Claims
- 1. A mucoadhesive solution or suspension for treatment or prevention of mucosal disorders, said solution or suspension having a viscosity of 50-50,000 cps.
- 2. The solution or suspension of claim 1 defined further as being a gel.
- 3. The solution or suspension of claim 1 wherein the viscosity is caused by the mucoadhesive.
- 4. The solution or suspension of claim 1 wherein viscosity is induced or enhanced by a viscosity-inducing agent.
- 5. The solution or suspension of claim 1 where the mucoadhesive is polyvinylpyrrolidone, carboxymethylcellulose, dextran sulfate, hydroxyalkylcellalose, dermatan sulfate, a water-soluble vinyl polymer, chitosan, guar gum, xanthan gum, tragacanth gum or pectin.
- 6. The solution or suspension of claim 1 where the mucoadhesive is cross-linked polyacrylic acid.
- 7. A method of treating or preventing mucocutaneous disorders comprising, applying a viscous mucoadhesive gel, suspension or solution to a mucocutaneous region, said gel, suspension or solution having sufficient residence time and being in a amount sufficient to substantially coat the mucocutaneous region.
- 8. The method of claim 7 where the viscous mucoadhesive has a viscosity of from about 50 cps to about 50,000 cps.
- 9. The method of claim 7 where the mucoadhesive is cross-linked polyacrylic acid.
- 10. A mucoadhesive viscous liquid or mucoadhesive gel suitable for coating a mucosal surface comprising: a cross-linked polyacrylic acid at a viscosity sufficient to enhance residence time of the mucoadhesive on a mucocal surface wherein said gel is usable to protect mucosa, provide relief of symptoms, and delay onset or decrease severity of signs and symptoms of mucositis, including erythema and ulceration, induced by chemotherapy or radiation therapy.
- 11. A mucoadhesive viscous liquid or mucoadhesive gel of claim 10 defined further as comprising a pharmaceutically active compound.
- 12. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 or 11 also containing a preservative with antibacterial activity.
- 13. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 or 11 defined further as being aqueous and comprising less than about 20% of a pharmaceutically-acceptable water-miscible organic solvent.
- 14. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 in which the mucosal surface is of the oral cavity.
- 15. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 in which the cross-linked polyacrylic acid is a Carbopol or polycarbophil.
- 16. The mucoadhesive viscous liquid or gel of claim 10 also containing a viscosity-inducing agent.
- 17. The mucoadhesive viscous liquid or mucoadhesive gel of claim 16 in which the viscosity-inducing agent is an inorganic salt of a monovalent, divalent, or trivalent cation.
- 18. The mucoadhesive viscous liquid or mucoadhesive gel of claim 17 where the salt is Na, K, Ca, Mg, Zn or Al with a pharmaceutically-acceptible chloride, bromide, phosphate, borate, tartrate or benzoate counterion.
- 19. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 in which the viscosity-inducing agent is a pharmaceutically-acceptable organic molecule containing at least two ionizable or hydrogen bonding groups suitable for the formation of electrostatic or H-bonded cross-links of the crosslinked polyacrylic acid.
- 20. The mucoadhesive viscous liquid or mucoadhesive gel of claim 19 where the inducing agent comprises at least one amino acid, peptide, diamine, alcohol, organic acid, fatty acid, polyol, polyvinylalcohol, ethylene oxide/propylene oxide block copolymer or surfactant.
- 21. The mucoadhesive viscous liquid or mucoadhesive gel of claim 12 in which the preservative is methyl parabens, propyl parabens, benzyl alcohol, phenoxyethanol, or mixtures thereof.
- 22. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 or 11 also containing a pharmaceutically-active ingredient.
- 23. The mucoadhesive vicous liquid or mucoadhesive gel of claim 22 where the ingredient is an analgesic, antibacterial, antioxidant, anti-inflammatory agent or free radical scavenger.
- 24. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 or 11 defined as having viscosity of 50-50,000 cps.
- 25. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 or 11 defined as having a viscosity of 100-15,000 cps.
- 26. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 or 11 defined a demonstrating sheer-thinning properties.
- 27. The mucoadhesive viscous liquid or mucoadhesive gel of claim 10 or 11 defined further as containing other pharmaceutically-acceptable excipients to improve the stability, mouth-feel, appearance, and flavor.
- 28. The mucoadhesive viscous liquid or mucoadhesive gel of claim 27 where the excipient is a preservative, humectant, emulsifying agent, antioxidant, antimicrobial agent, solubilizing agent, flavoring agent or sweetening agents.
- 29. The mucoadhesive viscous liquid of mucoadhesive gel of claim 11 in which the total content of pharmaceutically active compounds is less than 5%.
- 30. The mucoadhesive viscous liquid of mucoadhesive gel of claim 11 in which the total content of pharmaceutically active compounds is less than 1%.
- 31. The mucoadhesive viscous liquid of mucoadhesive gel of claim 11 in which the total content of pharmaceutically-active compounds is less than 0.1%.
- 32. The mucoadhesive viscous liquid of mucoadhesive gel of claim 11 in which the content of pharmaceutically-active compounds is 1-5%.
- 33. A viscous, mucoadhesive liquid for treating or preventing mucosal lesions comprising:
- 34. A mucoadhesive gel for treatment or prevention of mucosal lesions:
Parent Case Info
[0001] Continuation-in-part of U.S. patent application Ser. No. 10/077,459, filed Feb. 15, 2002, which in turn claims priority under 35 U.S.C. Section 119(e) to U.S. Provisional Application Serial No. 60/269,049, filed Feb. 15, 2001, now abandoned. The content of each application is hereby incorporated by reference into the present disclosure.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60269049 |
Feb 2001 |
US |
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
10077459 |
Feb 2002 |
US |
Child |
10219634 |
Aug 2002 |
US |