TREATING INFLAMMATION AND INFLAMMATORY PAIN IN MUCOSA USING MUCOSAL PROLONGED RELEASE BIOADHESIVE THERAPEUTIC CARRIERS
The present invention concerns a pharmaceutical composition comprising an alpha-2 adrenergic receptor agonist for preventing or treating inflammatory pain and diseases in mucosa of oral cavity, pharynx and larynx. Inanother aspect the present invention provides mucosal bioadhesive slow release carriers for the extended and controlled release of alpha-2 adrenergic receptor agonists that can be used on mucosal surfaces for preventing or treating inflammatory pain and diseases in mucosa of oral cavity.
1 .- 15 . (canceled)
16 . Clonidine and/or clonidine hydrochloride and/or a clonidine derivative and/or mixtures thereof for the prevention or treatment of an inflammatory pain and/or disease in the mucosa.
17 . A pharmaceutical composition comprising clonidine and/or clonidine hydrochloride and/or a clonidine derivative and/or mixtures thereof, as an active ingredient for the prevention or treatment of an inflammatory pain and/or disease in the mucosa.
18 . The pharmaceutical composition according to claim 17 , for the prevention or treatment of an inflammatory pain and/or disease in the mucosa of an oral cavity and/or pharynx and/or larynx.
19 . The pharmaceutical composition according to claim 17 , for the prevention and/or treatment of mucositis and/or stomatitis and/or lichen planus and/or periodontal disease and/or aphtous ulcers and/or oesophagitis and/or rectocolitis and/or Crohn's disease and/or orodental pain and/or orofacial pain and/or combinations thereof.
20 . The pharmaceutical composition according to claim 17 , for the prevention and/or treatment of inflammation due to chemotherapy or radiation treatment.
21 . The pharmaceutical composition according to claim 17 , for the prevention and/or treatment of mucositis.
22 . The pharmaceutical composition according to claim 16 , for use by administration to immunodepressed subjects.
23 . The pharmaceutical composition according to claim 16 , which comprises said clonidine and/or clonidine hydrochloride and/or a clonidine derivative and/or mixtures thereof in a form suitable for transmucosal administration.
24 . The pharmaceutical composition according to claim 16 , for use by transmucosal administration.
25 . The pharmaceutical composition according to claim 16 , wherein said clonidine and/or clonidine hydrochloride and/or a clonidine derivative and/or mixtures thereof is contained in a mucoadhesive and slow release bioadhesive carrier.
26 . The pharmaceutical composition according to claim 17 wherein said clonidine and/or clonidine hydrochloride and/or a clonidine derivative and/or mixtures thereof is contained in a mucoadhesive slow release bioadhesive carrier comprising between 0.001 to 10% of clonidine and/or clonidine hydrochloride and/or a clonidine derivative and/or mixtures thereof as an active ingredient, between 1% to 75% by weight of at least one diluent, between 5 to 80% by weight of at least one bioadhesive agent and between 5 to 80% by weight of at least one sustained release agent that provides sustained release of the active ingredient.
27 . A mucoadhesive slow release bioadhesive carrier according to claim 26 for the prevention and/or treatment of an inflammatory pain and/or disease of the mucosa.
28 . A mucoadhesive slow release bioadhesive carrier according to claim 26 for the prevention and/or treatment of an inflammatory pain and/or disease of mucositis.
29 . A process for preparing a mucoadhesive slow release tablet as defined in claim 16 comprising:
a) solubilizing clonidine and/or clonidine hydrochloride and/or a clonidine derivative and/or mixtures thereof in an aqueous solution;
b) granulating by applying the solution obtained in a) on a mixture of diluents, binder and eventually at least one bioadhesive agent;
c) blending said mixture with a lubricant and at least one bioadhesive agent and/or one sustained release polymer; and
d) compressing the blended mixture obtained in c).
30 . A process for preparing a mucoadhesive slow release tablet according to claim 29 characterized in that the granulation in step b) is carried out by spraying.
31 . The pharmaceutical composition according to claim 18 , for the prevention and/or treatment of mucositis and/or stomatitis and/or lichen planus and/or periodontal disease and/or aphtous ulcers and/or oesophagitis and/or rectocolitis and/or Crohn's disease and/or orodental pain and/or orofacial pain and/or combinations thereof.
32 . The pharmaceutical composition according to claim 18 , for the prevention and/or treatment of inflammation due to chemotherapy or radiation treatment.
33 . The pharmaceutical composition according to claim 19 , for the prevention and/or treatment of inflammation due to chemotherapy or radiation treatment.
34 . The pharmaceutical composition according to claim 18 , for the prevention and/or treatment of mucositis.
35 . The pharmaceutical composition according to claim 19 , for the prevention and/or treatment of mucositis.