"In one embodiment of the present invention it has been found that mucoadhesive devices including ovalbumin have produced excellent mucoadhesive results. Such embodiment generally comprise ovalbumin combined with one or more mucoadhesive agents (e.g. glycerol), one or more pharmacologically active agents and water. These embodiments have been shown to provide excellent adhesion (e.g. strength and contact duration) and have provided excellent transmucosal delivery of the pharmacologically active agents.
"The mucoadhesive delivery systems of the present invention are intended to incorporate drugs that may be delivered locally or systemically. For example, in one embodiment of the present invention a mucoadhesive device may deliver an anesthetic and/or analgesic agent to alleviate the pain associated with many oral mucosal wounds or lesions. The dynamic nature of oral mucosal and its wide range of variable health and tissue characteristics make this a challenging endeavor for the medical and dental community.
"The mucoadhesive devices of the present invention provide a new drug delivery biomaterial that is formulated into a mucoadhesive, protein engineered device for transmucosal drug applications. The mucoadhesive devices of the present invention including drugs such as demopressin have been found to provide a controlled systemic release through the oral mucosa. Furthermore, it has been determined that the delivery of pain relief medicaments, such as capsaicin, may be locally administered to the mucosal tissue to alleviate pain caused by wounds and/or lesions.
"The mucosa is characterized by an outermost layer of stratified squamous epithelium. Below this layer lies a basement membrane (lamina propria) followed by the submucosa as the innermost layer. The oral epithelium is similar to stratified squamous epithelia found in the rest of the body (e.g., skin) in that it has a mitotically active basal cell layer, advancing through a number of differentiating intermediate layers to the superficial layers, where cells are shed from the surface of the epithelium. The epithelium of the buccal mucosa is about 40-50 cell layers thick, while that of the sublingual mucosa is somewhat thinner. The turnover rate for the buccal epithelium is estimated to be at 5-6 days, which is representative of the entire oral mucosa. The mucosae of tissues subject to mechanical stress, that is the gingiva and hard palate, are keratinized. The mucosa of the soft palate, the sublingual, and the buccal regions are not keratinized. The keratinized epithelia contain neutral lipids like ceramides and acylceramides that serve as a physical barrier, to make the tissue impermeable to water and microorganisms. In contrast, the non-keratinized epithelia, such as the floor of the mouth and the buccal epithelia, do not contain acylceramides and only trace amounts of ceramide. The non-keratinized epithelia have been found to be considerably more permeable to water than keratinized epithelia, thereby enhancing drug absorption.
"The oral mucosa in general is somewhat leaky. It is estimated that the water permeability of the oral mucosa is 4-4000 times greater than that of the skin. This wide range in permeability is due to the relative thickness and degree of keratinization of the mucosal tissues. Among the intra-oral sites, the sublingual mucosa (i.e., the tissues lining the inner cheek) are intermediate in permeability. Although there are many factors that affect permeability of drugs through these barriers, including basement membrane, the outer epithelium is considered to be the primary barrier to mucosal penetration.
"The cells of oral epithelia are surrounded by mucus, which is comprised mainly of proteins and carbohydrates. This mucus matrix may play a role in cell-cell adhesion, and acts as a barrier and as a lubricant to allow cells to move relative to one another. The mucus matrix may also assist in the bioadhesion of mucoadhesive drug delivery systems. At physiologic pH the mucus network carries a negative charge, due to sialic acid and sulfate residues, and forms a strongly cohesive gel structure that binds to the epithelial cell surface. The mucus comes from the salivary glands and is secreted as part of the saliva. This water rich environment is the chief reason that hydrophilic polymeric matrices are suitable as vehicles for oral the transmucosal mucoadhesive systems of the present invention. The transmucosal mucoadhesive device of the present invention is generally hydrophilic and will breakdown in water when warmed by contact with the mouth in a customized time frame.
"Additionally, in some embodiments of the present invention, local and systemic drug delivery through the mucosal tissue has a number of potential applications, including the treatment of bacterial, viral and fungal infections, pain and inflammation, apthous stomatitis, toothaches, periodontal disease and pain/inflammation caused by dental procedures. In one example, the buccal mucosa has an expanse of smooth muscle and its mucosa is relatively immobile compared to sublingual space. Therefore, it can be used to retain transmucosal drug delivery systems. Alternatively, the sublingual area and roof of the mouth are also considered suitable tissue areas for attachment of the mucadhesive devices of the present invention. However, it is again noted that the delivery devices of the present invention are suitable for administration to any of the mucosal tissues of the body."
For additional information on this patent, see: Masters, David B.; Berg,
Keywords for this news article include: Alkenes, Therapy, Polyenes, Treatment, Hydrocarbons, Legal Issues, Polyethylenes, Organic Chemicals, Drug Delivery Systems,
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