Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2001-01-12
2002-12-10
O'Sullivan, Peter (Department: 1621)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S020800, C514S025000, C536S004100, C536S020000
Reexamination Certificate
active
06492350
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a method for preventing or treating common cold or treating pain by administering a new agent comprising a) at least one chitin oligosaccharide; b) at least one chitosan oligosaccharide; c) at least one partially deacetylated chitin oligosaccharide, wherein some, but not all, of the N-acetyl glucosamine or 2-acetamido-2-deoxy-D-glucose subunits are de-acetylated; d) a mixture of at least one chitin oligosaccharide and at least one chitosan oligosaccharide; e) a mixture of at least one chitin oligosaccharide and at least one partially deacetylated chitin oligosaccharide; or f) a mixture of at least one chitosan oligosaccharide and at least one partially deacetylated chitin oligosaccharide to a subject in need of common cold prevention or treatment or pain treatment. The new agent may further comprise N-acetyl glucosamine and/or glucosamine. The new agent may induce analgesia by absorbing, binding, or otherwise inhibiting bradykinin and ions at the nerve endings as its mechanism. This invention also relates to an oral method of delivery. The new agent is useful in the prevention of the common cold (non-allergic rhinitis, viral upper respiratory tract infection, viral URI, etc) and in reducing the duration and severity of the symptoms of such an infection should this occur.
BACKGROUND OF THE INVENTION
The common cold, one of mankind's most frequent disease afflictions (also called non-allergic rhinitis, viral upper respiratory tract infection, viral URI) is a contagious infectious disease that, while usually self-limiting and non-fatal, has long been a source of limitless suffering with huge expenditures of time and money, as well as being a leading cause of doctor visits. Very few humans escape infection each year and most will suffer multiple infections. It is estimated that most adults will suffer 2-5 colds per year while infants and pre-school children may have 4-8 such infections each year (1). In the course of a year, individuals in the U.S. suffer from over one billion colds which are a leading cause of school and job absenteeism as well as doctor visits. Broken down further, children have more colds than adults probably due to their relative lack of resistance to infection and to contact with other infected children in school and daycare centers. Women, particularly in the age range 20-30, have more colds than men due to their closer contact with children (2). The economic impact of the common cold can only be estimated. According to the National Center for Health Statistics, in 1995, 61 million cases of the common cold required medical attention. There were 58 million bed days lost to the common cold, 24 million days of restricted activity, and 22 million lost school days (3). The exact dollar figure spent or lost can only be estimated but probably is in the tens of billions. (It should be noted that these figures are for the United States only).
Although rarely fatal in and of itself, the common cold may lead to more serious complications in the very young, the very old, and those that are immunocompromised. Such complications include bacterial suprainfection, pneumonia, bacterial sinusitis, and otitis media. In addition, the common cold is responsible for many exacerbations of asthma, a serious multi-billion dollar per year respiratory disease responsible for over 5,000 deaths per year, a figure that keeps rising (4,5,6).
Yet despite the prevalence, destructiveness, and costs of the disease, surprisingly little or no progress has been made toward effective cold treatment (7). Antibiotics, which are prescribed with disturbing frequency by practitioners and demanded by patients who want “something done”, are ineffective both theoretically and in practice since the common cold is caused by a virus, not a bacteria (see Detailed Description of the Invention for a discussion of the pathology of the common cold) (8, 9, 10). In fact, the misuse and over-prescription of antibiotics for the common cold has led to dangerous mutant resistant strains of micro-organisms such as MRSA (methacillin resistant staphylococcus aureus). Vitamin C, as proclaimed by two-time Nobel Prize winner Dr. Linus Pauling, has also been reputed to both prevent colds and decrease the symptoms should a cold occur, when given in so-called “mega doses” ie>5-10 grams per day (RDA=65-130 mg per day). However, numerous studies since Dr. Pauling's work have failed to duplicate his results, and the role of vitamin C, if any, is still open to debate (11, 12, 13, 14, 15). Over-the-counter cold prescriptions invariably act to suppress symptoms locally through actions against such things as histamine (the antihistamine group of drugs ie Benadryl) or through various actions on the autonomic nervous system (such as ephedrine-a sympathomimetric amine. It should be noted that these drugs have side effects, some of which can be serious. Other experimental drugs such as BIRR 4 (also called tremacara) must be applied directly to the nose before being exposed to the virus, which does little good for the average individual who has no idea when or where he will come in contact with the cold virus. However, experiments involving tremacara have proven clinically the theoretical efficacy of blocking the rhinovirus/ICAM-1 receptor sites for reducing the severity of rhinovirus cold infections. A variety of alternative and folk remedies (zinc, ecchinacea, etc) have also been used over the years with variable and largely unreproducable results (16,17). Thus, there is a need for an agent effective in preventing and/or treating common cold. The present invention concerns such an agent and a method of preventing and/or treating common cold.
Pain and the suffering it causes is one of the oldest afflictions known to man/ The relief of such pain and suffering has long been one of the most solemn duties of the health professional. Between 75-100 million Americans suffer from chronic pain; osteoarthritis alone affects over 25 million Americans and over 40 million experience chronic recurring headaches. Upwards of $4,000,000,000 are spent on pain medication alone (not to mention physician fees, lost work time, hospitalization, etc) and it is estimated that chronic pain may play a factor in up to 50% of suicides. Yet despite the expense and trouble, 60-80% of people say that they are dissatisfied with their pain medication (28).
The International Association for the Study of Pain defines pain as “an unpleasant sensory or emotional experience arising from actual or potential tissue damage or described in terms of such damage”.
Acute pain is one dimensional and is always a sign or symptom of underlying pathology. Chronic pain (arising from a chronic condition, an injury that lasts longer than expected, or for which there is no known cause i.e. fibromyalgia) is considered to be without purpose and may be properly considered a disease.
Analgesics have classically been considered into three major groups:
1) central acting (opioids, tramadol);
2) peripheral acting (non-steroidal anti-inflammatory drugs also called NSAIDS as well as acetaminophen commonly called Tylenol); and
3) local (steroid injections, etc).
The opioids variably block and stimulate certain areas of the brain involved in pain and its perception. However, all narcotics can and do cause:
increasing tolerance (more and more of the drug is required as time goes on to achieve the same analgesic effect);
nausea and vomiting;
other gastrointestinal effects such as abdominal pain, constipation, and diarrhea;
addiction, with all of its social, legal, and financial implications as well as its toll on health;
overdose; and
sudden death (idiosyncratic reaction).
The peripheral acting agents which includes NSAIDS such as aspirin and other salicylates, ibuprofen, indomethacin, etc work by inhibiting the cyclooxygenase (COX) enzyme system in inflammatory cells thereby inhibiting prostaglandins and thus are of limited value in painful conditions where inflammation is not a prominent feature of the disease (such as osteoarthritis
Gauthier Jay H.
Konno Allen I.
Matahira Yoshiharu
Arent Fox Kintner & Plotkin & Kahn, PLLC
JDC (Hawaii) Inc.
O'Sullivan Peter
LandOfFree
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