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Claims for Patent: 6,432,440

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Claims for Patent: 6,432,440

Title: Pectin compositions and methods of use for improved delivery of drugs to mucosal surfaces
Abstract:Liquid pharmaceutical compositions for administration to a mucosal surface, comprising a therapeutic agent and a pectin with a low degree of esterification are described. Such compositions gel, or can be adapted to gel, at the site of application in the absence of an extraneous source of divalent metal ions.
Inventor(s): Watts; Peter James (Nottingham, GB), Illum; Lisbeth (Nottingham, GB)
Assignee: West Pharmaceutical Services Drug Delivery & Clinical Research Centre ( (Nottingham, GB)
Application Number:09/402,976
Patent Claims: 1. A liquid pharmaceutical composition for administration to a mucosal surface comprising a therapeutic agent, a pectin with a degree of esterification of less than 50%, and an aqueous carrier,

wherein the composition gels or is adapted to gel at a site of application on the mucosal surface in the absence of an extraneous source of divalent metal ions.

2. The composition of claim 1 wherein the mucosal surface is the nasal cavity.

3. The composition of claim 1 wherein the mucosal surface is the vagina.

4. The composition of claim 1 wherein the mucosal surface is the rectum.

5. The composition of claim 1 wherein the mucosal surface is the back of the throat.

6. The composition of claim 1 wherein the mucosal surfaces is the eye.

7. The composition of claim 1 which is administered as a spray or a liquid free flowing system.

8. The composition of claim 1 wherein the pectin concentration in the composition is from 1 to 100 g/L.

9. The composition of claim 1 wherein the pH of the composition is between 2 and 9.

10. The composition of claim 1 wherein the therapeutic agent is an antiviral agent for delivery to the nose or the vagina.

11. The composition of claim 1 wherein the therapeutic agent is a vaccine for delivery to the nose, the rectum, or the vagina.

12. The composition of claim 1 wherein the therapeutic agent is a decongestant agent.

13. The composition of claim 1 wherein the therapeutic agent is a contraceptive agent.

14. The composition of claim 1 wherein the therapeutic agent is a vaginal lubricating agent.

15. The composition of claim 1 wherein the therapeutic agent is an anti-allergic agent.

16. The composition of claim 1 in a pharmaceutically acceptable dosage form suitable for administration to a mucosal surface.

17. The composition of claim 16 wherein the form is a spray or a liquid free flowing system.

18. A kit of parts comprising a liquid pharmaceutical composition for administration to a mucosal surface, the composition comprising a therapeutic agent, a pectin with a low degree of esterification, and an aqueous carrier, which composition gels or is adapted to gel at the site of application, wherein the kit does not include a solution of divalent metal ions to be added extraneously to the mucosal surface.

19. The kit of claim 18 further comprising instructions to administer the composition to the mucosal surface in the absence of an extraneous source of divalent metal ions.

20. A pharmaceutical gel composition obtained by applying a liquid composition, comprising a therapeutic agent, a pectin with a degree of esterification of less than 50% and an aqueous carrier, to a mucosal surface of a mammalian patient in the absence of extraneous application of a solution of divalent metal ions to the mucosal surface.

21. A method of treatment or prophylaxis of a disease comprising administering to a mucosal surface of a patient in need of the treatment or prophylaxis a liquid pharmaceutical composition, comprising a therapeutic agent which is effective against the disease, a pectin with a low degree of esterification, and an aqueous carrier, which composition gels or is adapted to gel at the site of administration in the absence of extraneous application of a solution of divalent metal ions to the mucosal surface.

22. The method of claim 21 wherein the patient is a mammal.

23. A method for the delivery of therapeutic agents to a mucosal surface in a mammal, which method comprises administering a liquid pharmaceutical composition, comprising a therapeutic agent, a pectin with a degree of esterification of less than 50%, and an aqueous carrier, which composition gels or is adapted to gel at the site of administration in the absence of extraneous application of a solution of divalent metal ions to the mucosal surface.

24. A process for the preparation of a liquid pharmaceutical composition comprising providing a therapeutic agent, a pectin with a degree of esterification of less than 50%, and an aqueous carrier; and mixing together the therapeutic agent and the pectin in the aqueous carrier to form a liquid composition that gels or is to gel at a site of administration on a mucosal surface in the absence of extraneous application of a solution of divalent metal ions to the mucosal.
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