Studies in Vaginal Fluid

Lissimore, Norman; Currie, David W.

doi:10.1111/j.1471-0528.1939.tb05367.x

Cited by 5 publications

(3 citation statements)

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“…The model is implemented for healthy (nonpregnant), pregnant and geriatric female population. The volume of luminal fluid is 0.5 mL based on the value reported for 143 healthy subjects 20,21 . Due to lack of data, the same value has been assumed for pregnant and geriatric population.…”

Section: Methodsmentioning

confidence: 99%

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Development and verification of mechanistic vaginal absorption and metabolism model to predict systemic exposure after vaginal ring and gel application

Thakur,

Telaprolu,

Paterson

et al. 2024

Brit J Clinical Pharma

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AimsThe current work describes the development of mechanistic vaginal absorption and metabolism model within Simcyp Simulator to predict systemic concentrations following vaginal application of ring and gel formulations.MethodsVaginal and cervix physiology parameters were incorporated in the model development. The study highlights the model assumptions including simulation results comparing systemic concentrations of 5 different compounds, namely, dapivirine, tenofovir, lidocaine, ethinylestradiol and etonogestrel, administered as vaginal ring or gel. Due to lack of data, the vaginal absorption parameters were calculated based on assumptions or optimized. The model uses release rate/in vitro release profiles with formulation characteristics to predict drug mass transfer across vaginal tissue into the systemic circulation.ResultsFor lidocaine and tenofovir vaginal gel, the predicted to observed AUC0‐t and Cmax ratios were well within 2‐fold error limits. The average fold error (AFE) and absolute AFE indicating bias and precision of predictions range from 0.62 to 1.61. For dapivirine, the pharmacokinetic parameters are under and overpredicted in some studies due to lack of formulation composition details and relevance of release rate used in ring model. The predicted to observed AUC0‐t and Cmax ratios were well within 2‐fold error limits for etonogestrel and ethinylestradiol vaginal ring (AFEs and absolute AFEs from 0.84 to 1.83).ConclusionThe current study provides first of its kind physiologically based pharmacokinetic framework integrating physiology, population and formulation data to carry out in silico mechanistic vaginal absorption studies, with the potential for virtual bioequivalence assessment in the future.

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Section: Methodsmentioning

confidence: 99%

“…The volume of luminal fluid is 0.5 mL based on the value reported for 143 healthy subjects. 20,21 Due to lack of data, the same value has been assumed for pregnant and geriatric population. The pH of luminal fluid is set to 4.8 based on a metaanalysis of the available literature.…”

Section: What This Study Addsmentioning

confidence: 99%

Development and verification of mechanistic vaginal absorption and metabolism model to predict systemic exposure after vaginal ring and gel application

Thakur,

Telaprolu,

Paterson

et al. 2024

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…A more detailed description of the histological and immunological characteristics of these layers are provided in Table 3 and Currie, 1939;Lapan and Friedman, 1950;Perl et al, 1959;odebIad, 1964;Dusitsin et a/., 1967;Preti et aI., 1979;Wagner, 1979;Wagner and Levin~1980;Godley, 1985;Owen and Katz, 1999).…”

Section: The Human Vaginamentioning

confidence: 99%