Vaginal distribution of Replens® and K-Y® Jelly using three imaging techniques

Mauck, Christine; Katz, David F.; Sandefer, Erik P.; Nasution, Marlina D.; Henderson, Marcus H.; Digenis, George A.; Su, I.; Page, Richard C.; Barnhart, Kurt T.

doi:10.1016/j.contraception.2007.11.016

Cited by 43 publications

(40 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Remote sensing imaging techniques, such as magnetic resonance imaging (MRI) and single-photon emission computed tomography (SPEC-CT), can provide information about such vaginal gel distributions. [10][11][12][13][14][15] While these imaging modalities provide excellent information on the pelvic anatomy and general microbicide gel distribution, they typically lack the resolution to detect the thin coating layers, of the order of 100 μm, that may be sufficient for microbicide gel functioning. 7,8 Further, contrast agents typically must be added to the gels before imaging, and this may limit the time between gel insertion and imaging since the contrast agent can separate from the gel into the tissues and fluids of the body.…”

Section: Introductionmentioning

confidence: 99%

In vivooptical imaging of human vaginal gel thickness distributions with a probe-based, dual-modality instrument

et al. 2012

View full text Add to dashboard Cite

Abstract. We used a probe-based dual-modality optical imaging instrument to measure in vivo coating thickness distributions of a gel distributed along the vaginal lumen, in a clinical study. The gel was a surrogate for one delivering an anti-HIV topical microbicide. Imaging data from Fourier-domain multiplexed low-coherence interferometry (mLCI) and fluorimetric measurements were compared to assess the feasibility and accuracy of mLCI in measuring in vivo gel coating thickness distributions. In each study session, 3.5 mL of Replens gel was inserted to the vaginal fornix while the participant was supine. The participant either: 1. remained supine (10 or 60 min); or 2. sat up (1 min), stood up (1 min), sat down (1 min) and returned to the supine position; net elapsed time was 10 or 60 min after which the gel distribution was imaged. Local coating thickness distributions were qualitatively and quantitatively similar. Here mLCI did not accurately measure thicker gel coatings (>0.8 mm), a limitation not seen with fluorimetry. However, mLCI is capable of measuring in vivo microbicide gel distributions with resolution on the order of 10 μm, without the need for exogenous contrast agents, and can accurately capture relevant summary coating measures in good agreement with fluorimetry.

show abstract

Section: Introductionmentioning

confidence: 99%

In vivooptical imaging of human vaginal gel thickness distributions with a probe-based, dual-modality instrument

et al. 2012

View full text Add to dashboard Cite

show abstract

“…11 Initial measurements have been made of the distribution of gel coating thickness over the human vaginal epithelium. [11][12][13] The microbicide vehicle distribution, or coating, process is biomechanically complex. [14][15][16][17][18] As an understanding is developed of the determinants of the coating, such information can be used in the rational design of improved drug delivery vehicles.…”

Section: Introductionmentioning

confidence: 99%

A model of transluminal flow of an anti-HIV microbicide vehicle: Combined elastic squeezing and gravitational sliding

et al. 2008

View full text Add to dashboard Cite

Elastohydrodynamic lubrication over soft substrates is of importance in a number of biomedical problems: From lubrication of the eye surface by the tear film, to lubrication of joints by synovial fluid, to lubrication between the pleural surfaces that protect the lungs and other organs. Such flows are also important for the drug delivery functions of vehicles for anti-HIV topical microbicides. These are intended to inhibit transmission into vulnerable mucosa, e.g., in the vagina. First generation prototype microbicides have gel vehicles, which spread after insertion and coat luminal surfaces. Effectiveness derives from potency of the active ingredients and completeness and durability of coating. Delivery vehicle rheology, luminal biomechanical properties, and the force due to gravity influence the coating mechanics. We develop a framework for understanding the relative importance of boundary squeezing and body forces on the extent and speed of the coating that results. A single dimensionless number, independent of viscosity, characterizes the relative influences of squeezing and gravitational acceleration on the shape of spreading in the Newtonian case. A second scale, involving viscosity, determines the spreading rate. In the case of a shear-thinning fluid, the Carreau number also plays a role. Numerical solutions were developed for a range of the dimensionless parameter and compared well with asymptotic theory in the limited case where such results can be obtained. Results were interpreted with respect to trade-offs between wall elasticity, longitudinal forces, bolus viscosity, and bolus volume. These provide initial insights of practical value for formulators of gel delivery vehicles for anti-HIV microbicidal formulations.

show abstract

“…The most commonly used thermoreversible gels are pluronics (2). The pluronic-based in situ gelling dosage form is supposed to be easily applied and to give good spreading and coating of the vagina, making the treatment more effective and probably result in prolonged effect (1,3).…”

mentioning

confidence: 99%

Development and characterization of thermosensitive pluronic-based metronidazole in situ gelling formulations for vaginal application

Ibrahim¹,

Ismail²,

Fetih³

et al. 2012

Acta Pharmaceutica

View full text Add to dashboard Cite

Development and characterization of thermosensitive pluronic-based metronidazolein situgelling formulations for vaginal applicationThe purpose of this study was to develop pluronic-basedin situgelling formulations of metronidazole (MTZ) for treatment of bacterial vaginosis, aimed at prolonging the residence time, controlling drug release, enhancing efficacy, decreasing recurrence, and increasing patient compliance. Thein situgel formulations were prepared using different concentrations of pluronic F-127 (PF-127) alone and in combination with pluronic F-68 (PF-68). The prepared formulations were evaluated for their gelation temperature (Tgel),in vitrodrug release, rheological properties, mucoadhesion properties and tolerability by vaginal mucosa in tissue levels. TheTgeldecreased with increasing PF-127 concentration. TheTgelwas modulated by addition of PF-68 to be within the acceptable range of 25-37 °C. With increasing pluronic concentration, thein vitrodrug release decreased, viscosity and mucoadhesive force increased. Histopathological examination of rabbit vaginas from the control and treated groups revealed normal histology of the vagina and cervix. Based on thein vitroevaluation of prepared formulations, thein situgelling liquid formulated with PF-127/PF-68 (20/10 %,m/m) was selected for further clinical evaluation.

show abstract

Vaginal distribution of Replens® and K-Y® Jelly using three imaging techniques

Cited by 43 publications

References 24 publications

In vivooptical imaging of human vaginal gel thickness distributions with a probe-based, dual-modality instrument

In vivooptical imaging of human vaginal gel thickness distributions with a probe-based, dual-modality instrument

A model of transluminal flow of an anti-HIV microbicide vehicle: Combined elastic squeezing and gravitational sliding

Development and characterization of thermosensitive pluronic-based metronidazole in situ gelling formulations for vaginal application

Contact Info

Product

Resources

About