This core (""""""""Core B"""""""") will enable the two goals of the entire project: (1) provide knowledge needed for commercial mass production of CAP films and (2) establish optimal parameters for cellulose acetate phthalate (CAP) / zinc finger inhibitor (ZnFI) / reverse transcriptase (RT) inhibitor UC781 / hydroxypropyl-beta-cyclodextrin (HP-beta-CD ) combination microbicides. This complex task will be supported by five Core sites from academia [New York Blood Center (c); NIH/NCI (d)] and commercial companies [Adhesives Research (a); Dow Pharmaceutical Sciences (b): Bioqual (e);]. The primary role of these company sites is goal 1 by providing scientific, technological, analytical and regulatory support, based on iterative studies, for Project IV (Clinical development of CAP microbicide films). Once goal 1 of the Program Project is accomplished in laboratory scale and animal experiments, goal I will also encompass combination microbicides. Core Bc, in collaboration with Core Ba, will provide Project by Jiang (in vitro efficacy of CAP film & microbicide combinations)and Project by Harouse (in vivo safety and efficacy of CAP and combination films) with defined CAP films, microbicide combinations, and combination films to establish the safety, efficacy tn vitro and in animal models, and mucosal distribution of these products. Core Bc, in collaboration with Core Ba. Bb and Bd, will also provide analytical support. Core Bd will provide ZnFIs and analytical and regulatory support related to ZnFIs.
