Isomalt

344.31

344.31

908-700-6

DTXSID8020753

White to off-white

2940006000

201

-5.2

Odourless, white, slightly hygroscopic, crystalline mass.

1.69±0.1 g/cm3(Predicted)

215-217°C

788.5±60.0 °C(Predicted)

430.7±32.9 °C

1.634

Water: 250 mg/mL (726.09 mM)

Isomalt has very good thermal and chemical stability. When it is melted, no changes in the molecular structure are observed. It exhibits considerable resistance to acids and microbial influences. Isomalt is non-hygroscopic, and at 25°C does not significantly absorb additional water up to a relative humidity (RH) of 85%; paracetamol (acetaminophen) tablets based on isomalt were stored for 6 months at 85% RH at 20°C and retained their physical aspect.
If stored under normal ambient condition

0-0Pa at 20-50℃

Specific rotation: +89.8 deg to +92.2 deg

at 100.00%. odorless

Pure sweet taste (sweetening power =0.45 relative to sucrose in about a 10% solution)

12.89±0.70(Predicted)

Henry's Law constant = 4.2X10-21 atm-cu m/mol at 25 °C (est)

Water content <7% ... has a lower viscosity, higher specific heat capacity, and higher boiling-point elevation than sucrose ... The components are hydrolyzed to give 1 mol each of glucose and sorbitol or mannitol|Enthalpy of Solution: 14.6 kJ/mol|Hydroxyl radical reaction rate constant = 1.14X10-11 cu cm/molec-sec at 25 °C (est)

Sealed in dry,Room Temperature

NONH for all modes of transport

3

Xn

22-26-36/37/39-45

LZ4394500

Xn

Isomalt has very good thermal and chemical stability. When it is melted, no changes in the molecular structure are observed. It exhibits considerable resistance to acids and microbial influences. Isomalt is non-hygroscopic, and at 25°C does not significantly absorb additional water up to a relative humidity (RH) of 85%; paracetamol (acetaminophen) tablets based on isomalt were stored for 6 months at 85% RH at 20°C and retained their physical aspect.If stored under normal ambient conditions, isomalt is chemically stable for many years. When it is stored in an unopened container at 20°C and 60% RH, a re-evaluation after 3 years is recommended.

Isomalt has very good thermal and chemical stability. When it is melted, no changes in the molecular structure are observed.

20/21/22-37/38-41-48

SRP: Criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.

Food labeling. Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries. ... Eligible noncariogenic carbohydrate sweeteners are the sugar alcohols xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, and erythritol, or a combination of these.

Engineering controls such as exhaust ventilation are recommended.|Use a NIOSH approved respirator, if it is determined to be necessary by an industrial hygiene survey involving air monitoring. In the event that a respirator is not required, an approved dust mask should be used.

Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials.|This material is assumed to be combustible. As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity.

Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeled container for disposal. Wash spill site.

As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.|As a general rule, when handling USP Reference Standards avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling.|/Wear/ chemically compatible gloves /and/ safety glasses or goggles. Protect exposed skin.

Dental caries and periodontal disease are wide-spread oral illnesses whose etiology is intimately associated with the consumption of carbohydrate sweeteners....Human clinical trials and several animal experiments have shown promising clinical results obtained by replacing sucrose with certain sugar alcohols (polyols). Among the sugar alcohols, the best results so far have been obtained with xylitol, which is chemically a pentitol containing five carbon atoms. Chewing gums containing xylitol have been shown to be strong instruments against caries in caries-active age-groups and in high-risk subjects. More research is needed to assess the ability of mixtures of xylitol with sorbitol, palatinit, maltitol, other sugar alcohols, and intense sweeteners to prevent oral plaque diseases. Although thorough clinical trials on the relationship between carbohydrate sweeteners and periodontal diseases have not been performed, the available data indicate that dietary polyols may have a restricted dampening effect on periodontal and gingival inflammations.

LD50 Rat i.p. > 2,500 mg/kg b.w.|LD50 Rat i.v. > 2,500 mg/kg b.w.

Disaccharides; Sugar Alcohols; Sweetening Agents; Cariogenic Agents|By means of programmed feeding experiments on rats, the caries-producing properties of a new sugar substitute Palatinit were compared with those of other carbohydrates. The cariogenicity of Palatinit was significantly lower than that of sucrose and lactose and roughly comparable to that of L-sorbose. Reference strains of Streptococcus mutans are unable to produce extra-cellular polysaccharide or notable amounts of acid from Palatinit. The use of this substance as sugar substitute can be recommended for caries prophylaxis on the basis of these experiments.

Substances that promote DENTAL CARIES. (See all compounds classified as Cariogenic Agents.)

The in vivo metabolism of isomalt in the large intestine was simulated in an in vitro fermentation study to investigate its degradation using chyme from pigs as a basic substrate additionally inoculated with feces. In the first week, the fermentation of isomalt (3.65%) by non-adapted microflora was investigated. In the second week, isomalt fermentation by adapted microflora taken from pigs fed a basic diet supplemented with isomalt was studied. In the third week, both /non-adapted and adapted/ flora were studied in fermentation experiments with a high concentration of isomalt (7.30%). Isomalt was degraded to lactic acid, volatile fatty acids, and gases (CO2, CH4, and hydrogen). ...|Fistulated and normal pigs were fed 10% sucrose between meals, 5 or 10% isomalt between meals, or 10% isomalt with meals. The passage and absorption rate of these substances were determined at the terminal ileum (10 pigs per treatment) or over the whole distance of the digestive tract (4 pigs per treatment). Ten percent sucrose was completely digested and absorbed in the small intestine. In the 3 isomalt treatments, 61-64% of the ingested compound passed the terminal ileum in the form of intact isomalt plus free sorbitol, free mannitol, and free glucose. None of these sugars were excreted in the feces, indicating that isomalt and its constituents passing the terminal ileum are completely broken down in the large intestine.|Renal clearance studies were conducted in adult female rats (250 g b.w.) infused with 1.8 g isomalt, alpha-O-D-glucopyranosyl-1,6-D-sorbitol, or alpha-O-D-glucopyranosyl-1,6-D-mannitol over a period of 3 hours. Maximum plasma concentrations of 25 mM were obtained. These compounds were readily cleared and urinary concentrations of up to 100 mg/mL were recorded, which compares with a maximum urinary concentration of 0.6 mg/mL in rats receiving 5 g isomalt per day orally. After the infusion of either isomalt or alpha-O-D-glucopyranosyl-1,6-D-sorbitol, free sorbitol was not detected in blood or urine, and blood glucose concentrations were unchanged, demonstrating the metabolic inertness of these disaccharide alcohols. From the infusion and excretion rates and the plasma concentrations that were observed, the authors concluded that alpha-O-D-glucopyranosyl-1,6-D-sorbitol is distributed in extracellular water, but does not reach the intracellular compartments.|When isomalt was fed to rats for several weeks it was observed that fecal excretion declined steadily, while the cecum enlarged. The authors concluded that this resulted from adaptation and metabolism by the gut microflora. Similarly, during a 17-day feeding period in which 6 female rats received 3.5 g isomalt daily, the fecal content fell from 25% of the dose at the beginning to 1% at the end.|For more Absorption, Distribution and Excretion (Complete) data for Isomalt (9 total), please visit the HSDB record page.

Rat intestinal maltase was shown to be active against isomalt, alpha-O-D-glucopyranosyl-1,6-D-sorbitol, and alpha-O-D-glucopyranosyl-1,6-D-mannitol, but the rates of hydrolysis were slow. The ratio of the rates of hydrolysis of sucrose, isomaltulose, and isomalt by rat intestinal alpha-glucosidases was 100:30:12. Similarly, sucrose was hydrolysed about 20 times faster than alpha-O-D-glucopyranosyl-1,6-D-sorbitol or alpha-O-D-glucopyranosyl-1,6-D-mannitol by disaccharidases from the small intestine of the pig, and the relative rates of hydrolysis of maltose, sucrose, isomaltulose and isomalt by human intestinal alpha-glucosidases were 100:25:11:2.|The fate of isomalt in the gastrointestinal tract of female rats that had been adapted to the compound was investigated by increasing its dietary concentration from 10% to 34.5% over a period of 3-4 weeks. After administration of 1.7 g isomalt in 5 g feed, the contents of the stomach, small intestine, cecum, and large intestine were examined at intervals up to 6 hr. From the content of alpha-O-D-glucopyranosyl-1,6-D-sorbitol, alpha-O-D-glucopyranosyl-1,6-D-mannitol, sorbitol, mannitol, and sucrose found in these organs, the authors concluded that alpha-O-D-glucopyranosyl-1,6-D-sorbitol and alpha-O-D-glucopyranosyl-1,6-D-mannitol were only partially hydrolyzed by the carbohydrases in the small intestine, while a substantial proportion of these compounds reached the cecum where further hydrolysis of glycosidic bonds occurred. Fermentation of the liberated hexitols occurred in the cecum, which was enlarged, and only small amounts of alpha-O-D-glucopyranosyl-1,6-D-sorbitol, alpha-O-D-glucopyranosyl-1,6-D-mannitol, and hexitols reached the large intestine.

/Investigators/ compared the effect of a variety of sugar alcohols on calcium absorption from the rat small and large intestine in vitro. An Using chamber technique was used to determine the net transport of Ca across the epithelium isolated from the jejunum, ileum, cecum, and colon of rats. The concentration of Ca in the serosal and mucosal Tris buffer solution was 1.25 mM and 10 mM, respectively. The Ca concentration in the serosal medium was determined after incubation for 30 min and the net Ca absorption was evaluated. The addition of 0.1-200 mM erythritol, xylitol, sorbitol, maltitol, palatinit, or lactitol to the mucosal medium affected net Ca absorption in the intestinal preparations. Differences in Ca transport were observed between portions of the intestine, but not between sugar alcohols tested. /The authors/ concluded that sugar alcohols directly affect the epithelial tissue and promote Ca absorption from the small and large intestine in vitro.|Isomalt is a non-cariogenic sweetener, which is widely used in sugar-free candy and chewing gum. Little is known about the effects of Isomalt on de- and remineralization. Binding between calcium and Isomalt has been reported, which could affect the mineral balance. The objective of this study was to examine the effects of Isomalt on de- and remineralization of bovine enamel lesions, both in vitro and in situ. In in vitro study, subsurface enamel lesions were subjected to 3-weeks pH-cycling. Treatments were 5-min rinses with 10% Isomalt solutions daily and 10% Isomalt additions to re- or demineralizing solutions. Standard pH-cycling conditions were used with a 0.2 ppm fluoride background during the remineralization phase. In in situ study, subsurface lesions were exposed 2 months in vivo and brushed three times daily with 10% Isomalt containing toothpaste. Treatment effects were assessed by chemical analysis of the solutions (in vitro) and transversal microradiography (in vitro and in situ). In in vitro study, while 5-min rinses with 10% Isomalt gave slightly increased remineralization, continuous presence of 10% Isomalt (in re- or demineralizing solutions) inhibited both de- and/or remineralization. This lead to significantly smaller overall mineral loss when Isomalt was added during demineralization. In in situ study, remineralization enhancement during short Isomalt treatments was confirmed. Isomalt had a positive effect on the de/remineralization balance when given under conditions relevant to practical use.|... Reports from authoritative bodies and reviews indicates that the decrease in pH in plaque as a consequence of metabolic acid production by saccharolytic bacteria when exposed to fermentable carbohydrates (i.e. sugars and starches) may promote demineralization and prevent remineralization of the hydroxyapatite crystals. Tooth hydroxyapatite crystals are very resistant to dissolution at neutral pH, but their solubility drastically increases as pH drops. Typically, the critical pH for dental enamel is around 5.5. ... Demineralization of tooth tissues can also occur as a result of consumption of dietary acids in foods or beverages, and that frequent consumption can lead to dental erosion. Xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose are slowly metabolized by bacteria in the mouth. The rate and amount of acid production from these food constituents is significantly less than that from sucrose. ... Xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose do not promote dental caries because they do not lower plaque pH to the level associated with enamel demineralization. ... A cause and effect relationship has been established between the consumption of sugar-containing foods/drinks at an exposure frequency of four times daily or more and an increased tooth demineralization, and that the consumption of foods/drinks containing xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, instead of sugar in sugar-containing foods/drinks, may maintain tooth mineralization by decreasing tooth demineralization compared with sugar-containing foods, provided that such foods/drinks do not lead to dental erosion.|The food constituents xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose resulted in reduced post-prandial blood glucose (or insulinemic) responses compared with sugars on a weight by weight basis owing to their reduced/delayed digestion/absorption and/or to a decrease in the amount of available carbohydrates, and that the consumption of foods/drinks in which xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose replaced sugars induced lower post-prandial glycemic and insulinemic responses than sugar-containing foods/drinks. ... A cause and effect relationship has been established between the consumption of foods/drinks containing xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose instead of sugar and reduction in post-prandial blood glucose responses (without disproportionally increasing post-prandial insulinemic responses) as compared to sugar-containing foods/drinks.

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand-valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR as necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Higher alcohols (>3 carbons) and related compounds/|/SRP:/ Basic Treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if necessary. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for shock and treat if necessary ... . Monitor for pulmonary edema and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool. Administer activated charcoal ... . /Higher alcohols (>3 carbons) and related compounds/|/SRP:/ Advanced Treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques, with a bag-valve-mask device, may be beneficial. Consider drug therapy for pulmonary edema ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's (LR) if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Consider vasopressors if patient is hypotensive with a normal fluid volume. Watch for signs of fluid overload ... . Monitor for signs of hypoglycemia (decreased LOC, tachycardia, pallor, dilated pupils, diaphoresis, and/or dextrose strip or glucometer readings below 50 mg) and administer 50% dextrose if necessary ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Higher alcohols (>3 carbons) and related compounds/

/HUMAN EXPOSURE STUDIES/ The polyol isomalt (Palatinit) is a well established sugar replacer. The impact of regular isomalt consumption on metabolism and parameters of gut function in nineteen healthy volunteers was examined in a randomised, double-blind, cross-over trial with two 4-week test periods. Volunteers received 30 g isomalt or 30 g sucrose daily as part of a controlled diet. In addition to clinical standard diagnostics, biomarkers and parameters currently discussed as risk factors for CHD, diabetes or obesity were analysed. Urine and stool Ca and phosphate excretions were measured. In addition, mean transit time, defecation frequency, stool consistency and weight were determined. Consumption of test products was affirmed by the urinary excretion of mannitol. Blood lipids were comparable in both phases, especially in volunteers with hyperlipidaemia, apart from lower apo A-1 (P=0.03) for all subjects. Remnant-like particles, oxidised LDL, NEFA, fructosamine and leptin were comparable and not influenced by isomalt. Ca and phosphate homeostasis was not affected. Stool frequency was moderately increased in the isomalt phase (P=0.006) without changes in stool consistency and stool water. This suggests that isomalt is well tolerated and that consumption of isomalt does not impair metabolic function or induce hypercalciuria. ...|/HUMAN EXPOSURE STUDIES/ Isomalt, placebo, sorbitol, or sucrose (20 g dissolved in 200 mL water in the case of the placebo or 2 tablets of Natreen dissolved in the same amount of water) was administered to 24 type I diabetics at 6 a.m., 10 a.m., 2 p.m., and 6 p.m. Each test substance was administered 6 times at each of these 4 periods. Average and maximum serum insulin levels and average and maximum blood sugar levels were significantly higher after sucrose ingestion than after ingestion of the other test substances. There were no significant differences between sorbitol and isomalt. Side effects reported after isomalt ingestion included vomiting in one patient, but diarrhea was not reported with any of the test substances.|/HUMAN EXPOSURE STUDIES/ During a double-blind test, 12 volunteers ingested sorbitol, and 12 others isomalt, in 10, 20, or 40 g doses administered in 1-2 week intervals. The internal neurological and cardiovascular examinations, as well as hematology and blood chemistry analyses, revealed no modifications in initial data or values which could be related to the intake of either of the 2 sugar substitutes. The intestinal symptoms (meteorism, flatulence, and diarrhea) increased as the administered dose-strength increased. After 10 g of either substance, light abdominal pains were registered; after 20 g, these symptoms became stronger, and flatulence and diarrhea occurred; the 10 patients having indicated no symptoms were equally divided between the 2 test groups. From a clinical viewpoint, intestinal symptoms were significantly higher in those volunteers given 40 g isomalt or sorbitol, which represents the normal consumption level of a sugar substitute, than in the other groups. The differences in response to isomalt and sorbitol were not significant.|/HUMAN EXPOSURE STUDIES/ In a double-blind cross-over study, 200 healthy adult volunteers of both sexes received 50 g chocolate containing either 20 g isomalt or 20 g sucrose at 8 o'clock in the morning after a standard breakfast at intervals of 1 week. After isomalt ingestion, 16 of the volunteers (8%) reacted with diarrhea, whereas none experienced diarrhea after sucrose ingestion. The incidence of diarrhea was 10.8% in female volunteers versus only 4.5% in male volunteers. The subjects had been informed of the possible gastrointestinal symptoms in advance, so it is possible that the expectations of the female volunteers and also their subjective evaluation of the resulting symptoms were different than those of the male volunteers. A higher frequency of defecation and increased flatulence were reported after isomalt ingestion compared with the ingestion of sucrose.|For more Human Toxicity Excerpts (Complete) data for Isomalt (34 total), please visit the HSDB record page.

D-Glucitol, 6-O-alpha-D-glucopyranosyl-, mixt. with 1-O-alpha-D-glucopyranosyl-D-mannitol

Table of percent relative sweetness and caloric values: [Table#7905]|A mixture of diasteromers 6-O-apha-D-glucopyranosul-D-sorbitol and 1-O-alpha-D-glucopyranosyl-D-mannitol|... Sweetening power = 0.45 relative to sucrose in about 10% solution.

Food additives|Food Additives -> ANTICAKING_AGENT; BULKING_AGENT; GLAZING_AGENT; SWEETENER; -> JECFA Functional Classes|Fatty Acyls [FA] -> Fatty acyl glycosides [FA13] -> Fatty acyl glycosides of mono- and disaccharides [FA1301]|Cosmetics -> Humectant

Food Additives -> ANTICAKING_AGENT; BULKING_AGENT; GLAZING_AGENT; SWEETENER;