JP6353089B2 - 積層製剤 - Google Patents
積層製剤 Download PDFInfo
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- JP6353089B2 JP6353089B2 JP2017000075A JP2017000075A JP6353089B2 JP 6353089 B2 JP6353089 B2 JP 6353089B2 JP 2017000075 A JP2017000075 A JP 2017000075A JP 2017000075 A JP2017000075 A JP 2017000075A JP 6353089 B2 JP6353089 B2 JP 6353089B2
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- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
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- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
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Description
上記のように、製剤は、患者への投与を容易にするために様々な形状および大きさで構成され得る。錠剤に構成される製剤の製造は、当分野において公知のステップを含む。例えば、錠剤は、湿式造粒、乾式造粒または直接圧縮を介して調製され得る。積層製剤は、同様の方法で錠剤形態に構成され得る。それぞれの医薬層を製造するために、1つまたは複数の薬剤を、例えば、結晶、非晶質または粉末形態で得、希釈剤および/または賦形剤と混合し、または混合せずに、圧力で固体にする。固体医薬層を他の医薬層および/または中間層と合わせ、望ましい錠剤配列に、圧力を用いて構成する。
いくつかの実施形態において、積層製剤は、肥満の治療のために使用できる。肥満は、体内に過剰な脂肪が蓄積されることを特徴とする障害である。肥満は、疾患の主原因の1つとして認識されており、世界的な問題として浮上している。高血圧、非インスリン依存性糖尿病、動脈硬化、脂質異常症、ある種の癌、睡眠時無呼吸および変形性関節炎などの、肥満からの合併症の増加事実は、一般集団における肥満の増加事実と関連がある。
いくつかの実施形態において、抗鬱薬は、ドーパミン再摂取阻害剤またはドーパミン受容体拮抗薬を含む。ドーパミン再摂取阻害剤の例は、限定するものではないが、フェンテルミンおよびその医薬として許容し得る塩またはプロドラッグを含む。ドーパミン受容体拮抗薬の例は、限定するものではないが、ハロペリドール、オカペリドン、リスペリドン、オランザピン、クエチアピン、アミスルプリドおよびピモジドならびにそれらの医薬として許容可能な塩およびプロドラッグを含む。いくつかの実施形態において、抗鬱薬はノルエピネフリン再摂取阻害剤を含む。ノルエピネフリン再摂取阻害剤の例は、限定するものではないが、ブプロピオン、チオニソキセチン、アトモキセチンおよびレボキセチンならびにそれらの医薬として許容可能な塩およびプロドラッグを含む。他の実施形態は、限定するものではないが、抗鬱薬がドーパミン作動薬であるものを含む。市販のドーパミン作動薬は、カベルゴリン、アマンタジン、リスリド、ペルゴリド、ロピニロール、プラミペキソールおよびブロモクリプチンを含む。いくつかの実施形態において、抗鬱薬は、セロトニン再摂取阻害剤を含む。セロトニン再摂取阻害剤の例は、限定するものではないが、フルオキセチンおよびその医薬として許容可能な塩およびプロドラッグを含む。
いくつかの実施形態において、抗糖尿病薬は、限定するものではないが、ビグアニド、グルコシダーゼ阻害剤、インスリン、メグリチニド、スルホニル尿素またはチアゾリジンジオンを含む。いくつかの実施形態において、ビグアニドは、塩酸メトホルミンを含む。いくつかの実施形態において、グルコシダーゼ阻害剤は、限定するものではないが、アカルボースおよびミグリトールを含む。インスリンの例は、限定するものではないが、ヒトインスリン、ブタインスリン、ウシインスリン、ウシ-ブタインスリン、組換えDNAおよび動物源などの異なる供給源からのインスリン、ならびにレギュラー型、NPH型およびLENTE(登録商標)型のインスリンを、含む。インスリンの他の例は、限定するものではないが、様々な型のインスリン(例えば、NPHおよびレギュラーのヒトおよびブタのインスリン)の混合物を含む。インスリンの他の例は、Insulin Lispro ProtamineおよびInsulin Injection(rDNA起源)の混合物、Human Insulin Isophane SuspensionおよびHuman Insulin Injectionの50/50(または70/30)混合物、NPH Human Insulin Isophane SuspensionおよびHuman Insulin Injection(rDNA)の70/30混合物、インスリングラルギン、インスリンリスプロ、インスリンアスパルトならびに亜鉛結晶またはリン酸バッファーなどの他の成分と混合したインスリンを含む。インスリンは、サッカロミセス・セレビシエ(Saccharomyces cerevisiae)または他の供給源からであってよい。メグリチニドの例は、限定するものではないが、ナテグリニドおよびレパグリニドを含む。スルホニル尿素の例は、限定するものではないが、グリメピリド、グリブリド、グリベンクラミド、グリキドン、グリクラジド、クロルプロパミド、トルブタミド、トラザミドおよびグリピジドを含む。チアゾリジンジオンの例は、限定するものではないが、ロジグリタゾンおよびピオグリタゾンを含む。さらに、上記の薬剤の持続放出製剤ならびに上記の薬剤の組合せおよびそれらの医薬として許容可能な塩またはプロドラッグもまた含む。
いくつかの実施形態において、抗けいれん薬は、限定するものではないが、ゾニサミド、トピラマート、ネムブタル、ロラゼパム、クロナゼパム、クロラゼプ酸、チアガビン、ガバペンチン、フォスフェニトイン、フェニトイン、カルバマゼピン、バルプロ酸、フェルバメート、レベチラセタム、オキシカルバゼピン、ラモトリジン、メトスクシミドおよびエトスクシミドを含む群から選択される。
ある実施形態において、オピオイド拮抗薬は、哺乳動物においてμ-オピオイド受容体(MOP-R)に拮抗する。哺乳動物は、限定するものではないが、マウス、ラット、ラビット、モルモット、イヌ、ネコ、ヒツジ、ヤギ、ウシ、サル、チンパンジーおよび類人猿などの霊長類ならびにヒトを含む群から選択できる。
102A 医薬層
102B 医薬層
106 中間層
108 矢印
200 第2の積層製剤
202A 第2の医薬層
202B 第2の医薬層
202C 第2の医薬層
300 第3の積層製剤
302A 第3の医薬層
302B 第3の医薬層
302C 第3の医薬層
400 第4の積層製剤
402A 第4の医薬層
402B 第4の医薬層
404A 第1の薬剤
404B 第2の薬剤
404C 第3の薬剤
404D 第4の薬剤
408 スペース
500 第5の積層製剤
502A 第5の医薬層
502B 第5の医薬層
506A 第1の中間層
506B 第2の中間層
600 第6の積層製剤
602A 第6の医薬層
602B 第6の医薬層
700 第7の積層製剤
702A 第7の医薬層
702B 第7の医薬層
702C 第7の医薬層
702D 第7の医薬層
702E 第7の医薬層
702F 第7の医薬層
706 特有の中間層
Claims (62)
- 体重減少への影響、食欲の抑制、または肥満、高血圧、非インスリン依存性糖尿病、動脈硬化、脂質異常症、睡眠時無呼吸、禁煙と関連する体重増加、精神治療薬の使用と関連する体重増加、及び変形性関節炎からなる群から選択される肥満関連症状の治療のための、2つ以上の医薬品有効成分の投与用錠剤、顆粒またはカプセルの単一経口投与剤形の積層製剤であって、
ブプロピオンを含む第1の医薬層、
ナルトレキソンまたはゾニサミドを含む第2の医薬層、および
前記第1の医薬層と前記第2の医薬層の間に配置された中間層を含み、
前記中間層は、インビボで急速に溶解することにより、前記第1の医薬層および前記第2の医薬層が実質的にインタクトのままであるが、物理的に分離されるように構成されている積層製剤。 - 前記第1の医薬層が、同様の組成物の単一圧縮錠と同様の溶解プロフィールを備え、前記第2の医薬層が、同様の組成物の単一圧縮錠と同様の溶解プロフィールを備える、請求項1に記載の積層製剤。
- 前記第1の医薬層が持続放出ブプロピオンを含む、請求項2に記載の積層製剤。
- 前記第2の医薬層が持続放出ナルトレキソンを含む、請求項3に記載の積層製剤。
- 前記第2の医薬層が持続放出ゾニサミドを含む、請求項3に記載の積層製剤。
- 前記中間層が、単糖類、二糖類またはデンプンの少なくとも1つを含む、請求項1から5のいずれか一項に記載の積層製剤。
- 前記中間層がラクトースを含む、請求項6に記載の積層製剤。
- 前記第1の医薬層および前記第2の医薬層が、経口投与された際に1分未満でインビボで分離する、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が肥満である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が高血圧である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が非インスリン依存性糖尿病である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が脂質異常症である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が禁煙と関連する体重増加である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が精神治療薬の使用と関連する体重増加である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が動脈硬化である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が睡眠時無呼吸である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記肥満関連症状が変形性関節炎である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項1から5のいずれか一項に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項1から5のいずれか一項に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項6に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項6に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項6に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項7に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項7に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項7に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項8に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項8に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項8に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項9に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項9に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項9に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項10に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項10に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項10に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項11に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項11に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項11に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項12に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項12に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項12に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項13に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項13に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項13に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項14に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項14に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項14に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項15に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項15に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項15に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項16に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項16に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項16に記載の積層製剤。
- 前記単一経口投与剤形が錠剤である、請求項17に記載の積層製剤。
- 前記単一経口投与剤形が顆粒である、請求項17に記載の積層製剤。
- 前記単一経口投与剤形がカプセルである、請求項17に記載の積層製剤。
- 前記第1の医薬層が、約4mgから約10mgの間の持続放出ナルトレキソンを含む、請求項1に記載の積層製剤。
- 前記第2の医薬層が、約75mgから約150mgの間の持続放出ブプロピオンを含む、請求項1に記載の積層製剤。
- 前記第2の医薬層が、約85mgから約100mgの間の持続放出ブプロピオンを含む、請求項1に記載の積層製剤。
- 体重減少への影響、食欲の抑制、または肥満関連症状の治療のための、請求項1から5のいずれか一項に記載の積層製剤を含む医薬の調製における、第1の化合物と第2の化合物の使用。
- 医薬としての使用のための、請求項1から5のいずれか一項に記載の積層製剤。
- 複数の請求項1から5のいずれか一項に記載の積層製剤を含むキット。
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