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Maltitol Excipient | Uses, Suppliers, and Specifications

Maltitol is a disaccharide consisting of D-glucitol and an alpha-D-glucosyl residue (Chemical name: α-D-glucopyranosyl-1-4-glucitol and chemical formula, C12H24O11). It is obtained by reduction of Maltose (from corn starch) and is approximately 80% as sweet as Sucrose. When used as a pharmaceutical excipient Maltitol is supplied as a white, odourless, sweet, anhydrous crystalline powder.

Pharmacopoeial Compliance: USP-NF; Ph.Eur; J.P; B.P

Synonyms and Trade Names: Maltitol; D-Maltitol; α-D-glucopyranosyl-1-4-glucitol; Hydrogenated Maltose; E965; Maltidex; Maltilite®; SweetPearl®; Maltisweet; Lycasin HBC

Uses and Applications: Coating Agent; Diluent, Granulation Aid And Sweetening Agent

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MALTILITE® Maltitol - Tereos

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SweetPearl® Maltitol - Roquette

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Maltidex® Maltitol - Cargill Inc

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Description

Maltitol is a disaccharide and a member of the polyol family of polyhydric alcohols. It is produced by the hydrogenation of Maltose obtained from Starch. Its chemical name is α-D-glucopyranosyl-1-4-glucitol, alluding to having one Glucose unit linked with one Sorbitol unit via an α(1,4) bond. The crystal structure is orthorhombic. Maltitol is about 80% as sweet as sugar, non-cariogenic, and significantly reduced in calories.

Although a naturally occurring polyol, Maltitol is not widely distributed in nature (it is found in a handful of fruits, vegetables and roasted malt). Instead, it is produced semi-synthetically from Starch. The industrial process can be divided into two parts: The first part involves the hydrolysis of Starch into high content Maltose syrup. The second part involves the catalytic hydrogenation of the Maltose syrup, purification and crystallisation.

Maltitol is one of the largest produced polyols today (approximate annual volume of 160 000 metric tonnes). It provides a clean, pleasant taste, offers excellent humidity control and is not hygroscopic. In addition, it has a high melting point, properties which are used advantageously in food products (such as baked goods) as it stabilises and improves texture and mouthfeel. It is also suitable for reduced-calorie, reduced-fat and sugar-free foods. Maltitol does not promote tooth decay. However, it is more expensive than Sorbitol since it is more difficult to purify.

Pharmaceutical excipient-grade Maltitol is supplied as a white, odourless, sweet, anhydrous crystalline powder.

Chemical Structure & Identifiers


Chemical Name 4-O-α-D-Glucopyranosyl-D-glucitol
CAS Registration Number [585-88-6]
Empirical Formula C20H40O4
Molecular weight 344.32
EC Number 209-567-0
UNII Code D65DG142WK

Regulatory Status

Maltitol is an approved pharmaceutical excipient. It is listed in the pharmacopoeia (B.P, Ph.Eur, USP-NF and J.P) and is also GRAS listed. Maltitol is also listed in the US FDA Inactive Ingredients database (oral pharmaceutical formulations). In the European Union, Maltitol is an approved food additive (E965). A specification for maltitol syrup is contained in the Food Chemicals Codex (FCC).

Physicochemical Properties

Form Powder
Appearance White, anhydrous crystalline powder
Compressibility 9.5%
Bulk density 0.79 g/ml
Density (crystal) 1.6238 g/ml (calculated from crystallographic data)
Flowability 5 seconds
Melting point 148-1510C
Hygroscopicity Low to moderate
Heat of solution -79 kJ/kg
Cooling effect -18.9 kcal/g
Energy value 10.0 kJ/g
Particle size distribution 95% ≤500µm, 40% ≥ 100µm in size for SweetPearl 200 (Roquette)
Solubility Freely soluble in water (60-65 g/100 at 25 oC)

Pharmacopeoeal Specifications

  USP-NF Ph.Eur
Official name Maltitol Maltitol
Authorised use Excipient Excipient
Definition specified specified
Identification A, B A, B, C, D
Characters n/a specified
Appearance of solution n/a specified
Conductivity ≤ 20µScm ≤ 20µScm
Reducing sugars ≤ 0.3% ≤ 0.2%
Related substances n/a specified
Lead n/a ≤ 0.5 ppm
Nickel ≤ 1.0µg/g ≤ 1 ppm
Water ≤ 1.0% ≤ 1.0%
Microbial contamination

Aerobic bacteria

Fungi

 

≤ 1000 cfu/g

≤ 100 cfu/g

 

≤ 1000 cfu/g

≤ 100 cfu/g

Bacterial endotoxins n/a specified
Assay (dried basis) 92.0-100.5% 98.0-102.0%
Labelling n/a specified

Key: n/a Specification is not listed

*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.

Applications in Pharmaceutical Formulations or Technology

In the pharmaceutical industry, Maltitol is a pharmaceutical excipient that is currently used as a diluent, coating agent, granulation aid and sweetening agent. It is mainly used in the formulation of oral dosage forms.

Being a noncariogenic bulk sweetener, Maltitol is suitable for reduced-sugar formulations, including oral liquids, chewable tablets, chewing gums and gummies.

Maltitol is suitable for use in oral dosage forms, whether by wet granulation or direct compression. It can also be used in the fabrication of Sugar-free coatings.

Safety and Precautions

Maltitol is currently used in oral pharmaceutical formulations, chewing gums, baked goods, chocolates, and many other food products. It is a nontoxic, nonallergenic, and nonirritant material, is widely considered noncariogenic, and may be suitable for use in diabetic individuals, subject to medical supervision.

Maltitol’s safety has been reviewed and affirmed by many health authorities, including the World Health Organization, and the European Union. The US Food and Drug Administration also has also declared Maltitol and Maltitol Solution as essentially safe materials for use in food and pharmaceutical products. The WHO, in considering the safety of maltitol, did not set a value for the acceptable daily intake since the levels used in food to achieve the desired effect were not considered a hazard to health.

Maltitol digestion is thought to proceed via two different pathways: absorption in the small intestine and fermentation in the large gut. In the small intestines, Maltitol is hydrolysed to release Sorbitol and Glucose. the Glucose is actively transported and rapidly absorbed. Some of the Sorbitol may be absorbed but any nonabsorbed Sorbitol and nonhydrolyzed Maltitol are fermented by the microflora in the colon. For this reason, the impact of the two metabolic pathways should be put into consideration when assessing the total energy value of the formulation.

Even though safe for human consumption, consumption of Maltitol in excessive amounts can cause GI tract distress, bloating and diarrhoea. However, it is not a legal requirement to include a label warning for products that contain Maltitol since it has been shown to be well-tolerated at commonly consumed doses.

Stability and Storage Conditions

Maltitol exhibit excellent temperature and chemical stability. However, heating at temperatures above 200 °C, may instigate decomposition. Maltitol does not undergo browning reactions with amino acids, and absorbs atmospheric moisture only at high relative humidity (>89%) and > 200 °C).

When handling Maltitol, observe SHEQ protocols appropriate to circumstances and the quantity of material being processed. The use of eye protection and gloves is recommended.

Sustainability and Environmental Impact

A sustainability score for Maltitol has not been undertaken. However, as this substance is sourced from natural, biodegradable and sustainable feed material (Starch), we do not consider its impact on the environment and marine ecology adverse.

Manufacturers & Suppliers

Tereos Starch and Sweeteners

  • Maltilite® Maltitol

Roquette Freres

  • SweetPearl® Maltitol

Cargill Inc

  • Maltidex® Maltitol

Additional Resources (Downloads)

References and Literature Used

FAQS

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