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The development of vaginal microbicides for the prevention of sexual transmission of HIV is becoming an increasingly important strategy in the battle against the AIDS epidemic. Several first generation microbicide candidates are entering Phase III efficacy trials, and several other candidates are in earlier stages of clinical development. The capacity to(More)
Alkyl betaines and alkyl dimethylamine oxides have been shown to have pronounced antimicrobial activity when used individually or in combination. Although several studies have been conducted with these compounds in combinations, only equimolar concentrations of the C(12)/C(12) and C(16)/C(14) chain lengths for the betaine and the amine oxide, respectively,(More)
Two equations were developed which enable urinary excretion data to be utilized for estimating drug bioavailability within 12 hr-starting between one and two half-lives of the drug, depending upon the relative rates of absorption, distribution, and elimination. Both equations were examined using simulated data for both the one- and two-compartment open(More)
BACKGROUND The objective of this study is to identify the critical formulation parameters controlling distribution and function for the rectal administration of microbicides in humans. Four placebo formulations were designed with a wide range of hydrophilic characteristics (aqueous to lipid) and rheological properties (Newtonian, shear thinning, thermal(More)
The impact of controlled release (CR) formulations having different gel strength values (gamma) on in vivo tablet performance and the in vitro/in vivo correlation of the formulations was investigated. The CR tablets containing either hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), or carbomer were formulated with theophylline and Fast(More)
The impact of hydrogel polymers and dissolution media on tablet gel strength, Gamma, of controlled release (CR) hydrogel tablets was investigated. CR tablets containing either hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), or carbomer were formulated with theophylline and Fast Flo lactose, to produce tablets with a polymer content of(More)
The objective of this study was to evaluate the distribution and retention (deployment) of four prototype vehicles for delivery of prophylactic microbicides against vaginal HIV transmission. Study gels were created with different molecular compositions, producing different biophysical properties governing vaginal deployment. The study employed three(More)
A synthetic formulation has been developed with viscosity, spinnbarkeit, and pH comparable to that reported for human cervical mucus. The formulation contains guar gum crosslinked with borate ion, mucin (dried porcine gastric), and a mixed preservative system in pH 7.4, 0.1M phosphate buffer. The guar gum source, mucin concentration, and method of(More)