View source for Lactitol

{{Short description|Chemical compound}}
{{Use dmy dates|date=February 2020}}
{{Infobox drug
| drug_name = 
| INN = 
| type = <!-- empty -->
| image = lactitol.svg
| image_class = skin-invert-image
| caption = 
| JAN = Lactitol Hydrate
<!-- Clinical data -->
| tradename = Importal, Pizensy, Lacty
| Drugs.com = 
| MedlinePlus = 
| licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) -->
| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| DailyMedID = Lactitol
| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment = 
| pregnancy_US = N
| pregnancy_US_comment = 
| pregnancy_category= 
| routes_of_administration = By mouth
| class = 
| ATCvet = 
| ATC_prefix = A06
| ATC_suffix = AD12
<!-- Legal status -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| legal_AU_comment = 
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment = 
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment = 
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE_comment = 
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment = 
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment = 
| legal_US = Rx-only
| legal_US_comment = 
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment = 
| legal_status = <!--For countries not listed above-->
<!-- Pharmacokinetic data -->
| bioavailability = 
| protein_bound = 
| metabolism = 
| metabolites = 
| onset = 
| elimination_half-life = 
| duration_of_action = 
| excretion =
<!-- Identifiers -->
| CAS_number = 585-86-4
| PubChem = 157355
| DrugBank = DB12942
| ChemSpiderID = 138481
| UNII = L2B0WJF7ZY
| KEGG = D08266
| ChEBI = 75323
| ChEMBL = 1661
<!-- Chemical and physical data -->
| IUPAC_name = 4-O-α-<small>D</small>-Galactopyranosyl-<small>D</small>-glucitol
| C = 12 | H = 24 | O = 11
| molecular_weight  = 
| SMILES = C([C@@H]1[C@@H]([C@@H]([C@H]([C@@H](O1)O[C@H]([C@@H](CO)O)[C@@H]([C@H](CO)O)O)O)O)O)O
| StdInChI = 1S/C12H24O11/c13-1-4(16)7(18)11(5(17)2-14)23-12-10(21)9(20)8(19)6(3-15)22-12/h4-21H,1-3H2/t4-,5+,6+,7+,8-,9-,10+,11+,12-/m0/s1
| StdInChI_comment = 
| StdInChIKey = VQHSOMBJVWLPSR-JVCRWLNRSA-N
| melting_point = 146
| solubility = 
| sol_units = 
| specific_rotation = 
}}

'''Lactitol''' is a [[sugar alcohol|disaccharide sugar alcohol]] produced from [[lactose]]. It is used as a replacement bulk [[Sugar substitute|sweetener]] for low [[calorie]] [[foods]] with 30–40% of the sweetness of [[sucrose]]. It is also used medically as a [[laxative]].

==Production==
Lactitol is produced by hydrogenation of [[lactose]] using [[Raney nickel]] catalyst.  The product can be obtained as an anhydrous, monohydrate, or dihydrate. Two manufacturers, [[Danisco]] and Purac Biochem, produce about 10,000 tons/y.<ref name=Ullmann>{{cite book |doi=10.1002/14356007.a25_413.pub3 |chapter=Sugar Alcohols |title=Ullmann's Encyclopedia of Industrial Chemistry |year=2012 | vauthors = Schiweck H, Bär A, Vogel R, Schwarz E, Kunz M, Dusautois C, Clement A, Lefranc C, Lüssem B, Moser M, Peters S|isbn=9783527303854 }}</ref>

==Applications==
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]] [[candy|candies]], [[cookie|cookies (biscuits)]], [[chocolate]], and [[ice cream]], with a sweetness of 30–40% that of sucrose.<ref name="gänzle2011">{{cite book | vauthors = Gränzle MG |date=2011 |title=Encyclopedia of Dairy Sciences |edition=2nd |chapter=Lactose and Oligosaccharides {{!}} Lactose: Derivatives |pages=202–208 |publisher=Elsevier Ltd. |doi=10.1016/B978-0-12-374407-4.00275-2 |isbn=9780123744074 |chapter-url=https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/lactitol}}</ref> Lactitol also promotes [[colon (anatomy)|colon]] health as a [[Prebiotic (nutrition)|prebiotic]]. Because of poor absorption, lactitol only has 2–2.5 [[kilocalorie]]s (8.4–10.5 [[kilojoule]]s) per [[gram]],<ref name="gänzle2011"/> compared to 4 kilocalories (17 kJ) per gram for typical [[Saccharide (disambiguation)|saccharide]]s. Hence, lactitol is about 60% as caloric as typical saccharides.

===Medical===
Lactitol is listed as an [[excipient]] in some prescription drugs.<ref>{{cite web | title=Lactitol (Inactive Ingredient) | website=Drugs.com | date=23 September 2018 | url=https://www.drugs.com/inactive/lactitol-52.html | access-date=24 February 2020}}</ref><ref>{{cite web | title=Lactitol Monohydrate (Inactive Ingredient) | website=Drugs.com | date=3 October 2018 | url=https://www.drugs.com/inactive/lactitol-monohydrate-432.html | access-date=24 February 2020}}</ref>

Lactitol is a laxative and is used to prevent or treat [[constipation]],<ref>{{cite journal | vauthors = Miller LE, Tennilä J, Ouwehand AC | title = Efficacy and tolerance of lactitol supplementation for adult constipation: a systematic review and meta-analysis | journal = Clinical and Experimental Gastroenterology | volume = 7 | pages = 241–248 | date = 2014 | pmid = 25050074 | pmc = 4103919 | doi = 10.2147/CEG.S58952 | doi-access = free }}</ref> e.g., under the trade name Importal.<ref>{{cite web | title=Importal | website=Drugs.com | date=3 February 2020 | url=https://www.drugs.com/international/importal.html | access-date=24 February 2020 | archive-date=25 February 2020 | archive-url=https://web.archive.org/web/20200225033554/https://www.drugs.com/international/importal.html | url-status=dead }}</ref><ref>{{cite web | url = http://www.fass.se/LIF/produktfakta/artikel_produkt.jsp?NplID=19930305000024&DocTypeID=7&UserTypeID=2 | work = FASS.se (the Swedish Medicines Information Engine) | title = Importal® Ex-Lax | date = 12 February 2003 }}</ref>

In February 2020, Lactitol was approved for use in the United States as an osmotic laxative for the treatment of [[Functional constipation|chronic idiopathic constipation]] (CIC) in adults.<ref>{{cite web | title=Pizensy: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211281 | access-date=24 February 2020}}</ref><ref name="Pizensy label">{{cite web | title=Pizensy- lactitol powder, for solution | work = DailyMed | publisher = U.S. National Library of Medicine | date=21 February 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=579ef0af-4aaf-49b2-a5e4-fa6ea1e22cb6 | access-date=24 February 2020}}</ref><ref name="FDA Snapshot">{{cite web | title=Drug Trial Snapshot: Pizensy | website=U.S. [[Food and Drug Administration]] (FDA) | date=12 February 2020 | url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-pizensy | access-date=4 March 2020}} {{PD-notice}}</ref>

Lactitol in combination with [[Ispaghula]] husk is an approved combination for [[idiopathic]] constipation as a laxative and is used to prevent or treat constipation.{{medcn|date=February 2020}}

==Safety and health==
Lactitol, [[erythritol]], [[sorbitol]], [[xylitol]], [[mannitol]], and [[maltitol]] are all classified sugar alcohols (lactitol and maltitol are in fact disaccharide alcohols, since they contain one intact sugar).<ref name=Ullmann/> The U.S. [[Food and Drug Administration]] (FDA) classifies sugar alcohols as "[[generally recognized as safe]]" (GRAS).{{medcn|date=March 2020}} They are approved as food additives, and are recognized as not contributing to [[tooth decay]] or causing increases in [[blood glucose]].{{medcn|date=March 2020}} Lactitol is also approved for use in foods in most countries around the world.{{medcn|date=March 2020}}

Like other sugar alcohols, lactitol causes cramping, flatulence, and diarrhea in some individuals who consume it. These effects arise because humans lack a suitable beta-galactosidase in the upper gastrointestinal (GI) tract, and a majority of ingested lactitol reaches the large intestine,<ref>{{cite journal | vauthors = Grimble GK, Patil DH, Silk DB | title = Assimilation of lactitol, an 'unabsorbed' disaccharide in the normal human colon | journal = Gut | volume = 29 | issue = 12 | pages = 1666–1671 | date = December 1988 | pmid = 3220306 | pmc = 1434111 | doi = 10.1136/gut.29.12.1666 }}</ref> where it then becomes fermentable to gut microbes (prebiotic) and can pull water into the gut by osmosis.{{medcn|date=March 2020}} For these reasons, medical advice is often sought before their use.

==History==
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.<ref name="FDA Snapshot" /> 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.<ref name="FDA Snapshot" />

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

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.<ref name="FDA Snapshot" /> The third trial (Trial 3) was used to collect the side effects in subjects treated with Pizensy for one year.<ref name="FDA Snapshot" />

== References ==
{{reflist}}

== External links ==
* {{Commons category-inline}}
* {{cite web| url = https://druginfo.nlm.nih.gov/drugportal/name/lactitol | archive-url = https://web.archive.org/web/20170120014628/https://druginfo.nlm.nih.gov/drugportal/name/Lactitol | url-status = dead | archive-date = 20 January 2017 | publisher = U.S. National Library of Medicine| work = Drug Information Portal | title = Lactitol }}

{{Alcohols}}
{{E number infobox 950-969}}
{{Laxatives}}

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[[Category:Disaccharides]]
[[Category:E-number additives]]
[[Category:Laxatives]]
[[Category:Sugar alcohols]]
[[Category:Sugar substitutes]]
[[Category:Lactose]]