Peritoneal dialysis solutions containing maltodextrins and amino acids
AssigneeBaxter International Inc.
InventorsLeo Martis, Ron Burke, Ty Shockley, Lee W. Henderson, Bernadette Faller
Life of this patent
Estimating the term…
Abstract
A peritoneal dialysis solution comprising as osmotic agents approximately 2.0 to about 6.0% (w/v) maltodextrins and approximately 0.25 to about 2.0% (w/v) amino acids. The peritoneal dialysis solution will also include other components such as sodium, chloride, lactate, bicarbonate, calcium, and magnesium.
Claims22
A peritoneal dialysis solution comprising as an osmotic agent:
- approximately 2.0 to about 6.0% (w/v) maltodextrins wherein the maltodextrins have the following characteristics:
- Weight Average Mol. Wt. (Mw) 10,000-16,000 daltons Number Average Mol. Wt. (Mn) 4,000-8,000 daltons Polydispersity 1.0-4.0 Fraction > 100,000 daltons NMT 1.0% Mono, Di, Trisaccharides NMT 5.0% Distribution normal Alpha (1-4) NLT 90% Aluminum (10% solution) <10 ppb Aqueous Solubility NLT 10% (w/v) pH (10% solution) 5.0-7.0 Heavy Metals <5 ppm DP (Degree of polymerization) >75% greater than 20 DP greater than 50 >50% DP greater than 100 >25%;
- and
- approximately 0.25 to about 2.0% (w/v) amino acids.
A peritoneal dialysis solution comprising as an osmotic agent:
- approximately 2.0 to about 6.0% (w/v) maltodextrins and approximately 0.25 to about 2.0% (w/v) amino acids, the amino acids comprise:
- Amino Acid Conc. (mg %) Leucine 74-112 Valine 100-151 Threonine 47-71 Isoleucine 61-92 Lysine.HCl 55-83 Histidine 52-78 Methionine 32-48 Phenylalanine 42-62 Tryptophan 20-30 Alanine 68-103 Proline 43-65 Arginine 60-113 Glycine 36-55 Serine 48-72 Tyrosine 20-35 Aspartate 55-83 Glutamate 55-83.
A peritoneal dialysis solution comprising:
- Maltodextrins (% w/v) 2.0-6.0 Amino Acids (% w/v) 0.25-2.0 Sodium (mEq/L) 120-140 Chloride (mEq/L) 70-110 Lactate (mEq/L) 0.0-45.0 Bicarbonate (mEq/L) 0.0-45.0 Calcium (mEq/L) 0.0-4.0 Magnesium (mEq/L) 0.0-4.0 pH 6.0-7.4;
- and
- the maltodextrins being characterized in that the maltodextrins have a DP (Degree of polymerization) so that:
- DP greater than 20 ≧75% DP greater than 40 ≧50% DP greater than 80 ≧25%.
A method for providing an osmotic agent for use in a peritoneal dialysis solution comprising the steps of:
- selecting as a first component of the osmotic agent a first composition having a molecular weight equal to or greater than 10,000 daltons and comprising approximately 2.0 to about 6.0% (w/v) of the dialysis solution;
- and
- selecting as a second component of the osmotic agent a second composition having a molecular weight equal to or less than 300 daltons and comprising approximately 0.25 to about 2.0% w/v of the dialysis solution.
A two part peritoneal dialysis solution designed to be mixed prior to infusion into a patient comprising:
- a first part housed in a first structure including approximately 2.0 to about 6.0% (w/v) maltodextrin and a pH of approximately 4.0 to about 5.5;
- a second part housed in a second structure including amino acids;
- and
- including in either the first or the second structure a sufficient amount of the following ingredients so when the first part and second part are mixed the following is provided:
- 120 to about 140 (mEq/L) sodium;
- 70.0 to about 110.00 (mEq/L) chloride;
- 0.0 to about 5.0 (mEq/L) lactate;
- 0.0 to about 45.0 (mEq/L) bicarbonate;
- 0.0 to about 4.0 mEq/L) calcium;
- and 0.0 to about 4.0 (mEq/L) magnesium.
Dependencies are inferred from the claim text.