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Carbohydrate Composition for Dialysis

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Carbohydrate Composition for Dialysis (19) TZZ¥¥__T (11) EP 3 381 484 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 03.10.2018 Bulletin 2018/40 A61M 1/28 (2006.01) A61M 1/14 (2006.01) A61K 9/08 (2006.01) A61K 47/26 (2006.01) (2006.01) (21) Application number: 17164425.5 A61K 31/70 (22) Date of filing: 31.03.2017 (84) Designated Contracting States: (72) Inventors: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB • Grentzmann, Guido GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO 22359 Hamburg (DE) PL PT RO RS SE SI SK SM TR • Steinhauer, Hjalmar Bernulf Designated Extension States: 03050 Cottbus (DE) BA ME Designated Validation States: (74) Representative: Patentanwälte Bressel und MA MD Partner mbB Potsdamer Platz 10 (71) Applicant: Opterion Health AG 10785 Berlin (DE) 6365 Kehrsiten (CH) (54) CARBOHYDRATE COMPOSITION FOR DIALYSIS (57) A composition, comprising following carbohy- - glucan molecules of DP>24 are present in an amount drate composition: of 2-60 wt-% of the total weight of a)-d), a) maltose in a content of 5 to 75 wt-% of the total weight - glucan molecules of DP>55 are present in an amount of a)-d), of less than 15 wt-% of the total weight of a)-d), b) glucose in a content of less than 1/2 the content of and wherein maltose, and in a total content of less than 5 wt-% of the - the weight average molecular weight of a)-d), taken total weight of a)-d), together, is c) glucan molecules of DP 3 and DP 4, taken together, Mw 1 - 6.2 kD and in a content of less than 1/2 of the content of maltose, - the number average molecular weight of a)-d), taken d) glucan molecules of DP>4 in a content to give 100 together, is wt-% together with a), b) and c), wherein Mn 0.7 - 3 kD, - glucan molecules of DP>10 are present in an amount a method for producing it and its use as a medicament of 15-80 wt-% of the total weight of a)-d), or for use in therapy, particularly in peritoneal dialysis. EP 3 381 484 A1 Printed by Jouve, 75001 PARIS (FR) EP 3 381 484 A1 Description FIELD OF THE INVENTION 5 [0001] The present invention relates to a Carbohydrate composition, to an aqueous solution comprising such compo- sition and to the uses thereof. BACKGROUND OF THE INVENTION 10 [0002] Specifically in the area of peritoneal dialysis, many works have been accomplished, describing most different compositions of polymers and their dialysis parameters in the clinic or in animal models, and different measurement methods have been applied to establish parameters of their compositions. A very well described medically applied glucose polymer preparation for medical application is Icodextrin. [0003] Chronic dialysis treatment still causes significant side-effects, by interaction between dialysis material (tubes, 15 dialysis materials and solutions) and patient tissues. [0004] Hemodialysis (HD) is the most commonly applied dialysis treatment. Respective side-effects include inflam- matory, cardiovascular and infectious complications, causing increased death rates. [0005] Peritoneal dialysis (PD) represents an alternative to extra-corporal hemodialysis. It has the advantage of being independent from heavy instrumentation, and can be done at home. Furthermore, PD does not require drawing the 20 patient’s blood out of the body. Instead, the process uses the patient’s peritoneal capillary tissue as a membrane, exchanging fluids and dissolved substances (electrolytes, urea, glucose, and other small molecules) between blood and the dialysate. A PD-Fluid (hereinafter: PDF) is introduced through a permanent tube into the abdomen and, at the end of the peritoneal dialysis dwell, flushed out. Such dwells may be carried out repeatedly, for various durations, at different time intervals. Maybe the most important advantage of PD is, that it preserves residual kidney activities significantly, as 25 compared to hemodialysis (HD). This is not only of advantage to the patient allowing excretion of certain amounts of body fluid by natural ways, but is also of high advantage to peritoneal dialysis treatment itself, allowing a significant amount of excretion of slowly metabolizable, small molecular weight components from peritoneal dialysis fluids. [0006] Common PDFs use glucose as osmotic agent at concentrations between 1 and 5 %, to achieve transfer of fluid and toxic agent out of the blood into the dialysate. Glucose is a low molecular weight constituent of blood (normal 30 concentration around 0.1 %). High glucose concentration of conventional PDFs leads to back diffusion of glucose, from the dialysate into the patient’s blood stream, generating glucose overcharge, which is able to provoke hyperglycemia. Hyperglycemia is specifically problematic, since many dialysis patients are diabetic. [0007] One way to address this problem is the use of saccharide polymers as an alternative osmotic agent to replace glucose. Prior art of described polysaccharide is provided above. 35 [0008] The general advantage of glucose polymers is, that in the peritoneum, and in the blood, they are not catabolized to glucose but only to maltose and maltotriose. Both these molecules are significantly less metabolized by the body, and are, to a large extend excreted through residual renal function and/or through back dialysis into the dialysate of a next dwell. [0009] Another advantage, specifically of poly-glucoses based PDFs is, that these solutions maintain their own osmotic 40 pressure. At the same time as some osmotic material gets lost by resorption through the body, body-internal enzymes, called amylases, cut the polymer into smaller saccharides, thereby increasing the osmotic pressure. As a result polysac- charide based PDFs can be administered at low osmolality and will continue fluid resorption through ultrafiltration for many hours. [0010] In 1986, Mistry et al. and Winchester et al., independently describe PDFs containing glucose polymers in 45 "Frontiers in Peritoneal Dialysis, eds: John F. Maher M.D., James F. Winchester M.D., 1986, Springer Verlag, Heidelberg). Mistry describes a polymer preparation containing glucose polymers of DP 1 to 10, Winchester describes a polymer preparation with molecules of DP < 6 of less than 5 wt-%. [0011] EP 0115911 discloses glucose polymers containing more than 15% of molecules of DP>12wherein said prep- aration show an Mw 7 - 36kD, preferred 15 - 25 kD. 50 [0012] WO 8300087 A1 discloses glucose polymer preparations of an average DP of 4 to 10. [0013] EP 0076355 A2 discloses glucose polymer preparations for peritoneal dialysis containing at least 85 wt-% of molecules less than DP 11, and at least 99 wt-% of molecules of less than DP 26. [0014] US 4,182,756 B1 discloses a substantially clear, nonpyrogenic, stable and sterile solution for intravenous administration to human patients, said solution comprising at least 20% W/V of a glucose polymer mixture having an 55 average degree of polymerization of at least 4 and at least 99% of its molecules less than 26 glucose units, at least 85% of its molecules less than 11 glucose units, and at least 20% of its molecules less than 4 glucose units. [0015] US 6,248,726 B1 discloses a glucose polymer mixture, wherein at least 50% by weight of the polymer is of molecular weight in the range 5000 to 30000, wherein at least 80% by weight of the polymer is of molecular weight in 2 EP 3 381 484 A1 the range 5000 to 50,000, wherein a weight average molecular weight in the range of from 5000 to 100000, wherein a number average molecular weight of less than 8000, and wherein the content of mono-, di-, and tri-saccharide compounds present in the glucose polymer to be less than 5% by weight, and wherein the content of glucose polymers with molecular weight greater than 100000 in the glucose polymer is less than 5%. 5 [0016] GB 2 042 547 discloses starch hydrolysates, which optionally maybe hydrogenated, whose glucid spectrum displays: a content of monosaccharides (DP = 1) of less than 14%, a content of disaccharides (DP = 2) of less than 35%, a content of oligosaccharides of DP 4 to DP 10 in the range of from 42% to 70%; and a content of polysaccharides of DP greater than 10 of less than 32%; all said percentages being percentages by weight, calculated on the basis of dry matter. 10 [0017] Until now, high average molecular weight of saccharide polymers forming the osmotic agent are used, to reduce carbohydrate (hereinafter also abbreviated as: CHO) back diffusion from the dialysis fluid into the blood of the patient. The drawback of such high molecular weight polymer osmotic agents is that a solution’s osmolality decreases as the size of the osmotic active polymers increases (for a given w/v concentration), which has to be compensated by a further increase in the CHO concentration. On the other hand speed of fluid ultrafiltration is slow. Due to a relatively constant 15 absorption of dialysate from the peritoneum through the lymphatic system, a high carbohydrate uptake during the dialysis dwell is the consequence. Despite this fact recent new developments look for ever higher molecular weights of polysac- charides in PDFs, such as US2012/02385A1. [0018] Average osmolality of human blood is between 275 and 295 mOsm/kg, and is due to major solutes in the blood, such as salts, other low molecular weight solutes and proteins. Peritoneal fluids contain the major salts found in blood, 20 as well as a pH buffer, but generally no proteins. In any peritoneal treatment an osmotic pressure near to the human blood osmolality is necessary to avoid rapid absorption of the peritoneal liquid into the body.
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