US20050037066A1 - Formulation and manufacturing process for Coenzyme Q10 soft gel capsules - Google Patents
Formulation and manufacturing process for Coenzyme Q10 soft gel capsules Download PDFInfo
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- US20050037066A1 US20050037066A1 US10/945,038 US94503804A US2005037066A1 US 20050037066 A1 US20050037066 A1 US 20050037066A1 US 94503804 A US94503804 A US 94503804A US 2005037066 A1 US2005037066 A1 US 2005037066A1
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- thixatropic
- coenzyme
- carrier
- composition
- gelatine
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- ACTIUHUUMQJHFO-UPTCCGCDSA-N coenzyme Q10 Chemical compound COC1=C(OC)C(=O)C(C\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CCC=C(C)C)=C(C)C1=O ACTIUHUUMQJHFO-UPTCCGCDSA-N 0.000 title claims abstract description 74
- ACTIUHUUMQJHFO-UHFFFAOYSA-N Coenzym Q10 Natural products COC1=C(OC)C(=O)C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)=C(C)C1=O ACTIUHUUMQJHFO-UHFFFAOYSA-N 0.000 title claims abstract description 69
- 235000017471 coenzyme Q10 Nutrition 0.000 title claims abstract description 69
- 229940110767 coenzyme Q10 Drugs 0.000 title claims abstract description 26
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 7
- 239000000203 mixture Substances 0.000 title claims description 56
- 239000002775 capsule Substances 0.000 title claims description 18
- 238000009472 formulation Methods 0.000 title description 19
- 229920000159 gelatin Polymers 0.000 claims abstract description 27
- 235000019322 gelatine Nutrition 0.000 claims abstract description 27
- 239000001828 Gelatine Substances 0.000 claims abstract description 25
- 238000010438 heat treatment Methods 0.000 claims abstract description 5
- 239000000725 suspension Substances 0.000 claims abstract 2
- 238000000034 method Methods 0.000 claims description 24
- 230000008569 process Effects 0.000 claims description 22
- 239000003963 antioxidant agent Substances 0.000 claims description 8
- 230000003078 antioxidant effect Effects 0.000 claims description 8
- 235000006708 antioxidants Nutrition 0.000 claims description 8
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 7
- 239000008158 vegetable oil Substances 0.000 claims description 7
- 239000004094 surface-active agent Substances 0.000 claims description 6
- 239000004034 viscosity adjusting agent Substances 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 4
- 239000012530 fluid Substances 0.000 claims description 2
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 4
- 235000019482 Palm oil Nutrition 0.000 claims 4
- 235000019484 Rapeseed oil Nutrition 0.000 claims 4
- 239000002385 cottonseed oil Substances 0.000 claims 4
- 235000012343 cottonseed oil Nutrition 0.000 claims 4
- 229940049654 glyceryl behenate Drugs 0.000 claims 4
- FETSQPAGYOVAQU-UHFFFAOYSA-N glyceryl palmitostearate Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCC(O)=O.CCCCCCCCCCCCCCCCCC(O)=O FETSQPAGYOVAQU-UHFFFAOYSA-N 0.000 claims 4
- 229940046813 glyceryl palmitostearate Drugs 0.000 claims 4
- 229940049964 oleate Drugs 0.000 claims 4
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 claims 4
- 239000002540 palm oil Substances 0.000 claims 4
- 235000012424 soybean oil Nutrition 0.000 claims 4
- 239000003549 soybean oil Substances 0.000 claims 4
- 238000002156 mixing Methods 0.000 claims 2
- 238000001816 cooling Methods 0.000 claims 1
- 230000009974 thixotropic effect Effects 0.000 abstract description 2
- 239000007963 capsule composition Substances 0.000 abstract 1
- 239000000499 gel Substances 0.000 description 12
- 239000000843 powder Substances 0.000 description 9
- 101150113809 COQ10 gene Proteins 0.000 description 7
- 230000015572 biosynthetic process Effects 0.000 description 7
- 239000004615 ingredient Substances 0.000 description 7
- 210000003470 mitochondria Anatomy 0.000 description 7
- 238000003786 synthesis reaction Methods 0.000 description 7
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 6
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 5
- 238000010521 absorption reaction Methods 0.000 description 5
- 239000008280 blood Substances 0.000 description 5
- 210000004369 blood Anatomy 0.000 description 5
- 208000010354 Coenzyme Q10 deficiency Diseases 0.000 description 4
- 230000036765 blood level Effects 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 4
- 230000031891 intestinal absorption Effects 0.000 description 4
- ZKHQWZAMYRWXGA-KQYNXXCUSA-J ATP(4-) Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](COP([O-])(=O)OP([O-])(=O)OP([O-])([O-])=O)[C@@H](O)[C@H]1O ZKHQWZAMYRWXGA-KQYNXXCUSA-J 0.000 description 3
- ZKHQWZAMYRWXGA-UHFFFAOYSA-N Adenosine triphosphate Natural products C1=NC=2C(N)=NC=NC=2N1C1OC(COP(O)(=O)OP(O)(=O)OP(O)(O)=O)C(O)C1O ZKHQWZAMYRWXGA-UHFFFAOYSA-N 0.000 description 3
- 229930003427 Vitamin E Natural products 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 239000006185 dispersion Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 235000019165 vitamin E Nutrition 0.000 description 3
- 239000011709 vitamin E Substances 0.000 description 3
- 229940046009 vitamin E Drugs 0.000 description 3
- 230000002407 ATP formation Effects 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 230000001413 cellular effect Effects 0.000 description 2
- 238000005538 encapsulation Methods 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 239000008273 gelatin Substances 0.000 description 2
- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 230000002503 metabolic effect Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 229910052757 nitrogen Inorganic materials 0.000 description 2
- 230000003647 oxidation Effects 0.000 description 2
- 238000007254 oxidation reaction Methods 0.000 description 2
- 230000037081 physical activity Effects 0.000 description 2
- 210000002027 skeletal muscle Anatomy 0.000 description 2
- 230000000153 supplemental effect Effects 0.000 description 2
- 229930003231 vitamin Natural products 0.000 description 2
- 239000011782 vitamin Substances 0.000 description 2
- 235000013343 vitamin Nutrition 0.000 description 2
- 229940088594 vitamin Drugs 0.000 description 2
- 102000018832 Cytochromes Human genes 0.000 description 1
- 108010052832 Cytochromes Proteins 0.000 description 1
- 229940121710 HMGCoA reductase inhibitor Drugs 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 201000002169 Mitochondrial myopathy Diseases 0.000 description 1
- 201000004681 Psoriasis Diseases 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000001143 conditioned effect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 229910001873 dinitrogen Inorganic materials 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000027721 electron transport chain Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 206010016256 fatigue Diseases 0.000 description 1
- 235000019197 fats Nutrition 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 210000005003 heart tissue Anatomy 0.000 description 1
- 239000007970 homogeneous dispersion Substances 0.000 description 1
- 239000008240 homogeneous mixture Substances 0.000 description 1
- 208000023692 inborn mitochondrial myopathy Diseases 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- -1 lipid compound Chemical class 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000006609 metabolic stress Effects 0.000 description 1
- 210000004165 myocardium Anatomy 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 210000004789 organ system Anatomy 0.000 description 1
- 210000003463 organelle Anatomy 0.000 description 1
- 235000021400 peanut butter Nutrition 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 239000000955 prescription drug Substances 0.000 description 1
- NPCOQXAVBJJZBQ-UHFFFAOYSA-N reduced coenzyme Q9 Natural products COC1=C(O)C(C)=C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)C(O)=C1OC NPCOQXAVBJJZBQ-UHFFFAOYSA-N 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 230000000276 sedentary effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 235000019149 tocopherols Nutrition 0.000 description 1
- 235000021076 total caloric intake Nutrition 0.000 description 1
- 239000006163 transport media Substances 0.000 description 1
- 229940035936 ubiquinone Drugs 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- QUEDXNHFTDJVIY-UHFFFAOYSA-N γ-tocopherol Chemical class OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1 QUEDXNHFTDJVIY-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
-
- 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
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
-
- 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
- A61K31/355—Tocopherols, e.g. vitamin E
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- This invention relates to a composition and process of manufacturing Coenzyme Q10 with improved human absorption characteristics in a thixotropic gelatin carrier capable of admixing without heating the Coenzyme Q10, and capable of suspending Coenzyme Q10 in a uniform dispersion.
- Coenzyme Q10 (COQ10 or Ubiquinone) is a large molecular weight (863.63 grams) lipid compound that is produced in the liver and perhaps other body organs. The total human body content is estimated to be1.4 to 1.8 grams, depending on the age and the physical fitness of the individual.
- COQ10 is found in the mitochondria and other organelles of every living cell, it appears to be most abundant in tissues with a high number of mitochondria and a high level of metabolic activity. For example, there is approximately 4 mg of COQ10 in the heart tissues, and about 1000 mg in the skeletal muscle.
- the blood acts as a CoQ10 reservoir and transport media between endogenous CoQ10 synthesis in the intestinal liver, exogenous CoQ10 absorption from digested food substances in the intestinal tract, and the body cells.
- Endogenous synthesis appears to be responsible for 56 percent and exogenous sources for 44 percent of the body's CoQ10 requirements. These numbers are currently being studied and endogenous CoQ10 synthesis may be significantly deficient in the elderly.
- certain disease states such as mitochondrial myopathy
- prescription drugs such as cholesterol-lowering statin drugs, seem to deplete the endogenous CoQ10 levels in the body.
- These deficiencies are not related to the total caloric intake, but rather to the vitamin content of ingested foods as the body requires multiple vitamins for the synthesis of CoQ10.
- CoQ10 requirements of the body are also variable between individuals and are dependent on age, physical activity, and disease. It is estimated that the body COQ10 utilization is between 5 and 9 mg per day. Intercellular CoQ10 is required for the synthesis of energy and therefore essential for life. Energy synthesis occurs in the mitochondria, where CoQ10 provides an electron for the electron transport chain in the cytochrome system, in which adenosine triphosphate (ATP) is synthesized. As CoQ10 gives up an electron for the ATP synthesis, it gets oxidized. If CoQ10 is used as an antioxidant, it gets oxidized and is no longer available to provide electrons and function in the synthesis of ATP.
- ATP adenosine triphosphate
- CoQ10 has been used to treat heart failure, chronic fatigue and patients with psoriasis and planter warts. In all cases, it has been found that the improved soft gel formulation, at doses of 30-100 mg/day of CoQ10, have been proven to be superior to commercially available 60 mg dry powder capsules, and existing 100 mg/day CoQ10 soft gel formulations.
- CoQ10 dosage for a normal individual compared to the dosage necessary for a diseased individual has been difficult to ascertain.
- Recommended doses of 10 to 30 mg/day were found to be ineffective for patients with significant COQ10 deficiencies.
- the present invention comprises a formulation of Coenzyme Q10 for improved manufacturing of soft gelatine capsules containing Coenzyme Q 10.
- a preferred soft gel formulation includes Coenzyme Q 10, Vitamin E (mixed tocopherols) added as a functional antioxidant, and a thixatropic gelatin carrier which has the ability of enhancing the solubility and stability of the active ingredient and provides for better absorption thereof in humans.
- An additional ingredient, an antioxidant, either from natural or synthetic sources, can be added in order to prepare a potent combination antioxidant formulation.
- the preferred soft gel Coenzyme Q10 formulation is administered twice a day in dosages of about 30 mg, thereby reducing the Coenzyme Q10 cost while producing the desired retained Coenzyme Q10 in the human body.
- the present invention utilizes a gelatine carrier with thixatropic properties and substantial capacity to suspend active ingredients in a uniform dispersion.
- the carrier composition used in the present invention is described in U.S. Pat. No. 6,365,181 (issued to Matthews), and is a thixatropic carrier gel comprising a homogeneous dispersion of viscosity modifiers and surface active agents in vegetable oil.
- the carrier composition is agitated, such as by slow stirring, it becomes fluid, and when the agitation is stopped, it becomes a highly viscous semi-solid.
- Active agents are easily admixed with the carrier composition by stirring and high loadings of the active agents can be used to make a stable uniform dispersion within the carrier composition because the composition becomes semi-solid when stirring is stopped.
- the components of the carrier composition include from about 84% to 95% of a vegetable oil, from about 1% to 9% of a viscosity modifier, and from about 1% to 15% of a surface active agent such that the total amounts to 100%.
- a surface active agent such that the total amounts to 100%.
- the unique formulation of the present invention involves the following sequence of ingredients and process methodology:
- Typical amounts of ingredients per capsule are:
- the present invention's 30 mg CoQ10 soft gel formulation of CoQ10 provides approximately 50%, and with two capsules 100%, of the daily CoQ10 requirements of a normal sedentary individual. It would take at least three of the dry powder 30 mg CoQ10 capsules to produce the same effects as one of the present invention in 30 mg soft gel form, and six of the dry powder 30 mg COQ10 capsules to produce the same effect as two of the present invention 30 mg CoQ10 soft gel capsules.
- Cellular CoQ10 content is a function of the number and quality of the cellular mitochondria.
- the failing heart muscle has 2.2 fig COQ10 per mg tissue and a blood CoQ10 deficiency (0.3-0.5 ⁇ g/ml).
- the normal conditioned heart has 6.3 ⁇ g/gm in its tissue, and a low basal blood level (0.5-0.6 ⁇ g/ml).
Abstract
A soft gelatine capsule formulation improved manufacturing of Coenzyme Q10, comprising Coenzyme Q10 in a thixotropic gelatine carrier capable of admixing without heating with Coenzyme Q10, and capable of keeping Coenzyme Q10 in suspension at ambient temperature.
Description
- This is a Continuation of U.S. application Ser. No. 10/368,260 filed on Feb. 18, 2003, which is a Continuation-In-Part of U.S. application Ser. No. 09/873,156 which was filed Jun. 1, 2001, now abandoned, that in turn claims priority benefit of U.S. Provisional Application Ser. No. 60/263,953 filed January 24, 201, the contents of which are incorporated herein in their entirety.
- 1. Field of the Invention
- This invention relates to a composition and process of manufacturing Coenzyme Q10 with improved human absorption characteristics in a thixotropic gelatin carrier capable of admixing without heating the Coenzyme Q10, and capable of suspending Coenzyme Q10 in a uniform dispersion.
- 2. Background go of the Invention
- Coenzyme Q10(COQ10 or Ubiquinone) is a large molecular weight (863.63 grams) lipid compound that is produced in the liver and perhaps other body organs. The total human body content is estimated to be1.4 to 1.8 grams, depending on the age and the physical fitness of the individual. Although COQ10 is found in the mitochondria and other organelles of every living cell, it appears to be most abundant in tissues with a high number of mitochondria and a high level of metabolic activity. For example, there is approximately 4 mg of COQ10 in the heart tissues, and about 1000 mg in the skeletal muscle. The blood acts as a CoQ10 reservoir and transport media between endogenous CoQ10 synthesis in the intestinal liver, exogenous CoQ10 absorption from digested food substances in the intestinal tract, and the body cells. Endogenous synthesis appears to be responsible for 56 percent and exogenous sources for 44 percent of the body's CoQ10 requirements. These numbers are currently being studied and endogenous CoQ10 synthesis may be significantly deficient in the elderly. Furthermore, certain disease states, such as mitochondrial myopathy, and prescription drugs, such as cholesterol-lowering statin drugs, seem to deplete the endogenous CoQ10 levels in the body. These deficiencies are not related to the total caloric intake, but rather to the vitamin content of ingested foods as the body requires multiple vitamins for the synthesis of CoQ10.
- CoQ10 requirements of the body are also variable between individuals and are dependent on age, physical activity, and disease. It is estimated that the body COQ10 utilization is between 5 and 9 mg per day. Intercellular CoQ10 is required for the synthesis of energy and therefore essential for life. Energy synthesis occurs in the mitochondria, where CoQ10 provides an electron for the electron transport chain in the cytochrome system, in which adenosine triphosphate (ATP) is synthesized. As CoQ10 gives up an electron for the ATP synthesis, it gets oxidized. If CoQ10 is used as an antioxidant, it gets oxidized and is no longer available to provide electrons and function in the synthesis of ATP. Under conditions of high metabolic stress, endogenous sources may become inadequate to meet the body's CoQ10 requirement for ATP synthesis. Under such conditions, dietary CoQ10 supplementation has been shown to be an effective source. CoQ10 has been used to treat heart failure, chronic fatigue and patients with psoriasis and planter warts. In all cases, it has been found that the improved soft gel formulation, at doses of 30-100 mg/day of CoQ10, have been proven to be superior to commercially available 60 mg dry powder capsules, and existing 100 mg/day CoQ10 soft gel formulations.
- An appropriate CoQ10 dosage for a normal individual compared to the dosage necessary for a diseased individual has been difficult to ascertain. Recommended doses of 10 to 30 mg/day were found to be ineffective for patients with significant COQ10 deficiencies. In the past 15 years, it has become generally accepted that poor intestinal absorption of certain CoQ10 formulations limits their effective use. For this reason, 50 and 150 or even 200 mg tablets or capsules are commercially available to the consumer, at a considerable higher cost, the main cost driver being the CoQ 10.
- Folkers et al. (U.S. Pat. No. 4,824,669) addresses a soft gel capsule with CoQ10 and at least one vegetable oil. This formulation was determined to increase blood CoQ10 levels to 2.5 μg/ml compared to 1.6 μg/ml for an equivalent 100 mg dose of dry powder CoQ10. Many different CoQ10 formulations have appeared which are claimed to increase intestinal absorption. However, intestinal absorption data, collected under near basal conditions, which compare CoQ10 alone in oil with dry powder CoQ10, are inconclusive.
- The present invention comprises a formulation of Coenzyme Q10 for improved manufacturing of soft gelatine capsules containing Coenzyme Q 10.
- According to the present invention, a preferred soft gel formulation includes Coenzyme Q 10, Vitamin E (mixed tocopherols) added as a functional antioxidant, and a thixatropic gelatin carrier which has the ability of enhancing the solubility and stability of the active ingredient and provides for better absorption thereof in humans. An additional ingredient, an antioxidant, either from natural or synthetic sources, can be added in order to prepare a potent combination antioxidant formulation. The preferred soft gel Coenzyme Q10 formulation is administered twice a day in dosages of about 30 mg, thereby reducing the Coenzyme Q10 cost while producing the desired retained Coenzyme Q10 in the human body.
- Other features and advantages of the present invention will become more apparent from the following detailed description, which illustrate, by way of example, the principles of the invention.
- The present invention utilizes a gelatine carrier with thixatropic properties and substantial capacity to suspend active ingredients in a uniform dispersion. The carrier composition used in the present invention is described in U.S. Pat. No. 6,365,181 (issued to Matthews), and is a thixatropic carrier gel comprising a homogeneous dispersion of viscosity modifiers and surface active agents in vegetable oil. When the carrier composition is agitated, such as by slow stirring, it becomes fluid, and when the agitation is stopped, it becomes a highly viscous semi-solid. Active agents are easily admixed with the carrier composition by stirring and high loadings of the active agents can be used to make a stable uniform dispersion within the carrier composition because the composition becomes semi-solid when stirring is stopped.
- As described in the Matthews patent, the components of the carrier composition include from about 84% to 95% of a vegetable oil, from about 1% to 9% of a viscosity modifier, and from about 1% to 15% of a surface active agent such that the total amounts to 100%. Other details of the thixatropic gelatine carrier used in the present invention are described in the Matthews patent, and are incorporated herein by reference.
- The unique formulation of the present invention involves the following sequence of ingredients and process methodology:
-
- (A) Heat the thixatropic gelatine carrier to a temperature of about 25° C. to about 35° C. (preferably about 27° C. to about 30° C.);
- (B) Simultaneously add in a container under vacuum the following ingredients to the pre-heated thixatropic gelatine carrier: Coenzyme Q10, Vitamin E, and if desired, additional antioxidant in compatible form, the vacuum being to prevent oxidation of any of the ingredients;
- (C) Blend and continuously stir all of the ingredients into a mixture;
- (D) Cool the mixture to a temperature of about 23° C. to 28° C. (preferably about 25° C.);
- (E) Mix the mixture within the container under a blanket of nitrogen gas to prevent oxidation of any of the ingredients; and
- (F) Encapsulate the mixture in a soft gel capsule.
- If the cooled mixture sits for any length of time under its blanket of nitrogen before encapsulation, re-mix under the blanket of nitrogen to assure a homogenous mixture for encapsulation.
- Typical amounts of ingredients per capsule are:
- -50 to 500 mg of the thixatropic gelatine carrier, described above;
-
- 30 to 100 mg of Coenzyme Q10;
- 10 to 100 IU Vitamin E; and if desired
- 0.5 to 500 mg of additional antioxidant.
- The bioavailability or intestinal absorption of COQ10 has been a major controversy in the international CoQ10 research community. Previous data indicate that only 1 to 3% of a dry powder CoQ10 formulation is absorbed through the lacteals in the intestines and appears in the blood over a twelve hour interval. In general, blood levels of 1.2 to 1.6 μg/ml have been reported, when taking 30 to 60 mg/day dry powder CoQ10 formulation for 30 days. It has been reported that when a dry powder CoQ10 formulation is taken with a fat, such a peanut butter, steady-state blood levels of 2.0 to 2.8 μg/ml are measurable. Multiple clinical trials were conducted in the United States and Europe using the Folkers (U.S. Pat. No. 4,824,669) soft gel. With a dosage of 100 mg/day multiple investigators have reported group mean blood levels of 2.3 to 3.5 μg/ml depending on the laboratory conducting the measurement.
- The present invention's 30 mg CoQ10 soft gel formulation of CoQ10 provides approximately 50%, and with two capsules 100%, of the daily CoQ10 requirements of a normal sedentary individual. It would take at least three of the dry powder 30 mg CoQ10 capsules to produce the same effects as one of the present invention in 30 mg soft gel form, and six of the dry powder 30 mg COQ10 capsules to produce the same effect as two of the present invention 30 mg CoQ10 soft gel capsules.
- Regardless of the absorption mechanism, the significantly higher basal blood CoQ10 levels (167%) and the 273% greater absorption rate found in studies, establish that the present invention soft gel formulation is indeed a superior product to the dry powder CoQ10 formulations. This may be especially true for those individuals whose daily CoQ10 requirement is elevated due to: high physical activity; a need for CoQ10 as an antioxidant; or active disease associated with known COQ10 deficiencies.
- Cellular CoQ10 content is a function of the number and quality of the cellular mitochondria. For example, the failing heart muscle has 2.2 fig COQ10 per mg tissue and a blood CoQ10 deficiency (0.3-0.5 μg/ml). The normal conditioned heart has 6.3 μg/gm in its tissue, and a low basal blood level (0.5-0.6 μg/ml). These results indicate that supplemental CoQ10 enters the cell. This observation has also been reported for skeletal muscles of trained and non-trained athletes.
- The subjective and objective responses to supplemental CoQ10 in the normal individual appear more rapidly compared to that of the physically unfit or the diseased individual with a CoQ10 deficiency. The most probable reason for this observation is that the metabolic machinery (mitochondria) is viable in the non-diseased normal volunteer, whereas the mitochondria are atrophied in the cells of de-conditioned and diseased individuals. Therefore, it takes time in the diseased individual to build up the mitochondria to a more normal activity level and to normalize their distribution in the organ system involved.
- Thus, there has been described a novel CoQ10 formulation and method of formulation, which fulfill all the objects and advantages sought therefor. Many changes, modifications, variations and applications of the subject invention will become apparent to those skilled in the art after consideration of the specification. All such changes, modifications, alterations and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by the invention which is limited only by the claims that follow.
Claims (23)
1. A composition comprising Coenzyme Q10 in combination with an antioxidant in a thixatropic gelatine carrier for manufacturing soft gel capsules at a temperature of about 27° C. to about 30° C. containing a stable uniform suspension of Coenzyme Q10.
2. A composition comprising Coenzyme Q10 and a thixatropic gelatine carrier.
3. The composition of claim 2 , wherein the thixatropic gelatine carrier is a semi-solid at a temperature of about 23° C. to about 28° C. and becomes fluid when stirred.
4. The composition of claim 2 , wherein the thixatropic gelatine carrier comprises:
from about 84% to about 95% vegetable oil selected from the group consisting of soybean oil, rapeseed oil, palm oil, and cotton seed oil;
from about 1% to about 9% of a viscosity modifier selected from the group consisting of a glyceryl palmito stearate and glyceryl behenate; and
from about 1% to about 15% of a surface active agent comprising polyglyceryl oleate.
5. The composition of claim 2 , wherein the amount of Coenzyme Q10 in the composition ranges from 8 to 40% by weight.
6. A process of manufacturing a composition comprising Coenzyme Q 10, said process comprising the steps of:
(a) stirring a thixatropic gelatine carrier until the thixatropic gelatine carrier is liquefied; and
(b) adding Coenzyme Q10 to the liquefied carrier to form a mixture.
7. The process of claim 6 , wherein the thixatropic gelatine carrier comprises:
from about 84% to about 95% vegetable oil selected from the group consisting of soybean oil, rapeseed oil, palm oil, and cotton seed oil;
from about 1% to about 9% of a viscosity modifier selected from the group consisting of a glyceryl palmito stearate and glyceryl behenate; and
from about 1% to about 15% of a surface active agent comprising polyglyceryl oleate.
8. The process of claim 6 , further comprising the step of heating the thixatropic gelatine carrier from about 27° C. to about 30° C. prior to the addition of the Coenzyme Q10.
9. The process of claim 6 , wherein 30 to 100 mg of the Coenzyme Q10 are in each capsule.
10. The process of claim 6 , wherein the mixture is cooled from about 23° C. to 28° C.
11. The process of claim 6 , wherein 50 to 500 mg of the thixatropic gelatine carrier is in each capsule.
12. A composition, prepared by a process comprising the steps of:
(a) heating a thixatropic gelatine carrier to a temperature that liquefies the carrier;
(b) blending the heated thixatropic gelatine carrier and Coenzyme Q10; and
(c) cooling the blended mixture to a temperature, thereby causing the mixture to form a viscous semi-solid.
13. The composition prepared by the process of claim 12 , wherein the thixatropic gelatine carrier comprises:
from about 84% to about 95% vegetable oil selected from the group consisting of soybean oil, rapeseed oil, palm oil, and cotton seed oil;
from about 1% to about 9% of a viscosity modifier selected from the group consisting of a glyceryl palmito stearate and glyceryl behenate; and
from about 1% to about 15% of a surface active agent comprising polyglyceryl oleate.
14. The composition prepared by the process of claim 12 , wherein the thixatropic gelatine carrier is heated from about 27° C. to about 30° C.
15. The composition prepared by the process of claim 12 , wherein 30 to 100 mg of the Coenzyme Q10 are in each capsule.
16. The composition prepared by the process of claim 12 , wherein the mixture is cooled from about 23° C. to 28° C.
17. The composition prepared by the process of claim 12 , wherein 50 to 500 mg of the thixatropic gelatine carrier is in each capsule.
18. A process of manufacturing a composition comprising Coenzyme Q 10, said process comprising the step of:
(a) mixing a thixatropic gelatine carrier and Coenzyme Q10 to form a mixture.
19. The process of claim 18 , wherein the thixatropic gelatine carrier comprises:
from about 84% to about 95% vegetable oil selected from the group consisting of soybean oil, rapeseed oil, palm oil, and cotton seed oil;
from about 1% to about 9% of a viscosity modifier selected from the group consisting of a glyceryl palmito stearate and glyceryl behenate; and
from about 1% to about 15% of a surface active agent comprising polyglyceryl oleate.
20. The process of claim 18 , further comprising the step of heating the mixture from about 27° C. to about 30° C.
21. The process of claim 18 , wherein 30 to 100 mg of the Coenzyme Q10 are in each capsule.
22. The process of claim 18 , wherein the mixture is cooled from about 23° C. to 28° C.
23. The process of claim 18 , wherein 50 to 500 mg of the thixatropic gelatine carrier is in each capsule.
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US10/945,038 US20050037066A1 (en) | 2001-01-24 | 2004-09-20 | Formulation and manufacturing process for Coenzyme Q10 soft gel capsules |
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US26395301P | 2001-01-24 | 2001-01-24 | |
US09/873,156 US20020098172A1 (en) | 2001-01-24 | 2001-06-01 | Coenzyme Q10 formulation and process methodology for soft gel capsules manufacturing |
US10/368,260 US6855733B2 (en) | 2001-01-24 | 2003-02-18 | Formulation and manufacturing process for coenzyme Q10 soft gel capsules |
US10/945,038 US20050037066A1 (en) | 2001-01-24 | 2004-09-20 | Formulation and manufacturing process for Coenzyme Q10 soft gel capsules |
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US10/368,260 Continuation US6855733B2 (en) | 2001-01-24 | 2003-02-18 | Formulation and manufacturing process for coenzyme Q10 soft gel capsules |
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US10/944,992 Abandoned US20050031681A1 (en) | 2001-01-24 | 2004-09-20 | Formulation and manufacturing process for Coenzyme Q10 soft gel capsules |
US10/945,179 Abandoned US20050036998A1 (en) | 2001-01-24 | 2004-09-20 | Formulation and manufacturing process for Coenzyme Q10 soft gel capsules |
US10/945,038 Abandoned US20050037066A1 (en) | 2001-01-24 | 2004-09-20 | Formulation and manufacturing process for Coenzyme Q10 soft gel capsules |
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US10/944,992 Abandoned US20050031681A1 (en) | 2001-01-24 | 2004-09-20 | Formulation and manufacturing process for Coenzyme Q10 soft gel capsules |
US10/945,179 Abandoned US20050036998A1 (en) | 2001-01-24 | 2004-09-20 | Formulation and manufacturing process for Coenzyme Q10 soft gel capsules |
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Cited By (9)
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US20050069582A1 (en) * | 2003-09-29 | 2005-03-31 | Michael Fantuzzi | Solubilized CoQ-10 |
US20060013888A1 (en) * | 2003-09-29 | 2006-01-19 | Ronald G. Udell | Solubilized CoQ-10 |
US20080089877A1 (en) * | 2003-08-14 | 2008-04-17 | Udell Ronald G | Super Absorption Coenzyme Q10 |
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US8506995B2 (en) | 1999-03-29 | 2013-08-13 | Soft Gel Technologies, Inc. | Coenzyme Q10 formulation and process methodology for soft gel capsules manufacturing |
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Also Published As
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US6855733B2 (en) | 2005-02-15 |
US20050031681A1 (en) | 2005-02-10 |
US20030157083A1 (en) | 2003-08-21 |
US20050036998A1 (en) | 2005-02-17 |
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