PRODUCTS

LACTITOL

Lactitol is used as an oral powder or solution in the management of hepatic encephalopathy and in case of short-term treatment of occasional constipation.
Lactitol is used as a laxative, as an excipient, and as replacement bulk sweetener in some low-calorie foods.
Lactitol is used in food manufacturing as a nutritive sweetener and is approximately 35% as sweet as table sugar (i.e. sucrose).

CAS Number: 585-86-4
EC Number: 209-566-5
Molecular Formula: C₁₂H₂₄O₁₁
Molecular Weight: 344.31 g/mol

SYNONYMS:
Lactitol, Lactitol monohydrate, 4-O-β-D-galactopyranosyl-D-glucitol, Lactobiositol, E966, lactitol, 585-86-4, 4-O-beta-D-Galactopyranosyl-D-glucitol, Importal, D-lactitol, lactositol, Lactosit, Miruhen, lactitolum, lactobiosit, LACTITOL ANHYDROUS, Milchen, Lactit, Finlac dc, Lactitol acm 50, Lacty (saccharide), L2B0WJF7ZY, pizensy, INS NO.966, DTXSID9044247, CHEBI:75323, INS-966, NSC-231323, E-966, BLI-400, NSC-759131, Neda Lactiv Importal, NSC231323, (2S,3R,4R,5R)-4-((2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylol-tetrahydropyran-2-yl)oxyhexane-1,2,3,5,6-pentol, (2S,3R,4R,5R)-4-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylol-tetrahydropyran-2-yl]oxyhexane-1,2,3,5,6-pentol, RefChem:57073, GlyTouCan:G26039ES, DTXCID7024247, G26039ES, 209-566-5, (2S,3R,4S,5R,6R)-2-((2R,3S,4S,5R)-4,5-dihydroxy-2,5-bis(hydroxymethyl)oxolan-3-yl)oxy-6-(hydroxymethyl)oxane-3,4,5-triol, Lacitol, MFCD00079407, D-Glucitol, 4-O-beta-D-galactopyranosyl-, DSSTox_CID_24247, DSSTox_RID_80133, DSSTox_GSID_44247, (2S,3R,4R,5R)-4-(((2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)hexane-1,2,3,5,6-pentaol, (2S,3R,4R,5R)-4-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol, Emportal, Oponaf, CAS-585-86-4, Lactitolum [INN-Latin], UNII-L2B0WJF7ZY, Lactitol [INN:BAN:NF], Floralac, Portolac, CCRIS 7077, HSDB 7970, VQHSOMBJVWLPSR-JVCRWLNRSA-N, NCGC00166295-01, Importal (TN), EINECS 209-566-5, Pizensy (TN), NSC 231323, Lactitol (NF/INN), LACTITOL [INN], LACTITOL [MI], (2S,3R,4R,5R)-4-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydropyran-2-yl]oxyhexane-1,2,3,5,6-pentol, Epitope ID:922721, LACTITOL [USP-RS], LACTITOL [WHO-DD], SCHEMBL3849, CHEMBL1661, Lactitol, analytical standard, LACTITOL [ORANGE BOOK], orb1306606, MSK3109, GLXC-23694, HMS3264E13, Pharmakon1600-01301027, HY-N7104, Tox21_112397, EBC-26671, NSC760415, s5368, 4-beta-D-galactopyranosyl-D-glucito1, 4-O-?-D-Galactopyranosyl-D-glucitol, AKOS030228540, Tox21_112397_1, CCG-213712, DB12942, NSC-760415, OL09821, NCGC00263893-02, (2S,3R,4R,5R)-4-{[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}hexane-1,2,3,5,6-pentol, DA-74867, TS-08107, 4-O-b-D-Galactopyranosyl-D-glucitol, 9CI, beta-D-galactopyranosyl-(1->4)-D-glucitol, CS-0069039, A11574, D08266, AB00698230_06, 4-O-.BETA.-D-GALACTOPYRANOSYL-D-GLUCITOL, EN300-19737008, Q415020, BRD-K40787673-001-01-3, BRD-K40787673-001-02-1, 262A7827-24F7-47EE-B528-3AF52CA860CE

Lactitol is a sugar alcohol.
Lactitol has been determined to be GRAS for specified uses as a direct food additive and foods containing lactitol are eligible for a health claim related to dental caries.
Lactitol is a glycosyl alditol consisting of beta-D-galactopyranose and D-glucitol joined by a 14 glycosidic bond.

Lactitol has a role as a laxative, an excipient and a cathartic.
Lactitol, also known as 4-β-D-galactopyranosyl-D-glucitol, is a sugar alcohol synthesized from lactose.
Lactitol is an Osmotic Laxative.

The mechanism of action of lactitol is as an Osmotic Activity.
The physiologic effect of lactitol is by means of Stimulation Small Intestine Fluid/Electrolyte Secretion.
Lactitol, also known as 4-β-D-galactopyranosyl-D-glucitol, is a sugar alcohol synthesized from lactose.

Lactitol is used in food manufacturing as a nutritive sweetener and is approximately 35% as sweet as table sugar.
Lactitol operates primarily through its osmotic properties.
When ingested, it reaches the colon unchanged, where it is metabolized by colonic bacteria.

Unlike some other sugars, lactitol is not absorbed in the small intestine.
Instead, Lactitol draws water into the colon by osmosis, softening stools and promoting peristalsis.
The bacterial fermentation of lactitol also produces short-chain fatty acids and gases, which further stimulate bowel movements.

This dual action makes lactitol effective for treating constipation by both hydrating the stool and accelerating intestinal transit.
In patients with hepatic encephalopathy, lactitol reduces the absorption of ammonia in the gut by acidifying the colonic contents, thereby converting ammonia into ammonium ions, which are less readily absorbed.
This mechanism helps lower blood ammonia levels, alleviating the neuropsychiatric symptoms associated with hepatic encephalopathy.

Lactitol is a sugar alcohol (polyol) derived from lactose through catalytic hydrogenation.
Because Lactitol is poorly absorbed in the small intestine, it reaches the colon where it is fermented by gut microbiota, giving it functional properties beyond simple sweetening.
Lactitol is often preferred over other polyols like sorbitol because of its lower hygroscopicity and better taste profile.

Lactitol also has a cooling effect in the mouth, though less pronounced than xylitol.
Environmentally, lactitol is biodegradable and does not persist in ecosystems.
Lactitol's production typically involves catalytic hydrogenation using nickel-based catalysts.

Lactitol is a disaccharide binding a beta-D-galactopyranose and D-glucitol to produce the sugar alcohol also known as Lactitol.
Lactitol’s derived from lactose, a product of disaccharide’s glucose being reduced.
As all poyols, lactitol is a sugar alcohol or hydrogenated carbohydrate.

Lactitol is also known as sugar replacer, bulk sweetener or sugar-free sweetener.
Because of incomplete absorption, lactitol only contributes with 2.4 kcal (9 kilojoules) per gram, compared to 4 kcal (17 kJ) per gram for typical carbohydrates.
The United States Food and Drug Administration (FDA) classifies lactitol as “generally recognized as safe” (GRAS).
Lactitol monohydrate (D-Lactitol monohydrate) is a sugar analog of lactulose.

USES and APPLICATIONS of LACTITOL:
Lactitol treats chronic constipation.
Lactitol works by increasing the amount of water your intestine absorbs.
This softens the stool, making Lactitol easier to have a bowel movement.

Lactitol also increases pressure, which prompts the muscles in your intestines to move stool.
Lactitol belongs to a group of medications called laxatives.
Lactitol may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Lactitol is extensively used in multiple sectors.
In the food industry, Lactitol serves as a sugar substitute in low-calorie and diabetic-friendly products such as baked goods, chocolates, chewing gum, and confectionery.
Lactitol's stability and low sweetness profile make it particularly useful in formulations where bulk and texture are required without excessive sweetness.

In pharmaceutical applications, lactitol is used as an excipient and as an active ingredient in laxative formulations.
Lactitol is especially effective in treating constipation due to its osmotic effect in the colon.
Medically, lactitol is also used in the management of hepatic encephalopathy, where it helps reduce ammonia levels in the blood by acidifying the colon and promoting ammonia excretion.

Clinically, lactitol has been investigated for use as an osmotic laxative and, along with other non-absorbable disaccharides such as lactulose, in the treatment of hepatic encephalopathy in patients with cirrhosis.
Pizensy, an oral lactitol powder for solution, was approved by the FDA for use in chronic idiopathic constipation in February 2020.
Lactitol is used to treat chronic idiopathic (unknown cause) constipation (CIC).

Lactitol works by increasing peristalsis (contractions) in the colon, leading to an increase in the number of bowel movements.
Lactitol is widely used in the food, pharmaceutical, and medical industries due to its low caloric value and mild sweetness.
Lactitol has been used as a laxative agent, excipient, and low-calorie artificial sweetener.

Other characteristics of Lactitol display antibiotic and prebiotic activity.
Studies have demonstrated Lactitol decreases cholesterol metabolism and can treat liver diseases like hepatic encephalopathy.
This function arises from the management of ammonia in the blood following cirrhotic damage to the liver.

Revertant bacteria and aberrant cells were not seen to increase with the administration of Lactitol as a therapeutic substance, suggesting no mutagenicity.
Lactitol monohydrate acts as a prebiotic, fermented by intestinal flora, promoting the growth of beneficial bacteria (such as Lactobacillus and Bifidobacterium), inhibiting pathogenic bacteria, increasing volatile fatty acid production, and reducing ammonia levels.

Lactitol monohydrate can be used as an alternative sweetener.
Lactitol monohydrate can be also used in research on constipation and hepatic encephalopathy.

BENEFITS of LACTITOL:
Lactitol offers several functional and health-related advantages:
*Lactitol supports digestive health through prebiotic activity
*Lactitol helps regulate bowel movements
*Suitable for diabetic diets due to minimal impact on blood glucose
*Lactitol promotes oral health by reducing risk of dental caries
*Lactitol provides lower caloric intake compared to traditional sugars

PHYSICAL AND CHEMICAL PROPERTIES of LACTITOL:
Lactitol appears as a white, odorless crystalline powder with a mildly sweet taste (approximately 30–40% as sweet as sucrose).
Lactitol is highly soluble in water but practically insoluble in organic solvents such as ethanol.
Lactitol is stable under normal storage conditions and does not readily participate in Maillard reactions, making it suitable for heat-processed foods.

Lactitol has a melting point typically around 146–151°C (for the monohydrate form).
Lactitol exhibits low hygroscopicity compared to other polyols, which improves its stability in solid formulations.
Lactitol's aqueous solutions are generally neutral to slightly acidic.

Chemically, lactitol is a disaccharide alcohol consisting of galactose and sorbitol units.
Lactitol is non-reducing due to the hydrogenation of the carbonyl group of lactose.
This non-reducing nature contributes to Lactitol's chemical stability and reduced reactivity in food systems.

CHARACTERISTICS of LACTITOL:
*Lactitol is characterized by:
*Low glycemic index
*Non-cariogenic properties (does not promote tooth decay)
*Reduced caloric value (~2 kcal/g compared to 4 kcal/g for sucrose)
*Prebiotic effects due to fermentation in the colon
*High chemical stability under heat and varying pH conditions

WHAT IS LACTITOL USED FOR?
Lactitol is a synthetic disaccharide used primarily as a laxative and in medical nutrition therapy.
Lactitol is marketed under various trade names, including Importal, Pizensy, and Lactilol.

Developed in the 1920s, it has since become a staple in the management of constipation and certain hepatic conditions.
Lactitol targets the gastrointestinal tract, working locally without systemic absorption, making it a relatively safe and effective choice for long-term use.
Several research institutions and pharmaceutical companies continue to examine its properties, seeking to expand its indications and improve its efficacy.

Lactitol is classified as an osmotic laxative and has shown promising results in the treatment of hepatic encephalopathy and chronic idiopathic constipation.
Recent studies have aimed at comparing its effectiveness and side effect profile to other commonly used laxatives like lactulose, with some research suggesting that lactitol may offer advantages in terms of palatability and tolerability.

HISTORY of LACTITOL:
The U.S. Food and Drug Administration (FDA) approved Pizensy based on evidence from a clinical trial (Trial 1/ NCT02819297) of 594 subjects with CIC conducted in the United States.
The FDA also considered other supportive evidence including data from Trial 2 (NCT02481947) which compared Pizensy to previously approved drug (lubiprostone) for CIC, and Trial 3 (NCT02819310) in which subjects used Pizensy for one year as well as data from published literature.

The benefit and side effects of Pizensy were evaluated in a clinical trial (Trial 1) of 594 subjects with CIC.
In this trial, subjects received treatment with either Pizensy or placebo once daily for 6 months.

Neither the subjects nor the health care providers knew which treatment was being given until after the trials were completed.
In the second trial (Trial 2) of three months duration, improvement in CSBMs was used to compare Pizensy to the drug lubiprostone which was previously approved for CIC.
The third trial (Trial 3) was used to collect the side effects in subjects treated with Pizensy for one year.

PHYSICAL and CHEMICAL PROPERTIES of LACTITOL:
CAS Number: 585-86-4
EC Number: 209-566-5
Molecular Formula: C₁₂H₂₄O₁₁
Molecular Weight: 344.31 g/mol
Molecular Weight 344.31 g/mol
XLogP3-AA -5.2
Hydrogen Bond Donor Count 9
Hydrogen Bond Acceptor Count 11
Rotatable Bond Count 8

Exact Mass 344.13186158 Da
Monoisotopic Mass 344.13186158 Da
Topological Polar Surface Area 201 Å²
Heavy Atom Count 23
Formal Charge 0
Complexity 343
Isotope Atom Count 0
Defined Atom Stereocenter Count 9
Undefined Atom Stereocenter Count 0
Defined Bond Stereocenter Count 0
Undefined Bond Stereocenter Count 0

Covalently-Bonded Unit Count 1
Compound Is Canonicalized Yes
Empirical Formula (Hill Notation): C12H24O11
CAS Number: 585-86-4
Molecular Weight: 344.31
UNSPSC Code: 41116107
NACRES: NA.24
EC Number: 209-566-5
MDL number: MFCD00079407
Physical state solid

FIRST AID MEASURES of LACTITOL:
-Description of first-aid measures
*General advice:
Show this material safety data sheet to the doctor in attendance.
*If inhaled:
After inhalation:
Fresh air.
*In case of skin contact:
Take off immediately all contaminated clothing.
Rinse skin with
water/ shower.
*In case of eye contact:
After eye contact:
Rinse out with plenty of water.
Call in ophthalmologist.
Remove contact lenses.
*If swallowed:
After swallowing:
Immediately make victim drink water (two glasses at most).
Consult a physician.
-Indication of any immediate medical attention and special treatment needed.
No data available

ACCIDENTAL RELEASE MEASURES of LACTITOL:
-Environmental precautions:
Do not let product enter drains.
-Methods and materials for containment and cleaning up:
Cover drains.
Collect, bind, and pump off spills.
Observe possible material restrictions.
Take up dry.
Dispose of properly.
Clean up affected area.

FIRE FIGHTING MEASURES of LACTITOL:
-Extinguishing media:
*Suitable extinguishing media:
Carbon dioxide (CO2)
Foam
Dry powder
*Unsuitable extinguishing media:
For this substance/mixture no limitations of extinguishing agents are given.
-Further information:
Prevent fire extinguishing water from contaminating surface water or the ground water system.

EXPOSURE CONTROLS/PERSONAL PROTECTION of LACTITOL:
-Control parameters:
--Ingredients with workplace control parameters:
-Exposure controls:
--Personal protective equipment:
*Eye/face protection:
Use equipment for eye protection.
Safety glasses
*Body Protection:
protective clothing
*Respiratory protection:
Recommended Filter type: Filter A
-Control of environmental exposure:
Do not let product enter drains.

HANDLING and STORAGE of LACTITOL:
-Conditions for safe storage, including any incompatibilities:
*Storage conditions:
Tightly closed.
Dry.

STABILITY and REACTIVITY of LACTITOL:
-Chemical stability:
The product is chemically stable under standard ambient conditions (room temperature).
-Possibility of hazardous reactions:
No data available