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Characterization of a Reservoir-Style Implant for Sustained Release of Tenofovir Alafenamide (TAF) for HIV Pre-Exposure Prophylaxis (PrEP)

1
Engineered Systems, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC 27709, USA
2
Women’s Global Health Imperative, RTI International, 351 California Street, Suite 500, San Francisco, CA 94104, USA
3
PATH, 2201 Westlake Ave, Suite 200, Seattle, WA 98121, USA
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(7), 315; https://doi.org/10.3390/pharmaceutics11070315
Received: 31 May 2019 / Revised: 21 June 2019 / Accepted: 29 June 2019 / Published: 4 July 2019
(This article belongs to the Special Issue Novel Approaches for Delivery of Anti-HIV Drugs)
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Abstract

Long-acting (LA) HIV pre-exposure prophylaxis (PrEP) offers the potential to improve adherence by lowering the burden of daily or on-demand regimens of antiretroviral (ARV) drugs. This paper details the fabrication and in vitro performance of a subcutaneous and trocar-compatible implant for the LA delivery of tenofovir alafenamide (TAF). The reservoir-style implant comprises an extruded tube of a biodegradable polymer, poly(ε-caprolactone) (PCL), filled with a formulation of TAF and castor oil excipient. Parameters that affect the daily release rates of TAF are described, including the surface area of the implant, the thickness of the PCL tube walls (between 45 and 200 µm), and the properties of the PCL (e.g., crystallinity). In vitro studies show a linear relationship between daily release rates and surface area, demonstrating a membrane-controlled release mechanism from extruded PCL tubes. Release rates of TAF from the implant are inversely proportional to the wall thickness, with release rates between approximately 0.91 and 0.15 mg/day for 45 and 200 µm, respectively. The sustained release of TAF at 0.28 ± 0.06 mg/day over the course of 180 days in vitro was achieved. Progress in the development of this implant platform addresses the need for new biomedical approaches to the LA delivery of ARV drugs. View Full-Text
Keywords: poly(ε-caprolactone) (PCL); tenofovir alafenamide (TAF); pre-exposure prophylaxis (PrEP); long-acting drug delivery systems; implant poly(ε-caprolactone) (PCL); tenofovir alafenamide (TAF); pre-exposure prophylaxis (PrEP); long-acting drug delivery systems; implant
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Johnson, L.M.; Krovi, S.A.; Li, L.; Girouard, N.; Demkovich, Z.R.; Myers, D.; Creelman, B.; van der Straten, A. Characterization of a Reservoir-Style Implant for Sustained Release of Tenofovir Alafenamide (TAF) for HIV Pre-Exposure Prophylaxis (PrEP). Pharmaceutics 2019, 11, 315.

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