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Review
. 2017 Dec;7(6):775-795.
doi: 10.1007/s13346-017-0385-4.

On-demand microbicide products: design matters

Sravan Kumar Patel  1   2 , Lisa Cencia Rohan  3   4
Affiliations
Review

On-demand microbicide products: design matters

Sravan Kumar Patel et al. Drug Deliv Transl Res. 2017 Dec.

Abstract

Sexual intercourse (vaginal and anal) is the predominant mode of human immunodeficiency virus (HIV) transmission. Topical microbicides used in an on-demand format (i.e., immediately before or after sex) can be part of an effective tool kit utilized to prevent sexual transmission of HIV. The effectiveness of prevention products is positively correlated with adherence, which is likely to depend on user acceptability of the product. The development of an efficacious and acceptable product is therefore paramount for the success of an on-demand product. Acceptability of on-demand products (e.g., gels, films, and tablets) and their attributes is influenced by a multitude of user-specific factors that span behavioral, lifestyle, socio-economic, and cultural aspects. In addition, physicochemical properties of the drug, anatomical and physiological aspects of anorectal and vaginal compartments, issues relating to large-scale production, and cost can impact product development. These factors together with user preferences determine the design space of an effective, acceptable, and feasible on-demand product. In this review, we summarize the interacting factors that together determine product choice and its target product profile.

Keywords: Acceptability; Anogenital; HIV; On-demand products; Rectal microbicides; Vaginal microbicides.

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Conflict of interest statement

Conflicts of Interest

Lisa C. Rohan declares that she has no conflicts of interest. Sravan Kumar Patel declares that he has no conflicts of interest.

Figures

Fig. 1
Fig. 1
Drug, product, and user-related factors influencing the target product profile of on-demand microbicide dosage forms. CMOs – Contract Manufacturing Organizations, USPEs – Users’ Sensory Perceptions and Experiences
Fig. 2
Fig. 2
Interaction of drug molecules with vaginal physiological milieu. A. Vaginal and ectocervical region showing multilayer epithelium. Interaction of positively charged molecules with mucin and physical entrapment of large macromolecules, and permeation of neutral molecules is shown. B. Disrupted epithelium due to processes such as physical injury and inflammation showing viral entry and increased immune cell accumulation. Also shown is the interaction of drug molecules with bacteria (e.g. Gardnerella vaginalis). C. Ectocervical region showing single layer epithelium (similar to rectum), which increases vulnerability of tissue to viral entry. Note: Structures are not to scale
Fig. 3
Fig. 3
A putative theoretical flow diagram showing the influence of various factors on microbicide product development and optimization
See this image and copyright information in PMC

References

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