Xylitol pastilles

Xylitol pastilles with berry powder or natural flavour
Xylitol pastilles
Xylitol is a main raw material
Properties of xylitol
Xylitol Allergy: A Rare Occurrence
Compression of Xylitol into Pastilles
Xylitol usage
Manufacture of xylitol pastilles using an eccentric tablet machine
Manufacture of xylitol pastilles using a rotary tablet machine
Xylitol is not suitable for the dogs
Excipients in xylitol pastilles
Magnesium stearate
Carboxymethylcellulose
Polydextrose

Xylitol pastilles with berry powder or natural flavour

Xylitol pastilles for everyone, from babies to the elderly. We manufacture our xylitol pastilles in our production facility in Kitee, Finland. The xylitol pastilles are made in a variety of different flavours.
The taste comes from tooth-friendly xylitol, Finnish berry-powders and other natural flavours, for example chili powder. The xylitol pastilles also contain calcium phosphate, which is good for dental health and tooth enamel. The recommended dose of xylitol for teeth is 5 g per day which you get from 6 pastilles.

Xylitol pastilles

Each xylitol pastille contains 800 mg of xylitol, a binder, and a lubricant. There is also added calcium phosphate to improve the remineralization of tooth enamel. Colourants are not used, all colours are from Finnish wild berry powders. There are approximately 110 or 120 pastilles in a 100 g package.

Xylitol is naturally occurring in small amounts in fruits and berries. It can be produced from beech, birch, rice hulls, corn husk, or all the plants which contain hemicellulose. Xylitol is used as a sugar substitute in products like toothpaste, mouthwashes, pastilles, chewing gum, and as a household sweetener. It can also be used in baking.

The dental health benefits of xylitol are well established. The European Food Safety Agency has approved a health claim “xylitol chewing gum reduces the risk of caries in children”. Xylitol protects teeth from cavities and is a healthier alternative to normal sugar. Xylitol usage after every meal or snack prevents tooth decay. It also increases salivation and helps in dry mouth.

Xylitol has negligible effects on blood sugar because it is metabolized independently of insulin and has a low glycemic index. It is absorbed more slowly than sugar and xylitol supplies about 35 % fewer calories than basic table sugar. Because of that, it is the better option for diabetes or people having weight problems.

New studies of children in Finland appeared that xylitol has a moderate effect in preventing ear aches in healthy children. Daily use of xylitol can prevent 40% of ear infections.

Recommended daily dose of xylitol is 5 g, which means 6 pastilles per day.

Xylitol may have a laxative effect. Avoid that by taking pastilles several times a day, a small dose at a time.

• Not for animals
• Non-GMO
• Vegan, lactose-free, kosher
• Made in Kitee, Finland

Xylitol is a main raw material

Xylitol (birch sugar) molecular weight is 152,15 g/mol and the empirical formula is C5H12O5 (Fig 1). The melting point of xylitol is 92 – 96 degrees Celsius. In 50 %-wt. the aqueous solution its acidity varies from 5,0 to 7,0. The acidity of the xylitol solution depends on the manufacturing method. Usually, wood-based xylitol is more basic than xylitol made from other raw materials.

Xylitol is a natural sweetener. Xylitol is prepared from hemicellulose of plants, like deciduous trees, corn straw, rice straw, reeds, or seed husk. These contain about 25% - 35% of xylene which can be converted in hydrolysis to xylose. Xylose acts as a starting material for the preparation of xylitol. In the process, xylose is hydrogenated to xylitol, and xylitol crystals are obtained at the end of the process (Bond, 2009).
Other sugar alcohols in the pure xylitol may be less than 2.0% and a pure xylitol content is over 98% in the raw material (JP XV; USP32-NF27).
General impurities among xylitol are mannitol, sorbitol, and galactitol. The E-code for xylitol as an additive in food is E967.
In xylitol pastilles, the main raw material is the xylitol, and its %-weight mass is reported in the preparation (e.g., xylitol sweetener 94% indicates that 94 g of xylitol has been used per 100 g of product).

Properties of xylitol

Pure xylitol is extremely stable for at least 3 years if it is kept under 65% humidity and 25 degrees Celsius. Direct compression xylitol can form clumps during storage and therefore it should be processed into finished products within 9-12 months. Caking happens due to the hygroscopicity of xylitol.
Xylitol solutions have been reported to be very stable. Xylitol is microbiologically well preserved because it doesn't ferment and microbiological spoilage does not occur easily or at all (Mäkinen 1981).
In pharmaceuticals and food preparations, xylitol is classified as a non-toxic, non-allergic, and non-irritant substance. WHO has not set a daily intake recommendation for xylitol because it is considered a safe substance for humans. Most people can take up to 20-30 grams of xylitol as a single dose or 0.5 to 1.0 grams per kilogram of body weight during the day without any problems (Bond, 2009). In the intestinal system, 50% - 75% of the xylitol dose is absorbed. Intestinal flora metabolizes xylitol and can cause some users to have stomach problems such as diarrhoea or flatulence.

Xylitol Allergy: A Rare Occurrence

Introduction

There are many questions about allergies to sugar alcohols, such as xylitol and other sugar alcohols. This is understandable, as food allergies are very common in Western countries. Loh and Tang (2018) estimated that up to 10% of people suffer from food allergies, and they are more common in children. Fortunately, childhood food allergies often improve and may disappear as the child grows.

It is possible to be allergic to sugar alcohols as well, but fortunately, it is extremely rare.

History of Xylitol and Erythritol

The commercial use of xylitol began in the 1960s and that of another sugar alcohol, erythritol, in the 1990s. Therefore, there are many publications on both sugar alcohols, including on allergies.

Xylitol Allergy and Safety

Xylitol allergy is much less common than allergies to other sugar substitutes. A Japanese study (Ebisawa et al., 2013) found only 10 suspected and reported cases of xylitol allergy during its history of use, which emphasises the general safety of xylitol. Okamoto et al. (2019) consider it very challenging to demonstrate allergies to sugar alcohols because there may not be as good testing methods for them as for other allergenic substances.

Erythritol Allergy

Erythritol has been linked to significantly more allergic reactions than xylitol, but its detected allergies are also extremely rare. Erythritol allergy has been estimated to be less than 1 case per million users (Yunginger et al., 2001). This is significantly less than the commonly estimated food allergies in humans. The allergic reactions to erythritol described in the literature are generally increasing, but their number is still very small (Okamoto et al. 2019; Valls and Malo-Cerisuelo 2021).

Comparison to Other Food Allergies

The prevalence of xylitol and erythritol allergies is significantly lower than that of all food allergies in general, which can affect up to 10% of people in Western countries (Loh and Tang, 2018). Therefore, sugar substitutes are an excellent way to reduce sugar intake, and their allergies are extremely rare. Overall, the risk of developing an allergy to xylitol is extremely low. These sugar alcohols are safe for most people and can be a healthy way to reduce sugar intake.

Compression of Xylitol into Pastilles

Compressing fine xylitol into xylitol pastilles – or tablets – is challenging and the crushing strength of fine xylitol is usually very weak. That's why xylitol has many direct compression qualities where the xylitol is granulated with a binder, like polydextrose or cellulose derivatives. This direct compression xylitol has better compressibility and processability than 100% xylitol. The neat xylitol tablet with a diameter of 12,5mm has a crushing strength of 40 N when compressed with 20KN force. Direct compression xylitol has a crushing strength of 160N or more with a smaller compression force (Bond, 2009).

Xylitol usage

Xylitol is mainly used as a tooth-friendly sweetener in the food-, hygiene-, and pharmaceutical industry. Xylitol's sweetness is the same as normal sugar. Typical xylitol usage in the food industry is xylitol pastilles and chewing gums, sweetener, and sugar substitute in baking. Typical pharmaceutical usages are tablets, coatings, and solutions where xylitol works as an excipient. In hygiene products xylitol is used in mouthwash and toothpaste which prevent caries. In the cosmetic industry, xylitol is used in many kinds of lotions and creams where xylitol may be used to bind moisture and soften the skin's top layers.
Xylitol does not ferment into acids, so it is tooth-friendly. In addition, xylitol has been found to inhibit the growth of the Streptococcus Mutans bacteria which contributes to tooth decay (Hayes, Mäkinen 1996).

Manufacture of xylitol pastilles using an eccentric tablet machine

An eccentric tablet machine produces xylitol pastilles at the speed of about 10 kg per hour and is predominantly used in product development testing for the compressibility of raw materials and blends. In xylitol compression experiments the machine is excellent because the machine requires only 10 grams of the sample and only about 50-100 grams in the industrial test. New rotary tablet machines require 1 to 3 kg of mass to easily find compression adjustments.
Compression with the eccentric machine is done only with the upper punch, which compresses the xylitol in the die. The lower punch is only involved by removing the compressed xylitol pastille from the die (See the video clip below).

Manufacture of xylitol pastilles using a rotary tablet machine

On a rotary tablet machine, xylitol mass ends up in a die on a rotating table. The table rotates about 30 - 60 times per minute around its axis and the punches can be between 8 and 32 in the machine. The upper and lower punches are used to compress the pastille and a lower punch ejects the pastille out from the die.
Rotary tablet machines have displaced eccentric tablet machines e.g. in the pharmaceutical industry due to their higher hourly output. A small rotary tablet machine can compress easily 30 kg of pastilles per hour without compromising the quality of the pastilles (See the video clip below).

Xylitol is not suitable for dogs

Xylitol is not suitable for dogs or other pets. Xylitol causes animals, especially dogs, to have lower blood sugar levels (hypoglycemia), and high doses of xylitol can damage the liver. The mechanism by which liver toxicity in the dog is produced is still unclear (Xylitol-Veterinary-Toxicology, Gwaltney-Brant, SM). Hypoglycemia is caused by a strong release of insulin into the bloodstream of the dog, which lowers the sugar level in the bloodstream.
If your dog has eaten xylitol, contact your vet immediately!
The symptoms of dog hypoglycemia usually start within 30 minutes of ingesting xylitol and can continue for up to 12 to 18 hours, because xylitol is slowly absorbed from the dog's intestine, especially with chewing gum products. Typical symptoms of hypoglycemia in dogs are vomiting, weakness, sluggishness, disturbances in the coordination of intentional movements, despair, tremor, and loss of blood. Liver problems usually start within 24 to 48 hours of eating xylitol, but liver enzyme elevation can be detected earlier with a blood sample.
Each of our xylitol pastilles contains 800 mg of xylitol. Estimate how many xylitol pastilles your pet has eaten and report this to your veterinarian. With this information, the veterinarian knows how to treat your pet. Hypoglycemia in dogs may occur at a low dose of 50 to 100 mg xylitol per kg bodyweight of dog.

Excipients in xylitol pastilles

Magnesium stearate

Magnesium stearate (e470) ([CH3(CH2)16COO]2Mg, Mw 591,24 g/mol) is one of the most widely used tablet machine glidants in the world. Magnesium stearate is a salt consisting of magnesium cation and two stearate fatty acids. Some of the stearates may also be palmitate (Allen and Luner, 2009). The concentration of magnesium in the magnesium stearate powder must be between 4% and 5% in the final products.
The magnesium stearate has a melting point of 117-150 degrees Celsius. Magnesium stearate has been found in three different crystalline forms, i.e. anhydrate, hydrate, and trihydrate. Commercially approved products may contain less than 6% moisture. The true density of Magnesium Stearate is approx. 1.09 g / cm3 and the pour density is about 0.16 g / cm3. The powder flow is very poor and the material is very cohesive. The material feels greasy on the fingertips and easily adheres to the skin. Magnesium stearate is practically insoluble in water and ethanol.
Magnesium stearate can be prepared by using magnesium hydroxide or magnesium oxide as the starting material which reacts with the stearate fatty acid or salt, depending on which production method has been used.
The fatty acid may be animal or plant-based (Allen and Luner, 2009). In practice, all magnesium stearate lubricants today are derived from palm, rapeseed or cotton oil. Narskuttelu Oy currently uses magnesium stearate made from palm oil or rapeseed.
Magnesium stearate is widely used in the food, cosmetics and pharmaceutical industries at concentrations ranging from 0.25% to 5% of the composition.
In the production of xylitol pastilles, magnesium stearate prevents either the adhesion of the pressed mass to the metal surfaces or the friction between the punch and the mould.

Carboxymethylcellulose

Carboxymethylcellulose acts as a binder in xylitol. Due to the poor compressibility of xylitol, the direct compression xylitol powder is granulated with carboxymethyl cellulose. Carboxymethylcellulose improves the powder flow of xylitol in a tablet machine and increases the formation of bonds in the compression step, whereby xylitol is compressed into a pastille with a reduced compression force. As a binder in tablet and pastille formulations, carboxymethylcellulose is used in a range of about 1 to 2% of the composition, depending on the molecular size of the carboxymethylcellulose used.

Polydextrose

Polydextrose is used as a binder in xylitol granules instead of carboxymethylcellulose. Polydextrose has no melting point because it is an amorphous (non-crystalline) excipient. The glass transition point of polydextrose is about 150 to 160 degrees Celsius which means transformation from a glassy to a liquid state. As a binder in tablet and pastille preparations, polydextrose is used between 1 and 2% of the composition.

Author: Dr.Pharm. Pekka Hoppu, Narskuttelu Oy