Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10162268 | Journal of Pharmaceutical Sciences | 2014 | 10 Pages |
Abstract
Human monoclonal antibodies (mAbs) based on IgG and IgA have shown promise as topical microbicide candidates to protect women from HIV infection. Application of mAbs has been limited, however, by the inability of vaginal gels and conventional intravaginal ring (IVR) designs, the predominant vaginal product formulations, to effectively deliver biomolecules in a coitally independent fashion with retention of bioactivity. We have developed a novel podâIVR platform that delivers ovine IgG (ovâIgG) as a model for IgG and IgA human mAbs. In vitro release of ovâIgG from the podâIVRs was sustained for 14 days. Facile control of release rate was achieved by changing the size of delivery channels in the ring structure, and the feasibility of ovâIgG delivery in the range 0.5-30Â mg dayâ1 from a 10âpod IVR was demonstrated. The activity of ovâIgG in podâIVR formulations was maintained as confirmed by ELISA binding assay. PodâIVRs delivering ovâIgG show promise for the effective sustained topical delivery of antibodyâbased microbicides. This significantly broadens the range of microbicides that can be delivered in a sustained fashion from IVRs and enables a new arsenal of topical biologic microbicide candidates beyond small molecule antiretrovirals. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:3611-3620, 2014
Keywords
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Pharmacology, Toxicology and Pharmaceutical Science
Drug Discovery
Authors
Manjula Gunawardana, Marc M. Baum, Thomas J. Smith, John A. Moss,