Toxicological evaluation of a dietary supplement formulated for male sexual health prior to market release |
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| Authors: | A. Clewell,I. Qureshi,J. Endres,J. Horvá th,I. Financsek,J. Neal-Kababick,K. Jade,A.G. Schauss |
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| Affiliation: | 1. AIBMR Life Sciences Inc., 4117 South Meridian, Puyallup, WA 98373, USA;2. Pharmaceutical Control and Development Laboratory, Budapest H-1581, Hungary;3. Flora Research Laboratories, 1000 SE M Street #B, Grants Pass, OR 97526, USA |
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| Abstract: | The dietary supplement, 112 Degrees™, was formulated with the goal of supporting sexual functioning in men. Due to rampant problems with drug adulteration for this category of products, a comprehensive screening for active pharmaceutical agents, with an emphasis on drugs prescribed for erectile dysfunction such as type 5 phosphodiesterase (PDE-5) inhibitors, and known unapproved PDE-5 drug analogues, was performed along with preclinical toxicology studies prior to the introduction of this product into the marketplace. 112 Degrees™ was found to be free of all pharmaceutical adulterants tested, and was not mutagenic, clastogenic, or genotoxic as demonstrated by the Ames test, chromosomal aberration assay, and mouse micronucleus assay, respectively. The LD50 in the 14-day acute oral toxicity study was greater than 5000 mg/kg, the highest dose tested. |
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| Keywords: | ANOVA, analysis of variance API, active pharmaceutical ingredient bDNA, branched deoxyribonucleic acid CA, chromosomal aberration cGMP, current good manufacturing practices DMEM, Dulbecco&rsquo s Modified Eagle&rsquo s Medium DMSO, dimethyl sulfoxide FBS, Fetal Bovine Serum FDA, Food and Drug Administration GAPDH, glyceraldehyde-3-phosphate dehydrogenase HPLC, high performance liquid chromatography MN, micronucleus LD50, lethal dose (50%) LSD, least significant difference mRNA, messenger ribonucleic acid MS, mass spectrometry MTT, 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide OECD, Organization for Economic Cooperation and Development PBS, phosphate buffered saline PDA, photo diode array PDE, phosphodiesterase SOP, standard operating procedure v/v, volume per volume |
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