JP2016121159A - Bcl−2ファミリー阻害剤の経口投与用医薬剤形 - Google Patents
Bcl−2ファミリー阻害剤の経口投与用医薬剤形 Download PDFInfo
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Abstract
【解決手段】N−(4−(4−((2−(4−クロロフェニル)−5,5−ジメチル−1−シクロヘキサ−1−エン−1−イル)メチル)ピペラジン−1−イル)ベンゾイル)−4−(((1R)−3−(モルホリン−4−イル)−1−((フェニルスルファニル)メチル)プロピル)アミノ)−3−((トリフルオロメチル)スルホニル)ベンゼンスルホンアミド、またはその塩、水和物または溶媒和物、少なくとも1つの医薬的に許容され得るポリマー及び少なくとも1つの医薬的に許容され得る可溶化剤を含む固体分散生成物を含む医薬剤形。
【選択図】なし
Description
・約0.5〜40重量%、好ましくは約1〜25重量%のABT−263、
・約40〜97.5重量%、好ましくは約50〜94重量%の少なくとも1つの医薬的に許容され得るポリマー、
・約2〜20重量%、好ましくは約5〜20重量%の少なくとも1つの可溶化剤、及び
・約0〜15重量%、好ましくは約0〜10重量%の添加剤
を含む。
各種組成の製剤を下表1に示すように調製した。ABT−263をブレンダーにおいてコポピドン(N−ビニルピロリドンと酢酸ビニルのコポリマー)及び可溶化剤の予め顆粒化した混合物と混合した。指示されている場合、流動性を向上させるために1%のコロイド状二酸化ケイ素を添加した。粉末状混合物を表1に示す押出温度でLeistritzミクロ18 GMP−押出機を用いて押出した。
a)経口バイオアベイラビリティー研究のためのプロトコル
バイオアベイラビリティー評価のために、実施例1に記載されている押出物を微粉砕し、カプセルに充填した。各カプセルは50mgのABT−263を含有していた。
表1に規定されているABT−263の製剤6または8を図1及び図2に示すABT−263の量に相当する用量で断食させたまたは餌を与えたイヌに投与した。その後、指定した時点で採取した血液サンプルからABT−263の血漿濃度を測定した。図1及び図2中、白抜き記号及び黒塗り記号はそれぞれ餌を与えたイヌまたは断食させたイヌを表す。□、△及び○はそれぞれ50mg、100mgまたは200mgのABT−263の用量を表す。
餌を与えたイヌに50mgのABT−263の量に等しい表1に示す製剤13または製剤10を含有する1つのカプセルとして2つの製剤の1つを経口投与した。
選択した製剤(表1の6及び8)について貯蔵安定性を調べた。製剤を周囲条件(約19〜25℃、60%以下のRH)下で密閉容器中に保持した。ABT−263含量及びスルホキシドを含めた活性成分の分解生成物の含量を貯蔵期間の開始時(初期値)および4ヶ月後にHPLC(または、UPLC)を用いて分離し、UV/VIS検出器を用いて検出することにより測定した。結果を下表3に示す。
表1に規定されている製剤2、3、12、4、9、11、10、13及び14を開放皿において40℃/75%の相対湿度に曝す促進安定性研究においてスルホキシド形成について評価した。スルホキシド含量を実験の開始時(いずれも0.8%未満)、図4に指示されている製剤については1週、3週及び6週後に、図5に指示されている製剤については4週、5週及び7週後に測定した。
表1に規定されている製剤9、2、13及び14を下表4に示す方法パラメーターを用いて調製した。押出物の結晶性活性成分の存在について偏光顕微鏡により調べた。
表5に示す各種押出物を開放皿または密閉皿中に促進老化条件下に保持した。指定した時点で、結晶性活性成分の存在を偏光顕微鏡により評価した。
実施例1の手順に従って押出物を下表6にリストされている固体分散生成物成分から得た。実施例1からの押出物を微粉砕し、表6にリストされている錠剤化賦形剤と混合した。50mgのABT−263を含有する錠剤を製造するために1つのパンチ錠剤プレスを使用した。
Claims (24)
- 医薬活性成分、少なくとも1つの医薬的に許容され得るポリマー及び少なくとも1つの医薬的に許容され得る可溶化剤を含む固体分散生成物を含み、前記医薬活性成分がN−(4−(4−((2−(4−クロロフェニル)−5,5−ジメチル−1−シクロヘキサ−1−エン−1−イル)メチル)ピペラジン−1−イル)ベンゾイル)−4−(((1R)−3−(モルホリン−4−イル)−1−((フェニルスルファニル)メチル)プロピル)アミノ)−3−((トリフルオロメチル)スルホニル)ベンゼンスルホンアミド、その塩、水和物または溶媒和物である医薬剤形。
- 医薬的に許容され得る可溶化剤が、ノニオン性可溶化剤、アニオン性可溶化剤及びその組合せからなる群から選択される請求項1に記載の剤形。
- 医薬的に許容され得るノニオン性可溶化剤が、ポリオール脂肪酸エステル、ポリアルコキシル化ポリオール脂肪酸エステル、ポリアルコキシル化脂肪アルコールエーテル、トコフェリル化合物及びその2つ以上の混合物からなる群から選択され、医薬的に許容され得るアニオン性可溶化剤が、アルキルスルフェート、アルキルカルボキシレート、アルキルベンゾールスルフェート及び第2級アルカンスルホネートからなる群から選択される請求項2に記載の剤形。
- 医薬的に許容され得る可溶化剤が、ポリアルキレングリコール部分を有するトコフェリル化合物、ソルビタン脂肪酸エステル及びポリオキシエチレンソルビタン脂肪酸エステルからなる群から選択される請求項1に記載の剤形。
- 医薬的に許容され得る可溶化剤が、α−トコフェリルポリエチレングリコールスクシナート、ソルビタンモノラウレート及びポリオキシエチレンソルビタンモノラウレートの少なくとも1つを含む請求項1に記載の剤形。
- 少なくとも1つの医薬的に許容され得るノニオン性可溶化剤及び少なくとも1つの医薬的に許容され得るアニオン性可溶化剤を含む請求項2に記載の剤形。
- 医薬的に許容され得るノニオン性可溶化剤が、ソルビタン脂肪酸エステル、ポリオキシエチレンソルビタン脂肪酸エステル及びα−トコフェリルポリエチレングリコールスクシナートからなる群から選択され、医薬的に許容され得るアニオン性可溶化剤が、ラウリル硫酸ナトリウムである請求項6に記載の剤形。
- 医薬活性成分に対する非揮発性溶媒を含有し、前記溶媒は周囲温度で液体である請求項1に記載の剤形。
- 前記非揮発性溶媒が、プロピレングリコールである請求項8に記載の剤形。
- 前記医薬的に許容され得るポリマーが、N−ビニルピロリドンのホモポリマーまたはコポリマーである請求項1に記載の剤形。
- 前記医薬的に許容され得るポリマーが、N−ビニルピロリドンと酢酸ビニルのコポリマーである請求項1に記載の剤形。
- 前記医薬活性成分が、N−(4−(4−((2−(4−クロロフェニル)−5,5−ジメチル−1−シクロヘキサ−1−エン−1−イル)メチル)ピペラジン−1−イル)ベンゾイル)−4−(((1R)−3−(モルホリン−4−イル)−1−((フェニルスルファニル)メチル)プロピル)アミノ)−3−((トリフルオロメチル)スルホニル)ベンゼンスルホンアミドの遊離塩基、ナトリウム塩及び二塩酸塩、及びその組合せからなる群から選択される請求項1に記載の剤形。
- 流れ調整剤、崩壊剤、増量剤及び滑沢剤から選択される少なくとも1つの添加剤を含有する請求項1に記載の剤形。
- 固体分散生成物が、約0.5〜40重量%の医薬活性成分、40〜97.5重量%の少なくとも1つの医薬的に許容され得るポリマー、2〜20重量%の前記少なくとも1つの可溶化剤及び0〜15重量%の添加剤を含む請求項1に記載の剤形。
- 活性成分の重量に対し、活性成分のスルホキシド分解生成物を1.5重量%未満含む請求項1に記載の剤形。
- 活性成分の重量に対し、活性成分のスルホキシド分解生成物を1.2重量%未満含む請求項1に記載の剤形。
- 活性成分の重量に対し、活性成分のスルホキシド分解生成物を0.9重量%未満含む請求項1に記載の剤形。
- 固体分散生成物が、溶融加工し、凝固させた混合物である請求項1に記載の剤形。
- 請求項1に記載の剤形を治療を要する被験者に対して投与することを含む増殖性疾患の治療方法。
- 増殖性疾患が、腫瘍及び癌から選択される請求項19に記載の方法。
- 増殖性疾患が、中皮腫、膀胱癌、膵臓癌、皮膚癌、頭頸部癌、皮膚または眼内黒色腫、卵巣癌、乳癌、子宮癌、卵管癌、子宮内膜癌、頸部癌、膣癌、外陰癌、骨癌、子宮頸癌、結腸癌、直腸癌、肛門部の癌、胃癌、胃腸(胃、結腸直腸及び十二指腸)癌、慢性リンパ球性白血病、急性リンパ球性白血病、食道癌、小腸癌、内分泌系の癌、甲状腺癌、副甲状腺癌、副腎癌、軟組織肉腫、尿道癌、陰茎癌、精巣癌、肝細胞癌(肝臓及び胆管)、原発性または続発性中枢神経系腫瘍、原発性または続発性脳腫瘍、ホジキン病、慢性または急性白血病、慢性骨髄性白血病、リンパ球性リンパ腫、リンパ芽球性白血病、濾胞性リンパ腫、T細胞またはB細胞起源のリンパ系腫瘍、黒色腫、多発性骨髄腫、口腔癌、卵巣癌、非小細胞肺癌、前立腺癌、小細胞肺癌、腎臓及び尿管の癌、腎細胞癌、腎盂癌、中枢神経系の腫瘍、原発性中枢神経系リンパ腫、非ホジキンリンパ腫、脊髄軸腫瘍、脳幹グリオーマ、下垂体腺腫、副腎皮質癌、胆嚢癌、脾臓癌、胆管癌、線維肉腫、神経芽細胞腫、網膜芽細胞腫及びその組合せからなる群から選択される請求項20に記載の方法。
- (a)医薬活性成分、またはその塩、水和物または溶媒和物、少なくとも1つの医薬的に許容され得るポリマー及び少なくとも1つの可溶化剤の均質メルトを調製し、および、
(b)メルトを凝固させ、固体分散生成物を得る
ことを含む請求項1に記載の固体剤形の製造方法。 - 前記固体分散生成物を粉砕し、前記固体分散生成物を錠剤に圧縮することを更に含む請求項22に記載の方法。
- 前記固体分散生成物を粉砕し、前記固体分散生成物をカプセルシェルに充填することを更に含む請求項22に記載の方法。
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