Formula 7® Solution and Formula 7® Rapid MicroGel®
Topical formulation properties including small molecular size, low surface tension, stability, and lipid solubility are crucial for successful topical drug penetration. Increased penetration through the skin and nail can be achieved through a microemulsion drug delivery system. Microemulsions enhance permeation into the skin by: (i) their high solubilization capacity for both lipophilic and hydrophilic compounds increase the loading capacity and dose application; (ii) their large surface area and good skin contact, coupled with their occlusive nature ensures surface contact with the stratum corneum; (iii) their oil and surfactant components may have a direct permeation enhancement effect on the stratum corneum lipid structure.
By definition, a microemulsion is an emulsion in which the dispersed phase is in the form of tiny droplets usually produced and maintained with the aid of surfactants and having diameters of from 50 to 500 angstroms (5-50 nanometers). Microemulsions are synonymous with nanoemulsions due to their extremely small molecular size and surface tension which will allow successful flux through the very minute intercellular spaces of the skin and nail. Microemulsions are very stable, lipid-soluble and have a low polarity which all significantly improve penetration as well.
Both Formula 7® formulations contain soluble tolnaftate – a technology developed by The Tetra Corporation and first used in Formula 3®. They are formulated with cosmetic ingredients that rehydrate and restore the natural physical properties and appearance of the skin and nail with each use. The cosmetic ingredients are C12-15 Alkyl Benzoate, Jojoba Seed Oil, Glycerin, PEG-20 Hydrogenated Lanolin, Urea, Vitamin E Acetate, and Caprylyl Glycol. The N-acetyl-l-cysteine (NAC) is a penetration enhancer specifically designed to increase tolnaftate flux through keratin.(9) Studies have also found that NAC has bactericidal properties and breaks down bacterial biofilms of clinically relevant pathogens including Pseudomonas aeruginosa, Staphylococcus aureus, Enterococcus faecalis, Enterobacter cloacae, Staphylococcus epidermidis, and Klebsiella pneumoniae.
Formula 7® contains urea to increase the water content of the top layers of the skin. Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and increasing permeability of the nail plate for cosmetic debridement. Melaleuca Alternifolia (Tea Tree) Oil adds benefits of antifungal, antiseptic, germicidal and anti-bacterial properties. Tolnaftate is indicated for 11 organisms. To appreciate the full range of organisms that are sensitive to Formula 7® please visit www.TheTetraCorp.com.
Today, Soluble Tolnaftate is the gold standard for penetration and delivery of tolnaftate to the site of involvement. The Tetra Corporation has been the innovation leader in tolnaftate technology since its first patent in 1989. We do not share our technology; we do not manufacture private label products; our process is a closely guarded trade secret. So, if it’s not a Tetra product, it’s not Soluble Tolnaftate.