Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-07-29
2001-11-27
Fonda, Kathleen Kahler (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C536S020000
Reexamination Certificate
active
06323189
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention pertains to novel chitosan-containing liquid compositions, their methods of preparation, and their methods of use. In particular, the invention pertains to a chitosan-containing liquid suspension composition which remains stable and is usable as an additive, for instance, in water or water-based liquids.
BACKGROUND OF THE INVENTION
We live in a society obsessed with overall personal appearance and losing weight. Despite this obsession, medical reports confirm that 68% of all Americans are overweight, and 33% of those past the age of 20 are clinically obese. This equates to 64 million overweight adults in the just the United States alone. Beyond the obvious cosmetic considerations, obesity is one of the leading causes of heart disease, hypertension, stroke, and diabetes, and is a contributing cause in cancer. The size of the market for weight control products is estimated at over $100 billion per annum worldwide and is ever increasing. There clearly is a need for an effective, safe, and palatable weight control product to stop this growing problem.
The medical profession has long proclaimed the benefits of a high fiber, low fat diet. Chitosan has received considerable attention in this context since it can be applied to bind fat in food, creating an indigestible mass that lets the fat pass unabsorbed through an individual's digestive system and right out of the body. Chitosan (i.e., (1→4) 2-amino-2-deoxy-&bgr;-D-glucosamine, also known as polyglucosamine) is a water-immiscible biopolymeric compound comprising partially or fully deacetylated chitin. Chitin is a cellulose-like polymer that is present in fugal walls and the exoskeletons of arthropods, including insects, crabs, shrimp, and lobsters. Chitosan can bind up to 4 to 6 times its weight in oils, greases, and toxic substances (Nauss et al., Lipids, 18 (10), 714-719 (1983)). This capacity of chitosan derives from its possession of positively charged amino groups that bind to negatively charged fatty acids (the building blocks of fat) and bile acids (used in making cholesterol).
Chitosan's unique abilities are responsible for its employ as an additive or primary component in numerous applications in the fields of food, health, cosmetics, agriculture, waste-water treatment, as well as in other industries. In the food and health industry, chitosan currently is available in tablet form under several brand names. Also, tablets containing chitosan combined with ascorbic acid are presently marketed. Ascorbic acid acts in synergy with chitosan to provide fat absorption properties which are greatly enhanced over those of chitosan alone. However, chitosan tablets are bulky, need to be taken in large quantities, have an unpleasant taste, and may possess other noticeable side effects. Thus, there is a current need for a product that provides for weight control and is easy to use, particularly in comparison to capsules containing chitosan.
“U.S. Pat. No. 5,736,532 pertains to a fat absorption and cholesterol reduction formulation comprising chitosan and nicotinic acid, and describes the use of this formulation to reduce cholesterol. The patent describes that the formulation must contain chitosan and nicotinic acid, and additionally can contain one or more other water-soluble vitamin acid, such as ascorbic acid, folic acid, etc. The patent describes the formulation of the mixture as a powder which is then formed into tablets or packed into gelatin capsules. Of course, these tablers and capsules are as inconvenient to take as are the chitosan tablets. Also, it is well known that oral nicotinic acid (niacin) taken by itself in high doses is effective at reducing serum cholesterol and triglycenide levels. However, in therapeutic doses, niacin can have several side effects, including flushing, skin rash, liver problems, activation of peptic ulcers, gout, worsening of diabetes control, as well as others.”
Certain patents disclose, among other things, chitosan that may be in a liquid formulation. The related U.S. Pat. Nos. 5,453,282, and 5,654,001 each describe a liquid chitosan formulation that contains ascorbic acid (see, e.g., Table 8 disclosing a formulation containing fruit juice (210 g/l), sugar (100 g/l), ascorbic acid (1 g/l), essence (1 g/1), and chitosan (20 g/1)) that can be used in treating obesity. However, the liquid chitosan formulation of these patents has a questionable shelf life in that the liquid contains high amounts of sugar and no preservatives. Moreover, the patents provide no teaching of ways to solubilize the chitosan in the liquid (i.e., the weight ratio of chitosan to ascorbic acid employed in Table 8 is 20:1, and no instructions are given in the patent regarding special mixing to dissolve the chitosan in the liquid), meaning the chitosan in the disclosed liquid composition likely remains in flake or powder form.
Similarly, U.S. Pat. No. 4,223,023 claims a “method of reducing lipid absorption in mammals which comprises orally administering to the mammal an amount of chitosan effective to substantially reduce the lipid absorption” (claim
1
). Example 6 of this patent pertains to a chitosan powder mixture for oral administration which contains chitosan (80 g), lactose (10 g), sucrose (9.9 g), and flavor. The powder mixture is to be administered as a suspension in water, or other liquid. However, the patent provides no instruction regarding how much liquid the powder is to be added to, much less provide any instruction regarding solubilizing the chitosan in the liquid. All the remaining Examples of this patent pertain to formulations in which the chitosan is combined in the mixture with either shortening or fatty acid. Such combination will cause the precipitation of the chitosan in the composition within a short period of time.
By comparison, U.S. Pat. Nos. 4,202,881, 4,363,801, 4,474,769, and 4,512,968, and PCT International Application WO 98/32335 describe: (a) treatment of chitosan with acid, (b) rendering chitosan water-soluble by treatment with acid, and/or (c) chitosan liquid formulations. Namely, U.S. Pat. No. 4,202,881 claims a process for shampooing and conditioning hair that comprises adding to hair an aqueous solution, emulsion, or gel containing a “water soluble salt of chitosan, said chitosan salt having been prepared by reacting chitosan . . . with a sufficient amount of acid to neutralize the free amino groups present in said chitosan and to form a water soluble salt thereof” (claim
1
). Col. 2., lines 23-43 describes that amino groups in chitosan can be neutralized with acids (especially with acetic acid, formic acid, and lactic acid) to obtain salts which are water soluble. The patent, however, fails to describe the process by which a chitosan-containing solution, emulsion, or gel can be obtained without adding the water-soluble salt of a chitosan to hair conditioner and/or hair shampoo.
U.S. Pat. No. 4,512,968 claims a chitosan-containing composition (including a liquid mouth rinse) for reducing dental caries (claim
1
). Example 4 describes an aqueous mouth rinse formulation and Example 6 describes a liquid oral freshener. Col. 2, lines 37-47 describes that chitosan is first dissolved in inorganic weak acids to render it water-soluble. The patent, however, fails to describe the process by which a chitosan-containing composition can be obtained without including in the formulation other ingredients that impact the character of the composition (e.g., ethyl alcohol, sodium lauryl sulfonate, sodium &agr;-olefinsulfonate, sodium lauroyl sarcosinate, and/or glycerine or other agents).
By comparison, U.S. Pat. No. 4,474,769 claims a chitosan formulation as a contraceptive. Col. 2, lines 44-53 describes that chitosan is first dissolved in weak acids (especially acetic acid, formic acid, and lactic acid). The chitosan amount can range from 10 ppm to 5%, and the amount of acidic material used to dissolve the chitosan can range from 5 ppm to 10%.
U.S. Pat. No. 4,363,801 claims a “method of treating hyperbilirubinemia which comprises orall
e-nutriceuticals, Inc.
Fonda Kathleen Kahler
McDonnell & Boehnen Hulbert & Berghoff
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