Sildenafil citrate chewing gum formulations and methods of using the same
First Claim
Patent Images
1. A method for treating erectile dysfunction in an individual comprising the steps of:
- providing a chewing gum composition that includes a therapeutically effective amount of sildenafil citrate in the chewing gum composition; and
chewing the chewing gum composition to cause the sildenafil citrate to be released from the chewing gum composition into the oral cavity of the individual.
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Abstract
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.
192 Citations
33 Claims
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1. A method for treating erectile dysfunction in an individual comprising the steps of:
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providing a chewing gum composition that includes a therapeutically effective amount of sildenafil citrate in the chewing gum composition; and
chewing the chewing gum composition to cause the sildenafil citrate to be released from the chewing gum composition into the oral cavity of the individual. - View Dependent Claims (2, 3, 4)
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5. A method of reducing esophageal spasms or dysphagia in an individual comprising the steps of:
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providing a chewing gum composition that includes a therapeutically effective amount of sildenafil citrate; and
chewing the chewing gum composition to cause the sildenafil citrate to be released from the chewing gum composition into the oral cavity of the individual. - View Dependent Claims (6, 7, 8)
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9. A method of treating gastroparesis associated with diabetes comprising the steps of:
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providing a chewing gum composition including a therapeutically effective amount of sildenafil citrate; and
chewing the chewing gum composition and thereby causing the sildenafil citrate to be released into the saliva. - View Dependent Claims (10, 11, 12)
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13. A method of reducing or eliminating the gastroesophageal reflux side effect associated with orally administered sildenafil citrate comprising the steps of:
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providing a chewing gum composition that includes sildenafil citrate;
chewing the chewing gum composition to cause the sildenafil citrate to be gradually released from the chewing gum composition into the oral cavity of the individual; and
continuing to chew the chewing gum composition thereby causing said sildenafil citrate to enter the systemic system through the oral mucosa of the oral cavity via the buccal or sublingual absorption routes rather than the gastrointestinal tract. - View Dependent Claims (14)
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15. A chewing gum composition comprising:
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a water insoluble base portion;
a water soluble portion;
a therapeutically effective amount of a member selected from the group consisting of sildenafil, sildenafil citrate, derivatives thereof, and combinations thereof that is designed to be absorbed through the oral mucosa of an individual chewing the chewing gum;
a sweetener; and
a flavor. - View Dependent Claims (16, 17, 18, 19, 20, 21)
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22. A method of producing a chewing gum composition comprising a therapeutically effective amount of sildenafil citrate comprising the steps of:
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grinding the sildenafil citrate into a fine powder having a particle size of approximately 0.1 microns to about 200 microns;
mixing the sildenafil citrate powder with a liquid to form an incorporation vehicle; and
mixing the incorporation vehicle with a chewing gum carrier so that the sildenafil citrate is released into the oral mucosa of an individual placing the chewing gum in their mouth, the chewing gum carrier comprising;
a water insoluble gum base portion;
a water soluble portion;
a sweetener; and
a flavor. - View Dependent Claims (23, 24)
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25. A method of preparing a gum base comprises sildenafil citrate comprising the steps of:
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grinding the sildenafil citrate into a fine powder; and
incorporating the sildenafil citrate powder within a gum base to encapsulate the sildenafil citrate powder. - View Dependent Claims (26, 27)
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28. A chewing gum composition comprising:
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a water insoluble base portion;
a water soluble portion;
a therapeutically effective amount of a member selected from the group consisting of sildenafil, sildenafil citrate and combinations thereof;
a sweetener; and
a flavor. - View Dependent Claims (29, 30, 31, 32, 33)
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Specification