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オリジナル原稿
用途:フェノフィブラートとスタチンの併用療法は、混合脂質異常症治療の現在の臨床ガイドラインにより強く推奨されている。本研究では、以下のことを達成するために、フェノフィブラートの革新的な遅延放出製剤を節製しました。以下のこととは、フェノフィブラートの薬物動態プロフィールを変えることにより（この併用療法の同時投与が原因となる）筋毒性の危険性を低減し、放出調節製剤の経口生物学的利用可能性を改善することです。
方法:フェノフィブラートを、多粒子ペレットコーティングを行う前に、粉体層化過程を経て薬剤負荷コアを調製するために微粒子化しました。異なるコーティング製剤をスクリーニングし、そのin vitroでの放出プロフィールを、市販の持続放出ペレットであるLipilfen® のものと比較しました。ビーグル犬を使用して、2つの最適化された製剤を評価し、フェノフィブラートの2つの参考商業製剤（即時放出製剤であるリパンチル® および持続放出ペレットであるLipilfen®）と比較しました。
結果:in vitroでの試験から選出されたR1およびR2におけるフェノフィブラートのin vivoにおける放出は、遅滞期を示した後、迅速かつ完全な薬物放出が続いた。R1とR2の相対的な生物学的利用可能性は、それぞれ100.4％および201.1％であり、これはリピルフェン®（67.2％）のそれよりも高かった。
結論:修正されたフェノフィブラートは、強化された生物学的利用可能性および遅延放出特性を示し、スタチンとの同時投与時に安全性とコンプライアンスを改善する可能性がある。私たちの知る限りでは、これはフェノフィブラートを放出遅延する調製の最初の報告です。
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Purpose: Fenofibrate and statin combination therapy is highly recommended by the current clinical guidelines for treatment of combined dyslipidemia. In this study, an innovative delayed-release preparation of fenofibrate was designed to reduce the risk of muscle toxicity, caused by simultaneous administration of this combination therapy, by altering the pharmacokinetic profile of fenofibrate, as well as to improve the oral bioavailability of the modified-release formulation.
Methods: Micronized fenofibrate was used to prepare drug-loaded cores via a powder layering process before multiparticulate pellet coating. Different coating formulations were screened, and their in vitro release was compared with the commercial sustained-release pellets Lipilfen®. Two optimized formulations were evaluated in Beagle dogs using two commercial preparations of fenofibrate (the immediate release preparation Lipanthyl® and the sustained release pellets Lipilfen®) as references.
Results: The in vivo release of fenofibrate from R1 and R2 selected from in vitro tests exhibited a lag phase, and then rapid and complete drug release. The relative bioavailabilities of R1 and R2 were 100.4% and 201.1%, respectively, which were greater than that of Lipilfen® (67.2%).
Conclusion: The modified fenofibrate pellets developed enhanced bioavailability and delayed-release properties. They have the potential to improve safety and compliance when co-administrated with statins. This is the first report of a delayed-release fenofibrate preparation.
- [文法] 冠詞を追加しました
- [専門用語の選択] [SME] 文献に従って使用される正しい専門用語です
- [正確さ] より正確な語の選択です
- [誤訳] マイナーな誤訳を修正しました
- [語の選択] 明確さの改善のために、より良い語を選択しました
- [スペル] [言語] マイナーのスペルエラーを修正しました
Purpose: Combination therapy of fenofibrate and statins is highly recommended by the current clinical guidelines for the treatment of mixed dyslipidemia. In this study, we formulated an innovative delayed-release preparation of fenofibrate to achieve the following: to reduce the risk of muscle toxicity, caused by simultaneous administration of this combination therapy, by altering the pharmacokinetic profile of fenofibrate, as well as to improve the oral bioavailability of the modified-release formulation.
Methods: Fenofibrate was micronized to prepare drug-loaded cores via a powder layering process before multiparticulate pellet coating. Different coating formulations were screened, and their in vitro release profiles was compared with the commercial sustained-release pellets Lipilfen®. Two optimized formulations were evaluated in Beagle dogs and compared with two commercial preparations of fenofibrate (the immediate release preparation Lipanthyl® and the sustained release pellets Lipilfen®) as references.
Results: The in vivo release of fenofibrate from R1 and R2 selected from in vitro tests exhibited a lag phase, followed by rapid and complete drug release. The relative bioavailabilities of R1 and R2 were 100.4% and 201.1%, respectively, which were greater than that of Lipilfen® (67.2%).
Conclusion: The modified fenofibrate pellets showed enhanced bioavailability and delayed-release properties. They have the potential to improve safety and compliance when co-administered with statins. This is the first report of a delayed-release fenofibrate preparation.
| 修正ポイント |
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Purpose: Combination
therapy of Ffenofibrate
and statins combination
therapy is highly recommended by the current clinical guidelines for
the 1treatment of combinedmixed2
dyslipidemia. In this study, we formulated 3an
innovative delayed-release preparation of fenofibrate was designed to achieve
the following: to reduce the risk of muscle toxicity, caused by
simultaneous administration of this combination therapy, by altering the
pharmacokinetic profile of fenofibrate, as well as to improve the oral
bioavailability of the modified-release formulation.
Methods: Micronized
fFenofibrate was usedmicronized
to prepare drug-loaded cores via a powder layering process before
multiparticulate pellet coating. Different coating formulations were screened,
and their in vitro release profiles was
compared with the commercial sustained-release pellets Lipilfen®. Two optimized
formulations were evaluated in Beagle dogs using and compared with 4two commercial preparations
of fenofibrate (the immediate release preparation Lipanthyl® and the sustained release
pellets Lipilfen®) as references.
Results: The in vivo release of
fenofibrate from R1 and R2 selected from in vitro tests exhibited a lag phase, and thenfollowed by 5rapid
and complete drug release. The relative bioavailabilities of R1 and R2 were
100.4% and 201.1%, respectively, which were greater than that of Lipilfen®
(67.2%).
Conclusion: The modified fenofibrate
pellets developed
showed enhanced bioavailability and delayed-release properties. They
have the potential to improve safety and compliance when co-administratedadministered
6with statins. This is the first report of a delayed-release fenofibrate
preparation.
- [読みやすさ] 表現法を向上させ、読みやすくしました
- [文法] 冠詞を追加しました
- [専門用語の選択] [SME] 文献に従って使用される正しい専門用語です
- [正確さ] より正確な語の選択です
- [句読点] 複合修飾語の意味を明確に理解できるようにハイフンを追加しました
- [明確さ] よりわかりやすくするために追加しました
- [誤訳] マイナーな誤訳を修正しました
- [語の選択] 明確さの改善のために、より良い語を選択しました
- [語の選択] 語の選択をより的確にしました
- [スペル] [言語] マイナーのスペルエラーを修正しました
- [一貫性] [スタイル] 表現法を修正し、本文で以前使用していた表現法との整合性を保つようにしました（“Purpose”の下）。
Purpose: According to current guidelines.combination therapy of fenofibrate and statins is highly recommended for treating mixed dyslipidemia. In this study, we formulated an innovative delayed-release preparation of fenofibrate to reduce the risk of muscle toxicity, by altering the pharmacokinetic profile of fenofibrate and to improve the oral bioavailability of the modified-release formulation.
Methods: Fenofibrate was micronized and used to prepare drug-loaded cores via a powder-layering process before performing multiparticulate pellet coating. Different coating formulations were screened, and their in vitro release profiles were compared with those of the commercial sustained-release pellets Lipilfen®. Two optimized formulations were evaluated in Beagle dogs models and compared with two reference commercial preparations of fenofibrate, Lipanthyl®(the immediate-release preparation) and Lipilfen®(the sustained- release pellets) .
Results: The in vivo release of fenofibrate from R1 and R2 (selected from in vitro tests) exhibited a lag phase, which was followed by rapid and complete drug release. The relative bioavailabilities of R1 and R2 were 100.4% and 201.1%, respectively, which werehigher than that of Lipilfen® (67.2%).
Conclusion: Modified fenofibrate pellets showed enhanced bioavailability and delayed-release propertiesand can improve safety and compliance when co-administered with statins. To the best of our knowledge, this is the first report of a delayed-release preparation of fenofibrate.
| 修正ポイント |
Purpose: Combination1According to current guidelines.combination therapy of Ffenofibrate
and statins combination
therapy is highly recommended by the
current clinical guidelines for the 2treatment oftreating
combinedmixed3
dyslipidemia. In this study, we formulated 4an
innovative delayed-release preparation of fenofibrate was designed to achieve
the following: to reduce the risk of muscle toxicity, caused by simultaneous administration of this combination
therapy, by altering the pharmacokinetic profile of fenofibrate, as well asand to
improve the oral bioavailability of the modified-release formulation.
Methods: Micronized
fFenofibrate was usedmicronized
and used to prepare drug-loaded cores
via a powder-5layering process before performing 6multiparticulate pellet coating.
Different coating formulations were screened, and their in vitro release profiles waswere compared with those
of the commercial sustained-release pellets Lipilfen®. Two optimized
formulations were evaluated in Beagle dogs using7 models and compared with two
reference commercial preparations of
fenofibrate (,
Lipanthyl®(the immediate-release
preparation Lipanthyl®) and Lipilfen®(the sustained-release pellets Lipilfen®) as
references).
Results: The in vivo release of
fenofibrate from R1 and R2 (selected
from in vitro tests) exhibited a lag
phase, and thenwhich was followed by 8rapid and
complete drug release. The relative bioavailabilities of R1 and R2 were 100.4%
and 201.1%, respectively, which were greater9were higher than that of Lipilfen® (67.2%).
Conclusion: The
modifiedModified fenofibrate
pellets developed
showed enhanced bioavailability and delayed-release properties. They have the potential toproperties and can improve safety and compliance
when co-administratedadministered10 with statins. This To the best of
our knowledge, this is the first report of a delayed-release preparation of fenofibrate preparation11.
