Onychomycosis
Nail fungus is known to be incredibly resistant to treatment. The science of treating fungal and otherwise damaged nails requires deep knowledge of the human nail, fungal species, antifungal ingredients, cosmetic ingredients, and how each of these interacts in use.
Below are the core concepts that informed the development of Tolcylen and are important to understanding how Tolcylen achieves remarkable clinical success and patient satisfaction.01 The Human Nail
Your nails are surprisingly complex. Overall the nail plate comprises approximately 80% keratin proteins, 7–12% water, less than 1.5% leftover lipids from the live cell membranes, and trace amounts of minerals and electrolytes. The plate is arranged three distinct layers of the nail plate which have slightly different compositions and, thus, different properties that resist penetration.
The keratin in nails assembles into filaments that make up the nail matrix and have strong disulfide bonds. The compact structure, varied layers, strong bonds, keratin content, hydration, and electrochemical properties of the nail plate resulting in a complex barrier with significant challenges to transungual drug delivery. Designing a drug to deliver ingredients through this barrier has been unsuccessful until recently.
The Tolcylen delivery vehicle is patented for its ability to penetrate through the entire nail plate. It is developed specifically for the unique properties of the keratin matrix of your nails.
02 Nail Appearance
The nail appears transparent due to keratin’s natural transparent properties. As the nail plate grows from the matrix, it becomes transparent when the keratinocyte nuclei are lost and filled in with keratin. The keratin structures are disturbed due to the fungus channeling through the nail plate by releasing enzymes that break down the bonds between these cells. This disrupts the translucent appearance, leading to a thicker, more porous, discolored nail. Fungal nails are significantly more brittle than healthy nails, which can lead to cracking.
Hydration, keratin renewal, and penetration are critical to restoring a nail to the “normal-appearing” criteria. Water content in the nail is either held in free or bound form. Bound water is attached to the existing nail plate structures by a hydrogen bond, while free water forms clusters with other free water molecules. Clusters of broken keratin filaments and debris are caused by damage and fungal infection. Ingredients that break down keratin and allow the fibers to realign are needed to address these issues.
Tolcylen uses a complex mix of keratolytics and hydrating ingredients that rapidly improve the appearance of nails by breaking down keratin and bringing moisture into its bound form in the nail.
03 Extracellular Material & Biofilms
Historically and still typically, discussion around treatment for onychomycosis was in the context of the fungi being planktonic – cells that are “free” to drift or live in the medium they are in. In reality, the mold and dimorphic type fungus fungi form vast networks of hyphae and an extremely complex mix of organic materials that encase the cells and protect them. This extracellular material is referred to as a biofilm. Biofilms are formed by bacteria, fungi, and other microbes and are well-studied and understood in certain contexts.
The reason this is a critical factor in the treatment of onychomycosis is that biofilms are structured differently, interact with drugs differently, have different permeability characteristics, and are significantly more resistant to certain compounds than their planktonic counterparts – normal antifungals will not interact with fungus in a biofilm as they do with planktonic cells.
Tolcylen was developed with ingredients to help penetrate through not only the nail but also any potential fungal biofilms associated with dermatophytes and other common fungal species.
04 Delivery Vehicle
All of the above factors are irrelevant, however if they cannot penetrate through the entirety of the nail plate to the source of the infection. The interaction between nails and topical treatments overall governs their effectiveness. There are polar molecules that are attracted to water (hydrophilic) and non-polar molecules that are repelled by water (hydrophobic). The layers of the nail typically function as a hydrophilic membrane, although there is a minimal amount of hydrophobic material. Generally, a solution with a similar ratio of hydrophilic to hydrophobic material to the nail will penetrate well.
This concept and other nail surface and solution characteristics indicate how well a product will penetrate. Marlinz Pharma has utilized innovative analysis to determine how a product interacts with and penetrates the nail plate by understanding surface tension, wettability, polar/dispersive forces ratio, homogeneity, and molecular weight.
Tolcylen is the first and only treatment formulated in a proven, patented delivery vehicle that can penetrate the nail with all of the ingredients to treat fungal infections and rapidly renewing the appearance of the nail plate.
05 Fungal Species
Dermatophytes are mold-type fungi that cause most Onychomycosis cases in the US, with Trichophyton Rubrum, or T. Rubrum, being the most common dermatophyte species. The dermatophyte microbes will most commonly enter the nail through the hyponychium and reside in the nail bed, growing and extending into the layers of the nail plate. However, there are other possible modes of infection.
Dermatophytes release enzymes that break down keratin, weakening, discoloring and thickening your nail plate. The hyphae can form new fungal cells, spreading the infection throughout the nail. There are also yeast and non-dermatophyte molds that can be found to be the causative agents. Fungal infections commonly involve more than one species.
Through clinical studies, Tolcylen has been shown to penetrate and treat all species of fungal infection at the source of the infection, the nail bed.
Better Formulations for Better Results.
Marlinz Pharma was founded with the mission of setting a new standard in nail and skin care through innovative, science-backed products. The Tolcylen solution revolutionized the over-the-counter (OTC) market, and the Tolvere Nail Renewal solution is doing the same for cosmetic nail renewal.
Tolcylen and Tolvere do what others cannot. Our revolutionary patented nail delivery formulations deliver a full spectrum of ingredients deep into the nail plate for the most effective nail treatments available. Scientifically and clinically proven.