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A pilot study evaluating the safety of vaginal administration of a multi-particulate pellet formulation.

Guido Lopes dos Santos Santiago (UGent) , Hans Verstraelen (UGent) , Nele Poelvoorde (UGent) , Steven De Corte, Geert Claeys (UGent) , Marijke Trog (UGent) , Ellen De Backer (UGent) , Bart Saerens (UGent) , Chris Vervaet (UGent) , Fabienne De Boeck (UGent) , et al.
(2009) European Journal of Pharmaceutics and Biopharmaceutics. 73(3). p.399-403
Author
Organization
Abstract
Aim Quantitative evaluation of the effect caused by vaginal administration of gelatin capsules loaded with starch pellets and lyophilized powder, respectively, on vaginal pH and microflora. Method Administration of gelatin capsules loaded with fast-disintegrating starch pellets (group P) or lyophilized lactose/skimmed milk (group L) was compared to no intervention (group C) in a 3-way randomized, double-blinded, parallel study with 18 volunteers. Follow-up visits were at day 6 (immediately after administration), day 14 (pill stop), day 22 (after withdrawal bleeding) and day 35 (midcycle). Vaginal pH was measured and swabs were taken for Gram staining and culture to assess the presence of hydrogen peroxide-producing lactobacilli. Colposcopy was performed to assess the occurrence of adverse effects on the vaginal and ectocervical mucosa. Results No severe adverse events occurred. For all women, vaginal pH and Gram stain were normal from screening until pill stop. Although immediately after withdrawal bleeding, 8 out of 18 women had an elevated pH, a disturbed microflora or lacked hydrogen peroxide-producing lactobacilli, all women had hydrogen peroxide-producing lactobacilli and a normal vaginal pH at midcycle, and all but two had a normal Gram stain. Conclusion No major differences could be observed between the groups, whereby all changes in pH and microflora could be ascribed to withdrawal bleeding, indicating that gelatin capsules, starch pellets and lyophilized powder are acceptable carrier materials for the vaginal delivery of probiotic strains.

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MLA
Lopes dos Santos Santiago, Guido, et al. “A Pilot Study Evaluating the Safety of Vaginal Administration of a Multi-Particulate Pellet Formulation.” European Journal of Pharmaceutics and Biopharmaceutics, vol. 73, no. 3, 2009, pp. 399–403, doi:10.1016/j.ejpb.2009.08.009.
APA
Lopes dos Santos Santiago, G., Verstraelen, H., Poelvoorde, N., De Corte, S., Claeys, G., Trog, M., … Verhelst, R. (2009). A pilot study evaluating the safety of vaginal administration of a multi-particulate pellet formulation. European Journal of Pharmaceutics and Biopharmaceutics, 73(3), 399–403. https://doi.org/10.1016/j.ejpb.2009.08.009
Chicago author-date
Lopes dos Santos Santiago, Guido, Hans Verstraelen, Nele Poelvoorde, Steven De Corte, Geert Claeys, Marijke Trog, Ellen De Backer, et al. 2009. “A Pilot Study Evaluating the Safety of Vaginal Administration of a Multi-Particulate Pellet Formulation.” European Journal of Pharmaceutics and Biopharmaceutics 73 (3): 399–403. https://doi.org/10.1016/j.ejpb.2009.08.009.
Chicago author-date (all authors)
Lopes dos Santos Santiago, Guido, Hans Verstraelen, Nele Poelvoorde, Steven De Corte, Geert Claeys, Marijke Trog, Ellen De Backer, Bart Saerens, Chris Vervaet, Fabienne De Boeck, Lucas Van Bortel, Jean Paul Remon, Marleen Temmerman, Mario Vaneechoutte, and Rita Verhelst. 2009. “A Pilot Study Evaluating the Safety of Vaginal Administration of a Multi-Particulate Pellet Formulation.” European Journal of Pharmaceutics and Biopharmaceutics 73 (3): 399–403. doi:10.1016/j.ejpb.2009.08.009.
Vancouver
1.
Lopes dos Santos Santiago G, Verstraelen H, Poelvoorde N, De Corte S, Claeys G, Trog M, et al. A pilot study evaluating the safety of vaginal administration of a multi-particulate pellet formulation. European Journal of Pharmaceutics and Biopharmaceutics. 2009;73(3):399–403.
IEEE
[1]
G. Lopes dos Santos Santiago et al., “A pilot study evaluating the safety of vaginal administration of a multi-particulate pellet formulation.,” European Journal of Pharmaceutics and Biopharmaceutics, vol. 73, no. 3, pp. 399–403, 2009.
@article{766835,
  abstract     = {{Aim

Quantitative evaluation of the effect caused by vaginal administration of gelatin capsules loaded with starch pellets and lyophilized powder, respectively, on vaginal pH and microflora.
Method

Administration of gelatin capsules loaded with fast-disintegrating starch pellets (group P) or lyophilized lactose/skimmed milk (group L) was compared to no intervention (group C) in a 3-way randomized, double-blinded, parallel study with 18 volunteers. Follow-up visits were at day 6 (immediately after administration), day 14 (pill stop), day 22 (after withdrawal bleeding) and day 35 (midcycle). Vaginal pH was measured and swabs were taken for Gram staining and culture to assess the presence of hydrogen peroxide-producing lactobacilli. Colposcopy was performed to assess the occurrence of adverse effects on the vaginal and ectocervical mucosa.
Results

No severe adverse events occurred. For all women, vaginal pH and Gram stain were normal from screening until pill stop. Although immediately after withdrawal bleeding, 8 out of 18 women had an elevated pH, a disturbed microflora or lacked hydrogen peroxide-producing lactobacilli, all women had hydrogen peroxide-producing lactobacilli and a normal vaginal pH at midcycle, and all but two had a normal Gram stain.
Conclusion

No major differences could be observed between the groups, whereby all changes in pH and microflora could be ascribed to withdrawal bleeding, indicating that gelatin capsules, starch pellets and lyophilized powder are acceptable carrier materials for the vaginal delivery of probiotic strains.}},
  author       = {{Lopes dos Santos Santiago, Guido and Verstraelen, Hans and Poelvoorde, Nele and De Corte, Steven and Claeys, Geert and Trog, Marijke and De Backer, Ellen and Saerens, Bart and Vervaet, Chris and De Boeck, Fabienne and Van Bortel, Lucas and Remon, Jean Paul and Temmerman, Marleen and Vaneechoutte, Mario and Verhelst, Rita}},
  issn         = {{0939-6411}},
  journal      = {{European Journal of Pharmaceutics and Biopharmaceutics}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{399--403}},
  title        = {{A pilot study evaluating the safety of vaginal administration of a multi-particulate pellet formulation.}},
  url          = {{http://doi.org/10.1016/j.ejpb.2009.08.009}},
  volume       = {{73}},
  year         = {{2009}},
}
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