Interstitial therapy for immediate symptom relief and chronic therapy in interstitial cystitis
View Patent ↗The present invention relates to a disorder of the lower urinary tract, and in particular, reducing the symptoms (including treatment) of interstitial cystitis in vivo. In a preferred embodiment, the present invention relates to treatment formulations and methods for reducing interstitial cystitis in patients.
1. A method for inhibiting Interstitial Cystitis and its symptoms in a subject in need thereof, said method comprising administering to said subject an effective amount of a composition comprising a heparinoid, a local anesthetic agent and a buffering compound, thereby inhibiting Interstitial Cystitis and its symptoms in the subject.
2. The method of claim 1 further comprising administering to said subject an effective amount of an osmolar component.
3. The method of claim 2 , wherein the composition is in solution and the osmolar component is present in a sufficient amount so that the final solution is isotonic or near isotonic.
4. The method of claim 3 , wherein the osmolar component is at least one of sodium chloride, dextrose, dextran 40, dextran 60, starch and mannitol or a combination thereof.
5. The method of claim 1 , wherein the local anesthetic agent is at least one of lidocaine, bupivacaine, and mepivacaine.
6. The method of claim 1 , wherein the heparinoid comprises at least one of a heparin, a pentosan polysulfate sodium, a heparan sulfate, a heparin sodium, a hyaluronic acid, and a chondroitin sulfate.
7. The method of claim 6 , wherein the heparinoid comprises at least one of a heparin, a heparan sulfate, a heparin sodium, a hyaluronic acid, and a chondroitin sulfate, and the method further comprises the administration to said subject of an effective amount of sodium pentosan polysulfate to inhibit Interstitial Cystitis.
8. The method of claim 7 , wherein the sodium pentosan polysulfate is administered orally.
9. The method of claim 8 , wherein the sodium pentosan polysulfate is in a quantity from about 100 mg/day to about 600 mg/day.
10. The method of claim 9 , wherein the sodium pentosan polysulfate is in a quantity from about 100 mg/day to about 300 mg/day.
11. A method for repairing a mucin layer of bladder tissue by the method of claim 1 thereby inhibiting Interstitial Cystitis.
12. The method of claim 1 , wherein the buffering compound comprises at least one of sodium bicarbonate and THAM (tromethamine or Tris hydroxymethylpropyl).
13. The method of claim 1 , wherein the effective amount of the buffering compound is 3 ml of 8.4% sodium bicarbonate (w/v) per unit dose.
14. The method of claim 1 , wherein the effective amount of the heparinoid is
(i) about 0.5 mg to about 1000 mg of heparin per unit dose;
(ii) about 1 mg to about 600 mg of pentosan polysulfate sodium per unit dose;
(iii) about 0.5 mg to about 10,000 mg of heparan sulfate per unit dose;
(iv) about 5 mg to about 600 mg of hyaluronic acid per unit dose;
(v) about 1 mg to about 10,000 mg of chondroitin sulfate per unit dose; or
(vi) about 10 mg to about 600 mg of heparin sodium per unit dose.
15. The method of claim 1 , wherein the effective amount of the anesthetic agent is 10 ml of 1% lidocaine or 16 ml of 2% lidocaine per unit dose.
16. The method of claim 1 , wherein the heparinoid, the anesthetic agent, and the buffering compound are administered concomitantly or in sequence.
17. The method of claim 2 , wherein the heparinoid, the anesthetic agent, the buffering compound and the osmolar component are administered concomitantly or in sequence.
18. The method of claim 1 , wherein the subject is selected from the group consisting of human, monkey, ape, dog, cat, cow, horse, rabbit, mouse and rat subjects.
19. The method of claim 1 , wherein administration to said subject is effected by intravesicular administration, administration using liposomes, administration using biodegradable polymers, or administration using a hydrogel.
20. The method of claim 2 , wherein the heparinoid, the anesthetic agent, the buffering compound and the osmolar component are in solution.
21. The method of claim 20 , wherein the solution has a pH from about 7 to 12.
22. A method for monitoring the course of Interstitial Cystitis in a subject, said method comprising
intravesicularly administering a solution containing an amount of potassium that would elicit pain in a subject that has a compromised urothelium, wherein the subject has been administered the composition, comprising a heparinoid, a local anesthetic agent, and a buffering compound, and
monitoring the pain response of the subject at different points in time,
whereby a difference in the amount of pain determined is indicative of the course of the Interstitial Cystitis condition.