| abstract |
The described invention provides a topical bioadhesive film-forming pharmaceutical composition formulated for application directly to skin or to a substrate. The composition includes a therapeutic amount of an active agent; and one or more excipients selected from the group consisting of a non-cellulosic polymer or copolymer, a film forming agent, a plasticizer, a permeation enhancer, an antioxidant, a preservative, a solubilizer, a phase transfer catalyst, a viscosity modifier, a vitamin, a mineral nutrient, a solvent, a colorant and a fragrance. It further provides a delivery system comprising the composition and a means for administering the composition. It also describes uses of the delivery system in the manufacture of a medicament for treating a skin condition, disease or disorder, and a method for treating a skin condition, disease or disorder with the composition. The composition is characterized by: controlled release. The formed film is characterized by: locally sustained levels of a minimum effective concentration (MEC) of the active agent between applications; its adherence and conformance to a surface of the skin; its pliability, its resistance to breaking under tension (tensile strength); maintained potency of the active agent; and removability of the film from the skin without a residue. |