Absorption of sulindac from a novel (Pro-SorbTM) liquid formulation

Biopharm Drug Dispos. 1996 Apr;17(3):209-21. doi: 10.1002/(SICI)1099-081X(199604)17:3<209::AID-BDD956>3.0.CO;2-6.

Abstract

The absorption of sulindac from two different 200 mg oral dosage forms, Pro-SorbTM liquid and Clinoril tablets, was compared following administration to eight healthy human volunteers. Subjects received both formulations according to a randomized crossover design and blood samples were collected at selected times during 24 h. Concentrations of both sulindac and its active sulphide metabolite were determined by HPLC and individual serum concentration versus time profiles were constructed. Maximal serum concentrations (Cmax) and area under the curve values (AUClast and AUC0-infinity) were compared for both sulindac and sulindac sulphide. The results indicate that the rate and extent of absorption of sulindac from Pro-SorbTM liquid are significantly greater than those from Clinoril tablets, a finding consistent with the observation that the liquid form produces less gastric irritation following oral administration.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Absorption
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / blood
  • Anti-Inflammatory Agents, Non-Steroidal / pharmacokinetics*
  • Biological Availability
  • Chemistry, Pharmaceutical
  • Cross-Over Studies
  • Dosage Forms
  • Humans
  • Male
  • Middle Aged
  • Prodrugs / administration & dosage
  • Prodrugs / pharmacokinetics*
  • Single-Blind Method
  • Sulindac / administration & dosage
  • Sulindac / blood
  • Sulindac / pharmacokinetics*

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Dosage Forms
  • Prodrugs
  • Sulindac