Tilactase

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Identification

Summary

Tilactase is a beta-D-galactosidase use to treat lactose intolerance.

Generic Name

Tilactase

DrugBank Accession Number

DB13761

Background

Tilactase is a beta-D-galactosidase obtained from Aspergillus oryzae. It is produced as a chewable tablet that has to be taken before the consumption of a lactose-containing meal.¹ The beta-D-galactosidase us a large monomeric multi-domain enzyme of 985 residues that presents a catalytic (alpha/beta)8-barrel domain.³ It is considered by the WHO as part of the International Nonpropietary Names for Pharmaceutical Substances.⁶

Type

Biotech

Groups

Approved, Experimental

Biologic Classification

Protein Based Therapies
Other protein based therapies

Protein Structure

Protein Chemical Formula: Not Available
Protein Average Weight: 102000.0 Da

Sequences

>tr|B7VU80|B7VU80_ASPOZ Beta-galactosidase OS=Aspergillus oryzae OX=5062 GN=lacA PE=2 SV=1<<
MKLLSVAAVALLAAQAAGASIKHRLNGFTILEHPDPAKRDLLQDIVTWDDKSLFINGERI
MLFSGEVHPFRLPVPSLWLDIFHKIRALGFNCVSFYIDWALLEGKPGDYRAEGIFALEPF
FDAAKEAGIYLIARPGSYINAEVSGGGFPGWLQRVNGTLRSSDEPFLKATDNYIANAAAA
VAKAQITNGGPVILYQPENEYSGGCCGVKYPDADYMQYVMDQARKADIVVPFISNDASPS
GHNAPGSGTSAVDIYGHDSYPLGFDCANPSVWPEGKLPDNFRTLHLEQSPSTPYSLLEFQ
AGAFDPWGGPGFEKCYALVNHEFSRVFYRNDLSFGVSTFNLYMTFGGTNWGNLGHPGGYT
SYDYGSPITETRNVTREKYSDIKLLANFVKASPSYLTATPRNLTTGVYTDTSDLAVTPLI
GDSPGSFFVVRHTDYSSQESTSYKLKLPTSAGNLTIPQLEGTLSLNGRDSKIHVVDYNVS
GTNIIYSTAEVFTWKKFDGNKVLVLYGGPKEHHELAIASKSNVTIIEGSDSGIVSTRKGS
SVIIGWDVSSTRRIVQVGDLRVFLLDRNSAYNYWVPELPTEGTSPGFSTSKTTASSIIVK
AGYLLRGAHLDGADLHLTADFNATTPIEVIGAPTGAKNLFVNGEKASHTVDKNGIWSSEV
KYAAPEIKLPGLKDLDWKYLDTLPEIKSSYDDSAWVSADLPKTKNTHRPLDTPTSLYSSD
YGFHTGYLIYRGHFVANGKESEFFIRTQGGSAFGSSVWLNETYLGSWTGADYAMDGNSTY
KLSQLESGKNYVITVVIDNLGLDENWTVGEETMKNPRGILSYKLSGQDASAITWKLTGNL
GGEDYQDKVRGPLNEGGLYAERQGFHQPQPPSESWESGSPLEGLSKPGIGFYTAQFDLDL
PKGWDVPLYFNFGNNTQAARAQLYVNGYQYGKFTGNVGPQTSFPVPEGILNYRGTNYVAL
SLWALESDGAKLGSFELSYTTPVLTGYGNVESPEQPKYEQRKGAY

Download FASTA Format

Synonyms

beta-D-Galactosidase
beta-Galactosidase
Lactase
Tilactasa
Tilactase
Tilactasum

External IDs

S 2107
SL 396

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Pharmacology

Indication

Tilactase is indicated for the symptomatic treatment of lactose intolerance in infants and older patients requiring a parenteral nutrition or fluid diet.⁶

Lactose intolerance occurs when there is an existence of an inability to break down lactose which is commonly found in dairy products. This inability occurs when the lactase levels are reduced and thus there is no via to digest and break down the lactose. The undigested lactose moves into the large intestine where normal flora bacteria can interact with it and cause bloating, gas and diarrhea.⁴

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Associated Conditions

Indication Type	Indication	Combined Product Details	Approval Level	Age Group	Patient Characteristics	Dose Form
Reversal of	Lactose intolerance		••• •••••

Contraindications & Blackbox Warnings

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Pharmacodynamics

The use of a single oral administration of tilactase has been shown to be highly effective in decreasing the symptoms and hydrogen excretion of hypolactasia in tests of lactose H(2)-breath. The analysis has shown a decrease of approximately 80% in both malabsorbers and intolerants.¹The administration of tilacatase also decreases the presence of bloating and flatus.²

Mechanism of action

Lactose is the primary disaccharide found in dairy products. Tilactase is a type of lactase which is the enzyme that is in charge of the breakdown of lactose to glucose and galactose which can be used by the body.⁷ Basically, tilactase acts by replacing the missing lactase in the body and allows avoidance of the reach of lactose to the small intestine and the normal bacteria and thus, preventing the symptoms of the lactose intolerance. Once tilactase has metabolized the lactose, the metabolism products are reabsorbed by the normal process of digestion.⁸

Target	Actions	Organism
ALactose	cleavage	Humans

Absorption

Tilactase is not absorbed in the GI tract and thus the pharmacokinetic parameters related to absorption are not relevant.⁸

Volume of distribution

Tilactase is not absorbed and thus the volume of distribution is not relevant.

Protein binding

Tilactase is not absorbed and thus the plasma protein binding is not possible.

Metabolism

Tilactase is degraded by the stomach acid and by the normal flora bacterial metabolism.⁸

Route of elimination

Tilactase is completely eliminated in the feces either unchanged or as metabolites.⁸

Half-life

Tilactase half-life at 35ºC is registered to be 123.77 min. This half-life can be affected by temperature in an inversely proportional manner.⁵

Clearance

Tilactase is not absorbed and thus the clearance rate is not relevant.

Adverse Effects

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Toxicity

Tilactase is known to present a low acute oral toxicity in preclinical trials. The lowest toxic dose for subcutaneous exposure is of 26 g/kg administered over 30 days.⁷ There have not been performed enough studies regarding the use of pregnancy or related to the fetal development. There are no reports of overdose with tilactase.⁸

Pathways

Not Available

Pharmacogenomic Effects/ADRs

Not Available

Interactions

Drug Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

Not Available

Food Interactions

Take before a meal. Take tilactase before eating food containing lactose.

Products

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International/Other Brands

Dairyaid (Major Pharmaceuticals) / Lacdigest / Oryzatym

Over the Counter Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
Dairy Digestive Aid Tab 3000fcc Lactase Unit	Tablet	3000 unit	Oral	Pharmavite	1995-12-31	2000-08-24
Extra Strength Lactaid Tablets - 4500fcclu	Tablet	4500 unit / tab	Oral	Lactaid Inc.	1996-12-31	2000-05-01
Lactace Cap 3400unit	Capsule	3400 unit / cap	Oral	Nature's Way Products Inc.	1990-12-31	2004-07-26
Lactaid Tab 3000unit	Tablet	3000 unit	Oral	Lactaid Inc.	1985-12-31	2000-05-01
Lactaid Tab 3300unit	Tablet	3300 unit	Oral	Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc	1992-12-31	1998-08-10

Chemical Identifiers

UNII: 37515NWH9U
CAS number: 9031-11-2

References

General References

Portincasa P, Di Ciaula A, Vacca M, Montelli R, Wang DQ, Palasciano G: Beneficial effects of oral tilactase on patients with hypolactasia. Eur J Clin Invest. 2008 Nov;38(11):835-44. doi: 10.1111/j.1365-2362.2008.02035.x. [Article]
DiPalma JA, Collins MS: Enzyme replacement for lactose malabsorption using a beta-D-galactosidase. J Clin Gastroenterol. 1989 Jun;11(3):290-3. [Article]
Maksimainen MM, Lampio A, Mertanen M, Turunen O, Rouvinen J: The crystal structure of acidic beta-galactosidase from Aspergillus oryzae. Int J Biol Macromol. 2013 Sep;60:109-15. doi: 10.1016/j.ijbiomac.2013.05.003. Epub 2013 May 17. [Article]
Vandenplas Y: Lactose intolerance. Asia Pac J Clin Nutr. 2015;24 Suppl 1:S9-13. [Article]
Selvarajan E, Mohanasrinivasan V: Kinetic studies on exploring lactose hydrolysis potential of beta galactosidase extracted from Lactobacillus plantarum HF571129. J Food Sci Technol. 2015 Oct;52(10):6206-17. doi: 10.1007/s13197-015-1729-z. Epub 2015 Jan 16. [Article]
WHO [Link]
Australian Complementary Medicines Evaluation [Link]
Lacdigest monograph [Link]
AIFA: Lacdigest (Tilactase) Oral Tablet [Link]

External Links

PubChem Substance: 347911450
RxNav: 41397

MSDS

Download (269 KB)

Clinical Trials

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Phase	Status	Purpose	Conditions	Count	Start Date	Why Stopped	100+ additional columns
Unlock 175K+ rows when you subscribe.View sample data
Not Available	Completed	Basic Science	Lactose Intolerance	1	somestatus	stop reason	just information to hide
Not Available	Not Yet Recruiting	Treatment	Irritable Bowel Syndrome (IBS) / Lactose Intolerance / Lactose Malabsorption	1	somestatus	stop reason	just information to hide
3	Completed	Treatment	Hypolactasia	1	somestatus	stop reason	just information to hide
3	Completed	Treatment	Lactose Intolerance	1	somestatus	stop reason	just information to hide

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Tablet	Oral	3000 unit
Tablet	Oral	4500 unit / tab
Tablet, chewable	Oral	2250 U
Tablet, chewable	Oral
Tablet, chewable	Oral	2250 iu
Capsule	Oral	3400 unit / cap
Tablet	Oral	3300 unit
Capsule	Oral	3000 unit
Capsule	Oral	3300 unit / cap
Tablet	Oral	500 mg / tab
Solution / drops	Oral

Prices

Not Available

Patents

Not Available

Properties

State

Solid

Experimental Properties

Property	Value	Source
water solubility	Slightly soluble	Official monographs
isoelectric point	4.5	Tanaka Y., et al. J biochem. 1975.

Targets

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Details1. Lactose

Kind

Small molecule

Organism

Humans

Pharmacological action

Yes

Actions

Cleavage

References

Australian Complementary Medicines Evaluation [Link]

Drug created at June 23, 2017 20:48 / Updated at September 15, 2024 21:55

Tilactase

Identification

Pharmacology

Interactions

Products

Categories

Chemical Identifiers

References

Clinical Trials

Clinical Trial & Rare Diseases Add-on Data Package

Pharmacoeconomics

Properties

Targets

References