Absorbable solid compositions for topical treatment of oral mucosal disorders

Abstract

The invention provides a solid, self-bioadhesive composition for topical application that adheres to the oral mucosal tissue comprising a therapeutically effective amount of at least one herbal or homeopathic active agent; and a pharmaceutically acceptable solid bioadhesive carrier in an amount from about 40 to 99 percent based on the weight of the whole composition.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a divisional of pending prior application U.S. Ser. No . 10 / 083,413 filed Feb. 27, 2002, entitled “Absorbable Solid Compositions for Topical Treatment of Oral Mucosal Disorders”, by Abraham J. Domb and Joseph Simcha Wolnerman, which claims priority to U.S. Ser. No. 60 / 271,735 filed Feb. 28, 2001, both of which are herein incorporated by reference in their entirety.[0002]The present invention relates to oral care compositions in the form of a topical self-adhesive sticker that adheres to the oral tissue surface for treating mucosal disorders such as lesions, aphthous stomatitis, inflamation, microbial infection and toothache. The sticker is comprising at least a minimally effective amount of bioactive herb extract or essential oil. The herbal extract or essential oil is incorporated in the sticker as a powder prepared by evaporating plant extracts onto an inert carrier such as sugars, talc, silicone dioxide, titanium di...

AI Technical Summary

Benefits of technology

"The present invention provides a herbal medication in the form of a long-acting self-bioadhesive sticker that can be placed on oral mucosal lesions such as herpes labialis, aphthous stomatitis, and oral herpes simplex. The sticker contains a therapeutically effective amount of herbal or homeopathic active agents, which act as a physical barrier and provide a slow release of the active ingredients over a period of time. The active agents can include bioactive herb extracts, essential oils, and other natural or synthetic bioactive agents. The sticker can be used for the treatment of various oral lesions and inflammations caused by herpes viruses, allergies, and other factors. The sticker is easy to apply, comfortable to wear, and can stop the progression of the lesion. The invention also provides a bioadhesive solid composition for the treatment of oral lesions that can be easily prepared by compression molding of a powder."

Problems solved by technology

Gingivitis, mucosal lesions, and periodontal disease, are all undesirable conditions that affect many people.

Periodontal disease is an undesirable condition which has widespread occurrence.

These vesicles rupture quickly leaving small ulcerations.

The involved area of the skin is usually hyperesthetic and the associated pain may be severe.

Oral mucositis (stomatitis), a common side effect of chemotherapy, may develop when chemotherapeutic agents used to treat various neoplastic diseases interfere with the maturation and replication of the cells that comprise the oral epithelium.

Oral mucositis is painful and as a result patients neglect oral hygiene and fail to maintain adequate nutrition and hydration.

Tissue injury caused by thermal burns results in protein denaturation, burn wound edema and loss of intravascular fluid volume due to increased vascular permeability.

A pressure sore (decubitus ulcer) results when tissues overlying a bony prominence have been subjected to prolonged pressure resulting in ischemic necrosis and ulceration.

The decubitus ulcer lesion, when open at any stage, poses a risk of infection and, dependent upon the depth of the lesion and the proper elimination of the pressure, can lead to tissue necrosis, epidermal desquamation, osteitis and septicemia.

However, for many persons suffering from cold sores, fever blisters, etc., none of these medications is very effective.

We are concerned that there is potential for adverse reactions any time a patient takes medication systemically that interferes with DNA replication because of the risk of the medication interfering with normal cell DNA replication within the body, as is known to occur as a result of chemotherapy agents which are targeted to interfere with genetic replication of cancer cells and sometimes produce long term adverse side effects.

There are no effective over-the-counter remedies or medications for the treatment of oral lesions related to herpes zoster (shingles), varicella zoster (chickenpox), photodermatitis (sunburn), thermal burns, pressure sores (decubitus ulcers), allergic conjunctivitis or giant papillary conjunctivitis that alter the progression or severity of any of these disease states.

Conventional oral hygiene formulations are not effective in treating oral lesions as their main limitation is the contact time with the lesion surface and that the lesion is exposed to the oral environment.

The main limitation of these toothpaste, mouthwash, mouth rinse, gels, gums and lozenges formulations is the short contact time, typically for a few seconds, which is not enough for treating the lesion.