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Advances in development, scale-up and manufacturing of microbicide gels, films, and tablets.
Antiviral Res. 2010 Dec; 88 Suppl 1:S19-29.AR

Abstract

Vaginal HIV microbicides are topical, self administered products designed to prevent or significantly reduce transmission of HIV infection in women. The earliest microbicide candidates developed have been formulated as coitally dependent (used around the time of sex) gels and creams. All microbicide candidates tested in Phase III clinical trials, so far, have been gel products with non-specific mechanisms of action. However, recently, research is focusing on compounds containing highly potent and specific anti-retrovirals. These specific anti-retrovirals are being formulated as primary dosage forms such as vaginal gels or in alternative dosage forms such as fast dissolve films and tablets. Recent innovations also include development of combination products of highly active antiviral drugs such as reverse transcriptase inhibitors and entry inhibitors, which would theoretically be more effective and would reduce the possibility of drug resistance. In this article, an overview of recent advances in the microbicide gel, film, and tablet formulations and issues pertaining to scale-up, formulation, and evaluation challenges and regulatory guidelines have been presented. This article forms part of a special supplement covering presentations on gels, tablets, and films from the symposium on "Recent Trends in Microbicide Formulations" held on 25 and 26 January 2010, Arlington, VA.

Authors+Show Affiliations

School of Pharmacy, University of Auckland, 93 Grafton Road, Grafton, Auckland, New Zealand. s.garg@auckland.ac.nzNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

21109064

Citation

Garg, Sanjay, et al. "Advances in Development, Scale-up and Manufacturing of Microbicide Gels, Films, and Tablets." Antiviral Research, vol. 88 Suppl 1, 2010, pp. S19-29.
Garg S, Goldman D, Krumme M, et al. Advances in development, scale-up and manufacturing of microbicide gels, films, and tablets. Antiviral Res. 2010;88 Suppl 1:S19-29.
Garg, S., Goldman, D., Krumme, M., Rohan, L. C., Smoot, S., & Friend, D. R. (2010). Advances in development, scale-up and manufacturing of microbicide gels, films, and tablets. Antiviral Research, 88 Suppl 1, S19-29. https://doi.org/10.1016/j.antiviral.2010.09.010
Garg S, et al. Advances in Development, Scale-up and Manufacturing of Microbicide Gels, Films, and Tablets. Antiviral Res. 2010;88 Suppl 1:S19-29. PubMed PMID: 21109064.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Advances in development, scale-up and manufacturing of microbicide gels, films, and tablets. AU - Garg,Sanjay, AU - Goldman,David, AU - Krumme,Markus, AU - Rohan,Lisa C, AU - Smoot,Stuart, AU - Friend,David R, PY - 2010/07/14/received PY - 2010/09/15/revised PY - 2010/09/19/accepted PY - 2010/11/27/entrez PY - 2010/12/9/pubmed PY - 2011/2/23/medline SP - S19 EP - 29 JF - Antiviral research JO - Antiviral Res VL - 88 Suppl 1 N2 - Vaginal HIV microbicides are topical, self administered products designed to prevent or significantly reduce transmission of HIV infection in women. The earliest microbicide candidates developed have been formulated as coitally dependent (used around the time of sex) gels and creams. All microbicide candidates tested in Phase III clinical trials, so far, have been gel products with non-specific mechanisms of action. However, recently, research is focusing on compounds containing highly potent and specific anti-retrovirals. These specific anti-retrovirals are being formulated as primary dosage forms such as vaginal gels or in alternative dosage forms such as fast dissolve films and tablets. Recent innovations also include development of combination products of highly active antiviral drugs such as reverse transcriptase inhibitors and entry inhibitors, which would theoretically be more effective and would reduce the possibility of drug resistance. In this article, an overview of recent advances in the microbicide gel, film, and tablet formulations and issues pertaining to scale-up, formulation, and evaluation challenges and regulatory guidelines have been presented. This article forms part of a special supplement covering presentations on gels, tablets, and films from the symposium on "Recent Trends in Microbicide Formulations" held on 25 and 26 January 2010, Arlington, VA. SN - 1872-9096 UR - https://www.unboundmedicine.com/medline/citation/21109064/Advances_in_development_scale_up_and_manufacturing_of_microbicide_gels_films_and_tablets_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0166-3542(10)00732-1 DB - PRIME DP - Unbound Medicine ER -