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

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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.
Keywords
DRUG-DELIVERY, BACTERIAL VAGINOSIS, DISINTEGRATION TEST, ROUTE, MICROBICIDE, WOMEN, TABLETS

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MLA
Poelvoorde, Nele, et al. “In Vivo Evaluation of the Vaginal Distribution and Retention of a Multi-Particulate Pellet Formulation.” EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, vol. 73, no. 2, Elsevier Science, 2009, pp. 280–84, doi:10.1016/j.ejpb.2009.06.005.
APA
Poelvoorde, N., Verstraelen, H., Verhelst, R., Saerens, B., De Backer, E., Lopes dos Santos Santiago, G., … Remon, J. P. (2009). In vivo evaluation of the vaginal distribution and retention of a multi-particulate pellet formulation. EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 73(2), 280–284. https://doi.org/10.1016/j.ejpb.2009.06.005
Chicago author-date
Poelvoorde, Nele, Hans Verstraelen, Rita Verhelst, Bart Saerens, Ellen De Backer, Guido Lopes dos Santos Santiago, Chris Vervaet, et al. 2009. “In Vivo Evaluation of the Vaginal Distribution and Retention of a Multi-Particulate Pellet Formulation.” EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS 73 (2): 280–84. https://doi.org/10.1016/j.ejpb.2009.06.005.
Chicago author-date (all authors)
Poelvoorde, Nele, Hans Verstraelen, Rita Verhelst, Bart Saerens, Ellen De Backer, Guido Lopes dos Santos Santiago, Chris Vervaet, Mario Vaneechoutte, Fabienne De Boeck, Lucas Van Bortel, Marleen Temmerman, and Jean Paul Remon. 2009. “In Vivo Evaluation of the Vaginal Distribution and Retention of a Multi-Particulate Pellet Formulation.” EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS 73 (2): 280–284. doi:10.1016/j.ejpb.2009.06.005.
Vancouver
1.
Poelvoorde N, Verstraelen H, Verhelst R, Saerens B, De Backer E, Lopes dos Santos Santiago G, et al. In vivo evaluation of the vaginal distribution and retention of a multi-particulate pellet formulation. EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS. 2009;73(2):280–4.
IEEE
[1]
N. Poelvoorde et al., “In vivo evaluation of the vaginal distribution and retention of a multi-particulate pellet formulation,” EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, vol. 73, no. 2, pp. 280–284, 2009.
@article{790704,
  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.}},
  author       = {{Poelvoorde, Nele and Verstraelen, Hans and Verhelst, Rita and Saerens, Bart and De Backer, Ellen and Lopes dos Santos Santiago, Guido and Vervaet, Chris and Vaneechoutte, Mario and De Boeck, Fabienne and Van Bortel, Lucas and Temmerman, Marleen and Remon, Jean Paul}},
  issn         = {{0939-6411}},
  journal      = {{EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS}},
  keywords     = {{DRUG-DELIVERY,BACTERIAL VAGINOSIS,DISINTEGRATION TEST,ROUTE,MICROBICIDE,WOMEN,TABLETS}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{280--284}},
  publisher    = {{Elsevier Science}},
  title        = {{In vivo evaluation of the vaginal distribution and retention of a multi-particulate pellet formulation}},
  url          = {{http://dx.doi.org/10.1016/j.ejpb.2009.06.005}},
  volume       = {{73}},
  year         = {{2009}},
}

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