US20010034338A1 - Composition and method for reducing serum cholesterol levels - Google Patents
Composition and method for reducing serum cholesterol levels Download PDFInfo
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- US20010034338A1 US20010034338A1 US09/789,150 US78915001A US2001034338A1 US 20010034338 A1 US20010034338 A1 US 20010034338A1 US 78915001 A US78915001 A US 78915001A US 2001034338 A1 US2001034338 A1 US 2001034338A1
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- policosanol
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- phytosterol
- serum cholesterol
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- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 title claims abstract description 57
- 239000000203 mixture Substances 0.000 title claims abstract description 35
- 238000000034 method Methods 0.000 title claims abstract description 10
- 229960001109 policosanol Drugs 0.000 claims abstract description 24
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 claims abstract description 24
- 241001465754 Metazoa Species 0.000 claims abstract description 7
- 238000009472 formulation Methods 0.000 claims description 8
- 241000282412 Homo Species 0.000 claims description 6
- 239000003085 diluting agent Substances 0.000 claims description 5
- 239000000314 lubricant Substances 0.000 claims description 5
- 239000000375 suspending agent Substances 0.000 claims description 4
- 239000011230 binding agent Substances 0.000 claims description 3
- 239000000872 buffer Substances 0.000 claims description 3
- 239000011248 coating agent Substances 0.000 claims description 3
- 239000003995 emulsifying agent Substances 0.000 claims description 3
- 239000003755 preservative agent Substances 0.000 claims description 3
- 239000003381 stabilizer Substances 0.000 claims description 3
- 230000002195 synergetic effect Effects 0.000 abstract description 3
- 235000012000 cholesterol Nutrition 0.000 description 19
- 229940068065 phytosterols Drugs 0.000 description 12
- 239000004170 rice bran wax Substances 0.000 description 7
- 235000019384 rice bran wax Nutrition 0.000 description 7
- -1 aliphatic alcohols Chemical class 0.000 description 6
- REZQBEBOWJAQKS-UHFFFAOYSA-N triacontan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO REZQBEBOWJAQKS-UHFFFAOYSA-N 0.000 description 6
- CNNRPFQICPFDPO-UHFFFAOYSA-N octacosan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCCCO CNNRPFQICPFDPO-UHFFFAOYSA-N 0.000 description 5
- 102000015779 HDL Lipoproteins Human genes 0.000 description 4
- 108010010234 HDL Lipoproteins Proteins 0.000 description 4
- NOPFSRXAKWQILS-UHFFFAOYSA-N docosan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCO NOPFSRXAKWQILS-UHFFFAOYSA-N 0.000 description 4
- 235000021003 saturated fats Nutrition 0.000 description 4
- TYWMIZZBOVGFOV-UHFFFAOYSA-N tetracosan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCO TYWMIZZBOVGFOV-UHFFFAOYSA-N 0.000 description 4
- 239000001993 wax Substances 0.000 description 4
- 229960002666 1-octacosanol Drugs 0.000 description 3
- 102000007330 LDL Lipoproteins Human genes 0.000 description 3
- 108010007622 LDL Lipoproteins Proteins 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 241000196324 Embryophyta Species 0.000 description 2
- QOEHNLSDMADWEF-UHFFFAOYSA-N I-Dotriacontanol Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO QOEHNLSDMADWEF-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 150000001298 alcohols Chemical class 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 229960000735 docosanol Drugs 0.000 description 2
- 230000002255 enzymatic effect Effects 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- IRHTZOCLLONTOC-UHFFFAOYSA-N hexacosan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCO IRHTZOCLLONTOC-UHFFFAOYSA-N 0.000 description 2
- SKGCQRZZTHOERR-UHFFFAOYSA-N hexatriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO SKGCQRZZTHOERR-UHFFFAOYSA-N 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 230000031891 intestinal absorption Effects 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 description 2
- 231100000027 toxicology Toxicity 0.000 description 2
- OILXMJHPFNGGTO-UHFFFAOYSA-N (22E)-(24xi)-24-methylcholesta-5,22-dien-3beta-ol Natural products C1C=C2CC(O)CCC2(C)C2C1C1CCC(C(C)C=CC(C)C(C)C)C1(C)CC2 OILXMJHPFNGGTO-UHFFFAOYSA-N 0.000 description 1
- DNIAPMSPPWPWGF-GSVOUGTGSA-N (R)-(-)-Propylene glycol Chemical compound C[C@@H](O)CO DNIAPMSPPWPWGF-GSVOUGTGSA-N 0.000 description 1
- OQMZNAMGEHIHNN-UHFFFAOYSA-N 7-Dehydrostigmasterol Natural products C1C(O)CCC2(C)C(CCC3(C(C(C)C=CC(CC)C(C)C)CCC33)C)C3=CC=C21 OQMZNAMGEHIHNN-UHFFFAOYSA-N 0.000 description 1
- SGNBVLSWZMBQTH-FGAXOLDCSA-N Campesterol Natural products O[C@@H]1CC=2[C@@](C)([C@@H]3[C@H]([C@H]4[C@@](C)([C@H]([C@H](CC[C@H](C(C)C)C)C)CC4)CC3)CC=2)CC1 SGNBVLSWZMBQTH-FGAXOLDCSA-N 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 206010070840 Gastrointestinal tract irritation Diseases 0.000 description 1
- BTEISVKTSQLKST-UHFFFAOYSA-N Haliclonasterol Natural products CC(C=CC(C)C(C)(C)C)C1CCC2C3=CC=C4CC(O)CCC4(C)C3CCC12C BTEISVKTSQLKST-UHFFFAOYSA-N 0.000 description 1
- 108090001030 Lipoproteins Proteins 0.000 description 1
- 102000004895 Lipoproteins Human genes 0.000 description 1
- 240000000111 Saccharum officinarum Species 0.000 description 1
- 235000007201 Saccharum officinarum Nutrition 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- 229930182558 Sterol Natural products 0.000 description 1
- 108010055297 Sterol Esterase Proteins 0.000 description 1
- 102000000019 Sterol Esterase Human genes 0.000 description 1
- HZYXFRGVBOPPNZ-UHFFFAOYSA-N UNPD88870 Natural products C1C=C2CC(O)CCC2(C)C2C1C1CCC(C(C)=CCC(CC)C(C)C)C1(C)CC2 HZYXFRGVBOPPNZ-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 125000001931 aliphatic group Chemical group 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 238000012209 assay specification Methods 0.000 description 1
- LGJMUZUPVCAVPU-UHFFFAOYSA-N beta-Sitostanol Natural products C1CC2CC(O)CCC2(C)C2C1C1CCC(C(C)CCC(CC)C(C)C)C1(C)CC2 LGJMUZUPVCAVPU-UHFFFAOYSA-N 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 229910000389 calcium phosphate Inorganic materials 0.000 description 1
- 235000011010 calcium phosphates Nutrition 0.000 description 1
- SGNBVLSWZMBQTH-PODYLUTMSA-N campesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CC[C@@H](C)C(C)C)[C@@]1(C)CC2 SGNBVLSWZMBQTH-PODYLUTMSA-N 0.000 description 1
- 235000000431 campesterol Nutrition 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 125000004432 carbon atom Chemical group C* 0.000 description 1
- 210000000748 cardiovascular system Anatomy 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 150000001841 cholesterols Chemical class 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 235000021045 dietary change Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 150000002191 fatty alcohols Chemical group 0.000 description 1
- 235000021197 fiber intake Nutrition 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 230000000260 hypercholesteremic effect Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 229940057917 medium chain triglycerides Drugs 0.000 description 1
- 210000000110 microvilli Anatomy 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 235000003170 nutritional factors Nutrition 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 230000007505 plaque formation Effects 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- KZJWDPNRJALLNS-VJSFXXLFSA-N sitosterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CC[C@@H](CC)C(C)C)[C@@]1(C)CC2 KZJWDPNRJALLNS-VJSFXXLFSA-N 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 238000012453 sprague-dawley rat model Methods 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 108091008672 sterol hormone receptors Proteins 0.000 description 1
- 150000003432 sterols Chemical class 0.000 description 1
- 235000003702 sterols Nutrition 0.000 description 1
- HCXVJBMSMIARIN-PHZDYDNGSA-N stigmasterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)/C=C/[C@@H](CC)C(C)C)[C@@]1(C)CC2 HCXVJBMSMIARIN-PHZDYDNGSA-N 0.000 description 1
- 235000016831 stigmasterol Nutrition 0.000 description 1
- 229940032091 stigmasterol Drugs 0.000 description 1
- BFDNMXAIBMJLBB-UHFFFAOYSA-N stigmasterol Natural products CCC(C=CC(C)C1CCCC2C3CC=C4CC(O)CCC4(C)C3CCC12C)C(C)C BFDNMXAIBMJLBB-UHFFFAOYSA-N 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 238000009492 tablet coating Methods 0.000 description 1
- 239000002700 tablet coating Substances 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 230000002110 toxicologic effect Effects 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 235000013311 vegetables Nutrition 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
Definitions
- the present invention relates generally to compositions and methods for reducing serum cholesterol levels and, more particularly, to a composition and method for lowering serum cholesterol by administering policosanols and phytosterols.
- Elevated serum cholesterol levels have been indicated as a major risk factor for heart disease, the leading cause of death among Americans.
- experts have recommended that those individuals at high risk decrease serum cholesterol levels through dietary changes, a program of physical exercise, and lifestyle changes. It is recommended that the intake of saturated fat and dietary cholesterol be strictly limited and that soluble fiber consumption be increased. Strictly limiting the intake of saturated fat and cholesterol does not, itself, present a risk to proper health and nutrition. Even where saturated fat and cholesterol are severely restricted from the diet, the liver remains able to synthesize sufficient quantities of cholesterol to perform necessary bodily functions.
- TC total cholesterol level
- LDL Elevated low-density lipoprotein
- HDL high-density lipoproteins
- phytosterols have been well documented in human clinical trials and in animal studies to lower serum cholesterol levels. This cholesterol lowering effect has been attributed to interference with the absorption of dietary cholesterol.
- Phytosterols being structurally similar to cholesterol, competitively bind with cholesterol sterol receptor sites, thus preventing cholesterol uptake. Unlike their cholesterol counterparts, phytosterols are very poorly absorbed, and some are not absorbed at all. Therefore, phytosterols do not contribute to an increase in serum cholesterol levels.
- phytosterols also compete for the enzyme cholesterol esterase. This enzyme is required by cholesterol for its breakdown to components which may be absorbed through the microvilli which line the wall of the small intestine. Thus, phytosterols also impede the enzymatic breakdown and intestinal absorption of cholesterol, which further reduces serum cholesterol levels.
- the present invention provides a composition for reducing serum cholesterol levels in humans and animals, and a method for reducing serum cholesterol levels in humans and animals by administering the composition.
- the composition comprises from about 5% to about 75% by weight of phytosterol, and from about 1% to about 60% by weight of policosanol.
- the composition further comprises from 0% to about 65% by weight of pharmaceutically acceptable formulation aids, such as diluents, stabilizers, binders, buffers, lubricants, coating agents, preservatives, emulsifiers and suspension agents.
- the composition comprises from about 10% to about 60% by weight of phytosterol, and from about 3% to about 46% by weight of policosanol. In the most preferred embodiment of the invention, the composition comprises about 3.2:1 parts by weight of phytosterol and policosanol.
- policosanol is a mixture of high-molecular weight aliphatic alcohols. These alcohols occur naturally in wax form and are characterized by fatty alcohol chains ranging from 20 to 39 carbon atoms in length.
- the major component of policosanol are the aliphatic alcohols octacosanol and triacontanol.
- Policosanol is isolated from a number of different plant sources, including sugar cane wax and rice bran wax.
- the policosanol used in the preferred embodiment of the invention is obtained from rice bran wax and has the formulation set forth below in Table I. This material is sold under the name “Rice Bran Wax” and is available from Traco Labs, Inc.
- Phytosterols are also mixtures of long-chained aliphatic alcohols in a wax form. They are naturally occurring in many common vegetable food products.
- the particular phytosterol used in the preferred embodiment of the invention is derived from vegetable oil and has the formulation set forth in Table II. This material is sold under the trademark “CHOLESTATIN” and is available from Traco Labs, Inc. Again, however, it should be understood that the invention is not limited to this particular phytosterol product, and that any number of other commonly available phytosterols can be used.
- TABLE II Phytosterol composition Total sterols 88% Min. Assay Specification B-Sitosterol 43% Min. campesterol 25% Min. stigmasterol 15% Min.
- phytosterol and policosanol lower serum cholesterol links by two independent and unrelated mechanisms of action.
- both compounds together are expected to have a synergistic effect on lowering serum cholesterol.
- phytosterols impede the enzymatic breakdown and intestinal absorption of cholesterol, which reduces serum cholesterol levels.
- Policosanol acts directly on the cholesterol synthesis pathway itself, thereby inhibiting the bio-synthesis of cholesterol from saturated fat.
- both compounds together are expected to have a synergistic effect on lowering serum cholesterol levels.
- the combination of both phytosterol and policosanol into a single composition is expected to provide a more effective treatment for elevated serum cholesterol than would be expected from the additive effect of both components.
- compositions made according to the invention is set forth below:
- tablet formula ingredient amt/cap function “CHOLESTATIN” (Min. 88% phytosterols) 250 mg active “Rice Bran Wax” (23-33% policosanols) 250 mg active Calcium phosphate 261.7 mg base Cellulose 49.4 mg tablet coating agent Stearic acid 23.8 mg lubricant Magnesium stearate 6.8 mg lubricant Silicon dioxide 9.4 mg diluent
- Soft gelatin capsule formulation ingredient amt/cag function “CHOLESTATIN” (Min. 88% 250 mg active phytosterols) “Rice Bran Wax” (23-33% policosanols) 250 mg active Medium Chain Triglycerides 700 mg diluent/emulssifying suspending agent
- Toxicology performed on the 50% phytosterol/50% rice bran wax composition has proven that the composition is non-toxic at an oral dose of 5000 mg/kg of body weight in Sprague-Dawley rats. Accordingly, oral dosages in humans of up to a maximum dosage of 1500 mg administered three times per day is considered appropriate.
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Botany (AREA)
- Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
A composition and method for reducing serum cholesterol in humans and animals is provided. The method comprises administering phytosterol and policosanol which together produce a synergistic effect in lowering serum cholesterol levels. Preferably the administered composition includes about 3.2:1 parts by weight of phytosterol and policosanol.
Description
- This application is a continuation of application Ser. No. 09/395,524 filed on Sep. 14, 1999.
- The present invention relates generally to compositions and methods for reducing serum cholesterol levels and, more particularly, to a composition and method for lowering serum cholesterol by administering policosanols and phytosterols.
- Elevated serum cholesterol levels (>200 mg/dL) have been indicated as a major risk factor for heart disease, the leading cause of death among Americans. As a result, experts have recommended that those individuals at high risk decrease serum cholesterol levels through dietary changes, a program of physical exercise, and lifestyle changes. It is recommended that the intake of saturated fat and dietary cholesterol be strictly limited and that soluble fiber consumption be increased. Strictly limiting the intake of saturated fat and cholesterol does not, itself, present a risk to proper health and nutrition. Even where saturated fat and cholesterol are severely restricted from the diet, the liver remains able to synthesize sufficient quantities of cholesterol to perform necessary bodily functions.
- More recently, experts have begun to examine the individual components of the lipid profile, in addition to the total cholesterol level (TC). While an elevated TC is a risk factor, the levels of the various forms of cholesterol which make up TC may also be risk factors. Elevated low-density lipoprotein (LDL) is a cause for concern, as these loosely packed lipoproteins are more likely to lodge within the cardiovascular system leading to the formation of plaque. Low levels of high-density lipoproteins (HDL) are an additional risk factor, as they serve to sweep artery clogging cholesterol from the blood stream. A better indication of risk appears to be the ratio of TC:HDL.
- A number of nutritional factors have been shown to improve serum cholesterol levels. For example, the use of phytosterols has been well documented in human clinical trials and in animal studies to lower serum cholesterol levels. This cholesterol lowering effect has been attributed to interference with the absorption of dietary cholesterol. Phytosterols, being structurally similar to cholesterol, competitively bind with cholesterol sterol receptor sites, thus preventing cholesterol uptake. Unlike their cholesterol counterparts, phytosterols are very poorly absorbed, and some are not absorbed at all. Therefore, phytosterols do not contribute to an increase in serum cholesterol levels. In addition to competing for receptor sites, phytosterols also compete for the enzyme cholesterol esterase. This enzyme is required by cholesterol for its breakdown to components which may be absorbed through the microvilli which line the wall of the small intestine. Thus, phytosterols also impede the enzymatic breakdown and intestinal absorption of cholesterol, which further reduces serum cholesterol levels.
- Plant derived long-chained aliphatic alcohols have also been documented to reduce serum cholesterol levels in experimental models, healthy humans and in type II hypercholesterolemic patients. These aliphatic alcohols, collectively known as policosanol, have been employed in the treatment of elevated serum cholesterol levels in only the past five years, but policosanol has shown much promise, as reported in a number of published human clinical trials. The mechanism of action has not yet been elucidated, but policosanol's effectiveness is attributed to its influence on the bio-synthesis of cholesterol within the liver. This accounts for the ability of policosanol not only to decrease total cholesterol, but also to decrease LDL serum levels and increase HDL levels.
- The present invention provides a composition for reducing serum cholesterol levels in humans and animals, and a method for reducing serum cholesterol levels in humans and animals by administering the composition. The composition comprises from about 5% to about 75% by weight of phytosterol, and from about 1% to about 60% by weight of policosanol. The composition further comprises from 0% to about 65% by weight of pharmaceutically acceptable formulation aids, such as diluents, stabilizers, binders, buffers, lubricants, coating agents, preservatives, emulsifiers and suspension agents.
- In a preferred embodiment, the composition comprises from about 10% to about 60% by weight of phytosterol, and from about 3% to about 46% by weight of policosanol. In the most preferred embodiment of the invention, the composition comprises about 3.2:1 parts by weight of phytosterol and policosanol.
- As noted previously, policosanol is a mixture of high-molecular weight aliphatic alcohols. These alcohols occur naturally in wax form and are characterized by fatty alcohol chains ranging from 20 to 39 carbon atoms in length. The major component of policosanol are the aliphatic alcohols octacosanol and triacontanol. Policosanol is isolated from a number of different plant sources, including sugar cane wax and rice bran wax. The policosanol used in the preferred embodiment of the invention is obtained from rice bran wax and has the formulation set forth below in Table I. This material is sold under the name “Rice Bran Wax” and is available from Traco Labs, Inc. It should be understood, however, that the invention is not limited in this regard and that policosanol commonly available from other naturally occurring sources may be utilized.
TABLE I Rice Bran Wax typical long-chain aliphatic alcohol profile: Carbon Fatty Alcohol Composition (%) C22OH Docosanol (Behenyl Alcohol) 0.36 C24OH Tetracosanol (Lignoceryl Alcohol) 3.21 C26OH Hexacosanol (Cerotyl Alcohol) 2.93 C28OH Octacosanol (Montanyl Alcohol) 5.59 C30OH Triacontanol (Melissyl Alcohol) 8.35 C32OH Dotriacontanol 4.64 C34OH Tetratriacontanol 2.22 C36OH Hexatriacontanol .50 Total policosanols 23-33% - Phytosterols are also mixtures of long-chained aliphatic alcohols in a wax form. They are naturally occurring in many common vegetable food products. The particular phytosterol used in the preferred embodiment of the invention is derived from vegetable oil and has the formulation set forth in Table II. This material is sold under the trademark “CHOLESTATIN” and is available from Traco Labs, Inc. Again, however, it should be understood that the invention is not limited to this particular phytosterol product, and that any number of other commonly available phytosterols can be used.
TABLE II Phytosterol composition: Total sterols 88% Min. Assay Specification B-Sitosterol 43% Min. campesterol 25% Min. stigmasterol 15% Min. - As noted previously, phytosterol and policosanol lower serum cholesterol links by two independent and unrelated mechanisms of action. However, both compounds together are expected to have a synergistic effect on lowering serum cholesterol. As previously mentioned, phytosterols impede the enzymatic breakdown and intestinal absorption of cholesterol, which reduces serum cholesterol levels. Policosanol acts directly on the cholesterol synthesis pathway itself, thereby inhibiting the bio-synthesis of cholesterol from saturated fat. However, both compounds together are expected to have a synergistic effect on lowering serum cholesterol levels. Thus, the combination of both phytosterol and policosanol into a single composition is expected to provide a more effective treatment for elevated serum cholesterol than would be expected from the additive effect of both components.
- Examples of compositions made according to the invention is set forth below:
-
tablet formula: ingredient amt/cap function “CHOLESTATIN” (Min. 88% phytosterols) 250 mg active “Rice Bran Wax” (23-33% policosanols) 250 mg active Calcium phosphate 261.7 mg base Cellulose 49.4 mg tablet coating agent Stearic acid 23.8 mg lubricant Magnesium stearate 6.8 mg lubricant Silicon dioxide 9.4 mg diluent -
Soft gelatin capsule formulation: ingredient amt/cag function “CHOLESTATIN” (Min. 88% 250 mg active phytosterols) “Rice Bran Wax” (23-33% policosanols) 250 mg active Medium Chain Triglycerides 700 mg diluent/emulssifying suspending agent - Previous clinical and toxicological testing of policosanol and phytosterol has shown that the tolerance of both components is good. Significantly larger doses of both waxes are readily tolerated. Occasional GI irritation might be expected at extremely high doses, far greater than the normal dosage range. In the event such irritation should occur, it would be expected to be minimal, and would not pose any risk to health.
- Toxicology performed on the 50% phytosterol/50% rice bran wax composition has proven that the composition is non-toxic at an oral dose of 5000 mg/kg of body weight in Sprague-Dawley rats. Accordingly, oral dosages in humans of up to a maximum dosage of 1500 mg administered three times per day is considered appropriate.
- While preferred embodiments have been shown and described, various modifications and substitutions may be made without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the present invention has been described by way of example and not by limitation.
Claims (8)
1. A composition for reducing serum cholesterol levels in humans and animals, said composition comprising: from about 5% to about 75% by weight of phytosterol, from about 1% to about 60% by weight of policosanol, and from 0% to about 65% by weight of pharmaceutically acceptable formulation aids.
2. The composition of , wherein the composition comprises from about 10% to about 60% by weight of phytosterol, and from about 3% to about 46% by weight of policosanol.
claim 1
3. The composition of , wherein the composition comprises about 3.2:1 parts by weight of phytosterol and policosanol.
claim 1
4. The composition of , wherein the formulation aids comprise diluents, stabilizers, binders, buffers, lubricants, coating agents, preservatives, emulsifiers, and suspension agents.
claim 1
5. A method for reducing serum cholesterol levels in humans and animals by administering to at least one of a human and an animal from about 5% to about 75% by weight of phytosterol, from about 1% to about 60% by weight of policosanol, and from 0% to about 65% by weight of pharmaceutically acceptable formulation aids.
6. The method of , further comprising administering a mixture including from about 10% to about 60% by weight of phytosterol, and from about 3% to about 46% by weight of policosanol.
claim 5
7. The method of , further comprising administering about 3.2:1 parts by weight of phytosterol and policosanol.
claim 5
8. The method of , further comprising administering formulation aids selected from the group including diluents, stabilizers, binders, buffers, lubricants, coating agents, preservatives, emulsifiers and suspension agents.
claim 5
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US09/789,150 US20010034338A1 (en) | 1999-09-14 | 2001-02-20 | Composition and method for reducing serum cholesterol levels |
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US09/395,524 US6197832B1 (en) | 1999-09-14 | 1999-09-14 | Composition for reducing serum cholesterol levels |
US09/789,150 US20010034338A1 (en) | 1999-09-14 | 2001-02-20 | Composition and method for reducing serum cholesterol levels |
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US09/395,524 Continuation US6197832B1 (en) | 1999-09-14 | 1999-09-14 | Composition for reducing serum cholesterol levels |
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US09/789,150 Abandoned US20010034338A1 (en) | 1999-09-14 | 2001-02-20 | Composition and method for reducing serum cholesterol levels |
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