Method and apparatus for dispensing a composition

• US 20070118083A1
• Filed: 01/05/2007
• Published: 05/24/2007
• Est. Priority Date: 12/26/2002
• Status: Abandoned Application

• Current Assignee: Nycomed Us Incorporated (Novartis Ag)
• Original Assignee: Bradley Pharmaceuticals Incorporated (Novartis Ag)
• Inventors: Glassman, Daniel, Goldstein, Alan, Glassman, Bradley
• Application Number:
  US11/649,794
• Publication Number:
  US 20070118083A1
• Time in Patent Office: Days
• US Class Current: 604/296
• CPC Class Codes: A61M 2210/1067 Anus
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 35/003 Portable hand-held applicators having means for dispensing or spreading integral media hand-held massage devices with liquid delivery A61H7/003
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system

Abstract

A pharmaceutical dispenser including a tube having an open end and a space filled with a composition, and an applicator including a first end removably coupled to the open end of the tube and a longitudinal portion with at least one aperture is described. The dispenser can also include a removable cover extending longitudinally and having a bore surrounding the longitudinal portion of the applicator. The composition may be an anal medication. A single dosage unit of the composition is usually contained in the tube, and the tube, applicator, and cover are disposable after use. Methods of using the dispenser include squeezing the tube, allowing the composition to exit the aperture of the applicator, and applying the composition to a target area.

Claims

1. A disposable single-use pharmaceutical dispenser for anorectal topical application, comprising:

a reservoir portion defining a space, the reservoir portion being formed of a material deformable by squeezing, the reservoir portion has a length of less than approximately 5.5 to 6.5 cm;

the single dosage amount of a pharmaceutical composition comprising lidocaine and hydrocortisone acetate, the pharmaceutical composition substantially filling the space of the reservoir portion, the single dosage amount of the pharmaceutical composition formulated for topical non-systemic treatment of an anal ailment selected from the group consisting of hemorrhoids, anal fissures, and pruritis ani; and

an applicator portion defining one or more apertures, the applicator portion having a length of approximately 4.5 to 5.0 cm, the applicator portion comprising a first end adjacent to the reservoir portion and a longitudinal portion extending away from the reservoir portion, wherein the first end is flanged outward from the longitudinal axis of the applicator portion such that the first end defines an outer diameter that is substantially greater than any outer diameter along the longitudinal portion and that is less than the outer diameter of the portion of the reservoir portion adjacent the first end,

wherein the dispenser is configured, by squeezing the reservoir portion, for topically administering the single dosage amount of the pharmaceutical composition onto the surface of an anal target area afflicted by the anal ailment, wherein the squeezing causes a substantial portion of the single dosage amount of the pharmaceutical composition to be dispensed through the one or more apertures onto the anal target area, and

wherein an open end of the reservoir portion is threaded for removable coupling to the applicator portion.

2. The dispenser of claim 1, wherein an open end of the reservoir portion is threaded for removable coupling to the applicator portion and for removable coupling to a threaded cap.

3. The dispenser of claim 1, wherein the one or more apertures comprises a plurality of apertures, the dispenser configured to dispense the composition through the plurality of apertures.

4. The dispenser of claim 1, further comprising a sealed package defining an interior space configured to accommodate the reservoir portion and the applicator portion, wherein the package comprises a base approximately 86.25 mm long and 61.00 mm wide, wherein the sealed package comprises a blister pack having a child resistant seal, the blister pack defining a bubble that rises approximately 17.50 mm above a base of the blister pack, and wherein the dispenser is removably contained in the blister pack.

5. The dispenser of claim 1, wherein the squeezing applies pressure in a direction not substantially parallel to a longitudinal axis of a tubular portion of the reservoir portion.

6. The dispenser of claim 1, wherein the anal target area afflicted by the anal ailment comprises an external area of an outer region of the anus having less systemic pharmaceutical receptivity than an inner region of the anus.

7. The dispenser of claim 1, wherein the applicator portion comprises a first end adjacent to the reservoir portion and a tip opposite the first end, wherein at least one of the one or more apertures is longitudinally spaced from the tip.

8. The dispenser of claim 7, wherein the at least one aperture longitudinally spaced from the tip is configured to dispense a portion of the composition, in a direction not substantially parallel to the longitudinal axis of the applicator, onto the surface of the anal target area.

9. The dispenser of claim 1, wherein the applicator portion comprises a first end adjacent to the reservoir portion and a tip opposite the first end, wherein one of the one or more apertures is located on the tip of the applicator portion.

10. The dispenser of claim 1, further comprising a removable cover configured to surround the longitudinal portion of the applicator portion.

11. The dispenser of claim 10, wherein the applicator portion comprises a circumferential rib configured to engage the removable cover.

12. The dispenser of claim 10, wherein the cover comprises a protrusion configured to removably plug one of the one or more apertures.

13. The dispenser of claim 11, wherein the applicator portion comprises a first end adjacent to the reservoir portion and a longitudinal portion, the longitudinal portion extending away from the reservoir portion and defining an aperture at a tip opposite the first end, wherein the protrusion is configured to removably plug the aperture at the tip.

14. The dispenser of claim 10, wherein the cover is less than approximately 4.0 cm in length.

15. The dispenser of claim 10, wherein the cover is approximately 3.5-4.0 cm in length.

16. The dispenser of claim 1, wherein the applicator portion is configured for removable coupling to the reservoir portion.

17. A method for topically dispensing a single dosage amount of a pharmaceutical composition, comprising:

removing a covering from an applicator portion of a disposable dispenser, the dispenser also forming a reservoir portion, the reservoir portion being formed from a material deformable by squeezing, the reservoir portion defining a space containing a single dosage amount of a pharmaceutical composition formulated for the topical treatment of an anal ailment selected from the group consisting of hemorrhoids, anal fissures, and pruritis ani, the pharmaceutical composition comprising lidocaine and hydrocortisone acetate;

inserting the applicator portion into an anal area of an anus, the applicator portion defining one or more apertures and having a length of less than approximately 5.0 cm;

topically administering the single dosage amount of the pharmaceutical composition onto the surface of an anal target area afflicted by the anal ailment by dispensing a substantial portion of the single dosage amount through one or more apertures defined by an applicator portion of the dispenser, wherein the dispensing step is carried out by squeezing the reservoir portion to cause at least the substantial portion of the single dosage amount to dispense from the one or more apertures; and

discarding the dispenser after use.

18. A kit for topical application of anal medication, the kit comprising:

a disposable dispenser comprising;

a reservoir portion less than approximately 6.5 cm in length, the reservoir portion defining a space, the reservoir portion formed from a material deformable by squeezing;

a single dosage amount of a pharmaceutical composition formulated for the topical treatment of an anal ailment selected from the group consisting of hemorrhoids, anal fissures, and pruritis ani, the single dosage amount substantially filling the space and comprising lidocaine and hydrocortisone acetate; and

an applicator portion less than approximately 5.0 cm in length comprising a first end adjacent the reservoir portion and a longitudinal portion defining at least one aperture, the first end being flanged outward from the longitudinal axis of the applicator portion such that the first end defines an outer diameter that is substantially greater than any outer diameter of the longitudinal portion and that is less than the outer diameter of the portion of the reservoir portion adjacent the first end, the longitudinal portion being tapered from the first end to an opposite end of the longitudinal portion;

a removable cover configured to surround the longitudinal portion of the applicator portion; and

a blister pack defining an interior configured to accommodate the reservoir portion, the applicator portion, and the removable cover, the blister pack having a child resistant seal,

wherein the dispenser is configured, by squeezing the reservoir portion, for topically administering the single dosage amount of the pharmaceutical composition onto the surface of an anal target area afflicted by the anal ailment, wherein the squeezing applies pressure in a direction not substantially parallel to the longitudinal axis of the reservoir portion and causes a substantial portion of the single dosage amount of the pharmaceutical composition to dispense from the at least one aperture onto the anal target area.