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Claims for Patent: 5,242,391

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Claims for Patent: 5,242,391

Title: Urethral insert for treatment of erectile dysfunction
Abstract:Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (1) having a rapidly releasing coating (4) containing the agent on its exterior surface or by means of an inserter (27) carrying an agent containing dose of agent (31) which can be displaced into the urethra.
Inventor(s): Place; Virgil A. (Kawaihae, HI), Gale; Robert M. (Los Altos, CA), Berggren; Randall G. (Livermore, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Application Number:07/787,306
Patent Claims: 1. A dosage form for administering a therapeutic agent to the urethra, said dosage form comprising an insert component received within a container component, wherein:

a) said insert component comprises

(i) a shaft portion sized to be received within the urethra;

(ii) a plug attached to said shaft portion portion having a dimension greater than the diameter of the urethra to prevent complete insertion of said insert into the urethra; and

(iii) a dose containing a therapeutic amount of said agent, said dose being carried in its entirety by said shaft; and

b) said container component is closed at one end, open at the other end and of sufficient length to receive said shaft and at least a portion of said plug, the open end of said container being sized to form a sliding seal with said plug.

2. The dosage form of claim 1 wherein said plug is completely received within said container and said insert component further comprises a cap portion at the end of said plug opposite said shaft, said cap having a cross-sectional configuration which is not receivable within said container, the open end of said container abutting said cap.

3. The dosage form of claim 1 or 2 wherein said dose comprises an agent containing coating on at least a portion of the external surface of said shaft and the interior of said container component is sized to maintain a spaced apart relationship with said coating.

4. The dosage form of claim 3 wherein the amount of said dose does not exceed the dose retaining capacity of the urethra and comprises said agent dispersed in a dispersant.

5. The dosage form of claim 4 wherein said dose weighs less than 100 mg.

6. The dosage form of claim 1 or 2 wherein said insert component further comprises:

(iv) a cavity in the end of the shaft opposite said plug, said dose being within said cavity; and

(v) means within said shaft for displacing said dose from said cavity into the urethra, said means being movable from a first position where said dose is within said cavity to a second position where said dose is displaced into the urethra.

7. The dosage form of claim 6 wherein said insert component further comprises means for preventing unintentional displacement of said dose from said cavity.

8. The dosage form of claim 6 wherein the amount of said dose does not exceed the dose retaining capacity of the urethra and comprises said agent dispersed in a dispersant.

9. The dosage form of claim 8 wherein said dose weighs less than 100 mg.

10. The dosage form of claim 1 or 2 wherein the amount of said dose does not exceed the dose retaining capacity of the urethra and comprises said agent dispersed in a dispersant.

11. The dosage form of claim 10 wherein said dose weighs less than about 50 mg.

12. The dosage form of claim 10 wherein said shaft portion is about 2-5 cm in length.

13. The dosage form of claim 10 wherein said dose weighs less than 100 mg.
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