Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2000-10-10
2003-09-02
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S400000, C424S451000, C424S467000, C424S489000, C424S078010
Reexamination Certificate
active
06613356
ABSTRACT:
BACKGROUND FIELD OF INVENTION
The invention is a medication for weight loss in mammals through appetite suppression and a method for administering this medication.
BACKGROUND DESCRIPTION OF PRIOR ART
It is generally recognized in the medical profession that obesity among the populations of the United States and some other countries has been steadily increasing in the last several decades. Such obesity has caused or contributed to marked increases in the occurrence of heart disease, hypertension, diabetes, osteoarthritis of the knees and hips, and increased morbidity resulting from related medical conditions. It has been reported that 50% of all American adults are overweight. During the past five decades several medications have been tried with patients to reduce weight. Amphetamines acted on the brain by stimulating the release of norepinephrine and dopamine at the nerve synapses. This drug suffered from limited effectiveness and from side effects including nervousness, irritability, insomnia and potential for addiction. Other related compounds in this class of drugs include ephedrine, phenteramine, and phenylpropanolamine. While these medications have fewer side effects, they are approved by the FDA for use for only for three months at a time, a major disadvantage. Another medication, sibutramine (Meridia) also acts on the central nervous system but has as side effects headache, insomnia, chest palpitations, hypertension, and dry mouth. Another type of weight loss medication is orilistat (Xenecal), which acts by inhibiting the absorption of fat in the small intestine. This medication has as side effects oily stool, increased flatus, and occasional stool incontinence. Supplemental fat soluble vitamins (A, D, and E) must be given to avoid a deficiency of these vitamins caused by the medication. (Physician's Forum, March 2000, page 1 and 2; Harrison's Principles of Internal Medicine, 14th edition, page 456.)
Many methods and medications for weight reduction have been developed in the art. The following patents are representative of methods previously used.
U.S. Pat. No. 5,783,603, Jul. 21, 1998 to M. Majeed and V. Badmaev discloses a method of appetite suppression and weight loss by administering hydroxycitric acid in a form of a potassium salt extracted from Garcinia fruit. The patent also describes a method of increasing fat metabolism in the patient.
U.S. Pat. No. 4,497,798, Feb. 5, 1985 to T. C. Lambert discloses the administration of potassium compounds in liquid form to human beings to physiologically induce appetite suppression and appetite suppression response during times of hunger pains and for dampening the impulse to eat.
U.S. Pat. No. 4,843,093, Jul. 27, 1989 to Y. Nagai, T. Nakano, and Y. Oomura discloses various chemicals which are said to have an appetite regulating effect, including butyrolactone derivatives having the formula
wherein R is a C
4
-C
10
alkyl group.
The medications and methods of these patents, like many other patents, have as disadvantages, the fact that they involve chemicals which are either difficult to make, are not known to be naturally occurring in the body, or which may have unpleasant side effects for the patient.
SUMMARY OF INVENTION
The present invention comprises potassium butyrate and certain closely related chemical compounds, which reduce appetite in mammals when administered orally to the mammals. The invention also comprises certain other chemicals mixed with the butyrate compounds which facilitate the dispersion of the medication in the mammal's stomach, and it also involves a method both as to timing and dosage for administering the medication to humans. The invention is cheap, easy to manufacture, naturally occurring in mammals (and therefore is expected to have low toxicity) and may have other beneficial properties such as inhibited growth of certain cancers.
OBJECTS AND ADVANTAGES
The objects and advantages of the present invention are:
1. The medication is easy to manufacture.
2. The medication is inexpensive to manufacture.
3. The medication is a substance which often naturally occurs in the intestines of mammals, and is therefore expected to have minimal toxicity or side effects.
4. The medication adds to the physician's armamentarium against obesity.
5. There is a great body of literature about the substance's effects on humans, including beneficial effects such as promoting normal colonic epithelial growth while inhibiting cancerous growth (
Butyrate and the Colonocyte
, by Velazquez, Lederer and Rombeau, Digestive Diseases and Sciences, April, 1996).
6. The medication's dispersion in the mammal's stomach is facilitated by gas generating substances in the tablet or capsule.
7. The medication can be used for longer periods than many other weight loss medications.
REFERENCES:
patent: 4497798 (1985-02-01), Lambert
patent: 4771074 (1988-09-01), Lammerant
patent: 4812315 (1989-03-01), Tarabishi
patent: 4843093 (1989-06-01), Nagai
patent: 5292774 (1994-03-01), Hiraide
patent: 5563173 (1996-10-01), Yatsu
patent: 5858365 (1999-01-01), Faller
patent: 5939455 (1999-08-01), Rephaeli
patent: 6096885 (2000-08-01), Dezube et al.
Evans Charesse
Smith, Jr. Henry L.
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