Formulation of amino acids and riboflavin useful to reduce toxic effects of cytotoxic chemotherapy - Patents

Formulation of amino acids and riboflavin useful to reduce toxic effects of cytotoxic chemotherapy

Agent: Howrey LLP - Falls Church, VA, US
Inventor: Stanislaw R. Burzynski
Class: 514251000 (USPTO)
Related Patents: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Heterocyclic Carbon Compounds Containing A Hetero Ring Having Chalcogen (i.e., O,s,se Or Te) Or Nitrogen As The Only Ring Hetero Atoms Doai, Hetero Ring Is Six-membered Consisting Of Two Nitrogens And Four Carbon Atoms (e.g., Pyridazines, Etc.), 1,4-diazine As One Of The Cyclos, , At Least Three Rings In The Polycyclo Ring System,
#20050182064
08/18/05
Pharmaceutical compositions effective in alleviating or reducing the effects of fatigue and weakness associated with cancer and cancer chemotherapy are disclosed. The pharmaceutical compositions of the present invention comprise riboflavin, effectors of the urea cycle in free form or pharmacologically acceptable salts thereof, and amino acids selected from the groups of essential and non-essential amino acids, in free form or pharmaceutically acceptable salts thereof, suitably combined with appropriate carriers, diluents, or excipients. Also disclosed are methods of alleviating or reducing the effects of fatigue and weakness associated with cancer and cancer chemotherapy by administration of pharmaceutical compositions of the present invention.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to the fields of pharmaceutical chemistry and formulation. More particularly, it concerns the use of an effective amount of riboflavin and amino acids, in any combination, in the alleviation of the nutritional, metabolic and toxic symptoms of cancer and cancer chemotherapy in diagnosed cancer patients.
SUMMARY OF THE INVENTION
[0011] The present invention provides a method for alleviation or reduction of cancer chemotherapy toxicity, involving administering to a patient with a pharmaceutical composition comprising therapeutically-effective amounts of riboflavin, a component of the urea cycle, and effective amounts of the amino acids alanine, glycine, serine, taurine, threonine, and valine.
[0012] It is thus an object of the invention to provide a method for treatment of fatigue and weakness by administering to a subject with a composition comprising riboflavin, an effector of the urea cycle, and one or more amino acids.
[0013] A further aspect of the present invention is to provide a pharmaceutically acceptable agent for the alleviation of the symptoms of fatigue and weakness associated with cancer and cancer chemotherapy cytotoxicity, comprising a therapeutically effective amount of riboflavin, an effector of the urea cycle, and one or more amino acids selected from a group of essential and non-essential amino acids, wherein the latter two constituents are in free form or pharmacologically acceptable salts. A preferred composition consists of the six amino acids, alanine, glycine, serine, taurine, threonine, and valine; an effector of the urea cycle selected from L-arginine, L-ornithine, and L-citrulline; riboflavin; and a pharmaceutically acceptable diluent. A particularly preferred pharmaceutical composition of the present invention comprises riboflavin; an effector of the urea cycle selected from the group consisting of arginine, ornithine, citrulline, and mixture thereof; the amino acids alanine, glycine, serine, taurine, threonine, and valine; and a suitable solvent, diluent, excipient, or carrier, wherein the concentration of riboflavin is about 5 to about 300 mg/L, concentration of the effector of the urea cycle is about 2 to about 120 mg/mL, concentration of alanine is about 1 to about 90 mg/mL, concentration of glycine is about 1 to about 75 mg/mL, concentration of serine is about 1 to about 75 mg/mL, concentration of taurine is about 0.5 to about 30 mg/mL, concentration of threonine is about 1 to about 90 mg/mL, and concentration of valine is about 1 to about 50 mg/mL. The composition is is devoid of the amino acids, glutamine, leucine, and tryptophan.
[0014] A still further aspect of the present invention is to provide a pharmaceutically acceptable agent for the alleviation of the symptoms of fatigue and weakness associated with cancer and cancer chemotherapy cytotoxicity, comprising a therapeutically effective amount of riboflavin, an effector of the urea cycle, and one or more amino acids selected from a group of essential and non-essential amino acids, and 3-phenylacetylamino-2,6-piperidinedione or one or more of the compounds, phenylacetylglutamine, phenylacetylisoglutamine, or phenylbutyrate.
[0015] These and other objects will be more readily understood upon consideration of the following detailed descriptions of embodiments of the invention.
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