Document Detail


Properties of a new acid-buffering bioadhesive vaginal formulation (ACIDFORM).
MedLine Citation:
PMID:  11535216     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Vaginal prophylactic methodology may prevent heterosexual transmission of the HIV and other sexually transmitted disease-causing organisms as well as unplanned pregnancies. A new delivery system (ACIDFORM) was designed with acid-buffering, bioadhesive, and viscosity-retaining properties to (1) maintain the acidic vaginal milieu (the low pH inactivates many pathogens and spermatozoa), (2) form a protective layer over the vaginal/cervical epithelium (minimizing contact with pathogenic organisms), and (3) provide long-term vaginal retention. A Phase I clinical study with ACIDFORM provided initial information about its safety and showed the formation of a layer over the vaginal/cervical epithelium [1; Amaral et al., Contraception 1999;60:361-6]. To study the properties of the gel (without active ingredient) in more detail, ACIDFORM's acid-buffering, bioadhesive, viscosity-retaining, and spermicidal properties were compared in vitro to marketed formulations, and its long-term stability was assessed. ACIDFORM, either when titrated with NaOH or when mixed directly with semen, is highly acid buffering and much more effective than Aci-Jel, a commercial acid-buffering vaginal product. ACIDFORM adheres well to two model membranes (excised sheep vagina and cellophane) and is more bioadhesive than Conceptrol, Advantage S, Replens, Aci-Jel, and K-Y jelly. On dilution, ACIDFORM also retains its viscosity better than these marketed products. ACIDFORM is spermicidal and is stable for at least 2 years. These results suggest that ACIDFORM has advantages over presently marketed vaginal delivery systems. The gel may either be useful by itself as an antimicrobial contraceptive product or as a formulation vehicle for an active ingredient with antimicrobial and/or contraceptive properties.
Authors:
S Garg; R A Anderson; C J Chany; D P Waller; X H Diao; K Vermani; L J Zaneveld
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Contraception     Volume:  64     ISSN:  0010-7824     ISO Abbreviation:  Contraception     Publication Date:  2001 Jul 
Date Detail:
Created Date:  2001-09-05     Completed Date:  2001-11-01     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0234361     Medline TA:  Contraception     Country:  United States    
Other Details:
Languages:  eng     Pagination:  67-75     Citation Subset:  IM    
Affiliation:
Section of Ob/Gyn Research, Rush University, Rush Presbyterian St. Luke's Medical Center, Chicago, IL, USA.
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MeSH Terms
Descriptor/Qualifier:
Acrylic Resins
Chemistry, Pharmaceutical*
Female
HIV Infections / prevention & control*
Humans
Hydrogen-Ion Concentration / drug effects*
Male
Sexually Transmitted Diseases / prevention & control
Spermatocidal Agents / therapeutic use*
Grant Support
ID/Acronym/Agency:
2 PO1 AI37940-05/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Acrylic Resins; 0/BufferGel; 0/Spermatocidal Agents

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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