Granted Patent B2

US 7,544,348 · App. 10/219,634 · Granted Jun 9, 2009

Assignee: Access Pharmaceuticals, Inc.

Abstract

Claims (20)

1. A pseudoplastic liquid composition for treating or inhibiting an oral mucocutaneous disorder, said pseudoplastic liquid composition having a zero shear viscosity at 37±1 degrees Celsius of 100-20,000 centipoise, comprising 0.1 to 2.0 wt/wt% of one or more mucoadhesives, wherein the mucoadhesive(s) is/are selected from the group consisting of polyvinylpyrrolidone, carboxymethylcellulose, dextran sulfate, hydroxyalkylcellulose, dermatan sulfate, a water-soluble vinyl polymer, chitosan, guar gum, xanthan gum, tragacanth gum, pectin and polyacrylic acid; wherein said pseudoplastic viscous liquid composition, when administered to an oral mucosa:

1) remains liquid when shear is applied due to swishing the liquid in the mouth; and

2) attaches to and coats the oral mucosa upon discontinuance of said shear.

2. The pseudoplastic liquid composition of claim 1 , wherein the mucoadhesive is cross-linked polyacrylic acid.

3. The pseudoplastic liquid composition of claim 2 , wherein the mucoadhesive is selected from the group consisting of carbopol or polycarbophil.

4. The pseudoplastic liquid composition of claim 1 , wherein the mucositis is erythema or ulceration induced by chemotherapy or radiation therapy.

5. The pseudoplastic liquid composition of any one of claims 1 or 2 , further comprising a preservative with antibacterial activity.

6. The pseudoplastic liquid composition of claim 5 , wherein the preservative is selected from the group consisting of methyl parabens, propyl parabens, benzyl alcohol, phenoxyethanol and mixtures thereof.

7. The pseudoplastic liquid composition of any one of claim 1 or 2 , further comprising one or more viscosity-inducing agent(s).

8. The pseudoplastic liquid composition of claim 7 , wherein the viscosity-inducing agent is selected from the group consisting of an inorganic salt of a monovalent, divalent or trivalent cation.

9. The pseudoplastic liquid composition of claim 8 , wherein the inorganic salt is selected from the group consisting of pharmaceutically-acceptable sodium, potassium, calcium, magnesium, zinc or aluminum chloride, bromide, phosphate, borate, tartrate or benzoate.

10. The pseudoplastic liquid composition of claim 7 , wherein the viscosity-inducing agent is selected from the group consisting of agar, bentonite, glycerin, povidone, kaolin, tragacanth and sodium alginate.

11. The pseudoplastic liquid composition of any one of claims 1 or 2 , further comprising one or more pharmaceutically-acceptable excipients.

12. The pseudoplastic liquid composition of claim 11 , wherein the pharmaceutically-acceptable excipient(s) is/are selected from the group consisting of a preservative, a humectant, an emulsifying agent, an antioxidant, an antimicrobial agent, a solubilizing agent, a flavoring agent and a sweetening agent.

13. The pseudoplastic liquid composition of claim 1 wherein the amount of mucoadhesive is 0.35 weight percent.

14. A pseudoplastic liquid composition for treating or inhibiting an oral mucocutaneous disorder, said liquid composition having a zero shear viscosity at 37±1 degrees Celsius of 100-20,000 centipoise, said liquid composition comprising 5% by weight of glycerine, 0.35% by weight of carbopol, 0.35% by weight of potassium hydroxide, and about 1 .5% by weight of benzyl alcohol; wherein said viscous liquid composition, when administered to an oral mucosa:

1) remains liquid when shear is applied due to swishing the liquid in the mouth; and

2) attaches to and coats the oral mucosa upon discontinuance of said shear.

15. A pseudoplastic liquid composition of claim 1 , 13 or 14 , wherein the composition provides a mean Son is scale rating of less than 1 when contacted with the oral mucosa of a subject suffering from mucositis.

16. The pseudoplastic liquid composition of claim 15 , wherein the subject suffering from mucositis is a cancer patient undergoing cancer therapy.

Assignments (8)

Continuity (3)