Drug – bio-affecting and body treating compositions – Dentifrices – Oxygen or chlorine releasing compound containing
Reexamination Certificate
2000-01-27
2001-03-13
Dudash, Diana (Department: 1619)
Drug, bio-affecting and body treating compositions
Dentifrices
Oxygen or chlorine releasing compound containing
C424S054000, C424S613000, C424S616000, C514S588000, C514S714000, C514S901000
Reexamination Certificate
active
06200551
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to the use of hydrogen peroxide for the treatment of xerostomia (a medical condition commonly known as “dry mouth”). More specifically, the invention relates to the use of carbamide peroxide, a stable compound of hydrogen peroxide and urea, for relieving the symptoms and side-effects of xerostomia.
Saliva is a complex mixture of fluids, proteins, enzymes, and electrolytes that are produced by the salivary glands which surround the oral cavity, and is secreted into the mouth following appropriate stimulation of oral tissues. Secretion of saliva is regulated by the body's autonomic nervous system which permits involuntary secretion following an appropriate stimulus such as tasting or chewing food, smelling or thinking of food, or having any object within the mouth which stimulates the oral mucosa.
Xerostomia occurs when inadequate amounts of saliva are secreted into the mouth, preventing adequate lubrication of the oral cavity and resulting in an uncomfortable oral sensation and difficulty with speaking and swallowing. Severe cracking of the tongue can also result. In addition to the primary role of lubricating the oral cavity during conversation and eating, saliva also limits growth of bacteria that can cause tooth decay and oral infections, promotes digestion of food, and acts as a protective barrier against demineralization of tooth enamel.
Xerostomia can result from either decreased production of saliva within the glands and/or diminished secretion of saliva from the glands following autonomic stimulation. It is most commonly caused as an unwanted side effect of many classes of prescription medications including anticholinergics, antispasmodics, antihypertensives, antidepressants, anticonvulsants, pain killers, anti-rejection drugs, and antipsychotics, as well as over-the-counter decongestants and antihistamines. These classes of drugs either directly inhibit saliva production within the glands or inhibit its secretion into the mouth by inhibiting the autonomic nervous system.
Xerostomia can also occur during states of elevated stress, anxiety, depression, with certain endocrine diseases such as hypothyroidism, during chemotheraphy, and with auto-immune disorders such as Sjogren's syndrome. Additionally, people who have had radiation therapy to the neck, traumatic injury to the neck, or neck surgery may also develop xerostomia due to destruction of the glands by the therapeutic radiation dose, or direct injury of the gland and its controlling autonomic nerves. Xerostomia is increasingly common among people of advancing age.
Typical treatment considerations for xerostomia have involved supportive and replacement therapies to restore oral moisture, as well as pharmacologic agents to stimulate the body's own saliva production.
Supportive therapy incorporates behavior and dietary modifications to keep the mouth moist throughout the day to minimize discomfort. Such strategies include frequent drinks of water, avoiding liquids with caffeine or sugar, avoiding alcohol and tobacco products, avoiding spicy or acidic foods, and following a regular daily dental hygiene program.
Replacement therapy incorporates oral administration of exogenous saliva-like compounds in order to replenish lost moisture, fluids and enzymes in the oral cavity, while introducing an appropriately viscous compound that aids in the mechanics of speaking and swallowing. Reference to current medical literature reveals several saliva replacement products.
BIOTENE, produced by Laclede Inc., is a salivary enzyme replacement system in a toothpaste form that contains the active ingredient found in toothpaste (sodium monofluorophosphate) and the major enzymes found in saliva (lactoperoxidase, thiocyanate and glucoseoxidase). BIOTENE primarily functions to prevent the damage caused by harmful bacteria that can accumulate in the mouth when inadequate amounts of saliva are present. In toothpaste form it is less effective at long-term relief of the classic symptoms of dry mouth but is also available in mouthwash, chewing gum, and oral gel (ORALBALANCE) preparations which include oral moisturizing agents that are more effective in longer duration of symptom relief.
SALIX, produced by Reach4Life Enterprises, is available in tablet form and contains sorbitol, polyethylene glycol, malic acid, hydrogenated cottonseed oil, sodium citrate, dicalcium phosphate, citric acid, silicon dioxide, and carboxy methylcellulose. It acts as a temporary semi-viscous saliva substitute to improve the mechanics of speaking and swallowing but does little to inhibit oral bacteria responsible for tooth decay.
SALAGEN, commonly known as pilocarpine hydrochloride, produced by MGI Pharma, Inc., is a pharmacologic agent that is indicated and approved for treatment of xerostomia in persons who have undergone radiation therapy to the neck and in persons with Sjogren's syndrome. Available in tablet form, SALAGEN is a cholinergic agent that is effective in pharmacologically increasing secretions from the salivary glands thereby improving the symptoms of xerostomia. Salagen™ however acts on all exocrine glands in the body and also increases secretions from the skin, eyes, pancreas, intestines, and lungs with unwanted and sometimes deleterious side-effects. Additionally, pilocarpine can cause decreased visual acuity and cardiovascular collapse with serious and possibly life-threatening consequences.
It is evident that current supportive and replacement therapies for treating xerostomia (BIOTENE and SALIX) are temporary and do little to directly stimulate the body to produce and secrete more natural saliva. Current pharmacologic therapies (SALAGEN) which do increase the body's natural saliva production also cause unwanted increased secretions in other organs and can have serious side-effects. The current invention describes a compound that relieves the symptoms of xerostomia by causing the salivary glands to produce and secrete natural saliva into the oral cavity without the serious and lifestyle-limiting side effects of current pharmacologic agents.
While the previously discussed therapies are suitable for their particular purposes, they are not suitable for the purposes of the current invention which employs an over-the-counter drug compound to increase natural saliva production and secretion in persons with xerostomia without the serious side-effects associated with currently available prescription medication.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a system which effectively treats xerostomia, and relieves the discomfort associated therewith. Accordingly, the current invention relates to the use of carbamide peroxide as a salivary replacement system to stimulate the body's own production of saliva by an oxygen-releasing biochemical foaming process within the mouth. In addition, the composition according to the present invention can act as a oral moisturizer and a saliva substitute.
It is a further object of the invention to provide a system which is known to be safe, so that it is approved for use in the manner of the present invention. Accordingly, the active ingredient of the invention is carbamide peroxide. Carbamide peroxide is a stable organic compound of urea and hydrogen peroxide which is currently employed in several over-the-counter drug remedies for removal of ear wax (MURINE, DEBROX), oral debriding and cleansing agents (GLYOXIDE, ORAJEL) and tooth whitening agents (PLATINUM OVERNIGHT). Carbamide peroxide has been fully described in FDA drug monographs listed in the Federal Register (21 CFR Parts 201, 344, 353, 356, and 369) for over-the-counter agents.
It is a further object of the invention to provide a system which is both capable of stimulating saliva production, but is also capable of clearing some mechanical blocking of the salivary ducts. Accordingly, the effervescent reaction of the carbamide peroxide within the mouth is capable of clearing distal blockages of the salivary ducts.
The invention is a treatment for xerostomia, empl
Dudash Diana
Goldstein & Canino
Sharareh Shahnam
LandOfFree
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