティングによって、前記バリア層を前記拡張層に塗布するステップを含む、請求項34または35に記載の方法。
- 病態を治療する方法であって、病態の治療を必要とする患者に請求項1〜31のいずれか1項に記載の医薬組成物を投与するステップを含む、方法。
- 治療有効量の薬物を含む経口医薬組成物であって、前記医薬組成物が物理的に損傷を受けた形態で被験体に投与される際、多幸感の強度が、乱用を防止するための手段を含まない、物理的に損傷を受けた、生物学的に同等な組成物の投与後に達成される多幸感の強度と実質的に同一またはそれを下回るように構成される、経口医薬組成物。
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