JP2015520237A - 天然の併用ホルモン補充療法剤及び治療 - Google Patents
天然の併用ホルモン補充療法剤及び治療 Download PDFInfo
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- JP2015520237A JP2015520237A JP2015518529A JP2015518529A JP2015520237A JP 2015520237 A JP2015520237 A JP 2015520237A JP 2015518529 A JP2015518529 A JP 2015518529A JP 2015518529 A JP2015518529 A JP 2015518529A JP 2015520237 A JP2015520237 A JP 2015520237A
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- progesterone
- estradiol
- pharmaceutical formulation
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- fatty acid
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Abstract
Description
本出願は、次の米国特許出願に基づく優先権を主張する:米国特許出願第13/684,002号、発明の名称「天然の併用ホルモン補充療法剤及び治療」(2012年11月21日出願)、米国特許仮出願第61/661,302号、発明の名称「エストラジオール製剤」(2012年6月18日出願)、米国仮出願特許第61/662,265号、発明の名称「プロゲステロン製剤」(2012年6月20日出願)、米国特許出願第13/843,428号、発明の名称「天然の併用ホルモン補充療法剤及び治療」(2013年3月15日出願)。上記の全ての出願は、参照によりその全体が本明細書に援用される。
本開示は、それぞれエストラジオール及びプロゲステロンが単独で提供されている製剤による天然のエストロゲン及びプロゲステロン補充療法、並びにそれぞれ本願において以降に定義される通りのエストロゲン及びプロゲステロン欠乏状態の治療に関する閉経期前、閉経周辺期、閉経期及び閉経期後の女性の治療の際の組み合わせに関する。
ホルモン補充療法(HRT)は、ホルモンを十分に産生しない女性においてホルモン濃度を増加させるよう設計されている一群の薬剤のうちの1種以上の使用を包含する薬物療法である。HRTは、患者が閉経期前、閉経周辺期、閉経期又は閉経期後のいずれであろうと関係なく、循環エストロゲン及びプロゲステロンホルモンの減少により生じる症状を軽減及び予防する。しかしながら、閉経期の各段階の進行中には特異的な症状が存在し得る。
本明細書で使用するとき、用語「微紛化プロゲステロン」は、15μm未満のX50粒度値を有し、及び/又は25μm未満のX90粒度値を有する微紛化プロゲステロンを含む。
本願では、次の製剤:プロゲステロン不含有の可溶化エストラジオール、エストラジオール不含有の微紛化プロゲステロン、部分可溶化プロゲステロンを不含有の微紛化プロゲステロン、微紛化プロゲステロン含有可溶化エストラジオール、微紛化プロゲステロンを部分可溶化プロゲステロンと組み合わせて含む可溶化エストラジオール、並びに可溶化プロゲステロンを有する可溶化エストラジオールが提供される。本明細書に適用される典型的な製剤概念は、その他の天然又は合成形態のエストラジオール及びプロゲステロンに関し使用することもできる。微粒子化の仕様、態様、及び実施形態は、本明細書において更に定義される。
エストラジオール溶解度
各種実施例では、望ましい目標として、エストラジオールの20mg/g溶解度を達成することにより2mgのエストラジオールを100mg充填質量に十分に可溶化させるのに好適な溶媒を決定した。エストラジオールを各種溶媒と混合し、エストラジオールにより溶液を飽和させ、少なくとも3日間平衡化させ、非溶解粒子を濾去し、透明な上清を、HPLCによりエストラジオールの溶解量について分析することにより、初期溶解度実験を実施した。
200mgの総カプセル充填剤質量において、2mgエストラジオールも可溶化できる媒質に50mgのプロゲステロンを懸濁させることが求められた。この処方を達成するために必要とされるエストラジオールの溶解度は10mg/gである。総充填重量200mgは、5号の卵型ソフトジェルカプセルに適したものであると考えられた。
表3に掲載される通り、溶媒混合物中のエストラジオール(4〜6mg)の安定性を評価するために追加の試験を実施した。4% TRANSCUTOLを添加したMIGLYOL 812は熱/冷サイクルで96時間後に析出したのに対し、エストラジオールをMIGLYOL:CAPMULの30及び50%配合物、あるいはCAPMUL MCM単独に可溶化させたものは、最低でも14日間、同一の条件下で析出しなかった。
エストラジオール溶液の経時的な物理安定性を決定するのに加えて、カプセル封入プロセス中に充填材料が安定であるか決定する必要もある。これらの製剤を試験するための方法の1つは、充填剤に水を追加することによるものである。表5に示す通り、6mg/g濃度でのポリエチレングリコール400及びCAPMUL MCM中エストラジオール溶液は、再結晶化を生じずに最低限7%の水を吸収することができるのに対し、MIGLYOL 812:CAPMUL PG8(75:25)は同一濃度にて析出する。
代表的な実施形態では、次のものを含む、充填材料を含有するカプセルが提供される。
代表的な実施形態では、次のものを含む、充填材料を含有するカプセルが提供される。
プロゲステロン溶解度
各種実施態様では、エストラジオール及びプロゲステロンはいずれも溶媒に溶解させることができる。各種実施態様では、エストラジオール及びプロゲステロンの両方の溶解度は、治療有効量を合理的な質量で得ることができるようなものであり、一般的には、好ましくはカプセル封入に好適な3〜22号卵型又は楕円形カプセルで1mg〜1200mgであるものと考えられる。例えば、各種実施態様では、50mg〜100mgのプロゲステロンを溶媒用量に溶解させることもでき、すなわち、溶解度はカプセル当たり50mg〜100mgであり得る。MIGLYOLも試行したところ、MIGLYOLはプロゲステロンの良好な基剤として検討され得るものであったものの、単独では望ましいエストラジオール可溶化度(例えば、12mg/gの溶解度は各種実施形態において望ましいものであり得る)は提供されなかった。したがって、MIGLYOLは、プロゲステロンの懸濁液を含む実施形態で使用することができるものの、MIGLYOL単独では、完全可溶化されたプロゲステロン及び/又はエストラジオールを有する実施形態で使用するのに望ましくない。
代表的な実施形態では、完全可溶化プロゲステロン及びエストラジオールを有する充填材料を含有するカプセルが提供される。
代表的な実施形態では、次のものを含む、懸濁されたプロゲステロンを有する充填材料を含有するカプセルが提供される。
代表的な実施形態では、次のものを含む、懸濁されたプロゲステロンを有する充填材料を含有するカプセルが提供される。
本実施例の目的に関し、Beckman装置を使用することにより粒径分析を実施する。各種実施形態に従い、微紛化プロゲステロンを含むサンプルAPIが、分析用に提供される。
200mgの微紛化プロゲステロン及び2mgのエストラジオールを有する製剤サンプルを油に分散させる。MLMを取り付けたBeckman装置で60秒間分析を実施した。Beckman装置は、フラウンホーファー光学モデルを使用するよう構成した。Beckman装置によると、サンプルのX50は11.0μm、X75は17.3μm、並びにX25は5.3μmであった。同様に、Beckman装置によると、平均粒径は11.8μmであり、メジアン粒径は11.04μmであり、モード粒径は.13.6μmであり、標準偏差は7.8μmである。
最終溶液中のプロゲステロンの溶解度を上昇させる目的で、GELUCIRE 44/14を10重量/重量%加えた。
代表的な実施形態では、次のものを含む、完全可溶化エストラジオール及び部分可溶化プロゲステロンを有する充填材料を含有するカプセルが提供される。
代表的な実施形態では、次のものを含む、完全可溶化エストラジオール及び部分可溶化プロゲステロンを有する充填材料を含有するカプセルが提供される。
試験352−摂食条件下でのプロゲステロン及びエストラジオール併用試験
次の試験プロトコルを使用し、摂食条件下にある、24名の健常な成人の閉経期後女性被験者に、実施例14に記載のプロセスにより調製された通りの、プロゲステロン(200mg)とエストラジオール(2.0mg)を含む本開示の製剤を組み合わせて投与し、200mg PROMETRIUM(Catalent Pharmaceuticals(セントピーターズバーグ、フロリダ)(及び2.0mgのESTRACE(エストラジオール膣用クリーム、USP、0.01%)(Bristol−Myers Squibb社(プリンストン、ニュージーランド))と比較して、バイオアベイラビリティ及びバイオエクイバレンスパラメーターを確認した。
上記プロトコル並びに試験製剤及び参照製剤を使用する絶食試験も実施した。しかしながら、試験製剤及び参照製剤の投与前の高脂肪食を除き、各患者には製剤投与前少なくとも12時間にわたって絶食させた。
各種実施形態に従う製造方法を図1〜3に示す。図1の参照により、材料を充填する方法100が示される。工程102は、基材の油性ビヒクルを40℃±5℃に加熱することから構成される。加熱は任意の好適な手段により実施することができる。加熱は、ステンレス鋼容器などの任意の好適な容器で実施することができる。油性ビヒクルは、本明細書に記載の任意の油性ビヒクル(例えば、CAPMUL MCM)であってよい。
I.大豆油、ピーナッツ油、及び紅花油中エストラジオール溶解度
以下に記載の混合物を調製し、混合物を超音波処理し、次に透明な溶液が得られているか確認することにより、視覚的にデータを得た。透明な溶液が得られた場合、これは試験濃度での溶解度の指標とした。
工程1.
30mgのエストラジオールを溶媒に加え、適量を10gとし、それぞれの油中0.3%エストラジオール懸濁液を調製した。サンプルをボルテックスにより2時間混合し、50℃で30分間加熱し、次に1時間以上混合した。全てのサンプルは懸濁液形態のままであった。
各サンプルを0.24%に希釈(2.5g以上の油を加えることにより)し、2時間混合し、50℃にて30分間加熱し、再度1時間混合した。全てのサンプルは濁ったままであった。サンプルを一晩室温に維持し、サンプルが沈殿していないか、又は溶解されていないAPIが析出していないか確認した。室温で20時間後、全てのサンプルでAPIが未溶解のままだったことが観察された。
各サンプルを0.2%に希釈(2.5g以上の油を加えることにより)し、2時間混合し、50℃にて30分間加熱し、再度1時間混合した。全てのサンプルは僅かに濁ったままであったことから、エストラジオールは完全には溶解しなかったことが示された。
別個の実験では、50gのベニバナ油を85〜88℃に加熱し、60mgエストラジオールを加え、完全に溶解するまで混合し(1時間)、室温に冷却した。達成された溶解度は1.0mg/mLであった。エストラジオール溶液サンプルにプロゲステロンを加えてもエストラジオールの溶解度に影響はなかった。
溶解
本製剤を使用して、PROMETRIUMの溶解度に対してプロゲステロンの溶解度を比較し、ESTRACEの溶解度に対してエストラジオールの溶解度を比較して、溶解度試験を実施した。第1の試験では、200mgのプロゲステロン及び2mgのエストラジオールを含む、本製剤のカプセルを使用した。第2の試験では、50mgのプロゲステロン及び2mgのエストラジオールを含む、本製剤のカプセルを使用した。2つの製剤は、次のように構成した:
USP溶解装置(レシプロケーティングシリンダー)(「USP装置3」)を使用して溶解度試験を実施した。装置は、1分辺り30往復するよう設定した。37℃にて、3%ラウリル硫酸ナトリウムを添加した250mLの0.1N HCl溶液を使用した。
Claims (18)
- エストラジオール及びプロゲステロンを、これらを必要としている哺乳動物に投与するための、製剤処方であって、
(i)可溶化エストラジオールと、
(ii)完全可溶化プロゲステロン又は部分可溶化プロゲステロンと、
(iii)油と、を含み、該油が中鎖脂肪酸グリコールエステル又はこれらの混合物である、製剤処方。 - 前記油が、グリセロール、ポリエチレングリコール、若しくはプロピレングリコール、又はこれらの混合物の中鎖脂肪酸エステルを含み、該中鎖脂肪酸が、主に
C6〜C12脂肪酸、
C6〜C10脂肪酸、
C8〜C12脂肪酸、又は
C8〜C10脂肪酸である、請求項1に記載の製剤処方。 - 前記油が、主にモノ及びジグリセリドである、請求項2に記載の製剤処方。
- 前記脂肪酸が、主にC8〜C10である、請求項3に記載の製剤処方。
- 前記脂肪酸が、主に飽和されている、請求項3に記載の製剤処方。
- 前記脂肪酸が、主に飽和されている、請求項4に記載の製剤処方。
- 前記油が、主にトリグリセリドである、請求項2に記載の製剤処方。
- 前記脂肪酸が、主にC8及びC10である、請求項7に記載の製剤処方。
- 前記脂肪酸が、主に飽和されている、請求項7に記載の製剤処方。
- 前記脂肪酸が、主に飽和されている、請求項9に記載の製剤処方。
- 非イオン性界面活性剤を更に含む、請求項3〜6のいずれか一項に記載の製剤処方。
- 非イオン性界面活性剤を更に含む、請求項7〜10のいずれか一項に記載の製剤処方。
- エストラジオールと、微紛化及び部分的可溶化プロゲステロンとを含み、全プロゲステロンのうち少なくとも80%が可溶化されている、請求項1〜10いずれか一項に記載の製剤処方。
- 前記界面活性剤が、ラウロイルポリオキシル−32−グリセリドである、請求項11に記載の製剤処方。
- 経口投与用の硬質カプセル、軟質カプセル、又は錠剤中の、請求項1に記載の製剤処方。
- 請求項1に記載の製剤処方であって、
30〜35重量%のプロゲステロン、
0.1〜0.4重量%のエストラジオール、
主に中鎖脂肪酸モノ及びジグリセリドである55〜75重量%の油、及び
0.5〜10重量%の非イオン性界面活性剤、を含む、製剤処方。 - 前記カプセルが、ゼラチン、グリセロール、及び着色剤を含む、請求項16に記載の製剤処方。
- ホルモン補充療法を必要としている女性においてホルモン補充療法を作用させる方法であって、有効量の請求項1〜17のいずれか一項に記載のカプセル化された製剤処方を前記女性に経口投与することを含む、方法。
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