ArticlePharmaceutical research2015
Formulation and characterization of polymeric films containing combinations of antiretrovirals (ARVs) for HIV prevention.
Article in Pharmaceutical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed.
- FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir.Journal of the International AIDS Society · 2018Trial
- Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing.Journal of acquired immune deficiency syndromes (1999) · 2018Trial
- Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: A Double-Blind Randomized Trial.Journal of acquired immune deficiency syndromes (1999) · 2015Trial
- Engineering vaginal film platform for mucoadhesion and sustained drug release for HIV-1 prevention.Journal of controlled release : official journal of the Controlled Release Society · 2025Article
- Development and characterization of formulations based on combinatorial potential of antivirals against genital herpes.Naunyn-Schmiedeberg's archives of pharmacology · 2025Article
- Vaginal Sheets withGels (Basel, Switzerland) · 2023Article
- Tenofovir vaginal film as a potential MPT product against HIV-1 and HSV-2 acquisition: formulation development and preclinical assessment in non-human primates.Frontiers in reproductive health · 2023Article
- A mucoadhesive biodissolvable thin film for localized and rapid delivery of lidocaine for the treatment of vestibulodynia.International journal of pharmaceutics · 2022Article
- Recent Advances in the Excipients Used in Modified Release Vaginal Formulations.Materials (Basel, Switzerland) · 2022Review
- Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies.Pharmaceutics · 2021Article
- Recent Advances in Polymer-Based Vaginal Drug Delivery Systems.Pharmaceutics · 2021Review
- Hydroxypropyl Methylcellulose E15: A Hydrophilic Polymer for Fabrication of Orodispersible Film Using Syringe Extrusion 3D Printer.Polymers · 2020Article
- Preclinical contraceptive development for men and women.Biology of reproduction · 2020Review
- Mucoadhesive Vaginal Discs based on Cyclodextrin and Surfactants for the Controlled Release of Antiretroviral Drugs to Prevent the Sexual Transmission of HIV.Pharmaceutics · 2020Article
- Smart Freeze-Dried Bigels for the Prevention of the Sexual Transmission of HIV by Accelerating the Vaginal Release of Tenofovir during Intercourse.Pharmaceutics · 2019Article
- Pharmaceutical Vehicles for Vaginal and Rectal Administration of Anti-HIV Microbicide Nanosystems.Pharmaceutics · 2019Review
- A Quantitative Disintegration Method for Polymeric Films.Journal of pharmaceutical innovation · 2018Article
- Pharmaceutical Approaches to HIV Treatment and Prevention.Advanced therapeutics · 2018Article
- Multipurpose tenofovir disoproxil fumarate electrospun fibers for the prevention of HIV-1 and HSV-2 infections in vitro.International journal of pharmaceutics · 2017Article
- The Vaginal Microbiome and its Potential to Impact Efficacy of HIV Pre-exposure Prophylaxis for Women.Current HIV/AIDS reports · 2017Review
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
purposeTo develop polymeric films containing dual combinations of anti-HIV drug candidate tenofovir, maraviroc and dapivirine for vaginal application as topical microbicides.
methodsA solvent casting method was used to manufacture the films. Solid phase solubility was used to identify potential polymers for use in the film formulation. Physical and chemical properties (such as water content, puncture strength and in vitro release) and product stability were determined. The bioactivity of the film products against HIV was assessed using the TZM-bl assay and a cervical explant model.
resultsPolymers identified from the solid phase solubility study maintained tenofovir and maraviroc in an amorphous state and prevented drug crystallization. Three combination film products were developed using cellulose polymers and polyvinyl alcohol. The residual water content in all films was <10% (w/w). All films delivered the active agents with release of >50% of film drug content within 30 min. Stability testing confirmed that the combination film products were stable for 12 months at ambient temperature and 6 months under stressed conditions. Antiviral activity was confirmed in TZM-bl and cervical explant models.
conclusionsPolymeric films can be used as a stable dosage form for the delivery of antiretroviral combinations as microbicides.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.