Next-generation products for prevention of HIV infection in women (Project NIX HIV)

Project: Research project

Project Details

Description

Development of novel long-acting systemic ARV delivery systems for the prevention of HIV acquisition in women

Degradable subQ implants that show zero order release and degrade only after the release curve is complete are a challenging formulation to develop. Implants must be made from a small set of excipients, be tunable to release drug and allow for timed degradation. We will design and undertake preclinical development absorbable drug eluting implants of two drugs using scalable processing techniques. We will take our initial inspiration for the design of the implants from commercial testosterone subQ implants. The implants must also maintain mechanical strength over their usable life span and then dissolve. The core drug containing pellets will be designed so that they can be spray coated with a Wüster coater but still placed in a trocar for subQ insertion. By changing the thickness, crystallinity and other formulation variables of the rate controlling membrane we can modify the release of the drug and its duration. This particular implant system is designed to degrade in the period after the drug release has diminished. Our work will include long term release studies that generate many analytical samples, stability studies, development of methodology to study degradation and drug release. Furthermore, we will conduct pilot stability studies and assist with the technology transfer into CRO for clinical supply manufacturing.

Development and optimization of innovative long-acting multipurpose technologies (MPTs) with contraceptive and HIV prevention activity

We will complete the design engineering of a elvitegravir intrauterine system and develop manufacturing methods and test methods for the intrauterine system (IUS) being developed in this activity. We will reinforce and further engineer the wall/rate controlling membrane material and develop test methods to assure mechanical integrity of the IUS design. We will explore methods to include levonorgestril in the IUS reservoir or another reservoir design to achieve Mirena like release kinetics in vitro. We will support expanded product development, optimization, stress testing and tech transfer activities. We will also work to develop IUS systems that can elute other ARVs. Our work will include long term release studies that generate many analytical samples, stability studies, development of methodology to study degradation and drug release. Furthermore, we will conduct pilot stability studies and assist with the technology transfer into CRO for clinical supply manufacturing.
StatusFinished
Effective start/end date9/15/172/29/20

Funding

  • Eastern Virginia Medical School (NXS-17-001 AMD 1 // AID-OAA-A-17-00014)
  • Agency for International Development (NXS-17-001 AMD 1 // AID-OAA-A-17-00014)

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