Bioavailability of sulfonamide suspensions I

Dissolution profiles of sulfamethizole using paddle method

Jeffrey D. Strum, John Colaizzi, Thomas J. Goehl, James M. Jaffe, William H. Pitlick, Vinod P. Shah, Rolland I. Poust

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

A comparative bioavailability study was performed using two commercially available, chemically equivalent brands of sulfamethizole suspension. One gram of each suspension was administered to 12 different subjects following a completely randomized crossover design. Serum levels and derived pharmacokinetic parameters were compared statistically. There were no significant differences in the extent of sulfamethizole absorption from the two suspensions as evidenced by p <0.05) in the mean serum levels at 0.5 and 0.75 hr and differences in Cmax and tmax indicated that the absorption rate differed for the two products. In vitro tests including particle‐size analysis and dissolution studies were performed. The size‐frequency distribution of particles in the suspensions was studied using a resistance particle counter. The dissolution characteristics of the two products were studied using the Food and Drug Administration's paddle method and the spin‐filter apparatus. Suspension A had a significantly greater amount of drug dissolved at 15 and 30 min using either method. It also had a greater percentage of particles at the smaller size range, indicating that the greater dissolution rate may be related directly to the decreased particle size. A comparison of the in vivo and in vitro results demonstrated a definite rank‐order correlation between the dissolution performance of the two suspensions and the in vivo parameters reflecting the absorption rate. Suspension A had a greater amount of drug dissolved at 15 and 30 min and resulted in higher serum levels at 0.5 and 0.75 hr, a higher Cmax and a shorter tmax.

Original languageEnglish (US)
Pages (from-to)1399-1402
Number of pages4
JournalJournal of Pharmaceutical Sciences
Volume67
Issue number10
DOIs
StatePublished - Jan 1 1978

Fingerprint

Sulfamethizole
Sulfonamides
Biological Availability
Suspensions
Serum
United States Food and Drug Administration
Particle Size
Pharmaceutical Preparations
Cross-Over Studies
Pharmacokinetics

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

Keywords

  • Antibacterials—sulfamethizole, bioavailability in humans and in vitro dissolution, two suspensions compared
  • Bioavailability—sulfamethizole, two suspensions compared
  • Dissolution, in vitro—sulfamethizole, two suspensions compared
  • Sulfamethizole—bioavailability in humans and in vitro dissolution, two suspensions compared

Cite this

Strum, Jeffrey D. ; Colaizzi, John ; Goehl, Thomas J. ; Jaffe, James M. ; Pitlick, William H. ; Shah, Vinod P. ; Poust, Rolland I. / Bioavailability of sulfonamide suspensions I : Dissolution profiles of sulfamethizole using paddle method. In: Journal of Pharmaceutical Sciences. 1978 ; Vol. 67, No. 10. pp. 1399-1402.
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Bioavailability of sulfonamide suspensions I : Dissolution profiles of sulfamethizole using paddle method. / Strum, Jeffrey D.; Colaizzi, John; Goehl, Thomas J.; Jaffe, James M.; Pitlick, William H.; Shah, Vinod P.; Poust, Rolland I.

In: Journal of Pharmaceutical Sciences, Vol. 67, No. 10, 01.01.1978, p. 1399-1402.

Research output: Contribution to journalArticle

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AU - Strum, Jeffrey D.

AU - Colaizzi, John

AU - Goehl, Thomas J.

AU - Jaffe, James M.

AU - Pitlick, William H.

AU - Shah, Vinod P.

AU - Poust, Rolland I.

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