Calcium formate for use as a dietary supplement

Abstract

A calcium formate composition for oral administration to an individual for the purpose of supplementary dietary calcium is disclosed.

Description

[0001] This application is a continuation-in-part of U.S. Ser. No. 09 / 469,513, filed Dec. 22, 1999 and Ser. No. 09 / 649,710, filed Aug. 25, 2000. Both of these documents are incorporated by reference as if set forth fully herein.BACKGROUND OF THE INVENTION[0002] A. Calcium Formate as a Phosphate Binder[0003] Phosphorus retention plays a major role in chronic renal failure in the development of both secondary hyperparathyroidism and osteodystrophy. Bricker, N., S. et al. Archives of Internal Medicine 123:543-553 (1969); Rubini, M. E. et al. Archives of Internal Medicine 124:663-669 (1969); Slatopolsky, E., et al. Journal of Clinical Investigation 50:492-499 (1971); Bricker, N. S., New England Journal of Medicine 286:1093-1099 (1972); Slatopolsky, E.S., et al., Kidney Int. 2:147-151 (1972).[0004] 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 re...

AI Technical Summary

Benefits of technology

[0023] 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. As a result of these discoveries, 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. Preferably, this dose would be 0.5-10.0 grams when adjusted to doses intended for human patients.

[0025] As a result of the present invention it is possible to administer calcium formate to reduce absorption of dietary phosphorus, which has the net effect of reducing the risks of adverse effects (e.g., bone disease and secondary hyperparathyroidism) observed in individuals (e.g., chronic renal patients) in whom the ability to excrete phosphorus in the urine is impaired.

[0029] In another embodiment of the present invention, 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.

Problems solved by technology

Presently-used antacids are inefficient at binding phosphorus in vivo.

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.

These risks are particularly problematic in patients with chronic renal disease.

Nutritional and metabolic deficiencies of calcium can have adverse effects, typically manifested through deficiencies in the structure, function and integrity of the skeletal system.

However, calcium carbonate usage requires sufficient gastric acids for its utilization.

For such cases, calcium carbonate is poorly utilized.

Using large amounts of calcium carbonate may also lead to constipation and abdominal distention.