Xylitol
Xylitol is known as Coating agent, diluent, emollient, humectant, sweetening agent, tablet and capsule diluent, tablet filler. This product is available in Arvin Kala’s diverse product portfolio.
Description

Xylitol appears as a white, granular solid made up of crystalline, uniformly-sized particles with an average diameter of approximately 0.4 to 0.6 mm. It is odorless and has a sweet taste that provides a cooling sensation. Xylitol is also available commercially in powdered form and in various granular forms that are directly compressible.

Applications in Pharmaceutical Formulation or Technology
Xylitol is utilized as a non-cariogenic sweetener in various pharmaceutical dosage forms, such as tablets, syrups, and coatings. It is also extensively used as a sucrose substitute in foods and as a base for medicated confectionery. Xylitol is increasingly being applied in chewing gum, mouth rinses, and toothpastes to reduce dental plaque and tooth decay (dental caries). Unlike sucrose, xylitol does not ferment into cariogenic acid end products and has been shown to reduce dental caries by inhibiting the growth of cariogenic Streptococcus mutans bacteria. With sweetness intensity equal to sucrose and a distinct cooling effect upon dissolution, xylitol is highly effective in enhancing the flavor of tablets and syrups, masking unpleasant or bitter flavors associated with some pharmaceutical actives and excipients. In topical cosmetic and toiletry applications, xylitol is mainly used for its humectant and emollient properties. Additionally, it has been reported to enhance product stability by potentiating preservatives and through its own bacteriostatic and bactericidal properties. Xylitol granulates are used as diluents in tablet formulations, offering chewable tablets a pleasant sweet taste and cooling sensation without the ‘chalky’ texture found in some other tablet diluents. Xylitol solutions are also used in tablet-coating applications at concentrations exceeding 65% w/w. Xylitol coatings are stable, offering a sweet-tasting and durable hard coating. In liquid preparations, xylitol serves as a sweetening agent and vehicle for sugar-free formulations. In syrups, it effectively prevents crystallization around bottle closures, reducing the tendency for ‘cap-lock.’ Xylitol also has lower water activity and higher osmotic pressure compared to sucrose, which enhances product stability and freshness. Additionally, xylitol has demonstrated specific bacteriostatic and bactericidal effects, particularly against common spoilage organisms. Therapeutically, xylitol is also used as an energy source for intravenous infusion therapy following trauma.
Stability and Storage Conditions
Xylitol is heat-stable but slightly hygroscopic. Caramelization occurs only if heated for several minutes near its boiling point. Crystalline xylitol remains stable for at least 3 years when stored at less than 65% relative humidity and 25°C. Milled and specialized granulated grades of xylitol tend to cake and should be used within 9 to 12 months. Aqueous xylitol solutions are reported to be stable even with prolonged heating and storage. Since most microorganisms do not utilize xylitol, products made with it are generally safe from fermentation and microbial spoilage. Xylitol should be stored in a well-sealed container in a cool, dry place.
Method of Manufacture

Xylitol naturally occurs in many fruits and berries, but extracting it from these sources is not commercially viable. Industrially, xylitol is primarily derived from various types of hemicellulose found in sources such as wood, corn cobs, cane pulp, seed hulls, and shells. These materials typically contain 20 to 35% xylan, which is easily converted to xylose (wood sugar) through hydrolysis. This xylose is then converted to xylitol via hydrogenation (reduction). After hydrogenation, several separation and purification steps are performed to produce high-purity xylitol crystals. Due to the nature of this process and the stringent purification procedures, the final product has very low impurity content. Potential impurities that may appear in small quantities include mannitol, sorbitol, galactitol, or arabitol.
Less commonly used methods for manufacturing xylitol include converting glucose (dextrose) to xylose followed by hydrogenation to xylitol, and the microbiological conversion of xylose to xylitol.

Safety

Xylitol is utilized in oral pharmaceutical formulations, confectionery, and food products. It is generally considered to be nontoxic, nonallergenic, and nonirritant.
Xylitol has a very low glycemic response and is metabolized independently of insulin. After ingesting xylitol, blood glucose and serum insulin levels are significantly lower compared to glucose or sucrose ingestion. These characteristics make xylitol an appropriate sweetener for diabetic or carbohydrate-controlled diets.
Up to 100 g of xylitol in divided oral doses can be tolerated daily, although, like other polyols, large doses may have a laxative effect. The laxative threshold depends on several factors, including individual sensitivity, mode of ingestion, daily diet, and previous adaptation to xylitol. Single doses of 20 to 30 g and daily doses of 0.5 to 1.0 g/kg body weight are generally well tolerated by most individuals. About 25 to 50% of ingested xylitol is absorbed, while the remaining 50 to 75% passes to the lower gut, where it undergoes indirect metabolism through fermentative degradation by intestinal flora.
The WHO has set an acceptable daily intake for xylitol as ‘not specified,’ indicating that the levels used in foods do not pose a health hazard.

LD50 (mouse, IP): 22.1 g/kg
LD50 (mouse, IV): 12 g/kg
LD50 (mouse, oral): 12.5 g/kg
LD50 (rat, oral): 17.3 g/kg
LD50 (rat, IV): 10.8 g/kg
LD50 (rabbit, oral): 16.5 g/kg
LD50 (rabbit, IV): 4 g/kg

Handling Precautions
Take normal precautions suitable for the circumstances and the amount of material handled. Ingesting large quantities of xylitol may cause temporary gastrointestinal discomfort and can also irritate the eyes. It is recommended to use eye protection and gloves. Conventional dust-control practices should be followed. Xylitol is flammable but does not ignite easily.

Chemical-physical values

Test Item Unit Specification
LEAD
%
NMT 0.5
NICKEL
%
NMT 1.0
WATER CONTENT
%
NMT 0.5
TOTAL AEROBIC MICROBIAL COUNT
CFU/g
NMT 1000
TOTAL YEAST AND MOULDS COUNT
CFU/g
NMT 100
Test Item Unit Specification
DESCRIPTION
WHITE OR ALMOST WHITE, SLIGHTLY HYGROSCOPIC POWDER OR GRANULES
XYLITOL on DS
%
NLT 98.5 & NMT 101.0
CONDUCTIVITY
%
NMT 20
REDUCING SUGARS
%
NMT 0.2
RELATED SUBSTANCES
%
NMT 2.0
OTHER POLYOLS
%
NMT 2.0

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