Engineering and characterization of simplified vaginal and seminal fluid simulants

Rastogi, Rachna; Su, Jonathan T.; Mahalingam, Alamelu; Clark, Justin; Sung, Samuel; Hope, Thomas J.; Kiser, Patrick F.

doi:10.1016/j.contraception.2015.11.008

Cited by 30 publications

(19 citation statements)

References 19 publications

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“…A variety of organic acids such as lactic acid, acetic acid, succinic acid, and propionic acid, has been identified in the vaginal environment, with lactic acid being the major acid (Boskey et al, 2001). While some published studies investigating vaginal fluids focused on drug delivery and diffusion properties (Rastogi et al, 2016;Tietz and Klein, 2018), relatively few studies investigated bacterial growth (Juárez Tomás and Nader-Macías, 2007), and some do not account for the relevant acidic vaginal pH (Geshnizgani and Onderdonk, 1992;Owen and Katz, 1999). The SVF presented in this work has a pH of 4.5 and components that represent the actual vaginal fluid.…”

Section: Discussionmentioning

confidence: 99%

Comparative Analysis of Lactobacillus gasseri and Lactobacillus crispatus Isolated From Human Urogenital and Gastrointestinal Tracts

et al. 2020

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Lactobacillus crispatus and Lactobacillus gasseri are two of the main Lactobacillus species found in the healthy vaginal microbiome and have also previously been identified and isolated from the human gastrointestinal (GI) tract. These two ecological niches are fundamentally different, notably with regards to the epithelial cell type, nutrient availability, environmental conditions, pH, and microbiome composition. Given the dramatic differences between these two environments, we characterized strains within the same Lactobacillus species isolated from either the vaginal or intestinal tract to assess whether they are phenotypically and genetically different. We compared the genomes of the Lactobacillus strains selected in this study for genetic features of interest, and performed a series of comparative phenotypic assays including small intestinal juice and acid resistance, carbohydrate fermentation profiles, lactic acid production, and host interaction with intestinal Caco-2 and vaginal VK2 cell lines. We also developed a simulated vaginal fluid (SVF) to study bacterial growth in a proxy vaginal environment and conducted differential transcriptomic analysis between SVF and standard laboratory MRS medium. Overall, our results show that although strain-specific variation is observed, some phenotypic differences seem associated with the isolation source. We encourage future probiotic formulation to include isolation source and take into consideration genetic and phenotypic features for use at various body sites.

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Section: Discussionmentioning

confidence: 99%

Comparative Analysis of Lactobacillus gasseri and Lactobacillus crispatus Isolated From Human Urogenital and Gastrointestinal Tracts

et al. 2020

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“…Wagner and Levin reported a production rate of 0.33 ± 0.05 g/h, which would correspond to 7.92 ± 1.2 g/day (16). Vaginal resting fluid volumes seem to be less variable and are reported to be in the range of 0.5-0.75 g (15) or 0.5 mL (17). As stated before, it should be noted, that both the amount of fluid entering the vagina as well as the vaginal resting fluid volume are subject to inter-and intraindividual variability and are affected by a number of essential parameters like age, phase of the menstrual cycle, and sexual stimulation.…”

Section: Media Simulating Human Vaginal Fluidmentioning

confidence: 98%

“…After studying of how the physicochemical properties of native vaginal fluid, particularly the pH and osmolarity, affect the deployment and delivery of contraceptive and prophylactic compounds, VFS was specifically developed for addressing such impacts on in vitro dissolution/drug release testing of VDFs. The medium is intended to model vaginal fluid properties of healthy, non-pregnant and (17). For designing these media, they had collected HVF and determined its buffer capacity.…”

Section: Media Simulating Human Vaginal Fluidmentioning

confidence: 99%

Simulated Genital Tract Fluids and Their Applicability in Drug Release/Dissolution Testing of Vaginal Dosage Forms

Tietz¹,

Klein²

2018

Dissolution Technol.

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There has been a trend towards the development of novel vaginal dosage forms both for local therapy and systemic absorption. The growing number of vaginal dosage forms, however, presents with an increasing demand for appropriate in vitro test methods for ensuring a safe and reliable in vivo performance of each of the formulations. Application of biorelevant in vitro parameters, i.e., addressing in vivo parameters that significantly affect drug release from a vaginal dosage form in an in vitro test setup, could ensure that the results of the dissolution/drug release test are clinically meaningful and also predictive for detection of changes in the post-approval drug product. Thus, the development of predictive in vitro test methods for vaginal dosage forms is of great interest. A number of simulated vaginal fluids have been introduced in the recent past. In addition, several other genital fluids that could affect the intravaginal fluid composition, such as simulated cervical fluid/mucus, simulated intrauterine fluid, and simulated semen have been described in the literature. More frequent use of these media can be assumed, and future experiments will show if the current media will require more fine-tuning to even better reflect all physiological parameters that can affect drug release/dissolution in the vagina or if there is also a chance to simplify these media without losing their biorelevance.

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“…Developing buffered systems that simulate biological fluids is an active area of research in several biomedical areas (7,8). These buffers share many of the challenges encountered with buffers used for in vitro dissolution testing including requirements for ionic strength, buffer capacity, pH control, biological relevancy, and avoidance of incompatibilities.…”

Section: Introductionmentioning

confidence: 99%

Physicochemical Properties of Buffers Used in Simulated Biological Fluids with Potential Application for In Vitro Dissolution Testing: A Mini-review

Mauger¹

2017

Dissolution Technol.

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Although aqueous buffers alone cannot be expected to fulfill all the requirements of biorelevant media, buffers will likely continue to play a central role in controlling the pH of complex formulations simulating biological fluids (3,9). The use of biorelevant dissolution media to forecast in vivo drug performance has been reviewed (9). This minireview focuses on the physicochemical factors related to buffers used in these media and not the biorelevant dissolution media, per se. This mini-review is based on a survey of the literature associated with buffers in general ABSTRACTThis literature review focuses on the physicochemical properties of buffers used in biorelevant media for in vitro dissolution testing. Because biorelevant dissolution systems have been previously reviewed, this review is primarily related to the buffers used in biorelevant media and not the media, per se. It is based on a survey of the literature in areas including analytical chemistry; biochemistry; clinical, solution, and physical chemistry; dissolution science and technology; pharmaceutical sciences; simulated biological fluids; and buffer-related articles from the National Institute of Standards and Technology with the intent of identifying challenges in formulating buffered biorelevant dissolution media and also identifying general attributes that are useful in selecting a buffer for a particular dissolution application. Other topics include: (1) key physicochemical properties of buffers that affect experimental conditions and dissolution results; (2) buffer compatibility with a diverse array of ingredients found in biorelevant media; and (3) the potential to supplement the library of traditional buffers used for in vitro dissolution testing with zwitterionic buffers that were designed for biological application.

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Engineering and characterization of simplified vaginal and seminal fluid simulants

Cited by 30 publications

References 19 publications

Comparative Analysis of Lactobacillus gasseri and Lactobacillus crispatus Isolated From Human Urogenital and Gastrointestinal Tracts

Comparative Analysis of Lactobacillus gasseri and Lactobacillus crispatus Isolated From Human Urogenital and Gastrointestinal Tracts

Simulated Genital Tract Fluids and Their Applicability in Drug Release/Dissolution Testing of Vaginal Dosage Forms

Physicochemical Properties of Buffers Used in Simulated Biological Fluids with Potential Application for In Vitro Dissolution Testing: A Mini-review

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