Methods and chewing gum formulations for delivering a medicament, namely sildenafil citrate, to an individual are provided. Further, an improved dosage form and method of treating erectile dysfunction are provided. Methods of treating esophageal spasms, dysphagia, and gastroparesis utilizing chewing gum formulations containing sildenafil citrate are also provided.
This application is a continuation-in-part patent application of U.S. patent application Ser. No. 09/286,818, filed on Apr. 6, 1999, entitled "Pharmaceutical Chewing Gum Formulation", and U.S. patent application Ser. No. 09/621,780 filed on Jul. 21, 2000 which is a continuation and claims priority from PCT patent application PCT/US99/29792 filed Dec. 14, 1999 now WO 00/35298 entitled "Chewing Gum Containing Medicament or Other Active Agents."
Methods and chewing gums for delivering a medicament or agent to an individual are provided. The chewing gum includes a medicament or agent. The medicament or agent is present within the chewing gum composition (the water soluble portion and/or insoluble base portion). It has been found that by chewing the gum, the medicament or agent is released from the chewing gum. Continuing to chew the chewing gum creates a pressure within the buccal cavity forcing the agent or medicament directly into the systemic system of the individual through the oral mucosa contained in the buccal cavity. This greatly enhances the absorption of the drug into the systemic system as well as the bioavailability of the drug within the system.
A method for producing a coated chewing gum product with accelerated absorption of medicaments through oral mucosa, as well as the chewing gum product so produced, is obtained by using a xylitol or sorbitol coating, or by adding a water-soluble alkaline material, such as a bicarbonate salt, to the chewing gum center, a coating on the center, or both. Coatings made with sorbitol or xylitol or gum centers that include sodium bicarbonate are particularly preferred.
A method of making coated chewing gum products comprises the steps of providing chewing gum cores; providing a first coating syrup comprising a bulk sweetener; providing an aldehyde flavor; providing a second coating syrup separate from the first coating syrup and comprising a dipeptide sweetener; and applying the first and second coating syrups to the cores and drying the syrups to produce a coating on the cores. Calcium carbonate or another antacid may be incorporated in the coating by being mixed into the first coating syrup or applied as a dry charge.
