Abstract

We have developed a quantitative imaging refractometry technique, based on holographic phase microscopy, as a tool for investigating microscopic structural changes in water-soluble polymeric materials. Here we apply the approach to analyze the structural degradation of vaginal topical microbicide films due to water uptake. We implemented transmission imaging of 1-mm diameter film samples loaded into a flow chamber with a 1.5×2 mm field of view. After water was flooded into the chamber, interference images were captured and analyzed to obtain high resolution maps of the local refractive index and subsequently the volume fraction and mass density of film material at each spatial location. Here, we compare the hydration dynamics of a panel of films with varying thicknesses and polymer compositions, demonstrating that quantitative imaging refractometry can be an effective tool for evaluating and characterizing the performance of candidate microbicide film designs for anti-HIV drug delivery.

Highlights

  • Thin polymeric films have been utilized as dosage forms for oral and topical delivery of drugs

  • We have demonstrated that quantitative imaging refractometry can be an objective, quantitative tool for investigating differences in the water uptake, hydration, and dissolution behaviors of microbicide films with varying compositions and thicknesses

  • We have introduced the methodology and illustrated its use for a set of prototype films being evaluated for vaginal delivery of the topical anti-HIV microbicide Tenofovir

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Summary

Introduction

Thin polymeric films have been utilized as dosage forms for oral and topical delivery of drugs. Vaginal films are being developed as topical drug delivery vehicles for the prevention of infection and spread of HIV/AIDS [5,6,7]. Topical drug delivery by films and other vaginally administered microbicide products (e.g. gels) places requirements on the drug release rate and on subsequent spatial distribution of the active pharmaceutical ingredient (API). This derives from the spreading and hydration behavior of the delivery vehicle [9,10,11]. As computational film dissolution models are developed [14] and more advanced films are designed with complex dissolution and delivery characteristics, there is a need for objective and quantitative methodology that can verify that film formulations function as intended, delivering APIs to tissue with both the requisite spatial and temporal concentration distributions

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