The worldwide impact of HIV/AIDS is well recognized. This book provides for the first time a thorough and critical overview of current aspects, recent developments, and trends in the formulation and drug delivery concerning anti-HIV microbicides by leading scientists in the field. Additionally, pertinent regulatory aspects and socioeconomical issues related to the subject are discussed. In the absence of a cure, prophylaxis represents a cornerstone in the battle against infection. One promising strategy comprises the use around the time of sexual intercourse of vaginal/rectal products containing antiviral compounds, termed microbicides. It is now recognized that specific development of drug dosage forms and/or drug delivery systems is an indispensable aspect for the success of microbicides. Different groups strived over the last decade to optimize the biophysical and technological performance of traditional dosage forms (gels, tablets, and suppositories) to fulfill the specificities of microbicides use, without neglecting users’ preferences and affordability issues. Moreover, new formulation approaches, such as vaginal rings and films, nanotechnology-based systems, stimuli-sensitive formulations, targeted drug delivery systems, among others have been proposed and are currently undergoing pre-clinical or even clinical testing.
Table of Contents
Microbicides and the HIV Pandemic
HIV Transmission Models: Lessons Learned for Microbicide Formulation Design
Challenges in Microbicide Drug Delivery: Identifying Targets and Evolving Strategies
Safety Issues Related with Microbicide Formulations
Biophysics, Drug Transport Modeling and Performance of Microbicide Formulations
Dosage Forms for Microbicides Formulation: Advantages and Pitfalls
Microbicide Vaginal Rings
Vaginal Microbicide Films
Rectal Microbicide Development, Formulation and Delivery
Design of Stimuli-Sensitive Microbicide Formulations
Nanotechnology-Based Systems for Microbicide Development; Nanofibers for Microbicide Drug Delivery
Modified Microflora for Microbicide Drug Delivery
Scale-up, Affordability and Intellectual Property Issues Related with Microbicide Formulation Development
Regulatory Issues Pertaining Microbicide Products
Socioeconomic and Behavioral Factors Influencing Choice, Adherence and Success of Microbicide Formulations
José das Neves has a PhD in pharmaceutical sciences from the University of Porto, Portugal. He is a researcher at Instituto Superior de Ciências da Saúde-Norte, CESPU, Gandra, Portugal and Faculty of Pharmacy, University of Porto, Portugal. His current research interests include vaginal drug delivery and the development of nanotechnology-based solutions for the development of anti-HIV microbicides.
Bruno Sarmento has a PhD in pharmaceutical technology from the University of Porto, Portugal. He is an affiliated researcher at INEB – Instituto de Engenharia Biomédica, University of Porto, Portugal and assistant professor of pharmaceutical and biopharmaceutical technology at Instituto Superior de Ciências da Saúde-Norte, CESPU, Gandra, Portugal. His current research focuses on nanomedicines and their application in the pharmaceutical and biomedical fields.
"HIV prevention requires a multidisciplinary approach, even when focusing on a particular biomedical intervention such as anti-HIV microbicides. This book offers a comprehensive, integrative, and balanced overview on various aspects of microbicides, including mechanisms of transmission, drug development, and clinical and regulatory aspects, with a special emphasis on formulation. It is therefore equally useful for specialized basic, pharmacological, clinical, and biotechnological scientists and will hopefully stimulate future interdisciplinary research for prevention."
—Prof. Guido Vanham, Virology Unit, Institute of Tropical Medicine, Antwerp, Belgium
"This treatise offers an insightful analysis on the opportunities that drug delivery technologies can afford in HIV microbicide development. It provides first-of-its-kind comprehensive overview of the challenges in microbicide delivery as well as opportunities to develop novel formulations such as polymeric implants, stimuli-responsive nanotechnology, and strategies to alter the microbiome. It also addresses the issues of socioeconomics, compliance, and regulatory oversight in the development of novel microbicides."
—Prof. Mansoor M. Amiji, Distinguished Professor and Chairman, Department of Pharmaceutical Sciences, Northeastern University, USA