Lesion and ulcer medication

Details Lesion and ulcer medication Lesion and ulcer medication

2001-10-17

2003-04-29

Tate, Christopher R. (Department: 1651)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Implant or insert

C424S434000, C424S485000, C424S195180, C514S925000, C514S928000

Reexamination Certificate

active

06555125

ABSTRACT:

FIELD OF INVENTION
The present invention relates to the field of medications for the treatment of lesions and ulcers, and in particular to medications for treatment of intraoral ulcers. More particularly, the present invention provides a composition and a method for treatment of intraoral ulcers which promotes rapid healing, promotes immediate relief from severe pain, and prevents secondary infections.
BACKGROUND OF INVENTION
An effective cure of intraoral ulcers has been sought by the medical and dental communities without success. There is essentially no known cause or cure of intraoral ulcers. These ulcers can be extremely painful to patients, and generally persist for seven to ten days. Research over the last several decades has not provided any significant answers or treatment regimens.
While the etiologies of oral aphthae, or canker sores, are quite varied, the central concern is the severe pain they cause. This pain affects the quality of life for millions of individuals. It is believed that the pain related to the oral ulcerative lesions is made more severe by the secondary infections caused by the prevailing oral bacteria.
Historically, intraoral ulcers and lesions were treated with chemical cautering techniques, often involving silver nitrate sticks. These methods involve the use of highly caustic substances to cause a scarring of the ulcer or lesion. These methods all shared the common characteristic in that they themselves caused severe pain in the patients. There was concern as to whether the pain caused by these treatments actually exceeded the pain caused by the ulcer or lesion they were intended to treat. Examples of chemical cautering products include Negatan from Savage Laboratories. More recent treatments have similarly involved the use of caustic agents, such as chlorhexidine, the active ingredient in Kanka, an over-the-counter intraoral ulcer medication.
One currently used common treatment for intraoral ulcers is the use of acylovir, an antiviral agent effective in treatment of certain forms of herpes. Acyclovir is available from Glaxo Wellcome under the tradename Zovirax. Zovirax consists essentially of acyclovir in a polyethylene glycol base and is available as an ointment or rinse. This product approaches the problem of ulcers based on the hypothesis that such ulcers or lesions are viral in nature. Another recent treatment is use of a product called Aphthasol, available from the Block Drug Company. Aphtasol consists of amlexanox, an antihistamine, in an adhesive paste. This treatment is based on the hypothesis that oral ulcers and lesions are caused by an autoimmune or allergic response of the body. However, none of the above products has proven to be effective in reliably reducing the pain associated with the ulcer while simultaneously speeding the healing process and preventing secondary infections.
SUMMARY OF THE INVENTION
The present invention is based on the discovery that certain combinations of antimicrobial agents, anti-inflammatories, and antihistamines, along with an accompanying mucoadhesive provide unexpected and highly effective intraoral ulcer medications. The present invention provides an intraoral ulcer medication which prevents both secondary infection and promotes healing while simultaneously providing immediate relief from pain. This ulcer medication comprises an antimicrobial, an anti-inflammatory, an antihistamine, and optional antifungal and anesthetic components along with a mucoadhesive or equivalent.
The antimicrobial component can be any bacteria or microbe resistant compound suitable for intraoral application, including but not limited to Tetracycline HCl and Zinc Oxide. Tetracycline HCl is preferred due to the minimal chance of an allergic reaction due to its use. Tetracycline HCl is a very effective antibiotic for preventing secondary infections associated with intraoral ulcers. Such secondary infections may be due to, but not limited to,
Streptococcus mutans,
a bacteria commonly present in the mouth. Zinc oxide has also been shown to have antimicrobial properties, especially with respect to
Streptococcus mutans,
as well as providing a degree of soothing relief from the pain associated with intraoral ulcers. Zinc Oxide could be used alone, or in addition to Tetracycline HCL, or other antimicrobial agent that is selected. The advantage of Zinc Oxide is its availability as a non-prescription component, which is accentuated where the other components selected share this non-prescription characteristic, as well as its efficacy as an antimicrobial at low concentrations. The other antimicrobial agents which could be selected include, but are not limited, to the various forms of Penicillin based antibiotic/antimicrobial agents.
The antihistamine component can be any antihistamine compound suitable for intraoral application, including but not limited to Diphenhydramine. Diphenhydramine is preferred since it is an effective antihistamine and is available as an over-the-counter drug. The advantage of an over-the-counter component is accentuated where the other components selected share this non-prescription characteristic. The inclusion of an antihistamine in this medication is based on the observation of an allergy etiology with some aphthous ulcers.
The anti-inflammatory component helps promote the healing process for the lesion or ulcer. The anti-inflammatory component can be any steroid, or other form of anti-inflammatory, component suitable for intraoral application, including but not limited to Dexamethasone. Dexamethasone is preferred since it is a particularly effective steroid.
The optional antinfungal component can be any fungal resistant compound suitable for intraoral application.
Additionally, Metronidazole may be particularly useful when used in treatment of intraoral ulcers in patients who are HIV-positive. Metronidazole is preferred due to its efficacy in the treatment of aphthous ulcers. Particularly where the composition is to be used in patients who are HIV-positive, inclusion of an agent such as Metronidazole is recommended.
The addition of an optional topical anesthetic to the composition of the present invention can assist in the decrease of the pain associated with the ulcer or lesion. While the optional anesthetic can be any anesthetic suitable for intraoral application, Benzocaine is preferred. Special care must be taken with use in patients who are allergic to caine derivatives. The optional anesthetic functions to provide immediate relief in situations where the pain from the intraoral ulcer is particularly intense.
The mucoadhesive component can be any mucoadhesive component for intraoral application suitable for intraoral application, including but not limited to Karaya Gum or Orabase. Karaya gum is an effective mucoadhesive, which allows the compound to remain on the lesion. Karaya Gum is preferred due to its inexpensive nature, and its availability in powdered form for use in the powdered medication form.
In the preferred embodiment the medication comprises effective amounts of Tetracycline HCl, Metronidazole, Dexamethasone, Diphenhydramine, Zinc Oxide, and Karaya Gum. A representative example of a possible composition of the preferred embodiment is shown in Example 1 below. In another embodiment, the composition of Example 1 is formed omitting the optional component Metronidazole, keeping all other components the same.
Use of the compound shown in Example 1 on patients has resulted in oral lesions and ulcers disappearing within 72 hours, some within 24 to 48 hours. The pain associated with the ulcer is reported to disappear immediately.


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