JP2016517429A - 安定化調整放出ビタミンd製剤及びその投与方法 - Google Patents
安定化調整放出ビタミンd製剤及びその投与方法 Download PDFInfo
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Abstract
Description
2013年3月15日に出願された米国特許仮出願第61/801,896号の米国特許法第119条(e)下の利益はここで特許請求され、その開示は参照により本明細書に組み込まれる。
90μgの25−ヒドロキシビタミンD3、19.98重量%の硬パラフィン、37.85重量%のGMS、9.76重量%のGELUCIRE 44/14、2.36重量%の無水エタノール、29.88重量%の液体パラフィン、及び0.02重量%のBHTの混合物から製造された製剤(比較製剤1)の溶解を試験した。製剤はセルロース化合物を含まなかった。T=0及び5℃で周辺湿度での最大12ヶ月間の製剤の制御貯蔵の後の、1つの剤形当たりの名目上の薬物負荷の平均パーセンテージ(ラベルクレームの平均%、%LC)として計算された、放出される25−ヒドロキシビタミンD3の平均量は、下記の表にまとめる。試料は、試験の前に、15℃〜30℃の範囲の温度で周辺湿度で、約3ヶ月の期間貯蔵されたことが決定された。したがって、時間ゼロを表していたはずの試料はT=0p(疑似時間ゼロ)と標識され、名目上の1ヶ月、3ヶ月、6ヶ月、9ヶ月、及び12ヶ月老化試料も、直前に記載したおよそ3ヶ月老化期間を経験したことが理解されるはずである。より正確な基線を提供するために、同じ種類の試料の新しいバッチを調製してあらゆる老化を伴わずに試験し、このデータは新しい試料を示すためにT=0fと標識する。変動係数(%CV)も報告される。T=0p及びT=0fロットによって放出される25−ヒドロキシビタミンD3の、初期量からの%変化は、それぞれ括弧及び二重括弧内に提供される。
90μgの25−ヒドロキシビタミンD3、19.88重量%の硬パラフィン、15.29重量%のヒドロキシプロピルメチルセルロース、22.55重量%のGMS、9.76重量%のGELUCIRE 44/14、2.36重量%の無水エタノール、29.88重量%の液体パラフィン、及び0.02重量%のBHT(実施例製剤A)を含む持続放出製剤の溶解を、室温での0〜11週間の貯蔵の後に試験した。結果は以下の表にまとめる。
インビボ研究が、ヒト対象における、25−ヒドロキシビタミンD3の非安定化及び安定化制御放出製剤の臨床薬物動態を評価するために行われた。研究Aでは、3期または4期CKD、二次性副甲状腺機能亢進症(3期:70〜1000pg/mLのiPTH、4期:110〜1000pg/mLのiPTH)、及びビタミンD不足(血清中総計基線25−ヒドロキシビタミンD15ng/mL〜29ng/mL)を有する28人の対象が、450μgもしくは900μgの25−ヒドロキシビタミンD3、20.00重量%の硬パラフィン、37.85重量%のGMS、9.75重量%のGELUCIRE 44/14、2.32重量%の無水エタノール、30.06重量%の鉱油、及び0.02重量%のBHTを含む制御放出カプセル(比較製剤3)の単一経口投与、またはエタノール溶液中の448μgの25−ヒドロキシビタミンD3の単一静脈内投与を受けた。製剤のいずれもがセルロース化合物を含まなかった。
25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方と、
25℃で60%相対湿度の貯蔵条件に2ヶ月間曝露した後のインビトロ溶解中の4時間後の任意の所与の時点で放出されるビタミンD化合物の量と、該製剤を該貯蔵条件に曝露する前に行われるインビトロ溶解中の同じ溶解時点で放出される量との間の差を30%未満に維持するのに有効な量の安定化剤、任意でセルロース化合物と、の混合物を含む、該製剤。
25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方と、
ワックスマトリックスと、
任意でセルロース化合物である安定化剤と、の混合物を含む、該製剤。
25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方と、
ワックスマトリックスと、
任意でセルロース安定化剤である安定化剤と、の混合物を含む、該製剤。
25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方と、
ワックスマトリックスと、
25℃で60%相対湿度の貯蔵条件に2ヶ月間曝露した後のインビトロ溶解試験中の4時間後の任意の所与の時点に放出されるビタミンD化合物の量と、前記製剤を前記貯蔵条件に曝露する前に行われるインビトロ溶解中の同じ溶解時点で放出される量との間の差を30%未満に維持するのに有効な量の安定化剤、任意でセルロース化合物と、の混合物を含む、該製剤。
25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方を含む活性負荷ワックスマトリックスと、
セルロース安定化剤と、を含み、
該製剤が、25℃で60%相対湿度の貯蔵に2ヶ月間曝露した後のインビトロ溶解中に、該製剤を該貯蔵条件に曝露する前に行われるインビトロ溶解中の同じ溶解時点で放出される量と比較して、任意の所与の溶解時点で、セルロース安定化剤の不在下で30%以下変化する、ある量の25−ヒドロキシビタミンDを放出する、該製剤。
2時間で30%未満、
6時間で45%を超え、かつ
12時間で80%を超えるビタミンD化合物の放出を提供する溶解プロファイルを特徴とする、項1〜29のいずれか一項に記載の製剤または安定化剤形。
100〜140分で30%未満、
5〜7時間で45%を超え、かつ
11〜13時間で80%を超える、ビタミンD化合物の放出を提供するインビトロ溶解プロファイルを特徴とする、ビタミンD化合物を含む安定化持続放出経口剤形。
2時間で30%未満、
6時間で45%を超え、かつ
12時間で80%を超える、項32に記載の剤形。
2時間で約20%〜約40%、
6時間で少なくとも35%、かつ
12時間で少なくとも70%のビタミンD化合物の放出を提供するインビトロ溶解プロファイルを特徴とするビタミンD化合物を含む、安定化持続放出経口剤形。
6時間で少なくとも40%、及び
12時間で少なくとも75%である、項36に記載の該剤形。
Claims (73)
- 25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方を含むビタミンD化合物の制御放出製剤であって、前記ビタミンD化合物に放出可能に結合し、かつそれを制御可能に放出するマトリックスを含み、前記マトリックスがセルロース誘導体を含む、前記製剤。
- ビタミンD化合物の制御放出のための安定化製剤であって、
25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方と、
ワックスマトリックスと、
任意でセルロース化合物である安定化剤と、の混合物を含む、前記製剤。 - 前記製剤が、前記製剤を摂取する対象の消化管における前記ビタミンD化合物の制御放出のための経口製剤である、請求項1または2に記載の前記製剤。
- 前記製剤が、
25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方と、
ワックスマトリックスと、
25℃で60%相対湿度の貯蔵条件に2ヶ月間曝露した後のインビトロ溶解試験中の4時間後の任意の所与の時点に放出されるビタミンD化合物の量と、前記製剤を前記貯蔵条件に曝露する前に行われるインビトロ溶解中の同じ溶解時点で放出される量との間の差を30%未満に維持するのに有効な量の安定化剤、任意でセルロース化合物と、の混合物を含む、請求項1〜3のいずれか一項に記載の前記製剤。 - 前記製剤が、
25−ヒドロキシビタミンD2及び25−ヒドロキシビタミンD3の一方または両方を含む活性負荷ワックスマトリックスと、
セルロース安定化剤と、を含み、
前記製剤が、25℃で60%相対湿度の貯蔵に2ヶ月間曝露した後のインビトロ溶解中に、前記製剤を前記貯蔵条件に曝露する前に行われるインビトロ溶解中の同じ溶解時点で放出される量と比較して、任意の所与の溶解時点で、セルロース安定化剤の不在下で30%以下変化する、ある量の25−ヒドロキシビタミンDを放出する、請求項1〜4のいずれか一項に記載の製剤。 - 前記セルロース化合物またはセルロース安定化剤が、セルロースエーテルを含む、請求項1〜5のいずれか一項に記載の前記製剤。
- 前記セルロースエーテルが、メチルセルロース、ヒドロキシプロピルメチルセルロース、ヒドロキシエチルメチルセルロース、ヒドロキシエチルセルロース、及びヒドロキシプロピルセルロースから成る群から選択される、請求項6に記載の前記製剤。
- 前記セルロース化合物またはセルロース安定化剤がヒドロキシプロピルメチルセルロースを含む、請求項6に記載の前記製剤。
- 前記製剤が、40℃で75%相対湿度の貯蔵条件に1ヶ月間曝露した後のインビトロ溶解中に、前記製剤を前記貯蔵条件に曝露する前に行われるインビトロ溶解中の同じ溶解時点で放出される量と比較して、4時間後の任意の所与の溶解時点で30%以下変化する、ある量の25−ヒドロキシビタミンDを放出する、請求項1〜8のいずれか一項に記載の前記製剤。
- 前記マトリックスが、制御放出剤、乳化剤、及び吸収促進剤を含むワックスマトリックスを含む、請求項1〜9のいずれか一項に記載の前記製剤。
- 前記制御放出剤がパラフィンを含む、請求項10に記載の前記製剤。
- 前記乳化剤が7未満のHLB値を有する、請求項10または11に記載の前記製剤。
- 前記乳化剤がグリセロールモノステアレートを含む、請求項12に記載の前記製剤。
- 前記吸収促進剤が約13〜約18の範囲のHLB値を有する、請求項10〜13のいずれか一項に記載の前記製剤。
- 前記吸収促進剤がラウロイルマクロゴールグリセリドとラウロイルポリオキシルグリセリドとの混合物である、請求項14に記載の前記製剤。
- 油性賦形剤をさらに含む、請求項10〜15のいずれか一項に記載の前記製剤。
- 前記油性賦形剤が鉱油を含む、請求項16に記載の前記製剤。
- 前記製剤が、約20重量%のパラフィン、約20重量%〜約25重量%のグリセロールモノステアレート、約10重量%のラウロイルマクロゴールグリセリドとラウロイルポリオキシルグリセリドとの混合物、約30重量%〜約35重量%の鉱油、及び約10重量%〜約15重量%のヒドロキシプロピルメチルセルロースを含む、請求項17に記載の前記製剤。
- 前記製剤がグリセロールモノステアレートを含む、請求項10〜18のいずれか一項に記載の製剤。
- 前記製剤が1つ以上のポリグリコール化グリセリドを含む、請求項10〜19のいずれか一項に記載の製剤。
- 請求項1〜20のいずれか一項に記載の製剤を含む、カプセル、錠剤、サシェ、糖衣錠、または坐薬の形態の持続放出剤形。
- カプセルまたは錠剤を含む、請求項21に記載の前記剤形。
- カプセルを含む、請求項22に記載の前記剤形。
- 経口カプセル、錠剤、サシェ、または糖衣錠を含む、請求項21に記載の前記剤形。
- 2時間で30%未満、
6時間で45%を超え、かつ
12時間で80%を超えるビタミンD化合物の放出を提供する溶解プロファイルを特徴とする、請求項1〜24のいずれか一項に記載の製剤または安定化剤形。 - 6時間でのビタミンD化合物の前記放出が60%未満である、請求項25に記載の前記製剤または安定化剤形。
- 100〜140分で30%未満、
5〜7時間で45%を超え、かつ
11〜13時間で80%を超える、ビタミンD化合物の放出を提供するインビトロ溶解プロファイルを特徴とする、請求項1〜24のいずれか一項に記載の製剤または安定化持続放出経口剤形。 - ビタミンD化合物の前記放出が、
2時間で30%未満、
6時間で45%を超え、かつ
12時間で80%を超える、請求項27に記載の前記製剤または剤形。 - 5〜7時間でのビタミンD化合物の前記放出が60%未満である、請求項27または28に記載の前記製剤または剤形。
- 6時間でのビタミンD化合物の放出が60%未満である、請求項29に記載の前記製剤または剤形。
- 2時間で約20%〜約40%、
6時間で少なくとも35%、かつ
12時間で少なくとも70%のビタミンD化合物の放出を提供するインビトロ溶解プロファイルを特徴とする、請求項1〜24のいずれか一項に記載の製剤または安定化持続放出経口剤形。 - ビタミンD化合物の前記放出が、2時間で約25%〜約35%、
6時間で少なくとも40%、及び
12時間で少なくとも75%である、請求項31に記載の前記製剤または剤形。 - ビタミンD化合物の前記放出が6時間で75%以下である、請求項31または32に記載の前記製剤または剤形。
- ビタミンD化合物の前記放出が6時間で65%以下である、請求項33に記載の前記製剤または剤形。
- ビタミンD化合物の前記放出が6時間で60%以下である、請求項34に記載の前記製剤または剤形。
- 前記剤形のヒト患者への投与後の、少なくとも4時間のtmaxを特徴とする、請求項1〜35のいずれか一項に記載の製剤または安定化持続放出剤形。
- 前記tmaxが少なくとも8時間である、請求項36に記載の前記製剤または剤形。
- 前記tmaxが少なくとも12時間である、請求項37に記載の前記製剤または剤形。
- 前記tmaxが少なくとも18時間である、請求項38に記載の前記製剤または剤形。
- 前記tmaxが少なくとも20時間である、請求項39に記載の前記製剤または剤形。
- 前記tmaxが少なくとも24時間である、請求項40に記載の前記製剤または剤形。
- 前記tmaxが少なくとも28時間である、請求項41に記載の前記製剤または剤形。
- 前記tmaxが4〜96時間の範囲である、請求項36に記載の前記製剤または剤形。
- 前記tmaxが18〜30時間の範囲である、請求項43に記載の前記製剤または剤形。
- 前記tmaxが13〜28時間の範囲である、請求項44に記載の前記製剤または剤形。
- 前記tmaxが約28時間である、請求項45に記載の前記製剤または剤形。
- 25−ヒドロキシビタミンD化合物を含む製剤または安定化持続放出剤形であって、前記剤形が、成人ヒトに投与されるときに、1マイクログラムの25−ヒドロキシビタミンD当たり、約0.0133ng/mL〜約0.04ng/mLの範囲の基線調整したCmaxを提供することを特徴とする、前記製剤または安定化持続放出剤形。
- 請求項1〜47のいずれか一項に記載の製剤または安定化持続放出剤形をヒト患者に投与する方法であって、有効量の前記剤形を前記ヒト患者に投与して、少なくとも約0.2ng/mL〜110ng/mL未満の基線調整したCmaxを提供することを含む、前記方法。
- 有効量の前記製剤または剤形を投与して、約0.2〜約24ng/mLの範囲の基線調整したCmaxを提供することを含む、請求項48に記載の前記方法。
- 請求項1〜47のいずれか一項に記載の製剤または安定化持続放出剤形をヒト患者に投与する方法であって、有効量の前記剤形を前記ヒト患者に投与して、少なくとも52ng*時/mL〜34500ng*時/mL未満の基線調整したAUC0-infを提供することを含む、前記方法。
- 有効量の前記製剤または剤形を前記患者に投与して、約52ng*時/mL〜約12,000ng*時/mLの範囲の基線調整したAUC0-infを提供することを含む、請求項50に記載の前記方法。
- ビタミンD補給の方法であって、それを必要とする対象に、請求項1〜47のいずれか一項に記載の製剤または剤形を投与することを含む、前記方法。
- 対象におけるビタミンD応答性疾患の治療または予防の方法であって、請求項1〜47のいずれか一項に記載の製剤または剤形を前記対象に投与することを含む、前記方法。
- 前記疾患が、癌(例えば、乳、肺、皮膚、黒色腫、結腸、大腸、直腸、前立腺、及び骨癌)、自己免疫疾患、例えばI型糖尿病、多発性硬化症、関節リウマチ、多発性筋炎、皮膚筋炎、強皮症、線維症、グレーブス病、橋本病、急性もしくは慢性移植拒絶反応、急性もしくは慢性移植片対宿主病、炎症性腸疾患、クローン病、全身性紅斑性狼瘡、シェーグレン症候群、湿疹及び乾癬、アトピー性皮膚炎、接触皮膚炎、アレルギー性皮膚炎、及び/もしくは慢性皮膚炎を含む皮膚炎、炎症性疾患、例えば、喘息、慢性閉塞性肺疾患、多発性嚢胞腎疾患、多嚢胞性卵巣症候群、膵炎、腎炎、肝炎、及び/もしくは感染症、高血圧、心血管疾患、例えばアステローム性動脈硬化症を有する対象、動脈硬化症、冠動脈疾患、脳血管疾患、末梢血管疾患、心筋梗塞症、心筋虚血、脳虚血、脳卒中、鬱血性心不全、心筋症、肥満症もしくは他の体重障害、脂質障害(例えば高脂血症、関連糖尿病性脂質異常症及び混合型脂質異常症低アルファリポタンパク血症を含む脂質異常症、高トリグリセリド血症、高コレステロール血症、及び低HDL(高密度リポタンパク質))、代謝障害(例えばメタボリック症候群、II型糖尿病、I型糖尿病、高インスリン血症、耐糖能障害、インスリン抵抗性、神経症、腎障害、骨粗鬆症、網膜症、糖尿病性足部潰瘍、及び白内障を含む糖尿病性合併症)、及び/または血栓症から選択される、請求項53に記載の前記方法。
- 前記疾患が、(i)副甲状腺における、副甲状腺機能低下症、偽性副甲状腺機能低下症、二次性副甲状腺機能亢進症、(ii)膵臓における糖尿病、(iii)甲状腺における髄様癌、(iv)皮膚における乾癬、創傷治癒、(v)肺におけるサルコイドーシス及び結核、(vi)腎臓における、慢性腎疾患、低リン血症性VDRR、ビタミンD依存性くる病、(vii)骨における、抗痙攣治療、骨性線維形成不全症、嚢胞性線維性骨炎、骨軟化症、骨粗鬆症、骨減少症、骨硬化症、腎性骨ジストロフィー、くる病、(viii)腸における、グルココルチコイド拮抗作用、特発性高カルシウム血症、吸収不良症候群、脂肪便症、熱帯性スプルー、及び(ix)自己免疫障害から選択される、請求項53に記載の前記方法。
- 前記疾患が、癌、皮膚障害(例えば乾癬)、副甲状腺障害(例えば副甲状腺機能亢進症及び二次性副甲状腺機能亢進症)、骨障害(例えば骨粗鬆症)、及び自己免疫障害から選択される、請求項53に記載の前記方法。
- 前記疾患が二次性副甲状腺機能亢進症である、請求項56に記載の前記方法。
- 前記対象が慢性腎疾患(CKD)を有する、請求項57に記載の前記方法。
- 前記CKDが3期または4期である、請求項58に記載の前記方法。
- 前記患者がビタミンD欠乏である、請求項59に記載の前記方法。
- 前記患者がヒトである、請求項52〜60のいずれか一項に記載の前記方法。
- 前記ヒトが成人ヒトである、請求項61に記載の前記方法。
- 患者におけるビタミンD補給に使用するための請求項1〜47のいずれか一項に記載の製剤または安定化持続放出剤形。
- 患者におけるビタミンD応答性疾患の治療または防止に使用するための請求項1〜47のいずれか一項に記載の製剤または安定化持続放出剤形。
- 前記疾患が、癌(例えば、乳、肺、皮膚、黒色腫、結腸、大腸、直腸、前立腺、及び骨癌)、自己免疫疾患、例えばI型糖尿病、多発性硬化症、関節リウマチ、多発性筋炎、皮膚筋炎、強皮症、線維症、グレーブス病、橋本病、急性または慢性移植拒絶反応、急性または慢性移植片対宿主病、炎症性腸疾患、クローン病、全身性紅斑性狼瘡、シェーグレン症候群、湿疹及び乾癬;アトピー性皮膚炎、接触皮膚炎、アレルギー性皮膚炎、及び/または慢性皮膚炎を含む皮膚炎、炎症性疾患、例えば、喘息、慢性閉塞性肺疾患、多発性嚢胞腎疾患、多嚢胞性卵巣症候群、膵炎、腎炎、肝炎、及び/または感染症、高血圧、心血管疾患、例えばアステローム性動脈硬化症を有する対象、動脈硬化症、冠動脈疾患、脳血管疾患、末梢血管疾患、心筋梗塞症、心筋虚血、脳虚血、脳卒中、鬱血性心不全、心筋症、肥満または他の体重障害、脂質障害(例えば高脂血症、関連糖尿病性脂質異常症及び混合型脂質異常症低アルファリポ蛋白血症を含む脂質異常症、高トリグリセリド血症、高コレステロール血症、ならびに低HDL(高密度リポタンパク質))、代謝障害(例えばメタボリック症候群、II型糖尿病、I型糖尿病、高インスリン血症、耐糖能障害、インスリン抵抗性、神経症、腎障害、骨粗鬆症、網膜症、糖尿病性足部潰瘍、及び白内障を含む糖尿病性合併症)、及び/または血栓症から選択される、請求項64に記載の前記使用。
- 前記疾患が、(i)副甲状腺における、副甲状腺機能低下症、偽性副甲状腺機能低下症、二次性副甲状腺機能亢進症、(ii)膵臓における糖尿病、(iii)甲状腺における髄様癌、(iv)皮膚における乾癬、創傷治癒、(v)肺におけるサルコイドーシス及び結核、(vi)腎臓における、慢性腎疾患、低リン血症性VDRR、ビタミンD依存性くる病、(vii)骨における、抗痙攣治療、骨性線維形成不全症、嚢胞性線維性骨炎、骨軟化症、骨粗鬆症、骨減少症、骨硬化症、腎性骨ジストロフィー、くる病、(viii)腸における、グルココルチコイド拮抗作用、特発性高カルシウム血症、吸収不良症候群、脂肪便症、熱帯性スプルー、及び(ix)自己免疫障害から選択される、請求項64に記載の前記使用。
- 前記疾患が、癌、皮膚障害(例えば乾癬)、副甲状腺障害(例えば副甲状腺機能亢進症及び二次性副甲状腺機能亢進症)、骨障害(例えば骨粗鬆症)、及び自己免疫障害から選択される、請求項64に記載の前記使用。
- 前記疾患が二次性副甲状腺機能亢進症である、請求項67に記載の前記使用。
- 前記患者が慢性腎疾患(CKD)を有する、請求項68に記載の前記使用。
- 前記CKDが3期または4期である、請求項69に記載の前記使用。
- 前記患者がビタミンD欠乏である、請求項70に記載の前記使用。
- 前記患者がヒトである、請求項63〜71のいずれか一項に記載の前記使用。
- 前記ヒトが成人ヒトである、請求項72に記載の前記使用。
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