Treating inflammation and inflammatory pain in mucosa using mucosal prolonged release bioadhesive therapeutic carriers

Abstract

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.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a pharmaceutical composition comprising at least one alpha-2 adrenergic receptor agonist, as the active ingredient(s) for preventing or treating inflammatory pain and diseases of mucosa, and notably mucosa of the oral cavity, the pharynx and / or the larynx. In another aspect the present invention provides mucosal bioadhesive slow release carriers for the extended and controlled release of the active ingredient(s) that can be used on mucosal surfaces for preventing or treating inflammatory pain and diseases of mucosa, and notably mucosa of the oral cavity, the pharynx and / or the larynx.BACKGROUND OF THE INVENTION[0002]The mucosa (or mucous membranes) lines various body cavities that are exposed to the external environment. It is at several places continuous with skin: at the nostrils, the lips, the ears, the genital area, and the anus. The mucosa is composed of nonkeratinised stratified squamous epithelium. Its function is t...

AI Technical Summary

Benefits of technology

[0055]Yet another aspect of the present invention is a mucosal bioadhesive slow release carrier comprising or consisting essentially of or consisting of a first active ingredient(s) of clonidine and / or clonidine hydrochloride and / or a clonidine derivative and / or mixtures thereof and at least one second active ingredient(s) different from clonidine, clonidine hydrochloride, a clonidine derivative or mixtures thereof selected from the group of another alpha-2 adrenergic receptor agonist, an alpha-adrenoreceptor agonist, antiviral agents, analgesics, anaesthetics, antalgics, anti-inflammatory agents, antiemetics, antibiotics, antiseptics, an antiviral, an antifungal, a salivation agent, for preventing or treating inflammatory pain and diseases in mucosa, and notably, but not only, mucosa of the oral cavity, the pharynx and / or the larynx.

Problems solved by technology

Inflammation is often cause of pain, like orodental and orofacial pain.

Indeed, the oral cavity, the pharynx and the larynx are an entrance to the digestive tract or the respiratory organ and are susceptible to many stimulations and injuries and cause many kinds of inflammation such as mucositis, stomatitis, lichen planus, periodontal disease, aphtous ulcers, orodental and orofacial pain.

One frequent complication of radiotherapy and chemotherapy is the damage called mucositis that occurs in the mucosa, and more particularly in the mucosal lining of the mouth, the pharynx and / or the larynx.

The disorder is characterized by breakdown of the oral mucosa that results in the formation of ulcerative lesions.

While epithelial degeneration and breakdown ultimately result in mucosal ulceration, it appears that the early changes associated with radiation-induced mucosal toxicity occur within the endothelium, and connective tissue of the submucosa.

However, recent data indicates that even opiods are often insufficient to control mucositis pain.

Currently, the only approved treatment for mucositis is palifermin (Kepivance®), and its application is limited to mucositis in patients undergoing conditioning regimens prior to hematopoietic stem cell transplant.

In addition to the symptoms of mucositis and its impact on quality of life, mucositis adversely affects a variety of other health and economic outcomes.

The duration of hospitalization and risks of serious infection are significantly increased in patients with oral mucositis, which results in an increase of use of resources and higher costs.

Mucositis also threatens the efficacy of treatment plans by necessitating breaks in radiation therapy, reductions in doses of drugs used in chemotherapy and modifications in the selection of antineoplastic agents.

These different treatments are still insufficient for preventing and treating inflammatory pain and diseases in mucosa.

However clonidine has never been used to treat inflammatory pain and diseases in mucosa, particularly mucosa of the oral cavity, pharynx or larynx and more particularly oral mucositis.

However, none of the above patents describe the mucosal delivery of at least one alpha-2 adrenergic receptor agonist or the use thereof to prevent or treat inflammatory pain and diseases in mucosa, and notably mucosa of the oral cavity, the pharynx and / or the larynx.

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