U.S. patent application number 11/696883 was filed with the patent office on 2008-10-09 for melatonin-based composition for improved sleep.
Invention is credited to Shan Chaudhuri, Ken Clement, Marvin Heuer, Megan Thomas.
Application Number | 20080248106 11/696883 |
Document ID | / |
Family ID | 39827133 |
Filed Date | 2008-10-09 |
United States Patent
Application |
20080248106 |
Kind Code |
A1 |
Heuer; Marvin ; et
al. |
October 9, 2008 |
Melatonin-based composition for improved sleep
Abstract
A method for improving sleep in an individual comprising the
administration of a composition comprising melatonin, lavender
flower extract and Ferula extract is provided. The composition may
be in a layered solid dosage form to provide controlled and
sustained release of specific ingredients.
Inventors: |
Heuer; Marvin; (Mississauga,
CA) ; Clement; Ken; (Mississauga, CA) ;
Chaudhuri; Shan; (Mississauga, CA) ; Thomas;
Megan; (Mississauga, CA) |
Correspondence
Address: |
FITZPATRICK CELLA HARPER & SCINTO
30 ROCKEFELLER PLAZA
NEW YORK
NY
10112
US
|
Family ID: |
39827133 |
Appl. No.: |
11/696883 |
Filed: |
April 5, 2007 |
Current U.S.
Class: |
514/1.1 ;
424/725; 424/745; 424/778; 514/415; 514/563; 514/8.5 |
Current CPC
Class: |
A61K 9/4808 20130101;
A61K 31/4045 20130101; A61K 36/53 20130101; A61K 36/00 20130101;
A61K 31/4045 20130101; A61P 25/20 20180101; A61K 2300/00 20130101;
A61K 2300/00 20130101; A61K 2300/00 20130101; A61P 25/22 20180101;
A61K 36/53 20130101; A61K 31/195 20130101; A61K 31/195
20130101 |
Class at
Publication: |
424/457 ;
424/725; 424/745; 424/778; 514/2; 514/415; 514/563 |
International
Class: |
A61K 31/4045 20060101
A61K031/4045; A61K 31/195 20060101 A61K031/195; A61K 36/23 20060101
A61K036/23; A61K 36/53 20060101 A61K036/53; A61P 25/20 20060101
A61P025/20; A61P 25/22 20060101 A61P025/22 |
Claims
1. (canceled)
2. A method for improving sleep, comprising administrating to an
individual a composition comprising 0.0001-0.1 melatonin,
0.001-0.01 lavender flower powder, and 0.0001-0.005g Ferula
extract; and at least one member of the group consisting of
0.0001-0.005g Nyctanthes, 0.0001-0.005g Passion flower extract,
0.0001-0.005g Elettaria cardamom, 0.0001-0.005g milk protein
hydrolysate, 0.01-0.1g theanine, 0.0001-0.005g Gardenia gummifera
and 0.0001-0.005g Marjoram.
3. (canceled)
4. A method for improving sleep according to claim 2, wherein said
melatonin is in a solid dosage form comprising three or more
separate compartments, comprising a first compartment containing
0.0001-0.005g melatonin in a quick release format, a second
compartment containing 0.0001-0.005g melatonin in a slow-release
format and a third compartment containing 0.001- 0.01g melatonin in
an unmodified release format.
5. (canceled)
6. The method for improving sleep of claim 2 or 4, said composition
further comprising two or more of said Passion flower extract,
Nyctanthes, Elettaria cardamom, milk protein hydrolysate, theanine
Gardenia gummifera and or Marjoram.
7. (canceled)
8. The method for improving sleep of claim 2 or 4, said composition
further comprising three or more of said Passion flower extract,
Nyctanthes, Elettaria cardamom, milk protein hydrolysate, theanine
Gardenia gummifera or Marjoram.
9. (canceled)
10. The method for improving sleep according to claim 4, wherein
said first compartment contains 0.003g melatonin, said second
compartment contains about 0.002g melatonin, and said third
compartment contains about 0.005g melatonin.
11. The method for improving sleep according to claim 2, wherein
about 0.005g of said lavender powder is administered.
12. The method for improving sleep according to claim 10, wherein
about 0.005g of said lavender powder is administered.
13. The method for improving sleep according to claim 2, wherein
about 0.001g of Ferula extract is administered.
14. The method for improving sleep according to claim 10, wherein
about 0.001g of Ferula extract is administered.
15. The method for improving sleep according to claim 11, wherein
about 0.001g of Ferula extract is administered.
16. The method for improving sleep according to claim 12, wherein
about 0.001g of Ferula extract is administered.
17. The method for improving sleep of claim 2 or 4, said
composition further comprising four or more of said Passion flower
extract, Nyctanthes, Elettaria cardamom, milk protein hydrolysate,
theanine, Gardenia gummifera or Marjoram.
18. The method for improving sleep of claim 2 or 4, said
composition further comprising five or more of said Passion flower
extract, Nyctanthes, Elettaria cardamom, milk protein hydrolysate,
theanine, Gardenia gummifera or Marjoram.
19. The method for improving sleep of claim 2 or 4, said
composition further comprising six or more of said Passion flower
extract, Nyctanthes, Elettaria cardamom, milk protein hydrolysate,
theanine, Gardenia gummifera or Marjoram.
20. The method for improving sleep of claim 2 or 4, said
composition further comprising each of said Passion flower extract,
Nyctanthes, Elettaria cardamom, milk protein hydrolysate, theanine,
Gardenia gummifera and Marjoram.
Description
FIELD OF THE INVENTION
[0001] The present invention is directed towards supplemental
compositions containing melatonin and methods for improving sleep
and relaxation in an individual.
BACKGROUND OF THE INVENTION
[0002] Sleep occupies about one-third of our life and is necessary
for mental and physical well-being. It additionally affects mood,
behavior and physiology. Sleep and the control of sleep is a
complex process involving multiple neuro-chemical pathways and
associated brain structures. It is a dynamic process involving a
shift in the balance of distinct physiological changes, involving
both positive and negative signaling neural signaling. The
regulation of sleep in humans is governed by three processes--each
influenced by hormonal and environmental factors: a daily
sleep-wake cycle influenced by a circadian rhythm (24 hour cycle)
tied to light-dark cycles.
[0003] The need for sleep is a biological drive similar to thirst
or hunger. Interestingly though, the function of sleep is largely
unknown, however some evidence indicates that sleep is required for
learning. In North America, insomnia is estimated to affect a
significant portion of the population every year and is associated
with health problems and concomitant economic loss to society
(Stoller M K. Economic effects of insomnia. Clin Ther. 1994
September-October; 16(5):873-97 Abstract). It is clear that the
impairment of sleep is detrimental to one's health. In humans, mild
sleep deprivation results in indications of impaired immune system
function (Irwin M, McClintick J, Costlow C, Fortner M, White J,
Gillin J C. Partial night sleep deprivation reduces natural killer
and cellular immune responses in humans. FASEB J. 1996 April;
10(5):643-53). Prolonged sleep deprivation is even known to result
in death. It has been determined by many that an individual can
survive longer without food than one can without sleep; thus
indicating the importance of sleep.
[0004] Strategies to improve sleep are beneficial, not only in
terms of physical health, but also in terms of emotional health.
Furthermore, reinforcement of sleep of adequate quantity and
quality positively impacts most aspect of daily life.
SUMMARY OF THE INVENTION
[0005] The foregoing needs and other needs and objectives that will
become apparent for the following description are achieved in the
present invention, which comprises a supplemental composition
comprising an effective amount of melatonin, an effective amount of
an extract of lavender and an effective amount of an extract of
Ferula to improve sleep and relaxation in an individual. The
composition may be provided in a multi-compartmentalized
capsule-based form to facilitate a controlled and sustained release
of specific active ingredients in a specific sequence of
release.
DETAILED DESCRIPTION OF THE INVENTION
[0006] In the following description, for the purposes of
explanations, numerous specific details are set forth in order to
provide a thorough understanding of the present invention. It will
be apparent, however, to one of ordinary skill in the art that the
present invention may be practiced without these specific
details.
[0007] The present invention is directed towards compositions and
methods to improve sleep and relaxation. In an embodiment of the
present invention, the composition comprises melatonin, lavender
flower powder and Ferula.
[0008] In another embodiment of the present invention, the
composition comprises melatonin, lavender flower powder and Ferula
in a multi-compartmentalized dosage form comprised of a plurality
individual capsule-based compartments wherein each of the
capsule-based compartments contains specific ingredients to a
provide specific and controlled release of specific active
ingredients in a predetermined sequence to facilitate the quality
of sleep and relaxation in a mammal.
[0009] In another embodiment of the present invention, the
composition comprises melatonin, lavender flower powder and Ferula
in a multi-compartmentalized dosage form comprised of a plurality
of beadlets contained in a capsule dosage from wherein each of the
beadlets contains specific ingredients to a provide specific and
controlled release of specific active ingredients in a
predetermined sequence to facilitate the quality of sleep and
relaxation in a mammal.
[0010] It is herein understood that improvements in sleep may be
both of a quantitative nature, e.g. increased length of sleep,
decreased time of sleep onset, and of a qualitative nature e.g.
deeper, more restful undisturbed and following an ideal pattern
through the four known stages of sleep. It is further understood
that improvements in sleep may also be both direct and indirect.
For example, sleep will be directly improved by the administration
of a substance which is known to reduce time to sleep onset. Sleep
may be indirectly improved, for example, by the administration of a
substance which is known to result in feelings of relaxation and
calmness.
[0011] As used herein the term `unmodified-release` format is
understood to be defined as pertaining to the dissolution and
bioavailability profile of an ingested dietary ingredient wherein
no additional modifications, be it chemical or physical, have been
made to the ingredient with the specific intent to alter the
dissolution or bioavailability profile from that of ingredient in a
naturally occurring form. It is also understood that
unmodified-release is, essentially, immediate-release of active
ingredients. This is further understood to be traditional- or
conventional-release format where no slow-, delayed- or
extended-release effect is incorporated.
[0012] As used herein the term `controlled-release` format is
understood to be defined as a formulation of active ingredients and
appropriate excipients in a specific format to facilitate a
controlled- or non-immediate-release of active ingredients. The
components of a controlled-release format may have been subjected
to additional modifications, be it chemical or physical, with the
specific intent to alter the dissolution or bioavailability profile
from that of ingredient in a naturally occurring form.
[0013] As used herein the term `slow-release` format is understood
to be defined as a controlled-release format wherein the release of
active ingredients are delayed for a period of time or gradually
released over an extended period of time. This is accomplished
through the use of specific excipients and may include structural
features designed to facilitate controlled-release. It is further
understood that a slow-release format releases active ingredients
at a rate slower than immediate-release.
[0014] As used herein the term `delayed-release` format is
understood to be defined essentially as a controlled-release format
wherein the components of the delayed-release format have undergone
specific modifications, be it physical or chemical, to facilitate
the release of active ingredients at a specific time after
ingestion. It is further understood that delayed-release formats,
release active ingredients at a period of time later than
unmodified release.
[0015] As used herein the term `quick-release` format is understood
to be defined essentially as `unmodified-release`, as defined
above. However, the term `quick-release` may further include
components having modifications, chemical or physical, to enhance
the rate of dissolution or bioavailability of active
ingredients.
Melatonin
[0016] Melatonin is a hormone produced by the pineal gland and is
derived from the amino acid tryptophan. While possibly being
involved in multiple biological processes, melatonin has largely
been studied for its involvement in sleep regulation (Karasek M,
Winczyk K. Melatonin in humans. J Physiol Pharmacol. 2006 November;
57 Suppl 5:19-39) with respect to the circadian rhythm cycle of an
individual. Levels of melatonin cycle in the body based on lighting
conditions--i.e. low melatonin levels during the day, higher levels
at night. Typically, melatonin levels peak in the middle of the
night and diminish thereafter. Melatonin has further been explored
as a method to treat sleep disorders such as insomnia and `jet lag`
due to its apparent involvement the regulation of circadian
rhythms. Melatonin supplementation in humans has been found to be
efficacious for treating jet lag (Herxheimer A, Petrie K J.
Melatonin for the prevention and treatment of jet lag. Cochrane
Database of Systematic Reviews 2002, Issue 2. Art. No.: CD001520.
DOI: 10.1002/14651858.CD001520) as well as hastening the onset of
sleep (Brzezinski A, Vangel M, Wurtman R, Norrie G, Zhdanova I,
Ben-Shushan A, Ford I. 2005. Effects of exogenous melatonin on
sleep: a meta-analysis. Sleep Medicine Reviews 9:41-50).
[0017] In a preferred embodiment of the present invention which is
set forth in greater detail in the example below, the composition
includes melatonin to improve sleep onset and sleep quality. A
serving of the supplemental composition includes from about 0.0001
g to about 0.1000 g of melatonin. For the purposes of the present
invention, said melatonin is provided in three distinct formats
wherein each of said formats provided is designed to have different
rate of release. A first dosage format comprises from about 0.0001
g to about 0.005 g of melatonin in a quick-release format. About
0.0030 g of melatonin in said first dosage format is preferably
provided in a serving. A second dosage format of melatonin
comprising a slow-release technology in the present invention
comprises from about 0.0001 g to about 0.005 g of melatonin. About
0.0020 g of melatonin in said second dosage format is preferably
provided in a serving. A third dosage format of said melatonin of
the present invention comprises from about 0.0010 g to about 0.0100
g of melatonin in an unmodified release format. The preferred
dosage of said third format comprises about 0.0050 g of
melatonin.
Lavender (Lavandula officinalis)
[0018] Oil from the lavender plant is commonly used in aromatherapy
for relaxation. The mild sedative effects of lavender have been
demonstrated in animals and humans (Lis-Balchin M, Hart S. Studies
on the mode of action of the essential oil of lavender (Lavandula
angustifolia P. Miller). Phytother Res. 1999 September;
13(6):540-2). Transdermal absorption of the main constituent of
lavender oil, linalool, has been shown to reduce blood pressure and
skin temperature in humans, evidencing a relaxing effect (Heuberger
E, Redhammer S, Buchbauer G. Transdermal absorption of (-)-linalool
induces autonomic deactivation but has no impact on ratings of
well-being in humans. Neuropsychopharmacology. 2004 October;
29(10):1925-32).
[0019] In a preferred embodiment of the present invention which is
set forth in greater detail in the example below, the composition
includes lavender flower powder to promote a feeling of relaxation.
A serving of the supplemental composition includes from about
0.0010 g to about 0.0100 g of lavender flower powder. The preferred
dosage of lavender flower powder in the present invention comprises
about 0.0050 g. per serving.
Ferula
[0020] Ferula is a genus of herbaceous perennial plant that has
scented flowers and is native to the Mediterranean region east to
central Asia, mostly growing in arid climates. Ferula extracts have
demonstrated relaxant effects (Fatehi M, Farifteh F,
Fatehi-Hassanabad Z. Antispasmodic and hypotensive effects of
Ferula asafoetida gum extract. J Ethnopharmacol. 2004 April;
91(2-3):321-4 Abstract).
[0021] In an embodiment of the present invention which is set forth
in greater detail in the example below, the composition includes
Ferula to reduce anxiety. A serving of the supplemental composition
includes from about 0.0001 g to about 0.0050 g of Ferula. The
preferred dosage of Ferula in the present invention comprises about
0.0010 g per serving.
Nyctanthes
[0022] Is a genus of plants of the family Oleaceae, native to South
East Asia. It contains two species, the most well-known species is
the Night-Flowering Jasmine (Nyctanthes arbortirstis) and it is
sometimes called the tree of sorrow because the flowers lose their
brightness during daytime. Nyctanthes extracts have been shown to
have tranquilizing effects (Saxena R S, Gupta B, Lata S.
Tranquilizing, antihistaminic and purgative activity of Nyctanthes
arbor tristis leaf extract. J Ethnopharmacol. 2002 August; 81
(3):321-5 Abstract).
[0023] In a preferred embodiment of the present invention which is
set forth in greater detail in the example below, the composition
includes Nyctanthes to promote feelings of tranquility. A serving
of the supplemental composition includes from about 0.0001 g to
about 0.0050 g of Nyctanthes. The preferred dosage of Nyctanthes in
the present invention comprises about 0.0010 g per serving.
Passion Flower
[0024] Passion flower has been used traditionally for relaxation
and as a sleep-aid and treatment for anxiety. Specific flavonoids
contained in Passion flower have been shown to have sedative
properties. Furthermore, Passion flower extract has been noted to
reduce anxiety and induce sleep in mice (Soulimani R, Younos C,
Jarmouni S, Bousta D, Misslin R, Mortier F. Behavioural effects of
Passiflora incarnata L. and its indole alkaloid and flavonoid
derivatives and maltol in the mouse. J Ethnopharmacol. 1997 June;
57(1):11-20 Abstract). Clinical trials in humans have demonstrated
that Passion flower is effective in the treatment of anxiety
(Akhondzadeh S, Naghavi H R, Vazirian M, Shayeganpour A, Rashidi H,
Khani M. Passionflower in the treatment of generalized anxiety: a
pilot double-blind randomized controlled trial with oxazepam. J
Clin Pharm Ther. 2001 October; 26(5):363-7 Abstract).
[0025] In an embodiment of the present invention which is set forth
in greater detail in the example below, the composition includes an
extract of Passion flower to promote feelings of relaxation and
calmness and to induce sleep. A serving of the supplemental
composition includes from about 0.0001 g to about 0.0050 g of an
extract of Passion flower. The preferred dosage of an extract of
Passion flower in the present invention comprises about 0.002 g per
serving.
Elettaria cardamom
[0026] One of 2 species of the Indian spice cardamom, Elettaria
cardamom is used in Traditional Chinese Medicine for a variety of
medicinal purposes. Animal studies show that cardamom extract has
antispasmodic relaxant effects (al-Zuhair H, el-Sayeh B, Ameen H A,
al-Shoora H. Pharmacological studies of cardamom oil in animals.
Pharmacol Res. 1996 July-August; 34(1-2):79-82).
[0027] In an embodiment of the present invention which is set forth
in greater detail in the example below, the composition includes
Elettaria cardamom to promote feelings of relaxation. A serving of
the supplemental composition includes from about 0.0001 g to about
0.0050 g of Elettaria cardamom. The preferred dosage of Elettaria
cardamom in the present invention comprises about 0.0010 g per
serving.
Lactium.RTM.
[0028] Lactium.RTM. is a hydrolyzed milk peptide that has been used
in stress management in adult females, and has demonstrated a
protective effect on sleep during periods of mild chronic stress in
mice (http://www.lactium.com/). The action is likely mediated via
binding of this specific peptide, having the amino acid sequence of
.sup.91Typ-Leu-Gly-Tyr-Leu-Glu-Gln-Leu-Leu-Arg.sup.100 in a
benzodiazepine-like fashion (Lecouvey M, Frochot C, Miclo L,
Orlewski P, Driou A, Linden G, Gaillard J L, Marraud M, Cung M T,
Vanderesse R. Two-dimensional 1H-NMR and CD structural analysis in
a micellar medium of a bovine alphaS1-casein fragment having
benzodiazepine-like properties. Eur J Biochem. 1997 Sep. 15;
248(3):872-8), to Gamma Aminobutyric Acid (GABA) receptors (Miclo
L, Perrin E, Driou A, Papadopoulos V, Boujrad N, Vanderesse R,
Boudier J F, Desor D, Linden G, Gaillard J L. Characterization of
alpha-casozepine, a tryptic peptide from bovine alpha(s1)-casein
with benzodiazepine-like activity. FASEB J. 2001 August;
15(10):1780-2). The neurotransmitter GABA, is the primary
inhibitory neurotransmitter and one of its effects is to induce
sleep. Signaling through the GABA-receptor changes the
electrochemical gradient of the neuron, leading to activity
inhibition. Benzodiazepines are thought to act via interaction with
the GABA receptor; thus enhancing the inhibitory effects of GABA.
As such, benzodiazepines are a widely used class of drugs primarily
used as tranquilizers, muscle-relaxants, hypnotics or
sedatives.
[0029] In an embodiment of the present invention which is set forth
in greater detail in the example below, the composition includes
Lactium.RTM. to promote feelings of relaxation and to induce sleep.
A serving of the supplemental composition includes from about
0.0001 g to about 0.0050 g of Lactium.RTM.. The preferred dosage of
Lactium.RTM. in the present invention comprises about 0.0010 g per
serving.
Theanine
[0030] Theanine, also known as .gamma.-glutamethylethylamide and
N-ethyl-L-glutamine, is an amino acid found in green tea. It is
however distinct from the polyphenols and catechins which are
typically associated with the beneficial effects of green tea.
While catechins are generally associated with antioxidant
activities, theanine is associated with anti-stress. In
hypertensive rats, theanine lowers blood pressure (Yokogoshi H,
Kato Y, Sagesaka Y M, Takihara-Matsuura T, Kakuda T, Takeuchi N.
Reduction effect of theanine on blood pressure and brain
5-hydroxyindoles in spontaneously hypertensive rats. Biosci
Biotechnol Biochem. 1995 April; 59(4):615-8 Abstract). Moreover,
oral theanine administration to humans has additionally been shown
to reduce stress (Kimura K, Ozeki M, Juneja L R, Ohira H.
L-Theanine reduces psychological and physiological stress
responses. Biol Psychol. 2007 January; 74(1):39-45 Abstract).
[0031] In an embodiment of the present invention which is set forth
in greater detail in the example below, the composition includes
theanine to reduce stress. A serving of the supplemental
composition includes from about 0.010 g to about 0.100 g of
theanine. The preferred dosage of theanine in the present invention
comprises about 0.052 g per serving.
Gardenia gummifera
[0032] Gardenia gummifera is a plant indigenous to China where it
is commonly called zhi zhi. In traditional medicine this plant has
been purported to have actions which include calming, cooling
blood, and clearing away heat. These attribute are desirable for
improving the quality of sleep in an individual following
ingestion.
[0033] In an embodiment of the present invention which is set forth
in greater detail in the example below, the composition includes
Gardenia gummifera to promote feelings of relaxation. A serving of
the supplemental composition includes from about 0.0001 g to about
0.0050 g of Gardenia gummifera The preferred dosage of Gardenia
gummifera in the present invention comprises about 0.0010 g per
serving.
Marjoram
[0034] Marjoram is an herb commonly used in aromatherapy and is
known for its soothing effects and is additionally purported to
relieve anxiety.
[0035] In an embodiment of the present invention which is set forth
in greater detail in the example below, the composition includes
Marjoram to reduce anxiety and promote feelings of relaxation. A
serving of the supplemental composition includes from about 0.0001
g to about 0.0050 g of Marjoram. The preferred dosage of Marjoram
in the present invention comprises about 0.0010 g per serving.
[0036] The present invention may additionally further comprise
between from about 0.0001 g and about 0.0050 g of sweet violet per
serving. The preferred dosage of Sweet violet in the present
invention comprises about 0.0010 g per serving.
[0037] The present invention may additionally further comprise
between from about 0.000001 g and about 0.00001 g of Vitamin B12
per serving. The preferred dosage of Vitamin B12 in the present
invention comprises about 0.000006 g per serving.
[0038] In a preferred embodiment of the present invention, the
composition is comprised of melatonin, lavender flower extract and
Ferula extract.
[0039] In another embodiment of the present invention, the
composition is comprised of melatonin, lavender flower extract,
Ferula and one or more of the following: Passion flower extract,
Nyctanthes, Elettaria cardamom, Lactium.RTM., Theanine, Gardenia
gummifera and Marjoram.
[0040] Optionally, various embodiments of the present invention
comprise Sweet violet and Vitamin B12.
[0041] Not wishing to be bound by theory, it is believed that the
individual components of the present invention in all of its
embodiments will act to advantageously improve sleep by the
combined and synergistic effects of directly promoting sleep onset
and maintenance and indirectly by promoting feelings conducive to
sleep such as relaxation and calmness. Furthermore, the various
time-release formats and specific dosages thereof of specific
ingredient comprising the compositions disclosed herein contribute
to an effective dosing regime over the duration of an individual's
night sleep. The respective amounts of said ingredients in the
various time-release formats are herein understood by the inventors
provide an effective about of said ingredient at points during
one's sleep when they are in need thereof.
[0042] According to various embodiments of the present invention,
the supplemental composition may be consumed in any form. For
instance, the dosage form of the nutritional supplement may be
provided as, e.g., a powder beverage mix, a liquid beverage, a
ready-to-eat bar or drink product, a capsule, a liquid capsule, a
tablet, a caplet, or as a dietary gel. The preferred dosage form of
the present invention is that of a dietary gel.
[0043] It is know in the art that the various release formats may
be achieved through the use of specific excipients and specific
combinations of excipients. Furthermore, it is known that a single
oral solid dosage format may be produced that provides combinations
of release formats. Such formats may be described as having
multi-phasic release properties. Furthermore, each specific release
format contained in such a multi-phasic release format may be
physically separated into distinct compartments.
[0044] Such multi-phasic, multi-compartment formats may contain a
homogeneous mixture of ingredients separated into distinct
compartments, each with a distinct release format, to achieve a
complex controlled-release of all ingredients contained in the
multi-phasic, multi-compartment format.
[0045] Alternatively, such multi-phasic, multi-compartment formats
may contain specific different ingredients in different
compartments, each with a distinct release format, to achieve a
complex controlled-release of specific ingredients at distinct
times. The specific ingredients of specific compartments may be in
a particular form e.g. solid, powder, liquid, gel, beadlet, as
dictated by the nature of the specific ingredients or by the
desired release format.
[0046] Advantageously, in a preferred embodiment, the present
invention may be provided in a multi-phasic, multi-compartment
format that facilitates the specific release of particular
ingredients in such a way that the desired beneficial effect is
achieved. By way of example, specific components of the present
invention directed at promoting the onset of sleep may be contained
in a specific compartment of a multi-phasic, multi-compartment
format for immediate- or quick-release to quickly encourage sleep
in an individual. Other specific components of the present
invention directed at promoting the maintenance of sleep may be
contained in a specific different compartment of a multi-phasic,
multi-compartment format for slow- or delayed-release to encourage
the maintenance of sleep in an individual. In this way, the
specific ingredients of the various embodiments of the present
invention may be made bioavailable at a specific predetermined
time-frame to maximize beneficial effects based on mechanism of
action or intended use for improving sleep and relaxation in an
individual.
[0047] According to a preferred embodiment of the present
invention, the supplemental composition may be provided in a
dietary gel format. The dietary gel is comprised of ingredients
wherein like ingredient may be in various time-release formats; a
quick-release format, a slow-release format and unmodified release
format. In such a form each time-release format will provide unique
release characteristics such that a predetermined amount of a
specific ingredient is available within an individual following
ingestion at given time points. In this way a controlled release of
the composition can be achieved to maintain effective amounts
specific ingredients at time points wherein said ingredients would
provide the most effective benefit to improve the quality sleep in
an individual.
[0048] The dosage form of the supplemental composition may be
provided in accordance with customary processing techniques for
herbal and nutritional supplements in any of the forms mentioned
above. Additionally, the supplemental composition set forth in the
example embodiment herein may contain any appropriate number and
type of excipients, as is well known in the art.
[0049] Furthermore, by way of ingestion of the composition of the
present invention, a method for improving the onset of sleep and
improvement of sleep quality is provided.
[0050] The present nutritional composition or those similarly
envisioned by one of skill in the art, may be utilized in methods
to improve the quality of sleep in an individual.
[0051] Although the following examples illustrate the practice of
the present invention in two of its compositional example
embodiments. the examples should not be construed as limiting the
scope of the invention. Other embodiments will be apparent to one
of skill in the art from consideration of the specifications and
example.
EXAMPLES
Example 1
[0052] A nutritional supplement to help promote quality sleep for
use immediately prior to bedtime. A serving of the nutritional
supplement contains the following:
[0053] About 0.0050 g of unmodified-release melatonin, about 0.0030
g of quick-release melatonin, about 0.0020 g of slow-release
melatonin, about 0.0050 g of lavender flower powder, about 0.0010 g
of Ferula narthex, about 0.0020 g of Passion flower extract, about
0.0010 g of Elettaria cardamom, about 0.0010 g of Lactium.RTM.,
about 0.0520 g of Theanine, about 0.0010 g of Gardenia gummifera
and about 0.0010 g of Marjoram.
Example 2
[0054] A nutritional supplement to help promote quality sleep for
use immediately prior to bedtime. A serving of the nutritional
supplement contains the following:
[0055] About 0.0050 g of unmodified-release melatonin, about 0.0030
g of quick-release melatonin, about 0.0020 g of slow-release
melatonin, about 0.0050 g of lavender flower powder, about 0.0010 g
of Ferula narthex, about 0.0010 g of Nyctanthes, about 0.0020 g of
Passion flower extract, about 0.0010 g of Elettaria cardamom, about
0.0010 g of Lactium.RTM., about 0.0520 g of Theanine, about 0.0010
g of Gardenia gummifera, about 0.0010 g of Marjoram, about 0.0010 g
of Sweet violet, and about 0.000006 g of Vitamin B12.
Extensions and Alternatives
[0056] In the foregoing specification, the invention has been
described with a specific embodiment thereof, however, it will be
evident that various modifications and changes may be made thereto
without departing from the broader spirit and scope of the
invention.
* * * * *
References