期刊
INTERNATIONAL JOURNAL OF STD & AIDS
卷 21, 期 10, 页码 714-717出版社
ROYAL SOC MEDICINE PRESS LTD
DOI: 10.1258/ijsa.2010.010215
关键词
cellulose acetate 1,2-benzenedicarboxylate; topical microbicide; HIV; osmolality; drug formulation
资金
- UK Medical Research Council
- Department for International Development
- National Institutes of Health of the United States [U19 AI 076964]
- MRC [G0100137] Funding Source: UKRI
- Medical Research Council [G0100137] Funding Source: researchfish
We carried out a phase 1 trial of a candidate vaginal microbicide gel against HIV-1 and other sexually transmitted diseases, which contained cellulose acetate 1,2-benzenedicarboxylate (also known as cellulose acetate phthalate) in a glycerol-based vehicle. We had to terminate the study after five women had completed dosing, due to all women experiencing unacceptable vulvo-vaginal side-effects. Further investigations showed that the gel had a very high osmolality, which we believe led to excessive fluid transudation across the vaginal mucosa and acute mucosal dysfunction. We also showed that the rheology of the gel changed dramatically on fluid dilution. The osmolality and rheology of candidate microbicides and other genital mucosal products should therefore be analysed and considered at an early stage of product development.
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