US20010016603A1 - Calcium formate for use as a dietary supplement - Google Patents
Calcium formate for use as a dietary supplement Download PDFInfo
- Publication number
- US20010016603A1 US20010016603A1 US09/746,250 US74625000A US2001016603A1 US 20010016603 A1 US20010016603 A1 US 20010016603A1 US 74625000 A US74625000 A US 74625000A US 2001016603 A1 US2001016603 A1 US 2001016603A1
- Authority
- US
- United States
- Prior art keywords
- calcium
- calcium formate
- phosphorus
- formate
- dose
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
- CBOCVOKPQGJKKJ-UHFFFAOYSA-L Calcium formate Chemical compound [Ca+2].[O-]C=O.[O-]C=O CBOCVOKPQGJKKJ-UHFFFAOYSA-L 0.000 title claims abstract description 49
- 229940044172 calcium formate Drugs 0.000 title claims abstract description 49
- 235000019255 calcium formate Nutrition 0.000 title claims abstract description 49
- 239000004281 calcium formate Substances 0.000 title claims abstract description 49
- 235000015872 dietary supplement Nutrition 0.000 title description 3
- 239000011575 calcium Substances 0.000 claims abstract description 43
- 229910052791 calcium Inorganic materials 0.000 claims abstract description 42
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims abstract description 36
- 235000005911 diet Nutrition 0.000 claims abstract description 18
- 230000000378 dietary effect Effects 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims description 22
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims description 9
- 235000019166 vitamin D Nutrition 0.000 claims description 6
- 239000011710 vitamin D Substances 0.000 claims description 6
- 229930003316 Vitamin D Natural products 0.000 claims description 5
- 230000014759 maintenance of location Effects 0.000 claims description 5
- 229940046008 vitamin d Drugs 0.000 claims description 5
- 150000001875 compounds Chemical class 0.000 claims description 4
- -1 vitamin D compound Chemical class 0.000 claims description 4
- 235000005282 vitamin D3 Nutrition 0.000 claims description 4
- 239000011647 vitamin D3 Substances 0.000 claims description 4
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 claims description 4
- 229940021056 vitamin d3 Drugs 0.000 claims description 4
- 239000007903 gelatin capsule Substances 0.000 claims description 3
- 150000003710 vitamin D derivatives Chemical class 0.000 claims description 2
- 239000000203 mixture Substances 0.000 abstract description 8
- 239000011574 phosphorus Substances 0.000 description 39
- 229910052698 phosphorus Inorganic materials 0.000 description 39
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 38
- 229960005069 calcium Drugs 0.000 description 32
- 239000011230 binding agent Substances 0.000 description 16
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 14
- 238000010521 absorption reaction Methods 0.000 description 11
- 230000037213 diet Effects 0.000 description 9
- 241000700159 Rattus Species 0.000 description 7
- 229910000019 calcium carbonate Inorganic materials 0.000 description 7
- 210000002966 serum Anatomy 0.000 description 7
- 210000001035 gastrointestinal tract Anatomy 0.000 description 6
- 239000008194 pharmaceutical composition Substances 0.000 description 6
- 241001465754 Metazoa Species 0.000 description 5
- 229940069428 antacid Drugs 0.000 description 5
- 239000003159 antacid agent Substances 0.000 description 5
- 239000003826 tablet Substances 0.000 description 4
- 229910019142 PO4 Inorganic materials 0.000 description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- 229940069978 calcium supplement Drugs 0.000 description 3
- 208000020832 chronic kidney disease Diseases 0.000 description 3
- 239000003937 drug carrier Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 210000004211 gastric acid Anatomy 0.000 description 3
- 230000002496 gastric effect Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000013589 supplement Substances 0.000 description 3
- 230000001988 toxicity Effects 0.000 description 3
- 231100000419 toxicity Toxicity 0.000 description 3
- 208000020084 Bone disease Diseases 0.000 description 2
- BDAGIHXWWSANSR-UHFFFAOYSA-M Formate Chemical compound [O-]C=O BDAGIHXWWSANSR-UHFFFAOYSA-M 0.000 description 2
- 208000005770 Secondary Hyperparathyroidism Diseases 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 150000001450 anions Chemical class 0.000 description 2
- 235000013361 beverage Nutrition 0.000 description 2
- 230000037396 body weight Effects 0.000 description 2
- VSGNNIFQASZAOI-UHFFFAOYSA-L calcium acetate Chemical class [Ca+2].CC([O-])=O.CC([O-])=O VSGNNIFQASZAOI-UHFFFAOYSA-L 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 208000022831 chronic renal failure syndrome Diseases 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 235000012631 food intake Nutrition 0.000 description 2
- 229940044170 formate Drugs 0.000 description 2
- 235000014105 formulated food Nutrition 0.000 description 2
- 201000005991 hyperphosphatemia Diseases 0.000 description 2
- 230000001771 impaired effect Effects 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 210000000936 intestine Anatomy 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 235000012054 meals Nutrition 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 2
- 239000010452 phosphate Substances 0.000 description 2
- 239000002694 phosphate binding agent Substances 0.000 description 2
- 230000009469 supplementation Effects 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 210000002700 urine Anatomy 0.000 description 2
- 241000251468 Actinopterygii Species 0.000 description 1
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 240000007124 Brassica oleracea Species 0.000 description 1
- 235000003899 Brassica oleracea var acephala Nutrition 0.000 description 1
- 235000011299 Brassica oleracea var botrytis Nutrition 0.000 description 1
- 235000017647 Brassica oleracea var italica Nutrition 0.000 description 1
- 235000012905 Brassica oleracea var viridis Nutrition 0.000 description 1
- 240000003259 Brassica oleracea var. botrytis Species 0.000 description 1
- 244000233513 Brassica perviridis Species 0.000 description 1
- 235000008744 Brassica perviridis Nutrition 0.000 description 1
- 235000010149 Brassica rapa subsp chinensis Nutrition 0.000 description 1
- 235000000536 Brassica rapa subsp pekinensis Nutrition 0.000 description 1
- 241000499436 Brassica rapa subsp. pekinensis Species 0.000 description 1
- AIWCXRWJRXDPKP-UHFFFAOYSA-L CC([O-])=O.CC([O-])=O.CC(O)=O.CC(O)=O.CC(O)=O.P.[Ca+2] Chemical compound CC([O-])=O.CC([O-])=O.CC(O)=O.CC(O)=O.CC(O)=O.P.[Ca+2] AIWCXRWJRXDPKP-UHFFFAOYSA-L 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 206010012289 Dementia Diseases 0.000 description 1
- 208000037147 Hypercalcaemia Diseases 0.000 description 1
- 208000030136 Marchiafava-Bignami Disease Diseases 0.000 description 1
- 206010031240 Osteodystrophy Diseases 0.000 description 1
- 208000001132 Osteoporosis Diseases 0.000 description 1
- 208000019790 abdominal distention Diseases 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 235000014590 basal diet Nutrition 0.000 description 1
- 235000013527 bean curd Nutrition 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000037182 bone density Effects 0.000 description 1
- 235000008429 bread Nutrition 0.000 description 1
- 239000001639 calcium acetate Substances 0.000 description 1
- 235000011092 calcium acetate Nutrition 0.000 description 1
- 229960005147 calcium acetate Drugs 0.000 description 1
- FNAQSUUGMSOBHW-UHFFFAOYSA-H calcium citrate Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O FNAQSUUGMSOBHW-UHFFFAOYSA-H 0.000 description 1
- 239000001354 calcium citrate Substances 0.000 description 1
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 description 1
- 239000001527 calcium lactate Substances 0.000 description 1
- 229960002401 calcium lactate Drugs 0.000 description 1
- 235000011086 calcium lactate Nutrition 0.000 description 1
- 159000000007 calcium salts Chemical class 0.000 description 1
- 239000007894 caplet Substances 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 235000013339 cereals Nutrition 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 235000020940 control diet Nutrition 0.000 description 1
- 235000013365 dairy product Nutrition 0.000 description 1
- VECDXLFHABGCSJ-UHFFFAOYSA-K dicalcium carbonate formate Chemical compound C([O-])([O-])=O.[Ca+2].C(=O)[O-].[Ca+2] VECDXLFHABGCSJ-UHFFFAOYSA-K 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000000148 hypercalcaemia Effects 0.000 description 1
- 208000030915 hypercalcemia disease Diseases 0.000 description 1
- 208000017169 kidney disease Diseases 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 235000021374 legumes Nutrition 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 230000002037 soft tissue calcification Effects 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 238000012453 sprague-dawley rat model Methods 0.000 description 1
- 230000000153 supplemental effect Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 235000013337 tricalcium citrate Nutrition 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 239000003981 vehicle Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- A—HUMAN NECESSITIES
- 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
- A23L33/15—Vitamins
- A23L33/155—Vitamins A or D
-
- 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
- A23L33/16—Inorganic salts, minerals or trace elements
-
- 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
- A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- 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
- Antacids are often used to bind dietary phosphorus to prevent phosphorus retention and prevent its absorption. This process is referred to as phosphorus binding and appears to be a chemical reaction between dietary phosphorus and the cation present in the binder compound, which is usually albumin or calcium. The binding results in the formation of insoluble and unabsorbable phosphate compounds, adsorption of phosphorus ions on the surface of binder particles, or a combination of both.
- Antacids are used widely, often in large quantities, for indigestion, heartburn or peptic ulcer disease. Despite their consumption in large amounts and often over long periods of time, phosphorus depletion is uncommon in these settings. This fact is additional evidence of the inefficiency of antacids as phosphorus binding agents.
- the inefficiency of commonly used phosphorus binders creates a clinical dilemma.
- the dose of the binder must be increased to control hyperphosphatemia, but increased risk of toxicity of the binder results from the increased dose.
- This toxicity includes bone disease and aluminum dementia from aluminum-containing antacids and hypercalcemia and soft tissue calcification from calcium-containing antacids. These risks are particularly problematic in patients with chronic renal disease.
- a phosphorus binder available which does not have the risks associated with ingestion of presently available binders.
- the binder should be more efficient in binding phosphorus and, thus, would not have to be consumed in the large quantities necessary, for example, when calcium carbonate-containing compositions are used.
- Such a phosphorus binder would be particularly valuable for administration to individuals with chronic renal failure, in whom phosphorus retention is a serious concern and the risk of toxicity from consumption of presently- available binders is greater than in individuals in whom kidney function is normal.
- U.S. Pat. No. 4,870,105 addresses these concerns by disclosing a calcium acetate phosphorus binder. However, it would be advantageous to find a binder with a smaller anion and, hence, a smaller effective dose.
- Calcium is an abundant element in the human body and plays an important role in many physiological processes. Nutritional and metabolic deficiencies of calcium can have adverse effects, typically manifested through deficiencies in the structure, function and integrity of the skeletal system. The most common calcium-modulated metabolic bone disorder is osteoporosis.
- a preferred approach to calcium supplementation is through dietary sources.
- Dairy products are the major contributors of dietary calcium, as are green vegetables (e.g. broccoli, kale, turnip greens, Chinese cabbage), calcium-set tofu, some legumes, canned fish, seeds and nuts.
- green vegetables e.g. broccoli, kale, turnip greens, Chinese cabbage
- calcium-set tofu some legumes, canned fish, seeds and nuts.
- Breads and cereals can contribute significantly to calcium intake.
- Calcium supplements may be the preferred way to obtain supplemental calcium.
- Calcium carbonate is usually recommended for economic reasons.
- calcium carbonate usage requires sufficient gastric acids for its utilization.
- Some individuals, especially the elderly, may have limited amounts of gastric acid, and achlorhydric patients have little gastric acid.
- calcium carbonate is poorly utilized.
- Using large amounts of calcium carbonate may also lead to constipation and abdominal distention.
- Calcium lactate or calcium citrate may then be used.
- the present invention relates to a method of binding phosphorus in the gastrointestinal tract and, thus, reducing phosphorus absorption from the intestine. It also relates to a method of reducing serum phosphate levels because phosphorus bound in the gastrointestinal tract results in lower phosphorus absorption than would otherwise occur. It is particularly useful in the treatment and prevention of hyperphosphatemia in individuals with renal disease or other disease in which the ability to excrete phosphorus from the body (e.g., in the urine) is impaired.
- the method of the present invention comprises orally administering to an individual a composition which includes calcium formate in sufficient quantity to effectively bind phosphorus, preferably present in food and beverages consumed by the individual, and prevent its absorption in the intestine.
- the calcium formate is administered at a dose of between 0.5 and 10.0 grams.
- the present invention is also a method of using calcium formate as a dietary calcium supplement.
- the method comprises orally administrating to an individual a composition comprising calcium formate in sufficient quantities to improve calcium balance or retention.
- the calcium formate is administered in a dose between 0.5 and 3.0 g/day as a supplement.
- the present invention is also a pharmaceutical composition
- a pharmaceutical composition comprising calcium formate in combination with a pharmaceutically acceptable carrier.
- the composition comprises 0.5 grams of calcium formate per capsule or tablet.
- the composition comprises calcium formate and at least one additional therapeutic ingredient.
- this therapeutic ingredient is a vitamin D compound, typically cholecalciferol.
- the amount of calcium-containing compound sufficient to inhibit gastrointestinal phosphorus absorption is 10% lighter than therapeutically equivalent amounts of previously known calcium acetate compounds.
- calcium formate may be supplied orally to an individual in order to supplement the individual's calcium intake.
- the present invention relates to a calcium formate composition for oral administration to an individual.
- the composition is useful in reducing phosphorus absorption in the gastrointestinal tract.
- Calcium formate is shown below to be effective in inhibiting phosphorus absorption when administered orally in in vivo tests and has been shown to prevent the absorption of ingested phosphorus at a lower dose than other calcium-containing binders.
- calcium formate alone or in combination with other materials, can be used to bind phosphorus in the gastrointestinal tract, thus reducing the percentage of an amount of phosphorus consumed (i.e., of a given “dose” of phosphorus) which is absorbed.
- this dose would be 0.5-10.0 grams when adjusted to doses intended for human patients.
- the present invention also relates to a method of inhibiting gastrointestinal phosphorus absorption.
- the method of the present invention is based on the demonstration that calcium formate is an effective binder of phosphorus when administered orally to an individual.
- the method comprises orally administering a quantity of calcium formate sufficient to bind with phosphorus in the gastrointestinal tract.
- this dose is between 10-200 milliequivalents of calcium and is preferably present in either tablet or gelatin capsule form.
- the oral dose is ingested at mealtimes.
- phosphorus includes phosphorus and phosphate in its various forms (e.g. HPO 4 ⁇ , PO 4 ⁇ 3 , etc.).
- calcium formate is administered, alone or in combination with other substances (e.g., in a hard gelatin capsule; along with materials necessary to form a tablet or caplet as a delivery vehicle for the calcium formate; or along with a second phosphorus binder or other pharmaceutically useful substance) in sufficient quantities to reduce phosphorus absorption in the gastrointestinal tract.
- the calcium formate is administered orally, preferably close in time to food and beverage consumption.
- at mealtimes we mean within 30 minutes of a meal.
- anhydrous calcium formate (10-200 milliequivalents calcium) is taken prior to food consumption (e.g., meal time) and a second dose of 0.5-10.0 grams of anhydrous calcium formate is taken after food consumption.
- the dose or quantity to be taken at a given time varies on an individual-by-individual basis and can be adjusted as needed (e.g., by monitoring serum concentration of phosphorus and calcium).
- calcium formate is administered, alone or in combination with other substances, in sufficient quantities to supplement an individual's calcium intake.
- the Examples below indicate that calcium formate in quantities between 0.5 and 3.0 g/day are sufficient to improve calcium balance, bone density and calcium retention.
- the present invention is also a pharmaceutical composition
- a pharmaceutical composition comprising calcium formate in a pharmaceutically acceptable carrier, wherein the calcium formate is present in an amount between 0.5-1.0 grams.
- the pharmaceutical composition comprises calcium formate in amount suitable to inhibit gastrointestinal absorption of phosphorus, provides between 11 and 44 milliequivalents of calcium, and is 10% lighter than the corresponding calcium acetate dose and is the richest form of calcium available.
- corresponding or “therapeutically equivalent,” we mean a dose that is equally effective.
- the pharmaceutical composition essentially comprises only calcium formate and at least one pharmaceutically carrier, wherein the calcium formate is present in an amount sufficient to produce between 11 and 44 milliequivalents of calcium.
- essentially comprises we mean that calcium formate is the only active ingredient in the pharmaceutical composition.
- the present invention is also a pharmaceutical composition
- a pharmaceutical composition comprising calcium formate in a pharmaceutically acceptable carrier combined with other therapeutic agents, preferably a vitamin D compound.
- the calcium formate is combined with vitamin D is cholecalciferol in a range of 125 IU to 400 IU in a tablet or capsule.
- the animals were then placed on a basal diet that contains 0.02% calcium, i.e. an extremely low calcium diet. These animals served as controls. Another group were placed on the same diet containing calcium formate, providing calcium at 0.25% of the diet. Another group was supplied calcium formate at 0.47% calcium in the diet, and another group was provided 0.47% calcium in the form of calcium carbonate. Growth of the animals reflects the ability of the animals to utilize calcium. Using a growth assay of this type to illustrate the effectiveness of the calcium salt is supported by Steenbock, H. and D.C. Herting, J. Nutr. 57:449-468,1955.
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Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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US09/746,250 US20010016603A1 (en) | 1999-12-22 | 2000-12-21 | Calcium formate for use as a dietary supplement |
US09/961,729 US6528542B2 (en) | 1999-12-22 | 2001-09-24 | Calcium formate for use as a dietary supplement |
US13/281,754 US20120046252A1 (en) | 1999-12-22 | 2011-10-26 | Calcium Formate for Use as a Dietary Supplement |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US09/469,513 US6160016A (en) | 1999-12-22 | 1999-12-22 | Phosphorus binder |
US09/649,710 US6489361B1 (en) | 1999-12-22 | 2000-08-25 | Phosphorus binder |
US09/746,250 US20010016603A1 (en) | 1999-12-22 | 2000-12-21 | Calcium formate for use as a dietary supplement |
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US09/469,513 Continuation-In-Part US6160016A (en) | 1999-12-22 | 1999-12-22 | Phosphorus binder |
US09/649,710 Continuation-In-Part US6489361B1 (en) | 1999-12-22 | 2000-08-25 | Phosphorus binder |
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US09/961,729 Continuation US6528542B2 (en) | 1999-12-22 | 2001-09-24 | Calcium formate for use as a dietary supplement |
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US10/326,789 Abandoned US20030100609A1 (en) | 1999-12-22 | 2002-12-19 | Calcium formate for use as a dietary supplement |
US10/636,157 Abandoned US20040029964A1 (en) | 1999-12-22 | 2003-08-07 | Calcium formate for use as a dietary supplement |
US11/021,533 Expired - Fee Related US7850991B2 (en) | 1999-12-22 | 2004-12-23 | Calcium formate for use as a dietary supplement |
US12/943,660 Abandoned US20110059927A1 (en) | 1999-12-22 | 2010-11-10 | Calcium Formate For Use As A Dietary Supplement |
US13/281,754 Abandoned US20120046252A1 (en) | 1999-12-22 | 2011-10-26 | Calcium Formate for Use as a Dietary Supplement |
US14/172,423 Abandoned US20140155360A1 (en) | 1999-12-22 | 2014-02-04 | Calcium Formate for Use as a Dietary Supplement |
US15/342,908 Abandoned US20170049808A1 (en) | 1999-12-22 | 2016-11-03 | Calcium Formate for Use as a Dietary Supplement |
US15/596,587 Abandoned US20170246206A1 (en) | 1999-12-22 | 2017-05-16 | Calcium Formate for Use as a Dietary Supplement |
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US10/326,789 Abandoned US20030100609A1 (en) | 1999-12-22 | 2002-12-19 | Calcium formate for use as a dietary supplement |
US10/636,157 Abandoned US20040029964A1 (en) | 1999-12-22 | 2003-08-07 | Calcium formate for use as a dietary supplement |
US11/021,533 Expired - Fee Related US7850991B2 (en) | 1999-12-22 | 2004-12-23 | Calcium formate for use as a dietary supplement |
US12/943,660 Abandoned US20110059927A1 (en) | 1999-12-22 | 2010-11-10 | Calcium Formate For Use As A Dietary Supplement |
US13/281,754 Abandoned US20120046252A1 (en) | 1999-12-22 | 2011-10-26 | Calcium Formate for Use as a Dietary Supplement |
US14/172,423 Abandoned US20140155360A1 (en) | 1999-12-22 | 2014-02-04 | Calcium Formate for Use as a Dietary Supplement |
US15/342,908 Abandoned US20170049808A1 (en) | 1999-12-22 | 2016-11-03 | Calcium Formate for Use as a Dietary Supplement |
US15/596,587 Abandoned US20170246206A1 (en) | 1999-12-22 | 2017-05-16 | Calcium Formate for Use as a Dietary Supplement |
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US (10) | US20010016603A1 (de) |
EP (1) | EP1242067B1 (de) |
JP (1) | JP2003518058A (de) |
AT (1) | ATE333871T1 (de) |
AU (1) | AU782649B2 (de) |
CA (1) | CA2395530C (de) |
CY (1) | CY1105732T1 (de) |
DE (1) | DE60029628T2 (de) |
DK (1) | DK1242067T3 (de) |
ES (1) | ES2269218T3 (de) |
WO (1) | WO2001045695A2 (de) |
Cited By (1)
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US9351966B2 (en) * | 2008-02-20 | 2016-05-31 | The Curators Of The University Of Missouri | Composition comprising a combination of omeprazole and lansoprazole, and a buffering agent, and methods of using same |
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WO2001045695A2 (en) * | 1999-12-22 | 2001-06-28 | Wisconsin Alumni Research Foundation | Calcium formate for use as a phosphorus binder and a dietary supplement |
US20040161474A1 (en) * | 2002-05-24 | 2004-08-19 | Moerck Rudi E. | Rare earth metal compounds methods of making, and methods of using the same |
US20060083791A1 (en) | 2002-05-24 | 2006-04-20 | Moerck Rudi E | Rare earth metal compounds methods of making, and methods of using the same |
US20080160086A1 (en) * | 2004-02-19 | 2008-07-03 | Scepter Holdings, Inc. | Delivery Systems For Calcium |
US20060029641A1 (en) * | 2004-08-05 | 2006-02-09 | Keller Nathan I | Calcium and magnesium nutritional supplement |
WO2006044657A2 (en) * | 2004-10-15 | 2006-04-27 | Altairnano, Inc. | Phosphate binder with reduced pill burden |
CA2619643A1 (en) * | 2005-08-17 | 2007-02-22 | Altairnano, Inc. | Treatment of chronic renal failure and other conditions in domestic animals: compositions and methods |
WO2011143475A1 (en) | 2010-05-12 | 2011-11-17 | Spectrum Pharmaceuticals, Inc. | Lanthanum carbonate hydroxide, lanthanum oxycarbonate and methods of their manufacture and use |
US20160053281A1 (en) | 2013-08-15 | 2016-02-25 | The University Court Of The University Of Edinburgh | Enhanced Expression Of RNA Vectors |
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2000
- 2000-12-21 WO PCT/US2000/034869 patent/WO2001045695A2/en active IP Right Grant
- 2000-12-21 AT AT00988258T patent/ATE333871T1/de active
- 2000-12-21 EP EP00988258A patent/EP1242067B1/de not_active Expired - Lifetime
- 2000-12-21 ES ES00988258T patent/ES2269218T3/es not_active Expired - Lifetime
- 2000-12-21 US US09/746,250 patent/US20010016603A1/en not_active Abandoned
- 2000-12-21 DK DK00988258T patent/DK1242067T3/da active
- 2000-12-21 AU AU24485/01A patent/AU782649B2/en not_active Expired
- 2000-12-21 CA CA002395530A patent/CA2395530C/en not_active Expired - Lifetime
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- 2000-12-21 DE DE60029628T patent/DE60029628T2/de not_active Expired - Lifetime
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- 2002-12-19 US US10/326,789 patent/US20030100609A1/en not_active Abandoned
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2003
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2004
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2006
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2010
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2014
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2016
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2017
- 2017-05-16 US US15/596,587 patent/US20170246206A1/en not_active Abandoned
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9351966B2 (en) * | 2008-02-20 | 2016-05-31 | The Curators Of The University Of Missouri | Composition comprising a combination of omeprazole and lansoprazole, and a buffering agent, and methods of using same |
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US6528542B2 (en) | 2003-03-04 |
US20140155360A1 (en) | 2014-06-05 |
CA2395530A1 (en) | 2001-06-28 |
US20110059927A1 (en) | 2011-03-10 |
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DE60029628T2 (de) | 2007-07-26 |
US20170246206A1 (en) | 2017-08-31 |
US20040029964A1 (en) | 2004-02-12 |
WO2001045695A3 (en) | 2002-01-03 |
US7850991B2 (en) | 2010-12-14 |
US20120046252A1 (en) | 2012-02-23 |
WO2001045695A2 (en) | 2001-06-28 |
ATE333871T1 (de) | 2006-08-15 |
CY1105732T1 (el) | 2010-12-22 |
DE60029628D1 (de) | 2006-09-07 |
EP1242067A2 (de) | 2002-09-25 |
DK1242067T3 (da) | 2006-11-27 |
US20030100609A1 (en) | 2003-05-29 |
JP2003518058A (ja) | 2003-06-03 |
CA2395530C (en) | 2008-07-15 |
US20050106234A1 (en) | 2005-05-19 |
US20170049808A1 (en) | 2017-02-23 |
AU782649B2 (en) | 2005-08-18 |
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