Nelfinavir suspension obtained from nelfinavir tablets has equivalent pharmacokinetic profile

M. B. Regazzi, E. Seminari, P. Villani, P. L. Carriero, M. Montagna, F. Marubbi, R. Maserati

Research output: Contribution to journalArticlepeer-review

Abstract

The pharmacokinetics of nelfinavir tablets (A) and an oral simplified nelfinavir suspension (B) were studied. Twelve healthy volunteers randomly received either five 250-mg nelfinavir tablets or a simplified oral suspension obtained from tablets dissolved in water (nelfinavir 1250 mg in 100 mL of water) in a single dose before being crossed over to the second treatment after a one-week washout period. Blood samples were drawn up to 24 h after drug administration. Nelfinavir concentrations in plasma were analyzed by a specific and validated reverse-phase high-performance liquid chromatography assay (HPLC) with UV detection, and pharmacokinetic values were determined. For the AUC0-∞ with means±SD of 31.71±7.85, 30.88±10.28 (μg/L) respectively for treatments B and A, the ratio (FB/A) was of 1.1 with a C.I. of 0.90-1.24. For Cmax with means±SD of 3.1±0.6 (treatment B) and 3.2±0.8 mg/mL (treatment A), the ratio was 1.0. with C.I. of 0.92- 1.08. The two treatments evidenced no significant differences in AUC0-∞ and Cmax values and the two-one sided t-test showed that the two preparations are bioequivalent. There was no significant difference in Tmax between the liquid and tablets. Nelfinavir suspension might be a option for treating HIV-infected patients with swallowing disturbances or compliance problems.

Original languageEnglish
Pages (from-to)569-574
Number of pages6
JournalJournal of Chemotherapy
Volume13
Issue number5
Publication statusPublished - 2001

Keywords

  • HAART
  • Highly active antiretroviral therapy
  • HIV therapy
  • Nelfinavir
  • Protease inhibitors

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Microbiology (medical)

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