Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen
In order to assess the quality of a sustained-release pentoxyphylline tablet formulated and produced by a domestic company (PLTF-400), a comparative bioavailability study was carried out in twelve healthy Indonesian volunteers in two-way crossover design. TRTL-400, innovator's product, was take...
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[Yogyakarta] : Universitas Gadjah Mada
2003
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| author | Perpustakaan UGM, i-lib |
| author_facet | Perpustakaan UGM, i-lib |
| author_sort | Perpustakaan UGM, i-lib |
| collection | UGM |
| description | In order to assess the quality of a sustained-release pentoxyphylline tablet formulated and produced by a domestic company (PLTF-400), a comparative bioavailability study was carried out in twelve healthy Indonesian volunteers in two-way crossover design. TRTL-400, innovator's product, was taken as reference product. Plasma sample was used and unchanged pentoxyphylline compound was analyzed using HPLC method.
It was found that PLTF-400 was bioequivalent to the reference product (TRTL-400) with 90 % confidence intervals of C, , AUCG., and AUC (Test/Reference) of 93.1%-132.0%, 90.6% - 123.5%, and 84.2% - 116.2%, respectively. The pharmacokinetic parameters (C_, AUC, half-life) of the drug found in this study were comparable to those obtained previously by the other authors in differrent ethnics.
Keywords: Pentoxyphylline, sustained-release, bioavailability, pharmacokinetics.
ABSTRAK
Dalam rangka penilaian mutu sebuah sediaan tablet pentoksifilin yang dihasilkan oleh sebuah industri farmasi nasional (PLTF-400), telah dilakukan uji ketersediaan hayati komparatif pada 12 sukarelawan sehat Indonesia dengan cars silang lengkap. TRTL-400 digunakan sebagai produk pembanding. Sampel yang digunakan adalah plasma dan senyawa yang dianalisis adalah senyawa utuh pentoksifilin, yang ditentukan secarakromatografi cair kined a tinggi.
Hasil yang diperoleh menunjukkan bahwa PLTF-400 bioekivalen terhadap sediaan pembanding dengan nilai 90% confidence interval rasio C AUC., dan AUC secara berurutan 93,1% -132,0%, 90,6% - 123,5%, dan 84,2% - 116,2%. Harga parameter-parameter farmakokinetik (C.,� AUC, waktu paro eliminasi) yang dihasilkan dalam penelitian ini berdekatan dengan yang diperoleh pars peneliti lain sebelumnya pada etnik yang berbeda.
Kata kunci: pentoksifilin, lepas lambat, ketersediaan hayati, farmakokinetik.
Key Word:Pentoksilin, lepas lambat, ketersediaan hayati,Farmakokinetik |
| first_indexed | 2024-03-13T18:54:28Z |
| format | Article |
| id | oai:generic.eprints.org:24654 |
| institution | Universiti Gadjah Mada |
| last_indexed | 2024-03-13T18:54:28Z |
| publishDate | 2003 |
| publisher | [Yogyakarta] : Universitas Gadjah Mada |
| record_format | dspace |
| spelling | oai:generic.eprints.org:246542014-06-18T00:30:47Z https://repository.ugm.ac.id/24654/ Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen Perpustakaan UGM, i-lib Jurnal i-lib UGM In order to assess the quality of a sustained-release pentoxyphylline tablet formulated and produced by a domestic company (PLTF-400), a comparative bioavailability study was carried out in twelve healthy Indonesian volunteers in two-way crossover design. TRTL-400, innovator's product, was taken as reference product. Plasma sample was used and unchanged pentoxyphylline compound was analyzed using HPLC method. It was found that PLTF-400 was bioequivalent to the reference product (TRTL-400) with 90 % confidence intervals of C, , AUCG., and AUC (Test/Reference) of 93.1%-132.0%, 90.6% - 123.5%, and 84.2% - 116.2%, respectively. The pharmacokinetic parameters (C_, AUC, half-life) of the drug found in this study were comparable to those obtained previously by the other authors in differrent ethnics. Keywords: Pentoxyphylline, sustained-release, bioavailability, pharmacokinetics. ABSTRAK Dalam rangka penilaian mutu sebuah sediaan tablet pentoksifilin yang dihasilkan oleh sebuah industri farmasi nasional (PLTF-400), telah dilakukan uji ketersediaan hayati komparatif pada 12 sukarelawan sehat Indonesia dengan cars silang lengkap. TRTL-400 digunakan sebagai produk pembanding. Sampel yang digunakan adalah plasma dan senyawa yang dianalisis adalah senyawa utuh pentoksifilin, yang ditentukan secarakromatografi cair kined a tinggi. Hasil yang diperoleh menunjukkan bahwa PLTF-400 bioekivalen terhadap sediaan pembanding dengan nilai 90% confidence interval rasio C AUC., dan AUC secara berurutan 93,1% -132,0%, 90,6% - 123,5%, dan 84,2% - 116,2%. Harga parameter-parameter farmakokinetik (C.,� AUC, waktu paro eliminasi) yang dihasilkan dalam penelitian ini berdekatan dengan yang diperoleh pars peneliti lain sebelumnya pada etnik yang berbeda. Kata kunci: pentoksifilin, lepas lambat, ketersediaan hayati, farmakokinetik. Key Word:Pentoksilin, lepas lambat, ketersediaan hayati,Farmakokinetik [Yogyakarta] : Universitas Gadjah Mada 2003 Article NonPeerReviewed Perpustakaan UGM, i-lib (2003) Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen. Jurnal i-lib UGM. http://i-lib.ugm.ac.id/jurnal/download.php?dataId=7632 |
| spellingShingle | Jurnal i-lib UGM Perpustakaan UGM, i-lib Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen |
| title | Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen |
| title_full | Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen |
| title_fullStr | Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen |
| title_full_unstemmed | Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen |
| title_short | Pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained-release pentoxyphylline tablets in indonesian healthy volunteers: Profil farmakokinetik dan ketersediaan hayati komparatif pen |
| title_sort | pharmacoiunetic profile and comparative bioavailability of pentoxyphylline from two sustained release pentoxyphylline tablets in indonesian healthy volunteers profil farmakokinetik dan ketersediaan hayati komparatif pen |
| topic | Jurnal i-lib UGM |
| work_keys_str_mv | AT perpustakaanugmilib pharmacoiuneticprofileandcomparativebioavailabilityofpentoxyphyllinefromtwosustainedreleasepentoxyphyllinetabletsinindonesianhealthyvolunteersprofilfarmakokinetikdanketersediaanhayatikomparatifpen |