Vaginal multipurpose prevention technologies: promising approaches for enhancing women’s sexual and reproductive health

ABSTRACT

Introduction

Multipurpose prevention technologies (MPTs) have the potential to avert multiple concomitant sexual and reproductive health issues in women such as sexually transmitted infections and unintended pregnancy. MPTs incorporate one or more active pharmaceutical ingredients in a single product, which adds more convenience for users and may promote increased adherence. Various vaginal dosage forms/delivery systems have been studied for designing MPTs. However, several challenges remain that are mainly related to requirements of individual drugs or intended multiple applications.

Areas covered

This review focuses on the emerging need and development of vaginal MPTs. It illustrates numerous examples that are currently in the preclinical and clinical development pipeline, highlighting the concept behind vaginal MPTs. The article also highlights the challenges associated with formulation design and development, including regulatory issues that need to be addressed.

Expert opinion

Vaginal MPTs present great potential to empower women with novel, efficient, and safe products for protection against sexually transmitted infections and unintended pregnancy. However, several technological issues and regulatory gaps still need to be addressed in order to meet real-world needs.

KEYWORDS:

• Contraceptives
• dosage forms
• HIV
• drug development
• sexually transmitted infections
• vaginal drug delivery

Article highlights

• Vaginal multipurpose prevention technologies (MPTs) are defined, and their potential role in preventing the transmission of HIV and other sexually transmitted infections, as well as unintended pregnancy, is discussed.

• The basics of the vaginal route for drug administration are presented, as relevant to the development and evaluation of topical MPT products.

• Main challenges in developing vaginal MPTs are overviewed, including safety issues.

• The different dosage forms and delivery systems used for developing vaginal MPTs are presented and specific formulations are discussed.

• Relevant issues pertaining to regulatory approval of vaginal MPTs are briefly assessed.

This box summarizes key points contained in the article.

Declaration of interest

B. Sarmento and J. das Neves are inventors of a patent application on vaginal nanoparticles-in-film technology for preventing HIV transmission (WO/2017/077520 A1 (2016)). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work was financed by the project NORTE-01-0145-FEDER-000012 by Norte Portugal Regional Operational Programme (NORTE 2020), and COMPETE 2020 - Operacional Programme for Competitiveness and Internationalisation (POCI), under the PORTUGAL 2020 Partnership Agreement, through the FEDER - Fundo Europeu de Desenvolvimento Regional, and by Portuguese funds through FCT - Fundação para a Ciência e a Tecnologia/Ministério da Ciência, Tecnologia e Ensino Superior in the framework of the project ‘Institute for Research and Innovation in Health Sciences’ UID/BIM/04293/2019. This work was also supported by Programa Gilead GÉNESE, Gilead Portugal (refs. PGG/046/2015 and PGG/002/2016).