Mucoadhesive buccal tablets for the treatment of orofacial herpes

A method of ameliorating the severity of orofacial herpes in a patient infected with herpes simplex virus (HSV-1), comprising administering to the oral mucosa of said patient a mucoadhesive buccal tablet, said mucoadhesive buccal tablet comprising an effective amount of an acyclic guanosine antiviral agent and characterized by at least one, at least two, at least three, at least four, at least five or all six of the following properties:

• (a) the mucoadhesive buccal tablet adheres to said oral mucosa for a period of at least 5 hours following administration;
• (b) the mucoadhesive buccal tablet provides sustained release of said acyclic guanosine antiviral agent for a period of at least 20 hours following administration;
• (c) the acyclic guanosine antiviral agent is acyclovir, and the mucoadhesive buccal tablet provides a maximum salivary acyclovir concentration (“Cmax”) of at least 200,000 ng/ml;
• (d) the acyclic guanosine antiviral agent is acyclovir, and the mucoadhesive buccal tablet provides a salivary acyclovir concentration of greater than 22.5 ng/ml for a period of at least 24 hours following administration;
• (e) the acyclic guanosine antiviral agent is acyclovir, and the mucoadhesive buccal tablet provides time to maximum salivary acyclovir concentration (“Tmax”) of 7 to 13 hours following administration;
• and
• (f) the mucoadhesive buccal tablet comprises one, two, three, four or all five of the following components:
• (i) 1% to 75% by weight of one or more diluents;
• (ii) 1% to 10% by weight of one or more solubilizing agents that do not facilitate absorption of said acyclic guanosine antiviral agent;
• (iii) 0.1% to 5% by weight of one or more binding agents;
• (iv) 5% to 80% by weight of one or more bioadhesive polymers selected from the group of natural polymers wherein said natural polymers are polysaccharides or natural proteins from animal origin or vegetable origin, synthetic polymers, and mixtures thereof;
• (v) 5% to 80% by weight of one or more polymers that provide a sustained release of said acyclic guanosine antiviral agent;
• wherein (A) single dose of said acyclic guanosine antiviral agent is administered or (B) the patient is suffering from pre-vesicular symptoms of orofacial herpes.