Compositions and methods for mucosal delivery

A dosage unit comprising a mucosal surface-coat-forming film, wherein the mucosal surface-coat-forming film comprises a water-soluble hydrocolloid, an effective dose of an active agent and a mucosal adhesion enhancer;

• wherein the active agent is encapsulated within a polymer which is chemically or physically distinct from the hydocolloid;
• wherein the mucosal adhesion enhancer is a starch graft copolymer;
• wherein the film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70° C. for a 2% polymer solution, a dry film thickness of no more than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear propagation resistance of 0.001 to 1 N, and a dissolution time of not more than 600 seconds upon application to an oral mucosal surface.

A dosage unit comprising a mucosal surface-coat-forming film, wherein the mucosal surface-coat-forming film comprises a water soluble hydrocolloid and an effective dose of an active agent, wherein the active agent comprises sildenafil citrate;

• wherein the mucosal surface-coat-forming film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70° C. for a 2% polymer solution, a dry film thickness of not more than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear propagation resistance of 0.001 to 1 N, and a dissolution time of not more than 600 seconds upon application to an oral mucosal surface.