WO2013118136A1 - Stable taurine oral composition - Google Patents

Stable taurine oral composition Download PDF

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Publication number
WO2013118136A1
WO2013118136A1 PCT/IN2012/000727 IN2012000727W WO2013118136A1 WO 2013118136 A1 WO2013118136 A1 WO 2013118136A1 IN 2012000727 W IN2012000727 W IN 2012000727W WO 2013118136 A1 WO2013118136 A1 WO 2013118136A1
Authority
WO
WIPO (PCT)
Prior art keywords
energy
taurine
provider
revitaliser
dosage form
Prior art date
Application number
PCT/IN2012/000727
Other languages
French (fr)
Inventor
Kamlesh Rajnikant Zota
Sanjay Agrawal
Ketan Chandulal Zota
Manukant Chandulal Zota
Original Assignee
Zota Health Care Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zota Health Care Ltd filed Critical Zota Health Care Ltd
Publication of WO2013118136A1 publication Critical patent/WO2013118136A1/en

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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • 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
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention relates to stable oral pharmaceutical composition, in particular to compositions, which comprises taurine as active agent along with pharmaceutically acceptable excipients preferably in oral dosage form, which is useful as an energy provider booster for all age group.
  • Taurine is an amino acid that supports neurological development and helps to regulate the level of water and mineral salts in the blood. Taurine is also thought to have antioxidant properties.
  • Some marketed taurine products are Red Bull, Bacchus Energy Drink, BSN NO-Xplode, Gaspari Nutrition, SuperPump250, Muscle Tech, Cell-Tech, Hardcore Pro Series, Double-T ,Sports CreaDyl, Muscle Tech , Nitro-Tech, Hardcore Pro Series, AllMax Nutrition Taurine, Cheap Supplements Taurine, Higher Power L-Taurine XS, NOW Taurine, NOW Taurine Double Strength, NOW Taurine Powder, PrimaForce Taurine, SciFit L-Taurine, Supplement Direct Taurine, Twinlab Mega Taurine thereof.
  • Food supplement compositions comprise lipoic acid or a derivative thereof and creatine or a derivative thereof.
  • the compositions optionally, but preferably, further comprise of dextrose.
  • the food supplement compositions are suitable for supplementing the diet of an athlete and particularly for enhancing an athlete's muscle size or strength.
  • aft alertness inducing composition contains the active ingredients caffeine and taurine and various inert substances in a dry formulation.
  • Caffeine and taurine are delivered in an oral formulation that obviates the need for ingesting significant quantities of liquid or sugar.
  • the instant invention is to provide commercially viable and oral formulation.
  • the instant invention is to provide safe and effective dosage form with taurine composition because other ingredients which are using as energy drinks or oral formulation, with high amounts of caffeine or sugar can cause several diseases such as too much caffeine can increase heart rate and blood pressure; interrupt sleep, and cause nervousness and irritability. And added sugar may provide unwanted added calories.
  • the instant invention is to increased energy is derived from taurine then the absorption may be faster as comparative to caffeine.
  • the instant invention is to provide different release drug profile such as Sustained or controlled or retard formulation available in oral formulation (capsule, tablet, powder and in liquid thereof)
  • the taurine is present in an amount of 1000 -1200 mg by weight.
  • the said stable oral pharmaceutical composition is available in different drug release profiles such as Sustained or controlled or retard formulation with instant high energy booster oral dosage form such as capsule, tablet, powder and in liquid thereof.
  • the first 500 mg of Taurine will disintegrate for the immediate revitalisation and remaining 500 mg to 700mg of Taurine will be available after 12 hours.
  • the main active ingredient is taurine
  • taurine may have several different roles in the human body. It acts as an antioxidant, and helps prevent macular degeneration and other serious eye diseases. It reduces blood pressure and cholesterol level, thus, helps to prevent arteriosclerosis. It improves detoxification function of the liver. It helps to strengthen the heart muscle, thus, stabilizing the function of the heart. It lessens the accumulation of lactic acid which becomes the cause of fatigue.
  • taurine improves glucose tolerance wherein Taurine works by increasing the action of insulin, improving glucose tolerance and enhancing antioxidant levels which are important functions to balance the negative effects of high sugar diets.
  • taurine decreases risk of muscle damage wherein large amounts of taurine are also found in muscle, where it is believed to play an essential role. Taurine has shown the ability to lower muscle damage from intense exercise, and improve performance. Exercise depletes the muscles of taurine, making supplementation essential for anyone concerned with getting the maximum benefit from their exercise program.
  • Taurine is also used to help improve mental performance and is a common ingredient in energy drinks. Taurine is essential for proper development and growth such as Sports person and Growing /School going Children who needs instant energy thereof.
  • This type of supplementation may also be beneficial for the treatment in various diseases for example hypertension, congestive heart failure and diabetes,Congestive heart failure (CHF) ,Hepatitis ,Steatorrhea (fatty, frothy stools) in people with cystic fibrosis ,High blood pressure (hypertension) ,High cholesterol ,Seizures (epilepsy) ,Autism ,Attention deficit hyperactivity disorder (ADHD) ,RetinaI degeneration (an eye condition) ,Diabetes ,Alcoholism thereof.
  • the main characteristic of the taurine is that it will not break or damage by heating. However, it dissolves easily in water.
  • the taurine supplementation can reduce liver and blood cholesterol levels in the treated group.
  • taurine acts an as antioxidant. Antioxidants help protect damage to cells from free radicals wherein Taurine functions as a "potent" antioxidant, wherein Free radicals attack cells in body and can cause chronic conditions such as cancer, eye disease, and possibly diabetes. As many high energy drinks contain caffeine, it may be the caffeine or the combination of caffeine, taurine and/or any other ingredients which give the energy boosting qualities.
  • the absorption may be faster if it is in a drink than in food
  • L-Taurine may play a useful role in supporting a variety of processes, including:

Abstract

Disclosed herein this invention provides energy vitaliser provider oral composition with different release profile such as Sustained or controlled or retard formulation in various form such as capsule, tablet, powder and in liquid thereof for those individuals which are unable to get high energy easily such as non-breastfed infants, adults and people undergoing I.V. feedings, by this composition they can easily get high energy with less side effects than other energy provider dosage.

Description

TITLE OF THE INVENTION - "STABLE TAURINE ORAL COMPOSITION.
FIELD OF THE INVENTION
The present invention relates to stable oral pharmaceutical composition, in particular to compositions, which comprises taurine as active agent along with pharmaceutically acceptable excipients preferably in oral dosage form, which is useful as an energy provider booster for all age group.
BACKGROUND OF THE INVENTION
Taurine is an amino acid that supports neurological development and helps to regulate the level of water and mineral salts in the blood. Taurine is also thought to have antioxidant properties.
Some marketed taurine products are Red Bull, Bacchus Energy Drink, BSN NO-Xplode, Gaspari Nutrition, SuperPump250, Muscle Tech, Cell-Tech, Hardcore Pro Series, Double-T ,Sports CreaDyl, Muscle Tech , Nitro-Tech, Hardcore Pro Series, AllMax Nutrition Taurine, Cheap Supplements Taurine, Higher Power L-Taurine XS, NOW Taurine, NOW Taurine Double Strength, NOW Taurine Powder, PrimaForce Taurine, SciFit L-Taurine, Supplement Direct Taurine, Twinlab Mega Taurine thereof.
United States Patent 6,620,425 wherein Food supplement compositions comprise lipoic acid or a derivative thereof and creatine or a derivative thereof. The compositions optionally, but preferably, further comprise of dextrose. The food supplement compositions are suitable for supplementing the diet of an athlete and particularly for enhancing an athlete's muscle size or strength.
US Patent Application 20060094734 wherein aft alertness inducing composition contains the active ingredients caffeine and taurine and various inert substances in a dry formulation. Caffeine and taurine are delivered in an oral formulation that obviates the need for ingesting significant quantities of liquid or sugar.
l Thus, there is a need of stable taurine oral composition in the solid dosage form which can exhibited extended shelf life and can be prepared by a simple, efficient and cost effective method without using any advanced technology or high tech machinery.
SUMMARY OF THE INVENTION
In one aspect, the instant invention is to provide commercially viable and oral formulation.
In one aspect, the instant invention is to provide safe and effective dosage form with taurine composition because other ingredients which are using as energy drinks or oral formulation, with high amounts of caffeine or sugar can cause several diseases such as too much caffeine can increase heart rate and blood pressure; interrupt sleep, and cause nervousness and irritability. And added sugar may provide unwanted added calories.
In one aspect, the instant invention is to increased energy is derived from taurine then the absorption may be faster as comparative to caffeine.
In one aspect, the instant invention is to provide different release drug profile such as Sustained or controlled or retard formulation available in oral formulation (capsule, tablet, powder and in liquid thereof)
DETAILED DESCRIPTION OF THE INVENTION
The invention will now be described in detail in connection with certain preferred and optional embodiments. So that various aspects thereof may be more fully understood and appreciated.
According to the stable oral pharmaceutical composition of the present invention, the taurine is present in an amount of 1000 -1200 mg by weight. The said stable oral pharmaceutical composition is available in different drug release profiles such as Sustained or controlled or retard formulation with instant high energy booster oral dosage form such as capsule, tablet, powder and in liquid thereof.
In embodiment of the invention, the first 500 mg of Taurine will disintegrate for the immediate revitalisation and remaining 500 mg to 700mg of Taurine will be available after 12 hours.
For example the first 700 mg of Taurine will disintegrate for the immediate revitalisation and remaining 500 mg of Taurine will be available after 12 hours.
For example the first 500 mg of Taurine will disintegrate for the immediate revitalisation and remaining 700 mg of Taurine will be available after 12 hours.
In embodiment of the invention, the main active ingredient is taurine, is an amino acid. Because the human body can produce taurine on its own, this amino acid is not essential for human nutrition. However, some individuals in certain conditions (such as non-breastfed infants and people undergoing I.V. feedings) may benefit from taurine supplementation. Although this amino acid is also found in protein-rich foods. In addition to serving as a building block for making proteins, taurine may have several different roles in the human body. It acts as an antioxidant, and helps prevent macular degeneration and other serious eye diseases. It reduces blood pressure and cholesterol level, thus, helps to prevent arteriosclerosis. It improves detoxification function of the liver. It helps to strengthen the heart muscle, thus, stabilizing the function of the heart. It lessens the accumulation of lactic acid which becomes the cause of fatigue.
In embodiment of the invention, taurine improves glucose tolerance wherein Taurine works by increasing the action of insulin, improving glucose tolerance and enhancing antioxidant levels which are important functions to balance the negative effects of high sugar diets. In embodiment of the invention, taurine decreases risk of muscle damage wherein large amounts of taurine are also found in muscle, where it is believed to play an essential role. Taurine has shown the ability to lower muscle damage from intense exercise, and improve performance. Exercise depletes the muscles of taurine, making supplementation essential for anyone concerned with getting the maximum benefit from their exercise program.
In embodiment of the invention, Taurine is also used to help improve mental performance and is a common ingredient in energy drinks. Taurine is essential for proper development and growth such as Sports person and Growing /School going Children who needs instant energy thereof.
Those Patients are also able to getting energy instantly who suffered from chronic illness, Malnutrition, Long term drug therapy (cardiac, diabetic, Diabetic Condition anti tubercular and corticosteroids), Lethargy, Poor appetite thereof.
This type of supplementation may also be beneficial for the treatment in various diseases for example hypertension, congestive heart failure and diabetes,Congestive heart failure (CHF) ,Hepatitis ,Steatorrhea (fatty, frothy stools) in people with cystic fibrosis ,High blood pressure (hypertension) ,High cholesterol ,Seizures (epilepsy) ,Autism ,Attention deficit hyperactivity disorder (ADHD) ,RetinaI degeneration (an eye condition) ,Diabetes ,Alcoholism thereof.
The main characteristic of the taurine is that it will not break or damage by heating. However, it dissolves easily in water.
In the case of Vasodilation wherein Taurine supplementation can increase secretion of nitric oxide, which dilates blood vessels and improves blood flow and delivery of oxygen to muscles. However that taurine alone can increase energy and performance.
In the case of Lower Cholesterol wherein Taurine can lower cholesterol by improving gallbladder function which can then eliminate cholesterol through bile, the taurine supplementation can reduce liver and blood cholesterol levels in the treated group.
A further benefit of taurine is that it acts an as antioxidant. Antioxidants help protect damage to cells from free radicals wherein Taurine functions as a "potent" antioxidant, wherein Free radicals attack cells in body and can cause chronic conditions such as cancer, eye disease, and possibly diabetes. As many high energy drinks contain caffeine, it may be the caffeine or the combination of caffeine, taurine and/or any other ingredients which give the energy boosting qualities.
If increased energy is derived from taurine then the absorption may be faster if it is in a drink than in food
It has been suggested that L-Taurine may play a useful role in supporting a variety of processes, including:
Protein synthesis
Cell hydration
Metabolism
Cardiac function

Claims

CLAIMS,
1. Energy revitaliser provider oral dosage form comprises taurine as an active ingredient with pharmaceutical acceptable excipients such as surfactant, binder thereof.
2. Energy revitaliser provider oral dosage form as claimed in claim 1 wherein an active ingredient taurine is lOOOmg to 1200mg by weight.
3. Energy revitaliser provider oral dosage form as claimed in claim 1 wherein its available in different release profile such as Sustained or controlled or retard formulation in oral formulation ( such as capsule, tablet, powder and in liquid thereof)
4. Energy revitaliser provider oral dosage form as claimed in claim 2 & 3 wherein First 500 mg of Taurine will disintegrate for the immediate revitalisation and remaining 500 mg to 700 mg of Taurine will be available after 12 hours.
5. Energy revitaliser provider oral dosage form as claimed in claim 1 wherein it improves mental performance and is a common ingredient in energy drinks. It is essential for proper development and growth.
6. Energy revitaliser provider oral dosage form as claimed in claim 1 wherein it decreases risk of muscle damage wherein large amounts of taurine are also found in muscle.
7. Energy revitaliser provider oral dosage form as claimed in claim 2 wherein it works by increasing the action of insulin, improving glucose tolerance and enhancing antioxidant levels which are important functions to balance the negative effects of high sugar diets.
8. Energy revitaliser provider oral dosage form as claimed in claim 2 wherein individuals such as non-breastfed infants arid people undergoing I.V. feedings, Children ,adults and older age group , patients who are unable to get energy instantly thereof may benefit from taurine supplementation.
. Energy revitaliser provider oral dosage form as claimed in claim 2 wherein it also applicable for those patients who suffered from Chronic illness, Malnutrition, Long term drug therapy (cardiac, diabetic, Diabetic Condition anti tubercular and corticosteroids), Lethargy, Poor appetite thereof.
10. Energy revitaliser provider oral dosage form as claimed in claim 6 wherein it's also applicable for Sports person and Growing /School going Children who needs instant energy thereof.
PCT/IN2012/000727 2012-02-09 2012-11-06 Stable taurine oral composition WO2013118136A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN368/MUM/2012 2012-02-09
IN368MU2012 2012-02-09

Publications (1)

Publication Number Publication Date
WO2013118136A1 true WO2013118136A1 (en) 2013-08-15

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6207190B1 (en) * 1998-08-13 2001-03-27 Chronorx, Llc Dosage forms for the treatment of the chronic glaucomas
US20030078269A1 (en) * 2001-03-22 2003-04-24 Chronorx, Llc Biguanide and sulfonylurea formulations for the prevention and treatment of insulin resistance and type 2 diabetes mellitus
US6620425B1 (en) 1998-08-21 2003-09-16 Muscletech Research And Development Inc. Food supplements and methods comprising lipoic acid and creatine
US20060094734A1 (en) 2004-11-04 2006-05-04 Newman Arnold L Composition and method for inducing alertness
US20080050472A1 (en) * 2005-08-12 2008-02-28 Marvin Heuer Supplemental dietary composition including caffeine, taurine and antioxidant
CN101559064A (en) * 2008-04-15 2009-10-21 北京康比特体育科技股份有限公司 Medicament capable of protecting cell membrane
BRPI0901110A2 (en) * 2009-03-13 2010-11-16 Freitas Coelho Anna Carolina De energetic chewing gum

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6207190B1 (en) * 1998-08-13 2001-03-27 Chronorx, Llc Dosage forms for the treatment of the chronic glaucomas
US6620425B1 (en) 1998-08-21 2003-09-16 Muscletech Research And Development Inc. Food supplements and methods comprising lipoic acid and creatine
US20030078269A1 (en) * 2001-03-22 2003-04-24 Chronorx, Llc Biguanide and sulfonylurea formulations for the prevention and treatment of insulin resistance and type 2 diabetes mellitus
US20060094734A1 (en) 2004-11-04 2006-05-04 Newman Arnold L Composition and method for inducing alertness
US20080050472A1 (en) * 2005-08-12 2008-02-28 Marvin Heuer Supplemental dietary composition including caffeine, taurine and antioxidant
CN101559064A (en) * 2008-04-15 2009-10-21 北京康比特体育科技股份有限公司 Medicament capable of protecting cell membrane
BRPI0901110A2 (en) * 2009-03-13 2010-11-16 Freitas Coelho Anna Carolina De energetic chewing gum

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 201135, Derwent World Patents Index; AN 2010-Q52286, XP002697409 *
KLEPACKI ET AL: "Energy Drinks: A Review Article", STRENGTH & CONDITIONING JOURNAL,, vol. 32, no. 1, 1 February 2010 (2010-02-01), pages 37 - 41, XP009169730 *
SEIFERT SARA M ET AL: "Health Effects of Energy Drinks on Children, Adolescents, and Young Adults", PEDIATRICS, vol. 127, no. 3, March 2011 (2011-03-01), pages 511 - 528, XP002697713 *

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