Lactitol

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Lactitol
Chemical structure of lactitol
Names
IUPAC name
4-O-α-D-Galactopyranosyl-D-glucitol
Other names
Lactitol
Lacty
Identifiers
3D model (JSmol)
ChEBI
ChemSpider
ECHA InfoCard 100.008.698 Edit this at Wikidata
E number E966 (glazing agents, ...)
KEGG
UNII
Properties
C12H24O11
Molar mass 344.313 g·mol−1
Melting point 146 °C (295 °F; 419 K)
Pharmacology
A06AD12 (WHO)
Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa).
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Infobox references
Lactitol
Clinical data
Trade namesImportal, Pizensy
Other namesLactitol Hydrate (JAN JP)
License data
Pregnancy
category
  • US: N (Not classified yet)
Routes of
administration
By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
E numberE966 (glazing agents, ...) Edit this at Wikidata
CompTox Dashboard (EPA)
ECHA InfoCard100.008.698 Edit this at Wikidata
Chemical and physical data
FormulaC12H24O11
Molar mass344.313 g·mol−1
3D model (JSmol)

Lactitol is a sugar alcohol used as a replacement bulk sweetener for low calorie foods with approximately 40% of the sweetness of sugar.[not verified in body] It is also used medically as a laxative. Lactitol is produced by two manufacturers, Danisco and Purac Biochem.[not verified in body]

Applications[edit]

Lactitol is used in a variety of low food energy or low fat foods. High stability makes it popular for baking. It is used in sugar-free candies, cookies (biscuits), chocolate, and ice cream. Lactitol also promotes colon health as a prebiotic. Because of poor absorption, lactitol only has 2.4 kilocalories (9 kilojoules) per gram, compared to 4 kilocalories (17 kJ) per gram for typical saccharides. Hence, lactitol is about 60% as caloric as typical saccharides.

Medical[edit]

Lactitol is listed as an excipient in some prescription drugs.[1][2]

Lactitol is a laxative and is used to prevent or treat constipation,[3] e.g., under the trade name Importal.[4][5]

In February 2020, Lactitol was approved for use in the United States as an osmotic laxative for the treatment of chronic idiopathic constipation (CIC) in adults.[6][7][8]

Lactitol in combination with Ispaghula husk is an approved combination for idiopathic constipation as a laxative and is used to prevent or treat constipation.[medical citation needed]

Safety and health[edit]

Lactitol, erythritol, sorbitol, xylitol, mannitol, and maltitol are all sugar alcohols.[medical citation needed] The U.S. Food and Drug Administration (FDA) classifies sugar alcohols as "generally recognized as safe" (GRAS).{[medical citation needed] They are approved as food additives, and are recognized as not contributing to tooth decay or causing increases in blood glucose.{[medical citation needed] Lactitol is also approved for use in foods in most countries around the world.{[medical citation needed]

Like other sugar alcohols, lactitol causes cramping, flatulence, and diarrhea in some individuals who consume it. This is because humans lack a suitable beta-galactosidase in the upper gastrointestinal (GI) tract, and a majority of ingested lactitol reaches the large intestine,[9] where it then becomes fermentable to gut microbes (prebiotic) and can pull water into the gut by osmosis.{[medical citation needed] Those with health conditions should consult their GP or dietician prior to consumption.{[medical citation needed]

History[edit]

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.[8] 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.[8]

The benefit and side effects of Pizensy were evaluated in a clinical trial (Trial 1) of 594 subjects with CIC.[8] In this trial, subjects received treatment with either Pizensy or placebo once daily for 6 months.[8] Neither the subjects nor the health care providers knew which treatment was being given until after the trials were completed.[8]

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.[8] The third trial (Trial 3) was used to collect the side effects in subjects treated with Pizensy for one year.[8]

References[edit]

  1. ^ "Lactitol (Inactive Ingredient)". Drugs.com. 23 September 2018. Retrieved 24 February 2020.
  2. ^ "Lactitol Monohydrate (Inactive Ingredient)". Drugs.com. 3 October 2018. Retrieved 24 February 2020.
  3. ^ Miller LE, Tennilä J, Ouwehand AC (2014). "Efficacy and tolerance of lactitol supplementation for adult constipation: a systematic review and meta-analysis". Clin Exp Gastroenterol. 7: 241–8. doi:10.2147/CEG.S58952. PMC 4103919. PMID 25050074.
  4. ^ "Importal". Drugs.com. 3 February 2020. Retrieved 24 February 2020.
  5. ^ FASS.se (the Swedish Medicines Information Engine). Revised 2003-02-12.
  6. ^ "Pizensy: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 24 February 2020.
  7. ^ "Pizensy- lactitol powder, for solution". DailyMed. 21 February 2020. Retrieved 24 February 2020.
  8. ^ a b c d e f g h "Drug Trial Snapshot: Pizensy". U.S. Food and Drug Administration (FDA). 12 February 2020. Retrieved 4 March 2020. This article incorporates text from this source, which is in the public domain.
  9. ^ Grimble GK, Patil DH, Silk DB (1988). "Assimilation of lactitol, an unabsorbed disaccharide in the normal human colon". Gut. 29 (12): 1666–1671. doi:10.1136/gut.29.12.1666. PMC 1434111. PMID 3220306.

External links[edit]

  • Media related to Lactitol at Wikimedia Commons
  • "Lactitol". Drug Information Portal. U.S. National Library of Medicine.