Sildenafil citrate chewing gum formulations and methods of using the same

• US 6,592,850 B2
• Filed: 09/19/2001
• Issued: 07/15/2003
• Est. Priority Date: 12/15/1998
• Status: Expired due to Fees

• Current Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Original Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Inventors: Ream, Ronald L., Li, Weisheng, Gmunder, Charlean B.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Howard, S.
• Application Number:
  US09/956,445
• Publication Number:
  US 20020012633A1
• Time in Patent Office: 664 Days
• Field of Search: 424/48, 424/440, 424/489
• US Class Current: 424/48
• CPC Class Codes: A23G 4/06 characterised by the composition containing organic or inorganic compounds
• CPC Class Codes: A23L 27/86 Addition of bitterness inhibitors
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 9/0058 Chewing gums non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00
• CPC Class Codes: A61P 15/10 for impotence

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.

Claims

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.

2. The method of claim 1, wherein the chewing gum is chewed for at least 2 minutes.

3. The method of claim 1, wherein said therapeutically effective amount of sildenafil citrate is approximately 20 mg to about 100 mg.

4. The method of claim 1, wherein the method further includes the step of chewing the chewing gum composition for at least 30 minutes prior to engaging in a sexual activity.

5. A method for treating erectile dysfunction comprising the steps of:

chewing a chewing gum composition that includes at least 20 mg of sildenafil citrate in the chewing gum composition prior to engaging in a sexual activity.

6. The method of claim 5, wherein the chewing gum composition is chewed for at least 2 minutes.

7. The method of claim 5, wherein the chewing gum composition comprises of approximately 20 mg to about 100 mg of sildenafil citrate.

8. The method of claim 5, wherein said sildenafil citrate is included in the chewing gum composition as a powder having a particle of size of approximately 0.1 microns to about 200 microns.

9. The method of claim 5, wherein the chewing gum composition includes a coating that surrounds a chewing gum center, the coating comprising sildenafil citrate.

10. The method of claim 5, wherein the chewing gum composition comprises a chewing gum coating that surrounds a compressible excipient.

11. The method of claim 9, wherein the coating includes a masking agent.

12. A method of treating erectile dysfunction in an individual comprising the steps of providing a chewing gum composition comprising a therapeutically effective amount of sildenafil citrate provided by the steps of:

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;

chewing the chewing gum carrier.

13. A method of treating erectile dysfunction in an individual comprising the steps of:

causing an individual to chew a chewing gum composition that includes a therapeutically effective amount of sildenafil citrate in the chewing gum composition.