INDONESIAN JOURNAL OF PHARMACY
Vol 14 No 1, 2003

PHARMACOKINETIC PROFILE AND COMPARATIVE BIOAVAILABILITY OF PENTOXYPHYLLINE FROM TWO SUSTAINED-RELEASE PENTOXYPHYLLINE TABLETS IN INDONESIAN HEALTHY VOLUNTEERS

Yeyet C. Sumirtapura (Department of Pharmacy, Bandung Institute of Technology, Bandung, Indonesia)
Wibawati Sulistyo (Sanbe Farma, Bandung, Indonesia)
Herwanto Suhalim (Sanbe Farma, Bandung, Indonesia)



Article Info

Publish Date
01 Jan 2005

Abstract

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 Cmax, AUC0-t and AUC0- ratio (Test/Reference) of 93.1%-132.0%, 90.6% - 123.5%, and 84.2% - 116.2%, respectively. The pharmacokinetic parameters (Cmax, 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.

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Journal Info

Abbrev

3

Publisher

Subject

Medicine & Pharmacology

Description

Indonesian Journal of Pharmacy (ISSN-e: 2338-9486, ISSN-p: 2338-9427), formerly Majalah Farmasi Indonesia (ISSN: 0126-1037). The journal had been established in 1972, and online publication was begun in 2008. Since 2012, the journal has been published in English by Faculty of Pharmacy Universitas ...