In vivo evaluation of the vaginal distribution and retention of a multi-particulate pellet formulation

Nele Poelvoorde, Hans Verstraelen, Rita Verhelst, Bart Saerens, Ellen De Backer, Guido Lopes dos Santos Santiago, Chris Vervaet, Mario Vaneechoutte, Fabienne De Boeck, Luc Van Bortel, Marleen Temmerman, Jean Paul Remon

Research output: Contribution to journalArticlepeer-review

16 Citations (Scopus)

Abstract

Non-disintegrating microcrystalline cellulose pellets (MCC) and disintegrating starch-based pellets were evaluated as new vaginal drug delivery forms and compared with a powder formulation. Pellets and powder were packed in a HPMC or hard gelatine capsule and vaginally administered to five series of five healthy volunteers. Distribution and retention of the multi-particulate formulation was monitored by colposcopy and swabbing. Capsule disintegration in the vagina was slow. MCC pellets clustered around the fornix 3 h after administration, and after 24 h only a few pellets were detected in the vaginal cavity. In contrast, starch-based pellets already started to disintegrate 6 h after administration, resulting in a complete coverage of the vaginal mucosa after 24 h in 8 out of 10 volunteers. The powder formulation had a better distribution after 6 h, although after 24 h almost no powder remained in the vagina. These results were confirmed by swabbing to determine the amount of riboflavin sodium phosphate (used as marker) distributed in the different vaginal regions.

Original languageEnglish
Pages (from-to)280-284
Number of pages5
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Volume73
Issue number2
DOIs
Publication statusPublished - Oct 2009
Externally publishedYes

Keywords

  • Distribution
  • Gelatine capsule
  • HPMC capsule
  • Multi-particulates
  • Pellets
  • Retention
  • Starch
  • Vaginal delivery

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