Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-11-29
2003-06-24
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C514S909000
Reexamination Certificate
active
06582735
ABSTRACT:
1. INTRODUCTION
The present invention relates to novel methods and compositions for the treatment, prevention, or management of sleeplessness, restlessness and weight gain. The methods and compositions utilize plants, portions thereof or extracts therefrom belonging to the Magnoliaceae family. In addition, the methods and compositions utilize mixtures of specific small molecules extracted from the plants belonging to the family Magnoliaceae, such as, but not limited to, magnolol, honokiol, and magnoflorine. The unique compositions of the invention may also comprise various amounts of the Magnoliaceae plant, plant extract, plant extracts combined with different amounts of biologically active small molecules or other therapeutic agents. These compositions are particularly useful for the treatment of sleeplessness, restlessness and weight gain in humans. The invention also encompasses various modes of administration of the therapeutic extracts or other compositions of the invention.
2. BACKGROUND OF THE INVENTION
The recent growth in sales of natural products labeled as dietary supplements in the United States has renewed scientific interest in the study of the prophylactic and therapeutic effects of multi-component botanical products. Unlike single entity pharmaceutical products, botanical products comprise a large number of diverse chemical constituents that often act synergistically to exert a desired biological effect. The type of extraction process utilized and the manner in which the formulation is standardized have dramatic effects on the pharmacological activity of the final product. The development of new botanical products requires multidisciplinary effort consisting of expertise in ethnobotany, natural product chemistry, analytical chemistry, pharmacology, and natural product extraction.
2.1 Sleeplessness, Restlessness and Weight Control
Sleep is necessary for survival and good health, but why sleep is needed or exactly how it benefits people is not fully understood. Individual requirements for sleep vary widely; healthy adults may need as few as 4 hours or as many as 9 hours of sleep every day. Most people sleep at night, but many must sleep during the day to accommodate work schedules. This situation often leads to sleep disorders. Most sleep disorders are common.
How long a person sleeps and how rested a person feels on waking can be influenced by may factors, including excitement or emotional distress. Medications also can play a part; some medications make a person sleepy while other makes sleeping difficult. Even some food elements of additives such as caffeine, strong spices, and monosodium glutamate (MSG) may affect sleep.
Sleep is not a uniform state; it has several distinct stages through which it normally cycles five or six times every night. Sleep progresses from stage 1 (the lightest level, during which the sleeper can be awakened easily) to stage 4 (the deepest level, during which waking the sleeper is difficult). In stage 4, the muscles are relaxed, the blood pressure is at the lowest, and the heart and breathing rates are at their slowest. Besides these four stages, there is a form of sleep accompanied by rapid eye movements (REM) and behavioral activity. During REM sleep, electrical activity in the brain is unusually high, somewhat resembling that of wakefulness. The eye movement and brain wave changes that accompany REM sleep can be recorded electrically on an electroencephalogram (EEG).
In REM sleep, the rate and depth of breathing increase, but the muscles are greatly relaxed more so than during the deepest levels of non-REM sleep. Most dreaming occurs during REM and stage 3 sleep, while most talking during sleep, night terrors, and sleepwalking occur during stages 3 and 4. During a normal night's sleep, REM sleep immediately follows each of the five or six cycles of four-stage non-REM sleep, but it can occur at any of the stages.
If emotional stress is causing the sleep disorder, treatment to relieve the stress is more useful than taking sleep medication. When the sleep disorder is cause by depression, the depression should be thoroughly evaluated and treated by a doctor. Some antidepressant drugs can improve sleep because they have sedating properties. When sleep disorders interfere with a person's normal activities and sense of well-being, the intermittent use of sleep medications (sedatives, hypnotics) may be useful.
A sedative drug decreases activity, moderates excitement, and calms the recipient, whereas a hypnotic drug produces drowsiness and facilitates the onset and maintenance of a state of sleep that resembles natural sleep in its electroencephalographic characteristics and from which the recipient can be aroused easily. The latter effect sometimes is called hypnosis.
Nonbenozodiazepine sedative-hypnotic drugs belong to a group of agents that depress the central nervous system (CNS) in a relative nonselective, dose-dependent fashion, producing progressively calming or drowsiness (sedation), sleep (pharmacological hypnosis), unconsciousness, coma, surgical anesthesia, and fatal depression of respiration and cardiovascular regulation.
Hypnotics (sedatives, minor tranquilizers, anti-anxiety drugs) are among the most commonly used drugs. Most are quite safe, but all can lose their effectiveness once a person becomes accustomed to them. An undesirable side effect of hypnotics, however, are the withdrawal symptoms when use is discontinued. After more than a few days' use, discontinuing a hypnotic can make the original sleep problem worse (rebound insomnia) and increase anxiety. Also most hypnotics require a doctor's prescription because they may be habit-forming or addictive, and overdose is possible. Hypnotics are particularly risky for the elderly and for people with breathing problems because they tend to suppress brain areas that control breathing. They also reduce daytime alertness, making driving or operating machinery hazardous. Hypnotics are especially dangerous when taken with alcohol, other hypnotics, narcotics, antihistamines, and anti-depressants. All of these drugs cause drowsiness and can suppress breathing, making the combined effects more dangerous.
Stress plays a major role in weight management. Stress activates the hypothalamic/pituitary/adrenal axis resulting in an increase in cortisol levels. Cortisol increases the availability of glucose through hepatic gluconeogeneses and the release of glucose substrates from fat cells and muscles. The uptake of glucose is inhibited, resulting in hyperglycemia and hyperlipidemia. The increase in cortisol levels signals the brain that the body is in stress causing food cravings, especially high fat, high sugar foods. These foods, in turn, cause additional stress thereby fueling the stress-cortisol cycle. Eventually, more fat is stored than the body needs unless sufficient exercise is in place to compensate, or the stress is reduced. Central nervous stimulants have been used to suppress appetite in an attempt to counteract stress-induced appetite. This approach not only aggravates the problem due to a direct CNS stimulation effect, but also has a high abuse potential and several serious side effects including cardiovascular and cerebral vascular effects. Ephedra, which is also known as ma huang, is a dietary supplement that is used for weight control and is an example of this type of approach. The purported mechanism of action for Ephedra is CNS stimulation due to the presence of ephedrine alkaloids in the extract.
2.3 Magnoliaceae Plant Extracts
Extracts from plants belonging to the family Magnoliaceae have been and may still be used in Chinese herbalism. The bark of
Magnolia officinalis
Rehder et Wilson, “Hou-po” in Chinese, has been used in Chinese traditional medicine. (Watanabe, K.; Watanabe, H. Y.; Goto, Y.; Yamamoto, N.; Yoshizaki, M.; “Studies on the Active Principles of Magnolia Bark. Centrally acting Muscle Relaxant Activity of Magnolol and Honokiol,”
Japan. J. Pharmacol.
25, 605 (1975)). Magnolol is the bioactive constituent of
Magnolia Cortex,
the bark
Garrison, Jr. Robert
Stogniew Martin
NPI, LLC.
Stetina Brunda Garred & Brucker
Tate Christopher R.
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