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Vaginal semisolid products: Technological performance considering physiologic parameters.

Rita Monteiro Machado1, Ana Palmeira-de-Oliveira1, José Martinez-de-Oliveira2

  • 1CICS, UBI - Health Sciences Research Center, Faculty of Health Sciences, University of Beira Interior, Avenida Infante D. Henrique, 6200-506 Covilhã, Portugal; Labfit, HPRD - Health Products Research and Development, Lda, Edifício UBIMEDICAL, Estrada Municipal 506, 6200-284 Covilhã, Portugal.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|September 10, 2017
PubMed
Summary
This summary is machine-generated.

Developing ideal vaginal semisolid formulations requires improved characterization methods. Current products often lack optimal properties, highlighting the need for physiological parameter integration for better efficacy and safety prediction.

Keywords:
Physiologic methodsSemisolidsVaginal drug deliveryVaginal products

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Gynecological Therapeutics

Background:

  • Vaginal semisolid formulations are crucial for treating infections and menopausal symptoms.
  • Current characterization methods may not accurately predict in vivo performance.
  • Research has predominantly focused on anti-HIV vaginal preparations.

Purpose of the Study:

  • To enhance traditional characterization methods for vaginal semisolid formulations.
  • To incorporate physiological parameters for predictive tool development.
  • To establish criteria for an ideal vaginal semisolid formulation regardless of its therapeutic target.

Main Methods:

  • Evaluation of ten commercial vaginal products and two comparators.
  • Characterization included pH, buffering capacity, osmolality, texture analysis (firmness, adhesiveness, bioadhesion) using ex vivo porcine vaginal epithelium, and viscosity.
  • Measurements were performed in vaginal fluid simulant (VFS) and at physiological temperature (37°C).

Main Results:

  • Most commercial vaginal formulations exhibited suboptimal technological characteristics under physiological conditions.
  • Significant deviations from ideal parameters were observed for pH, osmolality, texture, and viscosity.
  • The study identified specific areas where current formulations fall short of optimal design.

Conclusions:

  • Improved characterization methods incorporating physiological parameters are necessary for vaginal semisolid formulations.
  • These adapted methods can predict efficacy and safety profiles early in development.
  • This approach is expected to optimize cost-efficiency in the development of novel vaginal products.