AU2023201650A1 - Formulation to aid metabolism and sleep - Google Patents

Formulation to aid metabolism and sleep Download PDF

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AU2023201650A1
AU2023201650A1 AU2023201650A AU2023201650A AU2023201650A1 AU 2023201650 A1 AU2023201650 A1 AU 2023201650A1 AU 2023201650 A AU2023201650 A AU 2023201650A AU 2023201650 A AU2023201650 A AU 2023201650A AU 2023201650 A1 AU2023201650 A1 AU 2023201650A1
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formulation
extract
dosage form
magnesium
ingredients
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AU2023201650A
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Chelsea Dyer
Zhanna Gee
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Slim By Nature Pty Ltd T/a Sbn Wellness
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Slim By Nature Pty Ltd T/a Sbn Wellness
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/221—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having an amino group, e.g. acetylcholine, acetylcarnitine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/02—Algae
    • A61K36/05—Chlorophycota or chlorophyta (green algae), e.g. Chlorella
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents

Abstract

The present disclosure relates to a formulation that promotes metabolism in the human body during sleep. The present disclosure also relates to dosage forms containing the formulation, such as tablets, and further relates to methods of treating and/or preventing overweight and obesity using the formulations and dosage forms, and relates to processes for preparing the dosage forms.

Description

AUSTRALIA Patents Act 1990
ORIGINAL COMPLETE SPECIFICATION STANDARD PATENT INVENTION TITLE: FORMULATION TO AID METABOLISM AND SLEEP THE FOLLOWING STATEMENT IS A FULL DESCRIPTION OF THIS INVENTION, INCLUDING THE BEST METHOD OF PERFORMING KNOWN TO ME: SLIM BY NATURE PTY LTD T/A SBN WELLNESS FORMULATION TO AID METABOLISM AND SLEEP
[001] The present application claims priority from Australian Provisional Patent Application No. 2022900641, filed on 16 March 2022, the entire contents of which is incorporated herein by reference.
FIELD
[002] The present disclosure relates to a formulation for supporting metabolism and for supporting sleep. The present disclosure also relates to dosage forms containing the formulation, such as tablets, further relates to methods of treating and/or preventing overweight and obesity using the formulations and dosage forms, and relates to processes for preparing the dosage forms.
BACKGROUND
[003] There are formulations currently on the market that claim to promote fat metabolism. Many of these formulations are presented either as a powder or a liquid or a tea. Due to the presence of plant extracts, many of these products have tastes that range from slightly unpleasant to very unpleasant. It would be more palatable to the consumer, and therefore increase patient compliance if the product were available as a tablet.
[004] There are many supplements that target fat burning but there are usually indicated to be taken before a workout to maximise the effect of the workout, or they are taken before a workout claiming to increase the energy a person has for the workout.
[005] The average person sleeps between 6 and 9 hours per night.
[006] The importance of a good night's sleep has been long known. However, increasingly people sleep less and there is an increase in people reporting all types of sleep issues - either being unable to fall asleep, being unable to stay asleep, or the quality of the sleep.
[007] More recently the connection between a good night's sleep and a healthy metabolism are becoming better understood. There are studies that show that some medicines are metabolism better when taken before bed. There are studies that show sleep deprivation interferes with metabolic rates and efficiency.
[008] There are many supplements, herbal medications and pharmaceuticals that promote improved sleep either by making it easier to go to sleep or stay asleep. Many herbal supplements rely on melatonin or valerian.
[009] The successful formulation of new nutraceutical and pharmaceutical products can be challenging, particularly in situations where multiple active components need to be formulated together. Components of formulations may be chemically incompatible with each other, and/or have poor chemical stability characteristics during production and/or on storage. Formulations may also have poor physical instability properties.
[010] It would be desirable to be able to boost metabolic processes, making use of the period of time during which people are asleep. It would also be desirable to both support metabolism and promote sleep/restfulness, assisting overall health and wellbeing. It would further be desirable to provide a formulation for supporting metabolism and sleep that is safe, efficacious, and which is stable on storage.
SUMMARY
[011] In one aspect, there is provided a formulation for supporting increased metabolism and for supporting sleep, including: a Citrus sinensis extract; and one or more of the following: a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract.
[012] Advantageously, the formulation supports metabolism and promotes sleep/restfulness, boosting metabolism during the time whilst people are asleep.
[013] In some embodiments, the formulation includes each of a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract.
[014] In some embodiments, the formulation has from 10 to 30 wt% Citrus sinensus extract. In some embodiments, the formulation has from 10 to 20 wt% Citrus sinensis extract.
[015] In some embodiments, the formulation has from 2 to 8wt% of magnesium ions. In some embodiments, the formulation has from 2 to 5wt% magnesium ions.
[016] In some embodiments, the formulation has from 5 to 20 wt% Passiflora incarnata extract. In some embodiments, the formulation has from 7 to 12 wt% Passiflora incarnata extract.
[017] In some embodiments, the formulation has from 2 to 8wt% of Humulus lupus extract. In some embodiments, the formulation has from 2 to 5wt% of Humulus lupus extract.
[018] In some embodiments, the formulation has from 10 to 30 wt% Citrus sinensus extract, from 2 to 8wt% of magnesium ions, from 5 to 20 wt% Passiflora incarnata extract, and from 2 to 8wt% of Humulus lupus extract. In some embodiments, the formulation has from 10 to 20 wt% Citrus sinensis extract, from 2 to 5wt% of magnesium ions, from 7 to 12 wt% Passiflora incarnata extract, and from 2 to 5wt% of Humulus lupus extract.
[019] In some embodiments, the magnesium salt is the form of a magnesium amino acid chelate.
[020] In some embodiments, the formulation includes one or more of the following additional active ingredients: glutamine, calcium folinate, colecalciferol, hesperidin, glycine, Chlorella Vulgaris whole plant powder, ascorbic acid, lysine and acetyl levocarnitine hydrochloride.
[021] In some embodiments, the formulation includes one or more of the following excipients: povidone, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, crospovidone, colloidal anhydrous silica, magnesium stearate and ethyl cellulose.
[022] In some embodiments, the formulation includes one or more of the following: AA000821 Spectrablend Violet TFN PI 143185, and carnauba wax.
[023] In some embodiments, the formulation consists or consists essentially of ingredients that are not derived from animal sources, e.g. which are suitable for and consistent with a vegan diet.
[024] In another aspect, there is provided a dosage form comprising a formulation as described herein.
[025] In some embodiments, the dosage form is a tablet.
[026] In some embodiments, the dosage form contains from 100 to 300mg of Citrus sinensus extract.
[027] In some embodiments, the dosage form contains from 25 to 75 mg magnesium ions.
[028] In some embodiments, the dosage form contains from 25 to 75 mg Humulus Lupus extract.
[029] In some embodiments, the dosage form contains from 60 to 180mg Passiflora incarnata extract.
[030] In another aspect, there is provided a formulation that comprises ingredients that support the metabolism of fats in the human body and ingredients that support sleep.
[031] In another aspect, there is provided a tablet that combines ingredients that support the metabolism of fats in the human body and ingredients that support sleep.
[032] In another aspect, there is provided a formulation comprising Citrus sinensis extract to support the metabolism of fats in the human body and one or more ingredients that support sleep.
[033] In another aspect, there is provided a formulation comprising Citrus sinensis extract, one or more ingredients that support sleep, and one or more of essential amino acids, vitamins and minerals that support a healthy metabolism.
[034] In another aspect, there is provided a formulation comprising Citrus sinensis extract, to promote the metabolism of fats in the human body, extracts of Passiflora incarnata and Humulus lupulus to aid sleep, and one or more of essential amino acids, vitamins and minerals.
[035] In another aspect, there is provided a formulation comprising: a) Citrus sinensis extract; b) amino acids, including glutamine, glycine, and lysine; c) Vitamins, including colecalciferol, ascorbic acid calcium folinate and levocarnitine; d) Minerals, including magnesium; and e) extracts from plants including Passiflora incarnata, Humulus lupulus, and Chlorella vulgaris.
[036] In another aspect, there is provided a formulation comprising: 100-1000 mg Citrus sinensis extract; 20-500 mg Magnesium; 0.25 g-8 g Passiflora incarnata extract; 500 mg-6 g Humulus lupulus extract; 50 mg-4 g Glutamine; 1-3 mg Calcium folinate; 1-25 mcg Colecalciferol; 10 mg-200 mg Hesperidin; 160-1800 mg Glycine; 10 mg-100 mg Chlorella vulgaris whole plant powder; 50 mg - 2 g Ascorbic Acid 50 mg-3 g Lysine 10 g-3 g Levocarnitine; and pharmaceutically acceptable excipients.
[037] In another aspect, there is provided a formulation comprising: 100-400 mg Citrus sinensis extract; 20-500 mg magnesium; 50 mg-3 g Passiflora incarnata extract; 20 mg-2 g Humulus lupulus extract; 50 mg-300 mg glutamine; 50-300 mcg calcium folinate; 5-30 mcg colecalciferol; 5 mg- 30 mg hesperidin; 20-150 mg glycine;
5-40 mg Chlorella vulgaris whole plant powder; 50-250 mg ascorbic acid; 50-250 mg lysine; 30-200 mg acetyl levocarnitine hydrochloride; and pharmaceutically acceptable excipients.
[038] In another aspect, there is provided a formulation comprising: 200 mg Citrus sinensis extract 50 mg Magnesium; 120 mg Passiflora incarnata extract; 50 mg Humulus lupulus extract; 100 mg Glutamine; 135.7 mcg Calcium folinate; 12.5 mcg Colecalciferol; 10 mg Hesperidin; 50 mg Glycine; 10 mg Chlorella vulgaris whole plant powder; 100 mg Ascorbic Acid 100 mg Lysine 50 mg Levocarnitine; and pharmaceutically acceptable excipients.
[039] In another aspect, there is provided a formulation comprising: about 200 mg Citrus sinensis extract; about 250 mg magnesium amino acid chelate (equivalent to about 50mg magnesium); about 120 mg Passiflora incarnata extract; about 50 mg Humulus lupulus extract; about 100 mg glutamine; about 135.7 mcg calcium folinate; about 12.5 mcg colecalciferol; about 10 mg hesperidin; about 40 mg glycine; about 10 mg Chlorella vulgaris whole plant powder; about 100 mg ascorbic acid; about 100 mg lysine; about 58.97 mg acetyl levocarnitine hydrochloride; and pharmaceutically acceptable excipients.
[040] In another aspect, there is provided a method of increasing metabolism of fat during sleep in a subject, comprising administering to the subject an effective amount of a formulation or dosage form as defined herein.
[041] In another aspect, there is provided a method of treating or preventing overweight or obesity in a subject, comprising administering to the subject an effective amount of a formulation or dosage form as defined herein.
[042] In another aspect, there is provided use of a formulation or dosage form as defined herein, for the manufacture of a medicament for of increasing metabolism of fat during sleep in a subject, or for treating or preventing overweight or obesity in a subject.
[043] In another aspect, there is provided a method of producing a formulation comprising plant extracts, amino acids, minerals, and vitamins.
[044] In another aspect, there is provided a process for making a tablet comprising plant extracts, amino acids, minerals, and vitamins comprising the steps of: a) blending the ingredients together and pressing into a tablet; and b) applying a film coating to the tablets of the first step, the film coating comprising a colouring agent and carnauba wax.
[045] In another aspect, there is provided a process for making a dosage form which is a tablet as defined herein, comprising: a. blending a Citrus sinensus extract; one or more of a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract; and optionally other active ingredients and/or excipients, and pressing into a tablet; and b. applying a film coating to the tablet.
[046] In some embodiments, the other active ingredients are selected from the group consisting of: glutamine, calcium folinate, colecalciferol, hesperidin, glycine, Chlorella Vulgaris whole plant powder, ascorbic acid, lysine and acetyl levocarnitine hydrochloride; the excipients are selected from the group consisting of povidone, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, crospovidone, colloidal anhydrous silica, magnesium stearate and ethyl cellulose; and the film coating includes carnauba wax and a colouring agent, optionally which colouring agent is AA000821 Spectrablend Violet TFN PI 1431821.
[047] In another aspect, there is provided a process for making a tablet comprising plant extracts, amino acids, minerals, and vitamins comprising the steps of: a) blending the ingredients together and pressing into a tablet; and b) applying a film coating to the tablets of the first step, the film coating comprising a colouring agent and carnauba wax.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
[048] Unless specifically defined otherwise, all technical and scientific terms used herein shall be taken to have the same meaning as commonly understood by one of ordinary skill in the art (e.g., healthcare, formulation science, nutrition, and the like).
[049] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of the common general knowledge.
[050] In the present specification and claims (if any), the word "comprising" and its derivatives including "comprises" and "comprise" include each of the stated integers but does not exclude the inclusion of one or more further integers.
[051] As used herein, the term "and/or", e.g., "X and/or Y" shall be understood to mean either "X and Y" or "X or Y" and shall be taken to provide explicit support for both meanings or for either meaning.
[052] As used herein, the term "about", unless stated to the contrary, refers to +/- 10%, of the designated value.
[053] As used herein, the unit "microgram" is denoted by "mcg" and is understood to have the same meaning as "pg".
[054] Throughout this specification, unless specifically stated otherwise or the context requires otherwise, reference to a single step, composition of matter, group of steps or group of compositions of matter shall be taken to encompass one and a plurality (i.e. one or more) of those steps, compositions of matter, groups of steps or groups of compositions of matter. Thus, as used herein, the singular forms "a", "an" and "the" include plural aspects unless the context clearly dictates otherwise. For example, reference to "a" includes a single as well as two or more; reference to "an" includes a single as well as two or more; reference to "the" includes a single as well as two or more and so forth.
[055] Unless otherwise indicated, terms such as "first," "second," etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to a "second" item does not require or preclude the existence of lower-numbered item (e.g., a "first" item) and/or a higher-numbered item (e.g., a "third" item).
[056] As used herein, the phrase "at least one of', when used with a list of items, means different combinations of one or more of the listed items may be used and only one of the items in the list may be needed. The item may be a particular object, thing, or category. In other words, "at least one of' means any combination of items or number of items may be used from the list, but not all of the items in the list may be required. For example, "at least one of item A, item B, and item C" may mean item A; item A and item B; item B; item A, item B, and item C; or item B and item C. In some cases, "at least one of item A, item B, and item C" may mean, for example and without limitation, two of item A, one of item B, and ten of item C; four of item B and seven of item C; or some other suitable combination.
[057] As used herein, the term "subject" refers to any organism that is susceptible to a disease or condition. For example, the subject can be an animal, a mammal, a primate, a livestock animal (e.g., sheep, cow, horse, pig), a companion animal (e.g., dog, cat), or a laboratory animal (e.g., mouse, rabbit, rat, guinea pig, hamster). In one embodiment, the subject is a mammal. In one embodiment, the subject is human. In one embodiment, the subject is a non-human animal.
[058] As used herein, the term "treating" includes alleviation of symptoms associated with a specific disorder or condition.
[059] As used herein, the term "prevention" includes prophylaxis of the specific disorder or condition.
[060] The disclosure also includes all of the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations or any two or more of said steps or features.
[061] Each embodiment of the present disclosure described herein is to be applied mutatis mutandis to each and every other embodiment unless specifically stated otherwise, or required otherwise by context.
Formulations
[062] The present disclosure provides a formulation for supporting increased metabolism and for supporting sleep, including: a Citrus sinensis extract; and one or more of the following: a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract.
[063] It is thought that by promoting healthy sleep patterns and at the same time providing an effective amount of an extract that promotes fat metabolism during exercise, that the fat metabolism processes can be maximised. It is known that many metabolic processes continue during sleep, but some are changed or improved.
[064] It is believed that the use of Citrus sinensis during sleep will affect the metabolism of fats in the human body.
[065] Citrus sinensis extract is an extract of a variety of oranges known as blood oranges or sweet oranges. Citrus extracts have effects on many of the process that affect weight loss or gain - they regulate lipid metabolism, play a role in appetite suppression and the use of energy when exercising, and they also regulate adipogenesis (Shi Feng and Yu Wang. Citrus phytochemicals and their potential effects on the prevention and treatment of obesity: review and progress of the past 10 years. J. Food Bioact. 2018;4:99-106).
[066] The Citrus sinensis extract is known to contain flavonoids, and in particular anthocyanin. Anthocyanin affects lipid metabolism and thereby interrupts the fat storage and accumulation process. Citrus sinensis is also thought to have anti-inflammatory effects and may affect oxygen availability. Citrus sinensis has been used in formulations to support workout performance and effectiveness. To the best of the inventor's knowledge, it has never been combined with sleep promoting or supporting ingredients and its effect in promoting the metabolism of fat during sleep has not been known before. The therapeutic dosage range for use of Citrus sinensis extract is understood to include a dosage of about 400 mg per day.
[067] In some embodiments, the Citrus sinensis extract is a dried aqueous extract from Citrus sinensis. In some embodiments, the Citrus sinensis extract contains one or more of the following: a flavonoid, an anthocyanin, a hydroxycinnamic acid, and ascorbic acid. In some embodiments, the Citrus sinensis extract contains a flavonoid, an anthocyanin, a hydroxycinnamic acid, and ascorbic acid. In some embodiments, the Citrus sinensis extract is an extract sold under the brand name MorosiTM sold by Bionap.
[068] In some embodiments, the formulation has from 10 to 30 wt% Citrus sinensis extract. In some embodiments, the formulation has from 10 to 20 wt% Citrus sinensis extract.
[069] The formulation contains one or more components to support sleep.
[070] The preferred sleep promoting and sleep supporting ingredients used in this invention is one or more of a magnesium salt, Passiflora Incarnata flower extract and Humulus lupulus flower extract.
[071] Where present, the magnesium salt is preferably provided in the form of a magnesium amino acid chelate.
[072] The therapeutic dosage range of Passiflora incarnata flower extract may be from 0.25 g-8 g daily. The therapeutic dosage range of Humulus lupulus flower extract may be from 0.5 g to 6 g daily.
[073] In some embodiments, the formulation has from 5 to 20 wt% Passiflora incarnata extract. In some embodiments, the formulation has from 7 to 12 wt% Passiflora incarnata extract.
[074] In some embodiments, the formulation has from 2 to 8 wt% of Humulus lupus extract. In some embodiments, the formulation has from 2 to 5 wt% of Humulus lupus extract.
[075] In some embodiments, the formulation has from 2 to 8 wt% of magnesium ions. In some embodiments, the formulation has from 2 to 5 wt% magnesium ions.
[076] In some embodiments, the formulation includes each of a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract.
[077] In some embodiments, the formulation has from 10 to 30 wt% Citrus sinensis extract, from 2 to 8 wt% of magnesium ions, from 5 to 20 wt% Passiflora incarnata extract, and from 2 to 8 wt% of Humulus lupus extract. In some embodiments, the formulation has from 10 to 20 wt% Citrus sinensis extract, from 2 to 5 wt% of magnesium ions, from 7 to 12 wt% Passiflora incarnata extract, and from 2 to 5 wt% of Humulus lupus extract.
[078] It is important to support the whole body and provide general support to the body when supporting the metabolism. Therefore, the formulation preferably includes amino acids, vitamins and minerals that support the metabolic processes.
[079] The preferred vitamins included in the formulation include vitamin C, and vitamin D. It is also preferred to include ingredients that are precursors to vitamins or that support or promote the production of vitamins in the body such as Folinic acid, which is a precursor of vitamin b9, and Chlorella vulgaris extract which is known to contain methylcobalamin, a form of vitamin b12. Chlorella vulgaris extract also contains other ingredients that support a healthy metabolism such as proteins, and minerals.
[080] It is preferred to include amino acids such as Glycine, which is essential in the production of proteins with the body, including collagen, and is an essential neurotransmitter; Glutamine, which is used to produce proteins in the body and to support the body in times of stress and may have a role in anti-inflammatory processes; and Lysine is an essential amino acid for the production of proteins, but also aids in the uptake of essential minerals from food consumption, and supports the production of carnitine, which is essential in the metabolism of fats. However, the amino acids that may be included are not limited to these amino acids. Any amino acid that supports the metabolism of the human body may be included.
[081] Other ingredients that may support the metabolism of fats in the human body may also be included in the formulation.
[082] In some embodiments, the formulation includes one or more of the following additional active ingredients: glutamine, calcium folinate, colecalciferol, hesperidin, glycine, Chlorella vulgaris whole plant powder, ascorbic acid, lysine and acetyl levocarnitine hydrochloride.
[083] In some embodiments, the formulation includes each of the following additional active ingredients: glutamine, calcium folinate, colecalciferol, hesperidin, glycine, Chlorella vulgaris whole plant powder, ascorbic acid, lysine and acetyl levocarnitine hydrochloride.
[084] In some embodiments, the formulation comprises: f) Citrus sinensis extract; g) amino acids, including glutamine, glycine, and lysine; h) Vitamins, including colecalciferol, ascorbic acid calcium folinate and levocarnitine; i) Minerals, including magnesium; and j) extracts from plants including Passiflora incarnata, Humulus lupulus, and Chlorella vulgaris.
[085] In some embodiments, the formulation comprises a. 100-1000 mg Citrus sinensis extract; b. 20-500 mg Magnesium; c. 0.25 g-8 g Passiflora incarnata extract; d. 500 mg-6 g Humulus lupulus extract; e. 50 mg-4 g Glutamine; f. 1-3 mg Calcium folinate; g. 1-25 mcg Colecalciferol; h. 10 mg-200 mg Hesperidin; i. 160-1800 mg Glycine; j. 10 mg-100 mg Chlorella vulgaris whole plant powder; k. 50 mg - 2 g Ascorbic Acid I. 50 mg-3 g Lysine m. 10 g-3 g Levocarnitine; n. and pharmaceutically acceptable excipients.
[086] In some embodiments, the formulation comprising: 100-400 mg Citrus sinensis extract; 20-500 mg magnesium; 50 mg-3 g Passiflora incarnata extract; 20 mg-2 g Humulus lupulus extract; 50 mg-300 mg glutamine; 50-300 mcg calcium folinate; 5-30 mcg colecalciferol; 5 mg- 30 mg hesperidin; 20-150 mg glycine; 5-40 mg Chlorella vulgaris whole plant powder; 50-250 mg ascorbic acid; 50-250 mg lysine; 30-200 mg acetyl levocarnitine hydrochloride; and pharmaceutically acceptable excipients.
[087] In some embodiments, the formulation comprises a. 200 mg Citrus sinensis extract b. 50 mg Magnesium; c. 120 mg Passiflora incarnata extract; d. 50 mg Humulus lupulus extract; e. 100 mg Glutamine; f. 135.7 mcg Calcium folinate; g. 12.5 mcg Colecalciferol; h. 10 mg Hesperidin; i. 50 mg Glycine; j. 10 mg Chlorella vulgaris whole plant powder; k. 100 mg Ascorbic Acid I. 100 mg Lysine m. 50 mg Levocarnitine; n. and pharmaceutically acceptable excipients.
[088] In some embodiments, the formulation comprises: about 200 mg Citrus sinensis extract; about 250 mg magnesium amino acid chelate (equivalent to about 50mg magnesium); about 120 mg Passiflora incarnata extract; about 50 mg Humulus lupulus extract; about 100 mg glutamine; about 135.7 mcg calcium folinate; about 12.5 mcg colecalciferol; about 10 mg hesperidin; about 40 mg glycine; about 10 mg Chlorella vulgaris whole plant powder; about 100 mg ascorbic acid; about 100 mg lysine; about 58.97 mg acetyl levocarnitine hydrochloride; and pharmaceutically acceptable excipients.
[089] The formulation may for example contain one or more excipients, such as fillers, antioxidants, preservatives, binders, lubricants and the like. Where the formulation is a tablet dosage form, the formulation may contain one or more excipients suitable for tableting.
[090] In some embodiments, the formulation includes one or more of the following excipients: povidone, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, crospovidone, colloidal anhydrous silica, magnesium stearate and ethyl cellulose.
[091] In some embodiments, the formulation includes each of the following excipients: povidone, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, crospovidone, colloidal anhydrous silica, magnesium stearate and ethyl cellulose.
[092] Where the formulation is in the form of a coated tablet, it may contain one or more coating excipients, for example a wax or polymeric coating, and/or a colouring.
[093] In some embodiments, the formulation includes one or more of the following: AA000821 Spectrablend Violet TFN PI 143185 (a pigment or colour), and carnauba wax.
[094] In some embodiments, the formulation includes the following: AA000821 Spectrablend Violet TFN PI 143185, and carnauba wax.
[095] In some embodiments, the formulation is comprised of ingredients that are not derived from animal sources and are suitable for and consistent with a vegan diet.
Dosage Forms
[096] The formulation of the present disclosure may be provided in any suitable dosage form known in the art, including a tablet, capsule, sachet, powder, solution or the like.
[097] In some embodiments, the dosage form (e.g. tablet) contains from 100 to 300mg of Citrus sinensus extract.
[098] In some embodiments, the dosage form (e.g tablet) contains from 25 to 75 mg magnesium ions.
[099] In some embodiments, the dosage form (e.g. tablet) contains from 25 to 75 mg Humulus Lupus extract.
[0100] In some embodiments, the dosage form (e.g. tablet) contains from 60 to 180mg Passiflora incarnata extract.
[0101] The formulation ordosageform may befor administration by any suitable route, but are preferably for oral administration.
[0102] In some preferred embodiments, the dosage form is provided in the form of a tablet, e.g. a tablet suitable for oral administration.
[0103] In some embodiments, the tablet is coated with a pharmaceutically suitable film layer.
Use in boosting metabolism/ promoting sleep
[0104] The formulations and dosage forms of the present invention find use in boosting metabolism (e.g. boosting fat metabolism) and/or promoting sleep, for example in boosting metabolism during sleep.
[0105] Accordingly, the present disclosure also provides a method of increasing metabolism of fat during sleep in a subject, comprising administering to the subject an effective amount of a formulation or dosage form as defined herein. There is also provided a method of treating or preventing overweight or obesity in a subject, comprising administering to the subject an effective amount of a formulation or dosage form as defined herein. There is also provided use of a formulation or dosage form as defined herein, for the manufacture of a medicament for of increasing metabolism of fat during sleep in a subject, or for treating or preventing overweight or obesity in a subject.
[0106] In some embodiments, the formulation or dosage form is used to enhance sleep quality and/or provide a deeper sleep.
[0107] In some embodiments, the formulation or dosage form is used to promote improved immunity.
[0108] The subject may for example be a human, e.g. an adult human (male or female).
[0109] The subject may be overweight or obese, or alternatively may be of healthy weight and wishing to prevent overweight or obesity.
[0110] Any suitable effective amount of the formulation or dosage form (e.g. tablet) may be administered. For example the formulation or dosage form may be administered as needed, e.g. once, twice or three times daily, or every other day.
[0111] In some embodiments, an effective dose of Citrus sinensis extract is in the range of from 200 to 600 mg per day, or from 300 to 500mg per day, or about 400 mg/day, for an adult human.
[0112] In some embodiments, an effective dose of magnesium ions is in the range of from to 150 mg per day, or from 75 to 125 mg per day, or about 100 mg/day, for an adult human.
[0113] In some embodiments, an effective dose of Passiflora incarnata extract is in the range of from 120 to 360 mg per day, or from 180 to 300 mg per day, or about 240 mg/day, for an adult human.
[0114] In some embodiments, an effective dose of Humulus lupus extract is in the range of from 50 to 150 mg per day, or from 75 to 125 mg per day, or about 100 mg/day, for an adult human.
[0115] In some embodiments, the formulation is administered in the form of a tablet dosage form containing about 200 mg Citrus sinensis extract, about 50 mg magnesium ions, about 120mg Passiflora incarnata extract, and about 50mg Humulus lupus extract, and the daily dosage is 2 tablets per day.
[0116] The formulation and dosage form of the present disclosure may be administered by any suitable route. Preferably, the formulation and dosage form are administered orally.
Production of Dosage Forms
[0117] There is also provided a process for making a dosage form which is a tablet as defined herein, comprising: a. blending a Citrus sinensis extract; one or more of a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract; and optionally other active ingredients and/or excipients, and pressing into a tablet; and b. applying a film coating to the tablet.
[0118] Any suitable process for producing the tablet dosage form may be employed.
[0119] In some embodiments, the tablet dosage form comprises each of a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract.
[0120] In some embodiments, the other active ingredients are selected from the group consisting of: glutamine, calcium folinate, colecalciferol, hesperidin, glycine, Chlorella Vulgaris whole plant powder, ascorbic acid, lysine and acetyl levocarnitine hydrochloride. In some embodiments, the tablet dosage form contains all of the other active ingredients listed above.
[0121] In some embodiments, the excipients are selected from the group consisting of povidone, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, crospovidone, colloidal anhydrous silica, magnesium stearate and ethyl cellulose. In some embodiments, the tablet dosage form contains all of the excipients listed above.
[0122] In some embodiments, the film coating includes a wax or polymer coating, for example a wax such as carnauba wax. In some embodiments, the film coating includes a wax or polymer coating and a colouring agent, optionally a colouring agent which is AA000821 Spectrablend Violet TFN PI 1431821.
[0123] In some embodiments, all dry ingredients, e.g. all dry active ingredients and all dry excipients are blended together using a suitable mixer, prior to pressing into a tablet.
[0124] There is also provided a process for making a tablet comprising plant extracts, amino acids, minerals, and vitamins comprising the steps of: c) blending the ingredients together and pressing into a tablet; and d) applying a film coating to the tablets of the first step, the film coating comprising a colouring agent and carnauba wax.
[0125] Those skilled in the art will appreciate that the disclosure herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the disclosure includes all such variations and modifications.
[0126] The present disclosure is further illustrated by the following non-limiting examples.
EXAMPLES
Example 1: Preparation of tablet dosage form comprising Citrus sinensis extract and ingredients for supporting sleep
The following ingredients were blended.
Active Ingredients Lbel claim Australian Approved Name mgiunit (AAN)
Magnesium Amino Acid Chelate 250 Passiflora incarnata Herb Ext 120 Dry Conc 10:1 with 100% Water Humulus Lupulus Flower Ext. Dry Conc. 10:1 with 100% 50 Water Glutamine 100 Calcium Folinate 135.7 mcg Colecalciferol 12.5 mcg Hesperidin 10 Glycine 50 Chlorella Vulgaris Whole Plant 10 Powder Ascorbic Acid 100 Lysine 100 Citrus Sinensis (Morosil @ HIA) Fruit Ext. Dry Conc. 150:1 with 200 100% water Acetyl Levocarnitine 58.97 Hydrochloride
Active ingredient weight 1070.05 mg
The blended mixture was combined with pharmaceutically acceptable tableting ingredients as shown below and then pressed into a tablet.
Excipient Ingredients - Quantity mg/unit Australian Approved Name (AAN) Povidone Microcrystalline cellulose Calcium hydrogen phosphate dihydrate Croscarmellose sodium Crospovidone Colloidal anhydrous silica
Magnesium stearate Ethylcellulose Excipient weight 319.20 mg
The resulting tablet was film coated with ingredients as shown below, i.e. carnauba wax and a colouring agent.
Coating Ingredients - Quantity mg/unit Australian Approved Name (AAN) AA000821 Spectrablend Violet TFN PI 143185 Carnauba Wax Coating ingredient weight 37.50 mg
Example 2: Preparation of tablet dosage form comprising Citrus sinensis extract and ingredients for supporting sleep
The following ingredients were blended.
Active Ingredients- Labelclaim Australian Approved Name (AAN) (AAN)mg/unit Magnesium Amino Acid Chelate 250 Passiflora incarnata Herb Ext 120 Dry Conc 10:1 with 100% Water Humulus Lupulus Flower Ext. Dry Conc. 10:1 with 100% 50 Water Glutamine 100 Calcium Folinate 135.7 mcg Colecalciferol 12.5 mcg Hesperidin 10 Glycine 40
Chlorella Vulgaris Whole Plant 10 Powder Ascorbic Acid 100 Lysine 100 Citrus Sinensis (Morosil @ HIA) Fruit Ext. Dry Conc. 150:1 with 200 100% water Acetyl Levocarnitine 58.97 Hydrochloride
Active ingredient weight 1060.05 mg
The blended mixture was combined with pharmaceutically acceptable tableting ingredients as shown below and then pressed into a tablet.
Excipient Ingredients - Quantity mg/unit Australian Approved Name (AAN) Povidone Microcrystalline cellulose Calcium hydrogen phosphate dihydrate Croscarmellose sodium Crospovidone Colloidal anhydrous silica Magnesium stearate Ethylcellulose Excipient weight 319.20 mg
The resulting tablet was film coated with ingredients as shown below, i.e. carnauba wax and a colouring agent.
Coating Ingredients - Quantity mg/unit Australian Approved Name (AAN) AA000821 Spectrablend Violet
TFN PI 143185 Carnauba Wax Coating ingredient weight 37.50 mg
Example 3: Preparation of tablet dosage form comprising Citrus sinensis extract and ingredients for supporting sleep
The following ingredients were blended.
Active Ingredients- Labelclaim Australian Approved Name (AAN) (AAN)mg/unit Magnesium Amino Acid Chelate 250 Passiflora incarnata Herb Ext 120 Dry Conc 10:1 with 100% Water Humulus Lupulus Flower Ext. Dry Conc. 10:1 with 100% 50 Water Glutamine 100 Calcium Folinate 183.2 mcg Colecalciferol 12.5 mcg Hesperidin 10 Glycine 50 Chlorella Vulgaris Whole Plant 10 Powder Ascorbic Acid 113.40 Lysine 100 Citrus Sinensis (Morosil @ HIA) Fruit Ext. Dry Conc. 150:1 with 200 100% water Acetyl Levocarnitine 58.97 Hydrochloride
Active ingredient weight 1070.05 mg
The blended mixture was combined with pharmaceutically acceptable tableting
Excipient Ingredients - Quantity mg/unit Australian Approved Name (AAN) Povidone Microcrystalline cellulose Calcium hydrogen phosphate dihydrate Croscarmellose sodium Crospovidone Colloidal anhydrous silica Magnesium stearate Ethylcellulose Excipient weight 319.20 mg
The resulting tablet was film coated with ingredients as shown below, i.e. carnauba wax and a colouring agent.
Coating Ingredients - Quantity mg/unit Australian Approved Name (AAN) AA000821 Spectrablend Violet TFN PI 143185 Carnauba Wax Coating ingredient weight 37.50 mg
Example 4: Administration of Tablets to Subjects Human subjects are administered a course of tablets prepared in accordance with Example 1, 2 or 3. The human subjects are administered 2 tablets per day, amounting to a dosage of 400 mg/day Citrus sinensus extract. The effects of the treatment regime on sleep and metabolism are measured.

Claims (34)

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
1. A formulation for supporting increased metabolism and for supporting sleep, including: a Citrus sinensis extract; and one or more of the following: a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract.
2. A formulation as claimed in claim 1, wherein the formulation includes each of a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract.
3. A formulation as claimed in claim 1 or 2, wherein the formulation has from 10 to 30 wt% Citrus sinensus extract.
4. A formulation as claimed in any of claims 1 to 3, wherein the formulation has from 2 to 8wt% of magnesium ions.
5. A formulation as claimed in any of claims 1 to 4, wherein the formulation has from 5 to 20 wt% Passiflora incarnata extract.
6. A formulation as claimed in any of claims 1 to 5, wherein the formulation has from 2 to 8wt% of Humulus lupus extract.
7. A formulation as claimed in any of claims 1 to 6, wherein the formulation has from 10 to 30 wt% Citrus sinensus extract, from 2 to 8wt% of magnesium ions, from 5 to 20 wt% Passiflora incarnata extract, and from 2 to 8wt% of Humulus lupus extract.
8. A formulation as claimed in any of claims 1 to 7, wherein the magnesium salt is the form of a magnesium amino acid chelate.
9. A formulation as claimed in any of claims 1 to 8, wherein the formulation includes one or more of the following additional active ingredients: glutamine, calcium folinate, colecalciferol, hesperidin, glycine, Chlorella Vulgaris whole plant powder, ascorbic acid, lysine and acetyl levocarnitine hydrochloride.
10. A formulation as claimed in any of claims 1 to 9, wherein the formulation includes one or more of the following excipients: povidone, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, crospovidone, colloidal anhydrous silica, magnesium stearate and ethyl cellulose.
11. A formulation as claimed in any of claims 1 to 10, wherein the formulation includes one or more of the following: AA000821 Spectrablend Violet TFN PI 143185, and carnauba wax.
12. A formulation as claimed in any one of claims 1 to 11, wherein the formulation consists or consists essentially of ingredients that are not derived from animals.
13. A dosage form comprising a formulation as claimed in any of claims 1 to 12.
14. A dosage form as claimed in claim 13, wherein the dosage form is a tablet.
15. A dosage form as claimed in claim 13 or 14, wherein the dosage form contains from 100 to 300 mg of Citrus sinensus extract.
16. A dosage form as claimed in any of claims 13 to 15, wherein the dosage form contains from 25 to 75 mg magnesium ions.
17. A dosage form as claimed in any of claims 13 to 16, wherein the dosage form contains from 25 to 75 mg Humulus Lupus extract.
18. A dosage form as claimed in any of claims 13 to 17, wherein the dosage form contains from 60 to 180mg Passiflora incarnata extract.
19. A formulation that comprises one or more ingredients that support the metabolism of fats in the human body and one or more ingredients that support sleep.
20. A tablet that combines one or more ingredients that support the metabolism of fats in the human body and one or more ingredients that support sleep.
21. A formulation comprising Citrus sinensis extract to support the metabolism of fats in the human body and one or more ingredients that support sleep.
22. A formulation comprising Citrus sinensis extract, one or more ingredients that support sleep and one or more of essential amino acids, vitamins and minerals.
23. A formulation comprising Citrus sinensis extract, extracts of Passiflora incarnata and Humulus lupulus, and one or more of essential amino acids, vitamins, and minerals.
24. A formulation comprising: a. Citrus sinensis extract; b. amino acids, including glutamine, glycine, and lysine; c. Vitamins, including colecalciferol, ascorbic acid calcium folinate and levocarnitine; d. Minerals, including magnesium; and e. extracts from plants including Passiflora incarnata, Humulus lupulus, and Chlorella vulgaris.
25. A formulation comprising: a. 100-1000 mg Citrus sinensis extract; b. 20-500 mg Magnesium; c. 0.25 g-8 g Passiflora incarnata extract; d. 500 mg-6 g Humulus lupulus extract; e. 50 mg-4 g Glutamine; f. 1-3 mg Calcium folinate; g. 1-25 mcg Colecalciferol; h. 10 mg-200 mg Hesperidin; i. 160-1800 mg Glycine; j. 10 mg-100 mg Chlorella vulgaris whole plant powder; k. 50 mg - 2 g Ascorbic Acid I. 50 mg-3 g Lysine m. 10 g-3 g Levocarnitine; n. and pharmaceutically acceptable excipients.
26. A formulation comprising: a. 100-400 mg Citrus sinensis extract; b. 20-500 mg magnesium; c. 50 mg-3 g Passiflora incarnata extract; d. 20 mg-2 g Humulus lupulus extract; e. 50 mg-300 mg glutamine; f. 50-300 mcg calcium folinate; g. 5-30 mcg colecalciferol; h. 5 mg- 30 mg hesperidin; i. 20-150 mg glycine; j. 5-40 mg Chlorella vulgaris whole plant powder; k. 50-250 mg ascorbic acid I. 50-250 mg lysine m. 30-200 mg acetyl levocarnitine hydrochloride; n. and pharmaceutically acceptable excipients.
27. A formulation comprising: a. 200 mg Citrus sinensis extract b. 50 mg Magnesium; c. 120 mg Passiflora incarnata extract; d. 50 mg Humulus lupulus extract; e. 100 mg Glutamine; f. 135.7 mcg Calcium folinate; g. 12.5 mcg Colecalciferol; h. 10 mg Hesperidin; i. 50 mg Glycine; j. 10 mg Chlorella vulgaris whole plant powder; k. 100 mg Ascorbic Acid I. 100 mg Lysine m. 58-60 mg Levocarnitine; n. and pharmaceutically acceptable excipients.
28. A formulation comprising: a. about 200 mg Citrus sinensis extract; b. about 250 mg magnesium amino acid chelate (equivalent to about 50mg magnesium); c. about 120 mg Passiflora incarnata extract; d. about 50 mg Humulus lupulus extract; e. about 100 mg glutamine; f. about 135.7 mcg calcium folinate; g. about 12.5 mcg colecalciferol; h. about 10 mg hesperidin; i. about 40 mg glycine; j. about 10 mg Chlorella vulgaris whole plant powder; k. about 100 mg ascorbic acid I. about 100 mg lysine m. about 58.97 mg acetyl levocarnitine hydrochloride; n. and pharmaceutically acceptable excipients.
29. A method of increasing metabolism of fat during sleep in a subject, comprising administering to the subject an effective amount of a formulation or dosage form according to any of claims 1 to 28.
30. A method of treating or preventing overweight or obesity in a subject, comprising administering to the subject an effective amount of a formulation or dosage form according to any of claims 1 to 28.
31. Use of a formulation or dosage form according to any of claims 1 to 28, for the manufacture of a medicament for increasing metabolism of fat during sleep in a subject, or for treating or preventing overweight or obesity in a subject.
32. A process for making a tablet comprising plant extracts, amino acids, minerals and vitamins comprising the steps of: a. blending the dry ingredients together and pressing into a tablet; and b. applying a film coating to the tablets of the first step, the film coating comprising a colouring agent and carnauba wax.
33. A process for making a dosage form which is a tablet in accordance with claim 14, comprising: a. blending a Citrus sinensus extract; one or more of a magnesium salt, a Passiflora incarnata extract, and a Humulus lupus extract; and optionally other active ingredients and/or excipients, and pressing into a tablet; and b. applying a film coating to the tablet.
34. A process as claimed in claim 33, wherein the other active ingredients are selected from the group consisting of: glutamine, calcium folinate, colecalciferol, hesperidin, glycine, Chlorella Vulgaris whole plant powder, ascorbic acid, lysine and acetyl levocarnitine hydrochloride; wherein the excipients are selected from the group consisting of povidone, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, crospovidone, colloidal anhydrous silica, magnesium stearate and ethyl cellulose; and wherein the film coating includes carnauba wax and a colouring agent, optionally which colouring agent is AA000821 Spectrablend Violet TFN PI 1431821.
AU2023201650A 2022-03-16 2023-03-16 Formulation to aid metabolism and sleep Pending AU2023201650A1 (en)

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