Abstract
Human immunodeficiency virus (HIV) infection and unintended pregnancy, which can lead to life-threatening complications, are two major burdens for female reproductive health. To address these pressing health issues, multipurpose prevention technologies (MPTs) are proposed to deliver two or more drugs simultaneously. MPTs could offer several benefits for users such as improved convenience, increased effectiveness, reduced cost, and decreased environmental burden. Here, we report the development, and in vitro and in vivo assessment of a bioadhesive vaginal film as a coitally-independent MPT dosage form for delivering dapivirine (DPV) and levonorgestrel (LNG) to prevent HIV infection and unintended pregnancy, respectively. After confirming the feasibility of bioadhesive film use for weekly drug delivery in vivo through colpophotography and MRI evaluation, the pharmacokinetics (PK) of DPV/LNG single entity and combination bioadhesive films was investigated in pigtailed macaques (n = 5). Both drugs from single entity or combination films were able to provide sustained drug release in vivo. The combination film showed lower local tissue clearance for DPV and exhibited significantly increased plasma concentration for LNG as compared to the single entity film. This proof-of-concept study demonstrates the ability of this novel bioadhesive film platform to deliver LNG and DPV simultaneously as an MPT product for the prevention of HIV infection and unintended pregnancy.
Highlights
In 2010 to 2014, approximately 44% of global pregnancies were unintended or mistimed [1].This percentage is even higher in some developing countries such as South Africa [2], where a high incidence of human immunodeficiency virus infection type-1 (HIV-1)infection is noted, mostly due to unprotected sexual intercourse [3]
It is believed that the design of products that combine Human immunodeficiency virus (HIV) prevention agents with contraceptives may lead to enhanced product uptake and effectiveness
FromThiolated thiol degree characterization, a large variability was observed for chitosan withweights a wide molecular chitosan was synthesized using chitosan with various molecular (Table 2)
Summary
In 2010 to 2014, approximately 44% of global pregnancies were unintended or mistimed [1].This percentage is even higher in some developing countries such as South Africa [2], where a high incidence of human immunodeficiency virus infection type-1 (HIV-1)infection is noted, mostly due to unprotected sexual intercourse [3]. In 2010 to 2014, approximately 44% of global pregnancies were unintended or mistimed [1] This percentage is even higher in some developing countries such as South Africa [2], where a high incidence of human immunodeficiency virus infection type-1 (HIV-1). Current existing multipurpose prevention technology (MPT) barrier methods include male and female condoms, diaphragms, and cervical caps. These MPT products provide protection for unintended pregnancy and sexually transmitted infections (STIs) including HIV-1 if they are used correctly and consistently [6,7,8,9,10]. Women need a new generation of safe and self-initiated MPT products to protect themselves from unintended pregnancy and HIV infection
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