Clinical evaluation of microbicide formulations

Morrow, Kathleen M.; Hendrix, Craig W.

doi:10.1016/j.antiviral.2010.09.008

Cited by 31 publications

(22 citation statements)

References 68 publications

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“…In order to achieve sufficient levels of coverage, retention, safety, drug release and therapeutic efficacy, many properties of the formulation have to be optimized to compliment the biological environment that is being treated. Important properties to consider include pH, viscosity, osmolality, mucoadhesivity, yield stress and shear rate [56, 84, 85]. …”

Section: Introductionmentioning

confidence: 99%

Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment

Nelson

Zhang

Ganapathi

et al. 2015

Journal of Controlled Release

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The year 2016 will mark an important milestone - the 35th anniversary of the first reported cases of HIV/AIDS. Antiretroviral Therapy (ART) including Highly Active Antiretroviral Therapy (HAART) drug regimens is widely considered to be one of the greatest achievements in therapeutic drug research having transformed HIV infection into a chronically managed disease. Unfortunately, the lack of widespread preventive measures and the inability to eradicate HIV from infected cells highlight the significant challenges remaining today. Moving forward there are at least three high priority goals for anti-HIV drug delivery (DD) research: (1) to prevent new HIV infections from occurring, (2) to facilitate a functional cure, i.e., when HIV is present but the body controls it without drugs and (3) to eradicate established infection. Pre-exposure Prophylaxis (PrEP) represents a significant step forward in preventing the establishment of chronic HIV infection. However, the ultimate success of PrEP will depend on achieving sustained antiretroviral (ARV) tissue concentrations and will require strict patient adherence to the regimen. While first generation long acting/extended release (LA/ER) DDS currently in development show considerable promise, significant DD treatment and prevention challenges persist. First, there is a critical need to improve cell specificity through targeting in order to selectively achieve efficacious drug concentrations in HIV reservoir sites to control/eradicate HIV as well as mitigate systemic side effects. In addition, approaches for reducing cellular efflux and metabolism of ARV drugs to prolong effective concentrations in target cells need to be developed. Finally, given the current understanding of HIV pathogenesis, next generation anti-HIV DDS need to address selective DD to the gut mucosa and lymph nodes. The current review focuses on the DDS technologies, critical challenges, opportunities, strategies, and approaches by which novel delivery systems will help iterate towards prevention, functional cure and eventually the eradication of HIV infection.

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Section: Introductionmentioning

confidence: 99%

Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment

Nelson

Zhang

Ganapathi

et al. 2015

Journal of Controlled Release

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“…Many variables can impact the in vivo effectiveness of any given microbicide product such as the anti-HIV activity (efficacy of the product), the user's willingness and ability to use the product as instructed (acceptability and adherence), the safety of the formulation, and HIV 'dose'-related variables (Morrow and Hendrix 2010). The appropriate drug-delivery strategy for each microbicide drug candidate will depend upon many variables such as the physicochemical characteristics and pharmacokinetic profile of the candidate, its mechanism of action against HIV-1 transmission, its dosing regimen, delivery route, and patient acceptability (Buckheit et al 2010).…”

Section: Microbicide Productsmentioning

confidence: 99%

Microbicide Dosage Forms

Rohan

Devlin

Yang

2013

Current Topics in Microbiology and Immunology

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Microbicides are topically applied, user controlled dosage forms that are being developed to prevent the transmission of HIV during coitus. Early candidates focused on coitally dependent dosage forms such as gels and creams. More recent development has focused on broadening the coitally dependent options through the introduction of films and fast dissolving tablets. Additionally, it has become important to have longer acting products to minimize the burden of user compliance and thus vaginal rings have been developed providing sustained delivery of antiretroviral drugs. This chapter discusses the history of microbicides along with a detailed description of coitally dependent products, gels, films, tablets diaphragms, as well as coitally independent dosage forms such as vaginal rings and the introduction of a new technology, electrospun fibers.

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“…The effectiveness of any given microbicide product is dependent on both the anti-HIV activity (efficacy of the product) and the user’s willingness and ability to use the product as instructed (acceptability and adherence). Furthermore, Morrow et al shows that the success of microbicide products depends on both drug-related variables and HIV ‘dose’-related variables [32]. The importance of product formulation in the development of a successful microbicide is evident.…”

Section: Microbicide Dosage Formulation Considerationsmentioning

confidence: 99%

The Importance of the Vaginal Delivery Route for Antiretrovirals in HIV Prevention

Ferguson

Rohan²

2011

Therapeutic Delivery

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The HIV/AIDS pandemic continues to be a global health priority, with high rates of new HIV-1 infections persisting in young women. One HIV prevention strategy is topical pre-exposure prophylactics or microbicides, which are applied vaginally or rectally to protect the user from HIV and possibly other sexually transmitted infections. Vaginal microbicide delivery will be the focus of this review. Multiple nonspecific and specific antiretroviral microbicide products have been clinically evaluated, and many are in preclinical development. The events of HIV mucosal transmission and dynamics of the cervicovaginal environment should be considered for successful vaginal microbicide delivery. Beyond conventional vaginal formulations, intravaginal rings, tablets and films are employed as platforms in the hope to increase the likelihood of microbicide use. Furthermore, combining multiple antiretrovirals within a given formulation, combining a microbicide product with a vaginal device and integrating novel drug-delivery strategies within a microbicide product are approaches to successful vaginal-microbicide delivery.

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Clinical evaluation of microbicide formulations

Cited by 31 publications

References 68 publications

Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment

Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment

Microbicide Dosage Forms

The Importance of the Vaginal Delivery Route for Antiretrovirals in HIV Prevention

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