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Pharmaceutical Research

Amaç: Fenofibrat ve statinlerle kombinasyon tedavisi, karışık dislipideminin tedavisinde güncel klinik kılavuzlar tarafından şiddetle tavsiye edilmektedir. Bu çalışmada, fenofibratın farmakokinetik profilini değiştirerek, bu kombinasyon tedavisinin eş zamanlı uygulanmasına bağlı kas toksisitesi riskini azaltmak ve modifiye salımlı formülasyonun oral biyoyararlanımını iyileştirmek için inovatif bir geciktirilmiş salımlı fenofibrat preparatı formüle edilmiştir.Yöntemler: Fenofibrat, çok-partiküllü pelet kaplama öncesinde toz katmanlama işlemi yoluyla ilaç yüklü çekirdekleri hazırlamak için mikronize edilmiştir. Farklı kaplama formülasyonları taranmış ve bunların in vitro salım profilleri, ticari yavaş salımlı peletler Lipilfen® ile karşılaştırılmıştır.. Optimize edilmiş iki formülasyon, Beagle köpeklerinde değerlendirilmiş ve fenofibratın iki referans ticari preparatı (çabuk salımlı preparasyon Lipanthyl® ve yavaş salımlı peletler Lipilfen®) ile karşılaştırılmıştır. Sonuçlar: In vitro testlerden seçilen R1 ve R2'den fenofibratın in vivo salımı için bir gecikme fazı, ardından hızlı ve tam ilaç salımı gözlenmiştir. R1 ve R2'nin bağıl biyoyararlanımı sırasıyla %100.4 ve %201.1 olarak kaydedilmiştir ve bu oranlar Lipilfen® ile tespit edilenden (%67.2) daha yüksek olmuştur.

Yorum: Modifiye fenofibrat, gelişmiş biyoyararlanım ve geciktirilmiş salım özellikleri göstermiştir ve statinlerle birlikte uygulandığında güvenliliği ve tedaviye uyumu potansiyel olarak iyileştirebilir. Bildiğimiz kadarıyla bu, fenofibratın geciktirilmiş salımlı preparatına ilişkin ilk bildiridir.

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.

  1. [Grammar] Article added
  2. [Technical word Choice] [SME]Correct technical term used as per literature
  3. [Accuracy] More accurate word choice
  4. [Mistranslation] Minor mistranslation rectified
  5. [Word and Phrase Choice] Better word choice for improved clarity
  6. [Spelling error] [Language] Minor spelling error rectified

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.

  1. [Readability] Phrasing enhanced for better readability
  2. [Grammar] Article added
  3. [Technical word Choice] [SME]Correct technical term used as per literature
  4. [Accuracy] More accurate word choice
  5. [Punctuation] Hyphen added so that their meaning of compound modifier is clearly understood
  6. [Clarity] Added for better clarity
  7. [Mistranslation] Minor mistranslation rectified
  8. [Word and Phrase Choice] Better word choice for improved clarity
  9. [Word and Phrase Choice] Word choice enhanced
  10. [Spelling error] [Language] Minor spelling error rectified
  11. [Consistency] [Style] Phrase was revised to maintain consistency with the phrase used previously in the text (under “Purpose”).

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.

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