Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from zingiberaceae
Reexamination Certificate
2002-01-17
2003-04-01
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from zingiberaceae
C424S773000, C424S746000, C424S725000
Reexamination Certificate
active
06541046
ABSTRACT:
RELATED INFORMATION
This application claims priority to Chinese Patent Application No. 01103777.6 filed Feb. 12, 2001, entitled “COMPOSITION AND METHOD FOR EFFECTING WEIGHT REDUCTION” and the disclosure is hereby incorporated by reference.
FIELD OF THE INVENTION
The present invention generally relates to dietary supplements and foods for reducing weight gain, effecting weight loss and causing favorable changes in body composition. More specifically, the invention relates to the field of herbal compositions, especially decoctions for oral administration containing rhubarb and other herbal ingredients.
BACKGROUND OF THE INVENTION
Body weight and body composition is determined by the competing balance of food intake and energy expenditure. Although both genetic and environmental factors can contribute to obesity, the most common cause of weight gain and an overweight body composition is excessively high caloric intake accompanied by a lack of physical activity. The resulting accumulation of surplus fat places overweight or obese individuals at increased risk of illness from hypertension, lipid disorders, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and respiratory problems, certain cancers, and a wide variety of other diseases and undesired physiological conditions, as well as overall mortality. According to a study, the proportion of overweight individuals in the United States increased from 25% in 1980 to 33% in 1991. (Third National Health and Nutrition Examination Survey, 1991). In 1998 the National Institutes of Health reported that over 55 percent of the U.S. population are now considered overweight or obese. (
Obesity Clinical Guidelines: NIH Statement Jun.
3, 1998, press release).
Obesity may become partially reversed or prevented by employing diet or nutrition and behavior modification programs or by using pharmaceutical intervention. Among the most widely administered drugs are: orlistat, which reduces the amount of dietary fat that is absorbed from the intestine; sibutramine, which suppresses appetite by inhibiting the re-uptake of norepinephrine and serotonin; fenfluramine and d-fenfluramine, which suppress appetite by both releasing serotonin and then inhibiting its re-uptake; and phentermine, which suppresses the appetite by stimulating the release of norepinephrine.
Most weight reduction drugs typically achieve only a 5-10% decrease in body weight. (
National Task Force on the Prevention and Treatment of Obesity: Long
-
term pharmacotherapy in the Management of Obesity,
JAMA 276:1907-15, 1996). In addition, most drugs have mild to serious side effects. For example, the once popular appetite suppressant drug “Fen-Phen” (the combination of fenfluramine and phentermine), which gave a 15-20% reduction in body weight, was clinically determined to have significantly increased the risk of heart valve damage. (F. Brenot et al., Appetite Suppressant Drugs and the Risk of Primary Pulmonary Hypertension, N. Engl. J. Med., 335:609-16, 1996). Consequently, after a number of confirmed “Fen-Phen”—related patient deaths, most of the drugs containing fenfluramine have been recalled and withdrawn. (Connolly H. M. et. al., N. Eng. J. Med. 337:581-88, 1997). In 1999 the FDA removed fenfluramine from the market. Other common side effects include dizziness, headaches, rapid pulse, palpitations, sleeplessness, hypertension, diarrhea, and intestinal cramping.
In addition to adverse side effects, current weight loss drugs may be habit forming, as exemplified by drugs containing amphetamines, and the initial weight reducing effect of many drugs wears off over time, requiring increased dosages to maintain weight reduction. The most serious problem, however, is that the lost weight is frequently regained after the drug is discontinued and the fairly limited utility of these drugs is more than offset by the side effects and other drawbacks inherent in their use.
The following table provides a synopsis of some of the characteristics of the most popular weight loss drugs and notes some of the impediments to wide-scale use:
Generic
Name and Mechanism
Brand Name
Comments
Amphetamine +
Adderall
Not commonly used
Dextroamphetamine
therapeutically for obesity.
sympathomimetic amine
High abuse potential.
appetite suppressants
Benzphetamine sympatho-
Didrex;
Not commonly used
mimetic amine appetite
Benzfetamine
therapeutically. High abuse
suppressant
potential.
Bromocriptine stimulates
Ergoset;
Not approved in US for
dopamine type-2 receptors
Parlodel
obesity. Used “off label”.
and antagonizes type-1
receptors in brain
Dexfenfluramine
Redux
Approved 04/96 in US with
appetite suppressant via
no limit on duration of use.
serotonin release and
Voluntarily withdrawn in
serotonin reuptake block;
US 09/15/97 due to heart
the d isomer of fenflu-
valve damage.
ramine; thought to be less
addicting than most others
Dextroamphetamine
Dexedrine
Not approved in US for
sympathomimetic amine
obesity. Used “off label”.
appetite suppressant
Highly abused.
Diethylpropion sympatho-
Amfepramone;
Possible link to primary
mimetic amine appetite
Tenuate;
pulmonary hypertension
suppressant
Tenuate
Dospan
Fenfluramine racemic
Pondimin;
One component of “fen/
mixture dexfenfluramine
Ponderal
phen”; Approved in US in
and L-fenfluramine;
1973. Voluntarily with-
mechanism like dexfenflu-
drawn in US due to heart
ramine (see above), except
valve damage 09/15/97
also affects dopamine
availability
Fluoxetine selective
Prozac
Not approved in US for
serotonin reuptake inhibitor
obesity. FDA application
(SSRI)
was withdrawn by manu-
facturer. Used “off label”.
Mazindol sympathomimetic
Mazanor;
Approved in US in 1973.
amine appetite suppressant
Sanorex
Rarely used. High abuse
potential.
Methamphetamine
Desoxyn;
Rarely used for obesity.
sympathomimetic amine
Methampex
High abuse potential.
appetite suppressant
Orlistat
Xenical
Recommended for approval
not a CNS-active drug;
in US 05/15/97; FDA panel
decreases the amount of fat
reconsidered and split 5-5
absorbed from the diet by
on 03/16/98; due to possi-
30%.
ble link to breast cancer
Phendimetrazine sympatho-
Adipost;
Approved in US in 1961.
mimetic amine appetite
Anorex;
Rarely used.
suppressant
Bontril;
Parzine;
Phendiet;
Plegine;
Wehless
Phentermine sympatho-
Adipex-P;
Approved as “resin
mimetic amine appetite
Fastin;
complex” in 1959.
suppressant
Ionamin;
Approved as hydrochloride
Oby-Cap;
in 1973. The other
Phentamine;
component of “fen/phen”.
T-Diet;
Zantryl
Phenylpropanolamine
Acutrim;
Available “over the
sympathomimetic amine
Dexatrim;
counter”.
appetite suppressant
Phenoxine;
Phenyldrine;
Propagest;
Rhindecon
Sibutramine
Meridia
Approved in US, 11/97
inhibits reuptake of
dopamine, norepinephrine,
and serotonin in brain
Various natural herbal weight reduction formulas have been suggested as safer alternatives to both prescription and over-the-counter weight loss compounds. Generally, herbal weight loss formulas have fewer side effects when properly formulated and administered. Despite the fact that herbs are natural substances, however, some herbal formulas can still be abused. For example, improper administration of herbal weight loss formulas based primarily on ma huang (ephedra) and high caffeine-containing herbs, such as guanrana and kola nut, may result in diminished energy and a depleted body.
New compounds for treatment of humans are often tested in animal models to insure their safety and efficacy. A number of rat models have been used to study the effect of drugs on obesity. Diet-related obesity can be created in the Osbom-Mendel, Wistar and Sprague-Dawley rats by altering their diets to increase caloric consumption. This is usually accomplished by increasing the percentage of fat in a carefully controlled diet and measuring a series of physiologic parameters that indicate changes in energy metabolism, weight gain, weight loss, body composition, and other indicia of overall health and the balance between food intake and energy expenditure. These rats experience the increased weight and fat deposition character
Hong Wei
Jing Wei
Wei Kaiyuan
Xian Wei
Xu Xiurong
Hong Wei
Jing Wei
Lankford , Jr. Leon B.
Mulville Kurt T.
Orrick Herrington & Sutcliffe LLP
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