Novel antiretroviral therapy delivery platform for infants and young children: oral dispensable strips (ODS)

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PROJECT ABSTRACT Between 1.3 – 2.4 million children under 15 live with HIV and are in need of regular treatment. Estimates for HIV related deaths among children are as high as 160,00 annually and often rooted in poor patient and caregiver adherence. Causes for poor adherence are rooted in low palatability of existing formulations (liquids, fast-dissolving tablets), the complexity of preparation and administration, and issues related to patient privacy / social stigma. Oak Therapeutics, Inc., is an early-stage pharmaceutical company that specializes in formulation and manufacturing of support matrix strips composed of oral-disintegrating polymers (ODS). The goal of this proposal is to develop dissolvable strip (ODS) platform that supports multi-drug pediatric formulation and to commercialize the first ever ODS formulation for pediatric antiviral therapy consisting of Abacavir/ Lamivudine/ Dolutegravir (ALD- ODS). We have already developed ODS containing a pediatric prophylactic dose of two HIV antiretroviral drugs (AZT and NVP) with appropriate properties for administration to infants and young children, including muco-adhesion, rapid oral dispersion, and taste-masking. In this proposal we will develop a novel computational method for multi- drug ODS formulation which will be used to encapsulate and make ALD-ODS strip. Optimal ODS candidate will be compared to commercial reference standard of treatment and analyzed in an in vivo PK/PD study to determine pharmacokinetics and toxicology profiles. The final ALD-ODS product will be the first oral film to contain HIV combination regiment medications. It will also be the first to achieve the targeted criteria of an orally dissolvable product, and it will be among the first pediatric products to contain all recommended first line drugs in a single formulation with easily modified dosing to simplify administration for caregivers.